Union of India - Act
The Drugs and Cosmetics Rules, 1945
UNION OF INDIA
India
India
The Drugs and Cosmetics Rules, 1945
Rule THE-DRUGS-AND-COSMETICS-RULES-1945 of 1945
- Published on 21 December 1945
- Commenced on 21 December 1945
- [This is the version of this document from 21 December 1945.]
- [Note: The original publication document is not available and this content could not be verified.]
8.
/452In exercise of the powers conferred by [sections 6(2), 12, 33 and 33-N] [Substituted by G.S.R. 370(E), dated 7.4.1994 (w.e.f. 7.4.1994).] of the Drugs [and Cosmetics] [Inserted by G.S.R. 1183, dated 17.8.1964.] Act, 1940 (23 of 1940), the Central Government is pleased to make the following Rules:-Part I – Preliminary
1. Short title, extent and commencement. - (1) These rules may be called The Drugs and Cosmetics Rules, 1945.
2. Definitions.
- In these rules, unless there is anything repugnant in the subject or context-Part II – The Central Drugs Laboratory
3. Functions.
- It shall be the function of the Laboratory-3A. [ [Substituted by S.O. 1124, dated 15.5.1961 (w.e.f. 20.5.1961).]
4. Despatch of samples for test or analysis.
5. Recording of condition of seals.
- On receipt of the packet, it shall be opened by an officer authorized in writing in that behalf by the Director, who shall record the condition of the seal on the packet.6. Report of result of test or analysis.
- After test or analysis the result of the test or analysis, together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2.7. Fees.
- The fees for test and analysis shall be those specified in Schedule B.8. Signature of certificates.
-Certificates issued under these Rules by the Laboratory shall be signed by the Director or by an officer authorized by the Central Government by notification in the Official Gazette to sign such certificates.Part III – 9 to 20.
-[ Omitted by S.R.O . 2136, dated 15th June , 1957.]Part IV – [IMPORT AND REGISTRATION] [Substituted by G.S.R. 604(E), dated 24.8.2001, for the heading " IMPORT" (w.e.f. 1.1.2003).]
21.
In this Part-22.
The licensing authority may with the approval of the Central Government by an order in writing delegate the [power to sign licenses and Registration Certificates and] [Substituted by G.S.R. 604(E), dated 24.8.2001, for " power to sign licenses and" (w.e.f. 1.1.2003).] such other powers as may be specified in the order to any other person under his control.23. [ Import licenses. [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]
- An import license in Form 10 shall be required for [Added by S.O. 2889, dated 2.7.1969 (w.e.f. 19.7.1969).] [import of drugs] [Substituted by G.S.R. 604(E), dated 24.8.2001, for " import of any biological or other special product specified in Schedule C or C(1)" (w.e.f. 1.1.2003).] [, excluding those specified in Schedule X, and an import license in Form 10-A shall be required for the import of drugs specified in Schedule X.] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]24. [ Form and manner of application for import license. [Substituted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).]
25. Licenses for import of drugs manufactured by one manufacturer.
26. Conditions of import license.
- An import license shall be subject to the following conditions:-1. Name of the drug,
2. Batch number,
3. Name and address of the manufacturer,
4. Date of transaction,
5. Opening stock on the business day,
6. Quantity of drug received, if any, and the source from which received,
7. Name of the purchaser, his address and license number,
8. Balance quantity of drug at the end of the business day,
9. Signature of the person under whose supervision the drugs have been supplied;]
27. Grant of import license.
- On receipt of an application for an import license in the form and manner prescribed in rule 24, the licensing authority shall, on being satisfied that, if granted, the conditions of the license will be observed, issue an import license in Form 10 [or Form 10-A, as the case may be] [Inserted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).].[27-A. Grant of Registration Certificate. [Inserted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).]28. [ Duration of import license. [Substituted by S.O. 1136, dated 10.4.1964 (w.e.f. 11.4.1964).]
- A license, unless, it is sooner suspended or canceled, shall be [valid for a period of three years from the date of its issue] [Substituted by G.S.R. 604(E), dated 24.8.2001, for " valid upto the 31st December of the year following the year in which it is granted" (w.e.f. 1.1.2003).]:[Provided that if application for a fresh license is made three months before the expiry of the existing license the current license shall be deemed to continue in force until orders are passed on the application.] [Substituted by S.O. 1136, dated 10.4.1964 (w.e.f. 11.4.1964).][28-A. Duration of Registration Certificate. [Inserted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).]- A Registration Certificate, unless, it is sooner suspended or canceled, shall be valid for a period of three years from the date of its issue:Provided that if the application for a fresh Registration Certificate is made nine months before the expiry of the existing certificate, the current Registration Certificate shall be deemed to continue in force until orders are passed on the application.]29. Suspension and cancellation of import license.
- If the manufacturer or licensee fails to comply with any of the conditions of an import license, the licensing authority may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel it for such period as it thinks fit either wholly or in respect of some of the substances to which it relates:[Provided that a person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter, as it considers necessary and after giving the said appellant an opportunity for representing his views, pass such orders in relation thereto as it thinks fit.] [Substituted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).][29-A. Suspension and cancellation of Registration Certificate. [Inserted by G.S.R. 604(E), dated 24.8.2001 w.e.f. 1.1.2003).]- If the manufacturer fails to comply with any of the conditions of the Registration Certificate, the licensing authority may after giving him an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the Registration Certificate for such period as it thinks fit either wholly or in respect of some of the substances to which it relates:Provided that a person, who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter, as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, pass such orders in relation thereto as it thinks fit.]30. Prohibition of import after expiry of potency.
- No biological or other special product specified in Schedule C or C(1) shall be imported after the date shown on the label, wrapper or container of the drug as the date up to which the drug may be expected to retain a potency not less than, or not to acquire a toxicity greater than, that required or, as the case may be, permitted by the prescribed test.30A. [ [Rule 30A omitted by G.S.R. 944(E), dated 21.9.1988 (w.e.f. 21.9.1988).]
* * *]30AA. [ Import of new Homeopathic medicines. [Inserted by G.S.R. 1185, dated 18.8.1964 (w.e.f. 22.8.1964).]
31. [ Standard for certain imported drugs. [Substituted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).]
- No drug shall be imported unless it complies with the standard of strength, quality and purity, if any, and the test prescribed in the rules shall be applicable for determining whether any such imported drug complies with the said standards:Provided that the drugs intended for veterinary use, the standards of strength, quality and purity, if any, shall be those that are specified in Schedule F(1) and the test prescribed in that Schedule shall be applicable for determining whether any such imported drug complies with the said standards and where no standards are specified in Schedule F(I) for any veterinary drug, the standards for such drug shall be those specified in the current edition, for the time being in force, of the British Pharmacopoeia Veterinary:Provided further that the licensing authority shall not allow the import of any drug having less than sixty per cent. residual shelf-life period as on the date of import:Provided also that in exceptional cases the licensing authority may, for reasons to be recorded in writing, may allow the import of any drug having lesser shelf-life period, but before the date of expiry as declared on the container of the drug.]32. [ Packing and labeling of imported drugs. [Substituted by S.O. 2889, dated 2.7.1969 (w.e.f. 19.7.1969).]
- No drug shall be imported unless it is packed and labeled in conformity with the rules in Parts IX and X [* * *] [and further conforms to the standards laid down in Part XII provided that in the case of drugs intended for veterinary use, the packing and labeling shall conform to the rules in Parts IX and X and Schedule F(I).] [Substituted by S.O. 2889, dated 2.7.1969 (w.e.f. 19.7.1969).][32-A. Packing and labeling of Homeopathic medicine. [Added by S.O. 2139, dated 5.6.1972 (w.e.f. 12.8.1972).]- No Homeopathic medicine shall be imported unless it is packed and labeled in conformity with the rules in Part IX-A.]33. Import of drugs for examination, test or analysis.
- Small quantities of drugs the import of which is otherwise prohibited under section 10 of the Act may be imported for the purpose of examination, test or analysis subject to the following conditions:-34. Application for license for examination, test or analysis.
35. Cancellation of license for examination, test or analysis.
36. Import of drugs for personal use.
- Small quantities of drugs, the imports of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions:-36A. [ Import of drugs by charitable hospital free of cost. [Inserted by Notification No. G.S.R. 103(E), dated 2.2.2017 (w.e.f. 21.12.1945).]
37. [ Packing of patent or proprietary medicines. [Substituted by S.R.O. 3262, dated 15.10.1954.]
- Patent or proprietary medicine shall be imported in containers intended for retail sale:][Provided that such medicine may be imported in bulk containers by any person who holds a license to manufacture, if such person has obtained permission in writing to import such medicines from the licensing authority at least three months prior to the date of import and the imports are made within a period of twelve months from the date of issue of such permission.] [Inserted by S.O. 115, dated 4.1.1961 (w.e.f. 14.1.1961).]38. Statement to accompany imported drugs.
- All consignments of drugs sought to be imported shall be accompanied by an invoice or other statement showing the name and address of the manufacturer and the names and quantities of the drugs.39. Documents to be supplied to the Customs Collector.
- Before drugs for the import of which a license is not required are imported a declaration signed by or on behalf of the manufacturer or by or on behalf of the importer that the drugs comply with the provisions of Chapter III of the Drugs and Cosmetics Act, 1940 and the rules thereunder shall be supplied to the Customs Collector.40. [ Procedure for the import of drugs. [Substituted by S.R.O. 2106, dated 3.11.1953.]
41. [ [Substituted by S.O. 218, dated 15.1.1954.]
42. [ [Rule 42 omitted by S.R.O. 2106, dated 3.11.1953.]
* * *]43.
The drugs specified in Schedule D shall be exempt from the provisions of Chapter III of the Act and of the rules made thereunder to the extent, and subject to the conditions specified in that Schedule.43A. [ [Substituted by G.S.R. 478(E), dated 6.8.1981 (w.e.f. 6.8.1981).]
No drug shall be imported into India except through one of the following places, namely:-Firozepur Cantonment and Amritsar Railway Stations:In respect of drugs imported by rail across the frontier with Pakistan.Ranaghat, Bongaon and Mohiassan Railway Stations:In respect of drugs imported by rail across the frontier with Bangldesh.[Petrapole Road in West Bengal, Sutarkandi in Assam, Old Raghna Bazar and Agartala in Tripura:In respect of drugs imported by road from Bangladesh.][Inserted by G.S.R. 116(E), dated 24.2.2009 (w.e.f. 24.2.2009).][Raxaul: in respect of drugs imported by road and railway lines connecting Raxaul in India and Birganj in Napal.] [Inserted by G.S.R. 120(E), dated 5.3.1998 (w.e.f. 5.3.1998) as corrected by G.S.R. 242(E), dated 5.4.1999.][Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva, Kandla, Inland Container Depots at Tuglakabad and Patparganj in Delhi, Tuticorin in Tamil Nadu, Marmugao port in Goa, Visakhapatnam and Krishnapatnam port in Andhra Pradesh and Hazira port and Inland Container Depot Khohdiyar, Gandhinagar in Gujarat: in respect of drugs imported by sea into India;] [Substituted 'Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva, Kandla, Inland Container Depots at Tuglakabad and Patparganj in Delhi, Tuticorin in Tamil Nadu, Marmugao port in Goa and Visakhapatnam in Andhra Pradesh: in respect of drugs imported by sea into India.' by Notification No. G.S.R. 41(E), dated 17.1.2017 (w.e.f. 21.12.1945).]Chennai, Kolkata, Mumbai, Delhi, Ahmedabad, Hyderabad, Goa, Bengaluru and Visakhapatnam:in respect of drugs imported by air into India.]43B. [ [Added by S.O. 1056, dated 19.3.1964 (w.e.f. 28.3.1964).]
Drugs, consignments of which are in transit through India to foreign countries and which shall not be sold or distributed in India shall be exempted from the requirements of Chapter III of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made thereunder:Provided that if the Government of the countries to which the drugs are consigned regulate their import by the grant of import licenses, the importer shall at the time of import into India, produce such import licenses.]Part V – [Government Analysts, Inspectors, Licensing Authorities and Controlling Authorities] [Substituted by G.S.R. 443(E), dated 12.4.1989 (w.e.f. 12.4.1989).]
44. [ Qualifications of Government Analyst. [Substituted by G.S.R. 1427, dated 10.10.1977 (w.e.f. 22.10.1977).]
- A person appointed as a Government Analyst under the Act shall be a person who-45. Duties of Government Analysts.
46. Procedure on receipt of sample.
- On receipt of a package from an Inspector containing a sample for test or analysis, the Government Analyst shall compare the seals on the packet [or on portion of sample or container] [Inserted by G.S.R. 59(E), dated 7.2.1995 (w.e.f. 7.2.1995).] with the specimen impression received separately and shall note the condition of the seals on the [packet or on portion of sample or container] [Substituted by G.S.R. 59(E), dated 7.2.1995 (w.e.f. 7.2.1995).]. After the test or analysis has been completed, he shall forthwith supply to the Inspector a report in triplicate in Form 13 of the result of the test or analysis, together with full protocols of the tests or analysis applied.[ Explanation. - It shall be deemed to be full and sufficient compliance with the requirement of the rule in respect of the supply of "protocols of the tests or analysis applied", if-47. Report of result of test or analysis.
- An application from a purchaser for test or analysis of a drug under section 26 of the Act shall be made in Form 14-A and the report of test or analysis of the drug made on such application shall be supplied to the applicant in Form 14-B.48. Fees.
- The fees to be paid by a person submitting to the Government Analyst under section 26 of the Act for test or analysis of a drug [or cosmetic] [Inserted by G.S.R. 1140, dated 26.8.1978 (w.e.f. 16.9.1978).] purchased by him shall be those specified in Schedule B.49. [ Qualifications of Inspectors. [Substituted by G.S.R. 658(E), dated 19.10.1993 (w.e.f. 19.10.1993).]
- A person who is appointed as Inspector under the Act shall be a person who has a degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialization in Clinical Pharmacology or Microbiology from a University established in India by law:Provided that only those Inspectors-50. [ Controlling Authority. [Substituted by S.O, 2139, dated 5.6.1972 (w.e.f. 12.8.1972).]
51. Duties of Inspectors of premises licensed for sale.
- Subject to the instructions of the controlling authority, it shall be the duty of an Inspector authorized to inspect premises licensed for the sale of drugs-52. Duties of Inspectors specially authorized to inspect the manufacture of [drugs or cosmetics] [Substituted by G.S.R. 504(E), dated 18.7.2002 (w.e.f. 18.7.2002).].
- Subject to the instructions of the controlling authority it shall be the duty of an Inspector authorized to inspect the manufacture of [drugs or cosmetics] [Substituted by G.S.R. 504(E), dated 18.7.2002 (w.e.f. 18.7.2002).]-53. Prohibition of disclosure of information.
- Except for the purposes of official business or when required by a Court of law, an Inspector shall not, without the sanction in writing of his official superior, disclose to any person any information acquired by him in the course of his official duties.54. Form of order not to dispose of stock.
- An order in writing by an Inspector under clause (c) of section 22 of the Act requiring a person not to dispose of any stock in his possession shall be in Form 15.[54-A. Prohibition of sale. [Added by S.O. 1449, dated 13.6.1961 (w.e.f. 24.6.1961).]- No person in possession of a [drug or cosmetic] in respect of which an Inspector has made an order under clause (c) of sub-section (i) of section 22 of the Act shall in contravention of that order sell or otherwise dispose of any stock of such [drug or cosmetic] [Substituted by G.S.R. 850(E), dated 7.12.1994 (w.e.f. 7.12.1994).].]55. [ Form of receipts for seized drugs, cosmetic, record, register, documents or any other material objects. [Substituted by G.S.R. 926, dated 24.6.1977 (w.e.f. 16.7.1977).]
- A receipt by an Inspector for the stock of any drug or cosmetic or for any record, register, document or any other material object seized by him under clause (c) or clause (cc) of sub-section (1) of section 22 of the Act shall be in Form 16.][55-A. Manner of certifying copies of seized documents. [Inserted by G.S.R. 89(E), dated 16.2.1985 (w.e.f. 16.2.1985).]- The Drugs Inspector shall return the documents, seized by him under clause (cc), or produced before him under clause (cca), of sub-section (1) of section 22 of the Act, within a period of twenty days of the date of such seizure or production, to the person from whom they were seized or, as the case may be, the person who produced them, after copies thereof of extracts therefrom have been signed by the concerned Drugs Inspector and the person from whom they were seized, or as the case may be, who produced such records.]56. Form of intimation of purpose of taking samples.
- When an Inspector takes a sample of a drug for the purpose of test or analysis, he shall intimate such purpose in writing in Form 17 to the person from whom he takes it.[56-A. Form of receipt for samples of drugs where fair price tendered is refused. [Inserted by G.S.R. 292(E), dated 29.5.1997 (w.e.f. 29.5.1997).]- Where the fair price, for the samples of drugs taken for the purpose of test or analysis, tendered under sub-section (1) of section 23 has been refused, the Inspector shall tender a receipt therefor to the person from whom the said samples have been taken as specified in Form 17-A.]57. Procedure for despatch of sample to Government Analyst.
58. [ Confiscation of drugs, implements, machinery, etc. [Substituted by S.O. 289, dated 20.12.1972 (w.e.f. 3.2.1973).]
Part VI – Sale Of Drugs Other Than Homeopathic Medicines
59.
| (4) Application for renewal of a license[to sell, stock, exhibit or offer for sale or distribute] [Substituted by G.S.R. 788(E), dated 10.10.1985 (w.e.f. 10.10.1985).]drugs, after its expiry but within six months of such expiry[shall be accompanied by a fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees five hundred per month or part thereof in Form 19, rupees five hundred plus an additional fee at the rate of rupees two hundred fifty per month or part thereof in Form 19-A and rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof in Form 19-C:] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).][Provided that in the case of an itinerant vendor or an applicant desiring to open a shop in a village or town having a population of 5,000 or less the application for such renewal shall be accompanied by a fee of rupees ten, plus an additional fee at the rate of rupees eight per month or part thereof.] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] |
60. [ [Substituted by G.S.R. 2136, dated 15.6.1957.]
A licensing authority may with the approval of the State Government by an order in writing delegate the power to sign licenses and such other powers as may be specified in the order to any other person under his control.]61. [ Forms of licenses to sell drugs. [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]
62. Sale at more than one place.
- If drugs are sold or stocked for sale at more than one place, separate application shall be made, and a separate license shall be issued, in respect of each such place:[Provided that this shall not apply to itinerant vendors who have no specified place of business and who will be licensed to conduct business in a particular area within the jurisdiction of the licensing authority.] [Added by S.R.O. 490, dated 10.3.1953.]62A. [ Restricted licenses in Forms 20-A and 21-A. [Added by S.O. 1588, dated 3.7.1961 (w.e.f. 8.7.1961).]
62B. [ Conditions to be satisfied before a license in Form 20-A or Form 21-A is granted. [Added by S.O. 1588, dated 3.7.1961 (w.e.f. 8.7.1961).]
62C. [ Application for license to sell drugs by wholesale or to distribute the same from a motor vehicle. [Inserted by G.S.R. 42(E), dated 25.1.1979 (w.e.f. 25.1.1979).]
62D. Form of licenses to sell drugs by wholesale or distribute drugs from a motor vehicle.
- A license shall be issued for sale by wholesale or for distribution from a motor vehicle of drugs other than those specified in Schedule C and Schedule C(1) in Form 20-BB and of drugs specified in Schedule C and Schedule C(1) in Form 21-BB:Provided that such a license shall not be required in a case where a public carrier or a hired vehicle is used for transportation or distribution of drugs.] [Inserted by G.S.R. 42(E), dated 25.1.1979 (w.e.f. 25.1.1979).]63. [ Duration of licence. [Substituted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).]
| 63A. [ Certificate of renewal of a sale license. [Added by S.O. 1326, dated 10.4.1964 (w.e.f. 11.4.1964).]- The certificate of renewal of a sale license in Forms 20, 20-A, 20-B[20-F, 20-G,] [Inserted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).][21, 21-A and 21-B shall be issued in Form 21-C.] [Added by S.O. 1326, dated 10.4.1964 (w.e.f. 11.4.1964).]63B. [ Certificate of renewal of license. [Inserted by G.S.R. 42(E), dated 25.1.1979 (w.e.f. 25.1.1979).]- A certificate of renewal of a license in Form 20-BB or Form 21-BB shall be issued in Form 21-CC.] |
64. [ Conditions to be satisfied before a license in [Amended by Notification No. F. 1-16/57-D, dated 15.6.1957 and Notification No. F. 1-19/59-D, dated 13.6.1961.] [Form 20, 20-B, 20-F, 20-G, 21 or 21-B] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] is [granted [***] [Substituted by G.S.R. 681(E), dated 6.6.1988 (w.e.f. 6.6.1988).]].
65. Condition of licenses.
- Licenses in [Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] shall be subject to the conditions stated therein and to the following general conditions:- [Substituted by G.S.R. 351(E), dated 26.4.2000 (w.e.f. 26.4.2000).]65A. [ Additional information to be furnished by an applicant for license or a licensee to the licensing authority. [Added by S.O. 2139, dated 5.6.1972 (w.e.f. 12.8.1972).]
- The applicant for the grant of a license or any person granted a license under this Part shall, on demand, furnish to the licensing authority, before the grant of the license or during the period the license is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises, specified in the application for license or in the license granted, constitution of the firm, or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee while applying for or after obtaining the license, as the case may be.]65B. [ Inspection for verification of compliance. [Inserted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).]
- The licensing authority shall cause inspection, by the Inspector appointed under the Act, of each premises licensed under this Part, to verify the compliance with the conditions of licence and the provisions of the Act and these rules, not less than once in three years or as needed as per risk based approach.]66. Cancellation and suspension of licenses.
66A. [ Procedure for disposal of drugs in the event of cancellation of license. [Substituted by G.S.R. 1242, dated 17.9.1979 (w.e.f. 6.10.1979).]
67. [ [Rule 67 omitted by S.O. 289, dated 20.12.1972 (w.e.f. 3.2.1973).]
* * *][Part VI-A] [Added by S.O. 1185, dated 18.8.1964 (w.e.f. 22.8.1964).] Sale Of Homeopathic Medicines67A.
67B.
A licensing authority may, with the approval of the State Government, by an order in writing, delegate the power to sign licenses and such other powers, as may be specified, to any other person under his control.67C. Form of licenses to sell drugs.
67D. Sale at more than one place.
- If drugs are sold or stocked for sale at more than one place, a separate application shall be made and a separate license shall be obtained in respect of each place.67E. Duration of licenses.
- An original license or a renewed license unless it is sooner suspended or canceled shall be [valid for a period of five years on and from the date on which] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).] it is granted or renewed:[Provided that if the application for renewal of a license in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the license shall continue to be in force until orders are passed on the application and the license shall be deemed to have expired if application for its renewal is not made within six months after its expiry.] [Substituted by S.O. 2139, dated 5.6.1972 (w.e.f. 28.8.1972).]67EE. [ Certificate of renewal. [Added by S.O. 594, dated 3.2.1969 (w.e.f. 15.2.1969).]
- The certificate of renewal of a sale license in Forms 20-C and 20-D shall be issued in Form 20-E.]67F. Conditions to be satisfied before a license in Form 20-C or Form 20-D is granted.
67G. Conditions of license.
- License in Form 20-C or 20-D shall be subject to the conditions stated therein and to the following further conditions, namely:-67GG. [ Additional information to be furnished by an applicant for license or a licensee to the licensing authority. [Added by S.O. 2139, dated 5.6.1972 (w.e.f. 12.8.1972).]
- The applicant for the grant of a license or any person granted a license under this part shall, on demand furnish to the licensing authority, before the grant of the license or during the period the license is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises specified in the application for license or in the license granted, constitution of the firm, or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the license, as the case may be.]67H. Cancellation and suspension of licenses.
Part VII – Manufacture For Sale [Or For Distribution] [Inserted By G.S.R. 788(E), Dated 10.10.1985 (W.E.F. 10.10.1985).] Of Drugs Other Than Homeopathic Medicines
68. Manufacture on more than one set of premises.
- If drugs are manufactured on more than one set of premises a separate application shall be made and a separate license shall be issued in respect of each such set of premises.68A. [ Grant [***] [Inserted by G.S.R. 923(E), dated 14.12.1992 (w.e.f. 14.12.1992).] of Licenses by the Central License Approving Authority.
68B. Delegation of powers by the Central License Approving Authority.
- The Central License Approving Authority may with the approval of the Central Government, by notification delegate his powers of signing licenses and any other power under the rules to any person under his control having same qualifications as prescribed for controlling authority under rule 50-A for such areas and for such periods as may be specified.]69. [ Application for license to manufacture drugs other than those specified in Schedules C and C(1) to the Drugs and Cosmetics Rules. [Substituted by S.O. 1196, dated 6.5.1960 (w.e.f. 14.5.1960).]
- [(1) Application for grant [***] of license to manufacture for sale [or for distribution] [Inserted by G.S.R. 788(E), dated 10.10.1985 (w.e.f. 10.10.1985).] [of drugs, other than those specified in Schedules C and C(1) shall be made to the licensing authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the licensing authority) and shall be made-(a)in the case of repacking of drugs excluding those specified in Schedule X for sale or distribution in Form 24-B;(b)in the case of manufacture of drugs included in Schedule X in Form 24-F;(c)in any other case, in Form 24.]| (3) If a person applies for the renewal of a license after the expiry thereof but within six months of such expiry the fee payable for the renewal of such license shall be-(i) [ in the case of Form 24-B a license fee of rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof in addition to an inspection fee of rupees two hundred; [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).](ii) in the case of Form 24-F a license fee of rupees six thousand plus an additional fee at the rate of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand;(iii) in the case of Form 24 a license fee of rupees six thousand plus an additional fee at the rate of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand and five hundred.] |
69A. [ Loan licenses [Amended by S.R.O. 2136, dated 15.6.1957.]
.] - [(1) Application for the grant [***] [Substituted by Notification No. G.S.R. 601(E) dated 24.8.2001 (w.e.f. 21.12.1945)] of loan licenses to manufacture for sale or for distribution of drugs other than those specified in Schedule C, Schedule C(1) and Schedule X shall be made up to ten items for each category of drugs [referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] [Substituted 'categorized in Schedule M and Schedule M-III' by Notification No. G.D.R. 640(E), dated 29.6.2016 (w.e.f. 21.12.1945).] and shall be made in Form 24-A accompanied by a license fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred to the licensing authority:[***] [Omitted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).][Explanation.-For the purpose of this rule a loan license means a license which a licensing authority may issue to an applicant who intends to avail the manufacturing facilities owned by a licensee in Form 25.] [Substituted by Notification No. G.S.R. 724 (E) dated 7.11.2013 (w.e.f. 21.12.1945)]70. [ Form of license to repack or manufacture drugs other than those specified in Schedules C and C(1) [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]
.-Licenses for repacking of drugs against application in Form 24-B shall be granted in Form 25-B, licenses for manufacture of drugs included in Schedule X against application in Form 24-F shall be granted in Form 25-F and licenses for manufacture of drugs against application in Form 24 shall be granted in Form 25.][70-A. Form of loan license to manufacture for sale [or for distribution] [Added by S.R.O. 2136, dated 15.6.1957 and Notification No. F. 1.22/59-D, dated 6.5.1960 (w.e.f. 14.5.1960).][of drugs other than those [specified in Schedules C, C(1) and X ] [Added by S.R.O. 2136, dated 15.6.1957 and Notification No. F. 1.22/59-D, dated 6.5.1960 (w.e.f. 14.5.1960).][.-A loan license to manufacture for sale [or for distribution] [Added by S.R.O. 2136, dated 15.6.1957 and Notification No. F. 1.22/59-D, dated 6.5.1960 (w.e.f. 14.5.1960).][of drugs other than those specified in [Schedules C, C(1) and X ] [Added by S.R.O. 2136, dated 15.6.1957 and Notification No. F. 1.22/59-D, dated 6.5.1960 (w.e.f. 14.5.1960).][shall be issued in Form 25-A.] [Added by S.R.O. 2136, dated 15.6.1957 and Notification No. F. 1.22/59-D, dated 6.5.1960 (w.e.f. 14.5.1960).]71. [ Conditions for the grant [***] [Substituted by Notification No. F. 1.16/57-D, dated 15.6.1957.] of a license in Form 25 [or Form 25-F ] [Inserted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).].
- Before a license in Form 25 [or Form 25-F ] [Inserted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] is granted [***] [Omitted 'or renewed' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f 21.12.1945).] the following conditions shall be complied with by the applicant:-71A. [ Conditions for the grant [***] [Inserted by S.O. 1196, dated 6.5.1960 (w.e.f. 14.5.1960).] of a license in Form 25-B.
- Before a license in Form 25-B is granted [***] [Omitted 'or renewed' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f 21.12.1945).] the following conditions shall be complied with by the applicant-71B. [ Conditions for the grant [***] [Added by G.S.R. 515, dated 24.3.1976 (w.e.f. 10.4.1976).] of a license in Form 25-A.
- Before a license in Form 25-A is granted [***] [Omitted 'or renewed' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f 21.12.1945).], the applicant shall, while applying for a license to manufacture patent or proprietary medicines, furnish to the licensing authority evidence and data justifying that the patent or proprietary medicines-72. [ Duration of licence. [Substituted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).]
| 73. [ Certificate of renewal. [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]- The certificate of renewal of a license in Form 25 or Form 25-F shall be issued in Form 26 or Form 26-F respectively.]73A. A certificate of renewal of loan license.- The certificate of renewal of a loan license in Form 25-A shall be issued in Form 26-A. |
73AA. [ Duration of loan licence [Substituted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).]
. - (1) A licence issued in Form 25A shall remain valid if licencee deposits a licence retention fee referred to in sub-rule (2) before the expiry of a period of every succeeding five years from the date of its issue, unless, it is suspended or cancelled by the licensing authority.73AB. [ Inspection for grant of licence and verification of compliance. [Inserted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).]
73B. [ [Omitted '73B' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f 21.12.1945).]
***]| 73B. [ Certificate of renewal of license in Form 25-B. [Added by S.O. 1196, dated 6.5.1960 (w.e.f. 14.5.1960).]- The certificate of renewal of a license in Form 25-B shall be issued in Form 26-B.] |
74. [ Conditions of license in [Form 25 and Form 25-F] [Substituted by S.O. 3868, dated 26.10.1968 (w.e.f. 2.11.1968).].
- A license in [Form 25 and Form 25-F] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] shall be subject to the conditions stated therein and to the following further conditions, namely:-| A. Account of the drugs specified in Schedule X used for the manufacture :- | |
| 1. | Date of issue. |
| 2. | Name of the drug. |
| 3. | Opening balance of stock on the production day. |
| 4. | Quantity received, if any, and source from where received. |
| 5. | Quantity used in manufacture |
| 6. | Balance quantity on hand at the end of the production day. |
| 7. | Signature of the person in charge |
| B. Account of production:- | |
| 1. | Date of manufacture. |
| 2. | Name of the drug. |
| 3. | Batch Number. |
| 4. | Quantity of raw material used in manufacture. |
| 5. | Anticipated yield. |
| 6. | Actual yield. |
| 7. | Wastage. |
| 8. | Quantity of the manufactured goods transferred. |
| C. Accounts of the manufactured drugs:- | |
| 1. | Date of manufacture. |
| 2. | Name of the drug. |
| 3. | Batch Number. |
| 4. | Opening Balance. |
| 5. | Quantity manufactured. |
| 6. | Quantity sold. |
| 7. | Name of the purchaser and his address. |
| 8. | Balance quantity at the end of the day. |
| 9. | Signature of the person in charge. |
74A. [ Conditions for license in Form 25-B. [Added by S.O. 1196, dated 6.5.1960 (w.e.f. 14.5.1960).]
- A license in Form 25-B shall be subject to the conditions stated therein and to the following conditions:-(a)the re-packing of drugs shall at all times be conducted under the personal supervision of at least one person who is approved as a competent person by the licensing authority;(b)the licensee shall either provide and maintain adequate arrangements in his own premises for carrying out tests of the strength, quality and purity of the drugs re-packed or make arrangements with some institutions approved by the licensing authority [under Part XV(A) of these rules] [for such tests to be regularly carried out on his behalf by the institutions; [Added by S.O. 1196, dated 6.5.1960 (w.e.f. 14.5.1960).](c)the licensee shall make adequate arrangements for the storage of drugs;(d)[ the licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act:Provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette;](e)[ the licensee shall allow any [Inspector appointed under the Act] [Added by S.O. 1196, dated 6.5.1960 (w.e.f. 14.5.1960).][to enter with or without notice, any premises where the packing of drugs in respect of which the license is issued is carried on, to inspect the premises and to take samples of repacked drugs; [Added by S.O. 1196, dated 6.5.1960 (w.e.f. 14.5.1960).](f)[ the licensee shall, either in his own laboratory or in any other laboratory approved by the licensing authority, test each batch or lot of raw material used by him for repacking and also each batch of the product thus repacked and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or register shall be retained for a period of five years from the date of repacking. The licensee shall allow the Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these rules have been observed;](g)[ the licensee shall maintain an Inspection Book, in Form 35, to enable an Inspector to record his impressions and the defects noticed;] [Added by S.O. 3868, dated 26.10.1968 (w.e.f. 2.11.1968).](h)[ the licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture.] [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).](i)[ No advertisement of the drugs specified in Schedule H, Schedule H1 and Schedule X shall be made except with the previous sanction of the Central Government.] [Inserted by Notification No. G.S.R. 289(E), dated 15.4.2015 (w.e.f. 21.12.1945)][74-B. Conditions of license in Form 25-A. [Added by S.O. 3868, dated 26.10.1968 (w.e.f. 2.11.1968).]75. [ Forms of application for license to manufacture for sale or distribution of drugs specified in Schedules C, C(1) [excluding those specified in Part X-B and Schedule X] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).].
- [(1) Applications for the grant [*] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] of license to manufacture for sale or distribution of drugs specified in Schedules C and C (1) [excluding those specified in Part X-B and Schedule X] [Substituted by G.S.R. 28(E), dated 22.1.1993 (w.e.f. 22.1.1993).],[shall be made to the licensing authority in Form 27, and shall be made upto ten items for each category of drugs [referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] and [shall be accompanied by a license fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection [*] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).]][***] [Omitted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).]75A. [ Loan licenses. [Added by S.R.O. 1136, dated 15.6.1957.]
76. [ Forms of licenses to manufacture drugs specified in Schedules C and C(1), [excluding those specified in Part X-B and Schedule X] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).][, or drugs specified in Schedules C, C(1) and X and the conditions for the grant [***] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] of such licenses.
- [A license to manufacture for sale or for distribution of drugs specified in Schedules C and C(1) other than [Large Volume Parenterals, Sera and Vaccines and Recombinant DNA (r-DNA) derived drugs,] [Substituted by G.S.R. 119(E), dated 11.3.1996 (w.e.f. 11.3.1996).][drugs specified in Part X-B and Schedule X shall be issued in Form 28 and a license to manufacture for sale or distribution of drugs specified under Schedules C and C(1) (other than [Large Volume Parenterals, Sera and Vaccines and Recombinant DNA (r-DNA) derived drugs,] [Substituted by G.S.R. 119(E), dated 11.3.1996 (w.e.f. 11.3.1996).][shall be issued in Form 28-B. A license to manufacture for sale or for distribution of Large Volume Parenterals, Sera and Vaccines and Recombinant DNA (r-DNA) derived drugs, shall be issued in Form 28-D. Before a license in Form 28 or Form 28-B or Form 28-D is granted [***] [Substituted by G.S.R. 119(E), dated 11.3.1996 (w.e.f. 11.3.1996).], the following conditions shall be complied with by the applicant-]76A. [ Forms of loan licenses to manufacture for sale or for distribution drugs specified in Schedule C and C1 excluding drugs specified in Schedule X or of Large Volume Parenterals, Sera and Vaccine and recombinant DNA (r-DNA) derived drugs, and conditions for the grant [***] [Substituted by Notification No. G.S.R. 574 (E) dated 17.7.2012 (w.e.f. 21.12.1945)] of such licenses.
- A loan license to manufacture for sale or for distribution of drugs specified in Schedules C and C(1), excluding drugs specified in Schedule X, and Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs specified in Part X-B shall be issued in Form 28A and a loan license to manufacture for sale or for distribution of Large Volume Parenterals, Sera and Vaccine and Recombinant DNA(r-DNA) derived drugs shall be issued in Form 28DA, and the] applicant shall, while applying for a license to manufacture patent or proprietary medicines, furnish to the licensing authority evidence and data justifying that the patent or proprietary medicines-| 77. [ Duration of license. [Substituted by S.O. 1326, dated 19.4.1964 (w.e.f. 11.4.1964).]- An original license in[Form 28, Form 28-B and Form 28-D or renewed license in Forms 26, 26-F and Form 26-H][, unless sooner suspended or canceled shall be[valid for a period of five years on and from the date on which] [Substituted by S.O. 1326, dated 19.4.1964 (w.e.f. 11.4.1964).][it is granted or renewed:[Provided that if the application for the renewal of a license is made before its expiry, or if the application is made within six months of its expiry, after payment of additional fee, the license shall continue to be in force until orders are passed on the application and the license shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.] [Substituted by S.O. 1326, dated 19.4.1964 (w.e.f. 11.4.1964).] |
78. Conditions of license.
- A license in [Form 28, Form 28-B or Form 28-D] [Substituted by G.S.R. 119(E), dated 11.3.1996 (w.e.f. 11.3.1996).] shall be subject to the special conditions, if any, set out in Schedule F or Schedule F(I), as the case may be, which relate to the substance in respect of which the license is granted and to the following general conditions:-(a)(i)The licensee shall provide and maintain an adequate staff and adequate premises and plant for the proper manufacture and storage of the substances in respect of which the license is issued;(ii)without prejudice to the generality of the foregoing requirement, every holder of a license who for any purpose engaged in the culture or manipulation of pathogenic spore-bearing micro-organisms shall provide to the satisfaction of the licensing authority separate laboratories and utensils and apparatus required for the culture or manipulation of such micro-organisms, the laboratories, utensils and apparatus so provided not being used for the manufacture of any other substance;(b)[ The licensee shall provide and maintain staff, premises and equipment as specified in rule 76;] [Substituted by S.R.O. 2136, dated 15.6.1957.](c)[(i) The licensee shall maintain records of manufacture as per particulars given in Schedule U. [Substituted by S.O. 3868, dated 26.10.1968 (w.e.f. 2.11.1968).](ii)The licensee shall either in his own laboratory or in any laboratory approved by the licensing authority [under Part XV(A) to these rules][test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained in the case of a substance for which a potency date is fixed for a period of two years from the expiry of such date, and in the case of other substances for a period of five years from the date of manufacture;] [Substituted by S.O. 3868, dated 26.10.1968 (w.e.f. 2.11.1968).](d)The licensee shall allow an [Inspector appointed under the Act, to enter, with or without prior notice, any premises where the manufacture is carried on and to inspect the premises, and in the case of substances specified in Schedules C and C(1), to inspect the plant and the process of manufacture and the means employed for standardizing and testing the substance;] [Substituted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).](e)The licensee shall allow an [Inspector, appointed under the Act, to inspect all registers and records maintained under these rules and to take samples of the manufactured product and shall supply to such Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and rules thereunder have been observed;] [Substituted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).](f)The licensee shall from time to time report to the licensing authority any changes in the expert staff responsible for the manufacture or testing of the substance and any material alterations in the premises or plant used for that purpose which have been made since the date of the last inspection made on behalf of the licensing authority before the issue of the license;(g)[ The licensee shall on request furnish to the licensing authority or controlling authority or to such authorities as the licensing authority or the controlling authority may direct, from every batch of drugs as the licensing authority or the controlling authority may from time to time specify, a sample of such quantity as may be considered adequate by such authority for any examination and, if so required, also furnish full protocols of the tests which have been applied.] [<SPAN class=amd2><A TITLE =](h)[ If the licensing authority or the controlling authority so directs, the licensee shall not sell or offer for sale any batch in respect of which a sample is, or protocols are furnished under the last preceding sub-paragraph until a certificate authorizing the sale of the batch has been issued to him by or on behalf of the licensing authority or the controlling authority;] [Substituted by S.R.O. 2136, dated 15.6.1957.](i)[ The licensee shall on being informed by the licensing authority or the controlling authority that any part of any batch of the substance has been found by the licensing authority or the controlling authority not to conform with the standards of strength, quality or purity specified in these rules and on being directed so to do, withdraw the remainder of that batch from sale and so far as may in the particular circumstances of the case be practicable recall all issues already made from that batch;] [Substituted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).](j)No drug manufactured under the license shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture;(k)[ The licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette;] [Substituted by S.O. 3868, dated 26.10.1968 (w.e.f. 2.11.1968).](l)[ The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and defects noticed;] [Substituted by S.O. 3868, dated 26.10.1968 (w.e.f. 2.11.1968).](m)[ The licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture;] [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).](n)[ The licensee, who has been granted a license in Form 28-B shall- [Inserted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).](i)forward to the licensing authority of the concerned States of manufacture and supply of drug a statement of the sales effected to the manufacturers, wholesalers, retailers, hospitals, dispensaries, Nursing Homes and Registered Medical Practitioners every three months;(ii)maintain accounts of all transactions giving details as indicated below in a register bound and serially page numbered, and such records shall be retained for a period of five years or one year after the date of expiry of potency, whichever is later.| A. Account of the drugs specified in Schedule X used for the manufacture :- | |
| 1. | Date of issue. |
| 2. | Name of the drug. |
| 3. | Opening balance of stock on the production day. |
| 4. | Quantity received, if any, and source from where received. |
| 5. | Quantity used in manufacture |
| 6. | Balance quantity on hand at the end of the production day. |
| 7. | Signature of the person in charge |
| B. Account of production:- | |
| 1. | Date of manufacture. |
| 2. | Name of the drug. |
| 3. | Batch Number. |
| 4. | Quantity of raw material used in manufacture. |
| 5. | Anticipated yield. |
| 6. | Actual yield. |
| 7. | Wastage. |
| 8. | Quantity of the manufactured goods transferred to stock. |
| C. Accounts of the manufactured drugs:- | |
| 1. | Date of manufacture. |
| 2. | Name of the drug. |
| 3. | Batch Number. |
| 4. | Opening Balance. |
| 5. | Quantity manufactured. |
| 6. | Quantity sold. |
| 7. | Name of the purchaser and his address. |
| 8. | Balance quantity at the end of the day. |
79. [ Inspection before grant [***] [Substituted by G.S.R. 923(E), dated 14.12.1992 (w.e.f. 14.12.1992) as corrected by G.S.R. 373(E), dated 13.4.1993.] of license.
- Before a license under this Part is granted [***] [Omitted 'or renewed' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f 21.12.1945).] the licensing authority or Central License Approving Authority, as the case may be, shall cause the establishment in which the manufacture is proposed to be conducted or being conducted to be inspected by one or more Inspectors appointed under the Act with or without an expert in the field concerned. The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardizing and testing the drugs to be manufactured or being manufactured and enquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the "Requirements of Good Manufacturing Practices" and the "Requirements of Plant and Equipment" as laid down in Schedule M read with the Requirements of Maintenance of Records as laid down in Schedule U.]80. [ Report by Inspector. [Substituted by G.S.R. 923(E), dated 14.12.1992 (w.e.f. 14.12.1992) as corrected by G.S.R. 373(E), dated 13.4.1993.]
81. Procedure of licensing authority.
82. [ Further application after rejection. [Amended by S.R.O. 2136, dated 15.6.1957.]
- If within a period of six months from the rejection of an application for a license the applicant informs the licensing authority or Central License Approving Authority, as the case may be, that the conditions laid down have been satisfied and deposits an inspection [fee of rupees two hundred and fifty] [the licensing authority [or Central License Approving Authority, as the case may be,] [Amended by S.R.O. 2136, dated 15.6.1957.][may, if after causing a further inspection to be made, he is satisfied that the conditions for the grant of a license have been complied with in respect of drugs notified under rule 68-A issue a license in Form 28 [or Form 28-B] [Amended by S.R.O. 2136, dated 15.6.1957.].][83 to 83AA. [Omitted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).]***]| 83. Renewal.- On application being made for renewal, the licensing authority may cause an inspection to be made and, if satisfied that the condition of the license and the rules under the Act are, and will continue to be observed[he shall prepare a report to that effect in respect of those drugs which have been notified by the Central Government under rule 68-A and forward it along with the application to the Central License Approving Authority] [Inserted by G.S.R. 923(E), dated 14.12.1992 (w.e.f. 14.12.1992).], and[he shall issue a certificate of renewal under this Part] [Substituted by G.S.R. 119(E), dated 11.3.1996 (w.e.f. 11.3.1996).].83A. [ Certificate of renewal of a loan license. [Inserted by S.R.O. 2136, dated 15.6.1957.]- The certificate of renewal of a loan license in[Form28 A or Form 28DA shall be issued in Form 26A or Form 26J respectively.]]83AA. [ Duration of loan license. [Inserted by S.O. 1326, dated 10.4.1964 (w.e.f. 11.4.1964).]- An original loan license in[Form 28A or Form 28DA]or renewed loan license in[Form 26A or Form 26J] [Substituted for the words "Form 26A" by Notification No. G.S.R. 574 (E) dated 17.7.2012 (w.e.f. 21.12.1945)], unless sooner suspended or canceled, shall be[valid for a period of five years on and from the date on which] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).][it is granted or renewed:[Provided that if the application for the renewal of license is made before its expiry, or if the application is made within six months of its expiry, after payment of the additional fee, the license shall continue to be in force until orders are passed on the application and the license shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.] [Inserted by S.O. 1326, dated 10.4.1964 (w.e.f. 11.4.1964).] |
84.
The provisions of this Part shall apply to the manufacture of drugs for sale notwithstanding that such drugs are manufactured for sale outside India.84A. [ Provisions for appeal to the State Government or Central Government by party whose license has not been granted [***] [Substituted by G.S.R. 923(E), dated 14.12.1992 (w.e.f. 14.12.1992) as corrected by G.S.R. 373(E), dated 13.4.1993.].
- Any person who is aggrieved by the order passed by the licensing authority or the Central License Approving Authority, as the case may be, refusing to [grant [***] [Substituted by G.S.R. 119(E), dated 11.3.1996 (w.e.f. 11.3.1996).] a license under this Part][, may within thirty days from the date of receipt of such order, appeal to the State Government or Central Government, as the case may be, and the State Government or the Central Government may, after such enquiry into the matter, as is considered necessary and after giving the said person an opportunity for representing his views, may pass such order in relation thereto as it thinks fit.] [Substituted by G.S.R. 923(E), dated 14.12.1992 (w.e.f. 14.12.1992) as corrected by G.S.R. 373(E), dated 13.4.1993.]84AA. Additional information to be furnished by an applicant for license or a licensee to the licensing authority.
- The applicant for the grant of a license or any person granted a license under this Part shall, on demand, furnish to the licensing authority, before the grant of the license or during the period the license is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises, specified in the application for license or in the license granted, constitution of the firm or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the license, as the case may be.84B. [ Prohibition for the manufacture for sale of cyclamates and preparations containing cyclamates. [Added by S.O. 2358, dated 21.6.1972 (w.e.f. 26.8.1972).]
- No person shall manufacture for sale cyclamates and preparations containing cyclamates.]84C. [ Inspection for verification of compliance. [Inserted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f 21.12.1945).]
85. [ Cancellation and suspension of licenses. [Substituted by G.S.R. 923(E), dated 14.12.1992 (w.e.f. 14.12.1992) as corrected by G.S.R. 373(E), dated 13.4.1993.]
85A. Manufacture on more than one set of premises.
- If Homeopathic medicines are manufactured in more than one set of premises a separate application shall be made and a separate license shall be obtained in respect of each such set of premises.85B. Application for license to manufacture Homeopathic medicines.
85C. Application to manufacture "New Homeopathic medicines"
.-Subject to the other provisions of these rules,-85D. [ Form of license to manufacture Homeopathic medicines. [Substituted by S.O. 4186, dated 19.11.1969 (w.e.f. 6.12.1969).]
- License for manufacture of Homeopathic medicines is a license to manufacture potentised preparations from back potencies by Pharmacies who are already licensed to sell Homeopathic medicines by retail shall be granted in Form 25-C.]85E. Conditions for the grant or renewal of a license in Form 25-C.
- Before a license in Form 25-C is granted or renewed the following conditions shall be complied with by the applicant:-85EA. [ Inspection before grant or renewal of license. [Inserted by G.S.R. 493(E), dated 9.6.1995 (w.e.f. 9.6.1995) as corrected by G.S.R. 184(E), dated 12.4.1996.]
- Before a license under this Part is granted or renewed in Form 25-C or Form 26-C, the licensing authority shall cause the establishment, in which the manufacture is proposed, to be conducted or being conducted to be inspected by one or more Inspectors appointed under the Act. The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardizing and testing the substances to be manufactured and inquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the requirements of plant and equipment as laid down in Schedule M I read with the requirements of maintenance of records as laid down in Schedule U.85EB. Report by Inspector.
- The Inspector or Inspectors shall forward a detailed descriptive report giving his or their findings on each aspect of inspection along with his or their recommendations after completion of his or their inspection to the licensing authority.85EC. Grant or refusal of license.
85ED. Further application after rejection.
- If within a period of six months from the rejection of an application for a license, the applicant informs the licensing authority that the conditions laid down have been fulfillled and deposits an inspection fee of [rupees two hundred and fifty] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).], [the licensing authority may, if, after causing further inspection to be made, he is satisfied that the conditions for the grant of license have been complied with, issue a license in Form 25-C or Form 26-C.85EE. Appeal to the State Government.
- Any person who is aggrieved by the order passed by the licensing authority refusing to grant or renew a license under this Part, may within ninety days from the date of receipt of such order, appeal to the State Government and the State Government may, after such enquiry into the matter as is considered necessary and after giving the said person an opportunity for representing the case, pass such order as it thinks fit.] [Inserted by G.S.R. 493(E), dated 9.6.1995 (w.e.f. 9.6.1995) as corrected by G.S.R. 184(E), dated 12.4.1996.]85F. Duration of license.
- An original license or a renewed license unless it is sooner suspended or canceled shall be [valid for a period of five years on and from the date on which] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).] it is granted or renewed:[Provided that if the application for renewal of a license in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the license shall continue to be in force until orders are passed on the application and the license shall be deemed to have expired if application for its renewal is not made within six months of its expiry.] [Substituted by S.O. 2139, dated 5.6.1972 (w.e.f. 12.8.1972).]85G. Certificate of renewal.
- The certificate of renewal of a license in Form 25-C shall be issued in Form 26-C.85H. Conditions of license.
- A license in Form 25-C shall be subject to the conditions stated therein and to the following further conditions, namely:-85HH. [ Additional information to be furnished by an applicant for license or a licensee to the licensing authority. [Added by S.O. 2139, dated 5.6.1972 (w.e.f. 12.8.1972).]
- The applicant for the grant of license or any other person granted a license under this Part shall, on demand, furnish to the licensing authority, before the grant of the license or during the period the license is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises, specified in the application for license or in the license granted, constitution of the firm, or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the license, as the case may be.]85I. Cancellation and suspension of licenses.
Part VIII – Manufacture For Examination, Test Or Analysis
86. Conditions relating to manufacture for examination, test or analysis.
- The provisions of section 18 of the Act shall not apply to the manufacture of any drug in small quantities for the purpose of examination, test or analysis if the conditions prescribed in this Part are fulfillled.87. Labelling.
- Any drug manufactured for the purpose of examination, test or analysis shall be kept in containers bearing labels, indicating the purpose for which it has been manufactured.88. Labelling of drugs supplied to other persons.
- If any drug manufactured for the purpose of examination, test or analysis is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the substance if known, or if not known a reference which will enable the substance to be identified and the purpose for which it has been manufactured.89. License.
- If the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a license in Form 25 or Form 28 in respect of such drugs he shall, before commencing such manufacture, obtain a license in Form 29:[Provided that in the case of a drug the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety of drugs as safe for use, no license in Form 29 shall be granted unless the applicant produces a certificate from the licensing authority mentioned in rule 21, to the effect that there would be no objection to such license being granted.] [Inserted by S.O. 1449, dated 13.6.1961 (w.e.f. 24.6.1961).]90. Form of application.
- [(1)] [Renumbered as sub-rule (1) thereof and sub-rule (2) inserted by S.O. 903, dated 10.2.1976 (w.e.f. 28.2.1976).] An application for a license in Form 29 shall be made to the licensing authority appointed by the State Government for the purposes of this Part (hereafter in this Part referred to as the licensing authority) in Form 30 and shall be made by or countersigned by the head of the institution in which, or a director of the firm or company by which, the substance will be manufactured.91. Duration of license.
- A license in Form 29 shall, unless sooner canceled, be in force for a period of [three years from the date of issue] [Substituted by Notification No. G.S.R. 103(E), dated 2.2.2017 (w.e.f. 21.12.1945).], and may thereafter be renewed for periods of one year at a time.92. Conditions of license.
- A license in Form 29 shall be subject to the following conditions:-93. Cancellation of licenses.
Part IX – Labelling And Packing Of Drugs Other Than Homeopathic Medicines
94. Exemption of certain drugs from certain provisions of this Part.
95. Prohibition of sale or distribution unless labelled.
- Subject to the other provisions of these rules, no person shall sell or distribute any drug (including a patent or proprietary medicine) unless it is labelled in accordance with these rules.96. [ Manner of labelling. [Substituted by G.S.R. 19, dated 15.12.1977 (w.e.f. 7.1.1978).]
97. Labelling of medicines.
- [(1) The container of a medicine for internal use shall-(a)if it contains a substance specified in Schedule G, be labelled with the words Caution "it is dangerous to take this preparation except under medical supervision"-conspicuously printed and surrounded by a line within which there shall be no other words;(b)if it contains a substance specified in Schedule H be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label and be also labelled with the following words:-"Schedule H drug-Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only";(c)if it contains a substance specified in Schedule H and comes within the purview of the [Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985)] [be labelled with the symbol NRx which shall be in red and conspicuously displayed on the left top corner of the label, and be also labelled with the following words:- [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]"Schedule H drug-Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only";(d)if it contains a substance specified in Schedule X, be labelled with the symbol XRx which shall be in red conspicuously displayed on the left top corner of the label, and be also labelled with the following words:-"Schedule X drug-Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only";(e)[ if it contains a drug substance specified in Schedule H1, the drug formulation shall be labelled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label, and shall also be labelled with the following words)n a box with a red border:| SCHEDULE H1 DRUG – WARNING;-It is dangerous to take thispreparation except in accordance with the medical advice.-Not to be sold by retail without the prescription of aRegistered Medical Practitioner.; |
98. to 101.
[* * *] [Rules 98 to 101 omitted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]102. [ Non-Sterile Surgical Ligature and Suture. [Amended by S.R.O. 3262, dated 15.10.1954.]
- Every container of, and wrapper enclosing surgical ligature or suture other than a ligature or suture offered or intended to be offered for sale as sterile, shall bear a label on which are printed or written in a conspicuous manner in indelible red ink the words "Non-sterile surgical ligature (suture)-not to be used for operations upon the human body unless efficiently sterilized".]103.
[* * *] [Sub-rule (1) omitted by S.R.O. 2136, dated 15.6.1957.]104. [ Use of letters I.P., etc. [Substituted by G.S.R. 19, dated 15.12.1977 (w.e.f. 7.1.1978).]
- The letters "I.P.," and recognized abbreviations of pharmacopoeias and official compendia of drug standards prescribed under these rules shall be entered on the label of the drug only for the purpose of indicating that the drug is in accordance with standards set out in the Indian Pharmacopoeia or in any such pharmacopoeia or official compendium of drug standards recognized under the rule.]104A. [ Prohibition against altering inscriptions on containers, labels or wrappers of drug. [Inserted by G.S.R. 1242, dated 17.9.1979 (w.e.f. 6.10.1979).]
- No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any drug:Provided that nothing in this rule shall apply to any alteration, any inscription or mark made on the container, label or wrapper of any drug at the instance or direction or with the permission of the licensing authority.]105. [ Packing of drugs. [Substituted by G.S.R. 796(E), dated 1.10.1992 (w.e.f. 1.10.1993).]
1. Pack sizes or dosages forms not covered by the foregoing provisions of this rule.
2. The imported formulations in finished form.
3. Preparations intended for Veterinary use.
4. Preparations intended for Export.
5. Vitamins/Tonics/Cough Preparations/Antacids/Laxatives in Liquid Oral forms, Unit dose (including applicaps).
6. Pack sizes or dosage forms meant for retail sale to Hospitals, Registered Medical Practitioners, Nursing Homes.
7. Physician's Samples.
8. Pack sizes of Large Volume Intravenous Fluids:
[Provided further that] pack sizes of any of the new drug as and when approved by the licensing authority appointed under rule 21 and if not covered under this rule, shall be examined for the purpose of approval with specific justification by the said licensing authority:][[Provided also that] [Inserted by G.S.R. 242(E), dated 3.4.2001 (w.e.f. 3.4.2001).] Oxytocin injection meant for sale shall be in single unit blister pack only.][Provided also that Diclofenac injection for human use shall be in single unit dose pack only.] [Inserted by Notification No. G.S.R. 558 (E), dated 17.7.2015 (w.e.f. 21.12.1945).]105A. [ Packing of drugs specified in Schedule X. [Inserted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]
- The drugs specified in Schedule X shall be marketed in packings not exceeding-106. [ Diseases which a drug may not purport to prevent or cure. [Substituted by S.R.O. 2122, dated 22.6.1954.]
106A. Manner of labelling of Homeopathic medicines.
- (A) The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Homeopathic medicine and on every other covering in which the container is packed:-106B. [ Prohibition of quantity and percentage. [Inserted by G.S.R. 108(E), dated 22.2.1994 (w.e.f. 22.6.1994).]
- No Homeopathic medicine containing more than 12% alcohol v/v (Ethyl Alcohol) shall be packed and sold in packing or bottles of more than 30 millilitres, except that it may be sold to hospitals/dispensaries in packings or bottles of not more than 100 millilitres.]Part X – Special Provisions Relating To Biological And Other Special Products
107. [ Name of substance. [Amended by Notification No. F.1-5/47-D, dated 25.11.1949.]
- If any substance specified in Schedule C is advertised or sold as a proprietary medicine or is contained in a medicine so advertised or sold, the proper name of the substance shall appear on the label in the manner prescribed in this Part.[ Explanation. - For the purpose of this rule the expression "proper name" means the proper name stated in Schedule F or if no such name is stated, the name descriptive of the true nature and origin of the substance. Provided that in the case of veterinary biological product the expression "proper name" means the proper name stated in Schedule F(I) or if no such name is stated, the name or synonym given in the current edition for the time being of the [British Pharmacopoeia (Veterinary)],[or if no such name is stated either in Schedule F(I) or the British Pharmacopoeia (Veterinary), the name descriptive of the true nature and origin of the substance approved by the licensing authority.] [Substituted by S.O. 2889, dated 2.7.1969 (w.e.f. 19.7.1969).]108. Container.
- [(1) No substance specified in Schedule C shall be sold or offered for sale unless it has been sealed in a previously sterilised container made of glass or any other suitable material approved for the purpose by the licensing authority appointed under rule 21, in such manner as may, in the opinion of the licensing authority, suffice to preclude the access of bacteria:Provided that it shall not be necessary to use a previously sterilised container if the filled and sealed container is to be sterilised after the sealing and such sterilising procedure would render the products sterile. However, the licensing authority may, for any special reasons, direct the licensee to pre-sterilise such containers.] [Substituted by G.S.R. 245, dated 3.2.1976 (w.e.f. 21.2.1976).]109. [ Labelling. [Substituted by G.S.R. 19, dated 15.12.1977 (w.e.f. 7.1.1978).]
109A. [ Labelling of medical devices. [Substituted by Notification No. G.S.R. 690 (E) dated 25.9.2014 (w.e.f. 21.12.1945)]
- Subject to the other provisions of these rules, the following particulars shall be printed in indelible ink on the label or sticker on the shelf pack of the medical device or on the outer cover of such medical device and on every outer covering in which the medical device is packed, namely:-109B. [ Exemption of certain labelling requirements for medical devices for export from India. [Inserted by Notification No. G.S.R. 690 (E) dated 25.9.2014 (w.e.f. 21.12.1945)]
- The labels on packages or container of devices for export shall be adopted to meet specific requirements of the law of the country to which the device is to be exported, but the following particulars shall appear in conspicuous manner on the label of the shelf pack of the medical device in which the device is packed and every other outer covering in which the container is packed-109.
-C. Shelf life of the medical devices. - The shelf life of the medical devices shall not exceed sixty months from the date of manufacture:Provided that this period may be extended by the licensing authority, in respect of any specified medical device, if satisfactory evidence is produced by the manufacturer to justify such an extension.]110. Prohibition of sale of substance after prescribed date.
- No person shall sell, or exhibit for sale any substance specified in Schedule C after the date recorded on the container, label or wrapper as the date up to which the substance may be expected to retain a potency not less than, or not to acquire a toxicity greater than that required or permitted by the prescribed test as the case may be.110A. [ [Rule 110A omitted by G.S.R. 1242, dated 17.9.1979 (w.e.f. 6.10.1979).]
* * *]111. [ Standards. [Substituted by S.O. 2889, dated 2.7.1969 (w.e.f. 19.7.1969).]
- Every substance specified in Schedules C and C(1) intended for sale shall conform with the standards of strength, quality and purity specified in these rules and in Schedule F or F(I), as the case may be, and the tests for determining such conformity shall be applied to samples taken from the final product after every manufacturing process has been completed.112. Tests for strength and quality.
- The tests, if any, required for determining the strength and quality of each of the substances specified in Schedules C and C(1) shall be those set out in Schedule F or Schedule F(I) [or as specified] [Added by G.S.R. 663(E), dated 3.7.1992 (w.e.f. 3.7.1992).], as the case may be.]113. to 114.
[* * *] [Rules 113 and 114 omitted by G.S.R. 663(E), dated 3.7.1992 (w.e.f. 3.7.1992).]115. Application of tests for sterility.
- The tests shall be applied-116. to 118.
[* * *] [Rules 116 to 118 omitted by G.S.R. 663(E), dated 3.7.1992 (w.e.f. 3.7.1992).]119.
120.
Notwithstanding anything contained in the last preceding rule, in any case where-121. [ Test for freedom from abnormal toxicity. [Substituted by G.S.R. 834(E), dated 29.12.1999 (w.e.f. 30.12.1999).]
- The test for freedom from abnormal toxicity shall be carried out as per the current edition of Indian Pharmacopoeia in the case of each batch of the serum tested by the licensee or by an institution approved by the licensing authority for the purpose of carrying out the test on its behalf.]121A. [ Test for pyrogens. [Added by Notification No. F.1.27/56-D, dated 18.12.1956 and amended by S.O. 1449, dated 13.6.1961.]
- Solution of substances intended for parenteral administration in large volumes (10 ml. or more at a time) shall be pyrogen-free and tested for pyrogens. If water or any other aqueous solvent is supplied alongwith the substances for preparing such solutions, it shall also be pyrogen-free and tested for pyrogens.]122. Substances specified in Schedule C(1)
.-The following provisions shall apply in the case of a substance specified in Schedule C(1):-122A. Application for permission to import new drug.
- [(1) (a) No new drug shall be imported, except under, and in accordance with, the permission granted by the licensing authority as defined in clause (b) of rule 21.(b)An application for the grant of permission to import a new drug shall be made in Form 44 to the licensing authority, accompanied by a fee of fifty thousand rupees:Provided that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with new claims, is made, the fee to accompany such application shall be fifteen thousand rupees:Provided further that any application received after one year of the grant of approval for the import and sale of new drug, shall be accompanied by a fee of fifteen thousand rupees and such information and data as required by [Appendix I or Appendix I-A or Appendix IB] [Substituted by G.S.R. 900(E), dated 12.12.2001 (w.e.f. 12.12.2001).] of Schedule Y, as the case may be.]122B. Application for approval to manufacture new drug [* * *] [The words " other than the Drugs classifiable under Schedules C and C(1)" omitted by G.S.R. 26(E), dated 19.1.2006 (w.e.f. 19.1.2006).]
.- [(1) (a) No new drug shall be manufactured for sale unless it is approved by the licensing authority as defined in clause (b) of rule 21.(b)An application for grant of approval to manufacture the new drug and its formulations shall be made in Form 44 to the licensing authority as defined in clause (b) of rule 21 and shall be accompanied by a fee of fifty thousand rupees:Provided that where the application is for permission to import a new drug (bulk drug substance) and grant of approval to manufacture its formulation/s, the fee to accompany such application shall be fifty thousand rupees only:Provided further that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with new claims, is made, the fee to accompany such subsequent application shall be fifteen thousand rupees:Provided further also that any application received after one year of the grant of approval for the manufacture for sale of the new drug, shall be accompanied by a fee of fifteen thousand rupees and such information and data as required by [Appendix I or Appendix I-A or Appendix IB] [Substituted by G.S.R. 900(E), dated 12.12.2001 (w.e.f. 12.12.2001).] of Schedule Y, as the case may be.]122C. [ [Rule 122-C omitted by G.S.R. 900(E), dated 12.12.2001 (w.e.f. 12.12.2001).]
* * *]122D. [ Permission to import or manufacture fixed dose combination. [Substituted by G.S.R. 900(E), dated 12.12.2001 (w.e.f. 12.12.2001).]
122DA. Application for permission to conduct clinical trials for New Drug/ Investigational New Drug.
122DAA. [ [Omitted 'Definition of Clinical trial. - For the purpose of this Part, 'Clinical trial' means a systematic study of new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and/or adverse effects with the objective of determining safety and/or efficacy of the new drug.' by Notification No. G.S.R. 826(E), dated 30.10.2015 (w.e.f. 21.12.1945).]
* * *]122DAB. [ Compensation in case of injury or death during clinical trial. [Inserted by Notification No. G.S.R. 53(E) dated 30.1.2013 (w.e.f. 21.12.1945)]
122DC. Appeal.
- Any person aggrieved by an order passed by the licensing authority under this Part, may within sixty days from the date of such order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as is considered necessary, pass such order in relation thereto as it thinks fit.]122DD. [ Registration of Ethics Committee. [Inserted by Notification No. G.S.R. 72 (E) dated 8.2.2013 (w.e.f. 21.12.1945)]
122E. Definition of new drug.
- For the purpose of this part, new drug shall mean and include-122EA. [ Definitions. [Inserted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).]
122F. Form of application for license for operation of Blood Bank/processing of whole human blood for components/manufacture of blood products for sale or distribution.
122G. Form of license for the operation of a Blood Bank/processing of whole human blood for components and manufacture of blood products and the conditions for the grant or renewal of such license.
- [(1)] [Renumbered as sub-Rule (1) thereof by G.S.R. 733(E), dated 21.12.2005 (w.e.f. 21.12.2005).] A license for the operation of a blood bank or for processing whole human blood for components and manufacture of blood products shall be issued in [Form 28-C or Form 28-E or Form 26-G or Form 26-I, as the case may be] [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).]. Before a license in [Form 28-C or Form 28-E or Form 26-G or Form 26-I, as the case may be,] [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).] is granted or renewed the following conditions shall be complied with by the applicant:-(i)[ The operation of blood bank and/or processing of whole human blood for components shall be conducted under the active direction and personal supervision of competent technical staff consisting of at least one person who is whole-time employee and who is Medical Officer, and possessing- [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).](a)Post-graduate degree in Medicine-M.D. (Pathology/Transfusion Medicines); or(b)Degree in Medicine (M.B.B.S.) with Diploma in Pathology or Transfusion Medicines having adequate knowledge in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components; or(c)Degree in Medicine (M.B.B.S.) having experience in Blood Bank for one year during regular service and also has adequate knowledge and experience in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components, the degree or diploma being from a University recognized by the Central Government.Explanation. - For the purposes of this condition, the experience in Blood Bank for one year shall not apply in the case of persons who are approved by the licensing authority and/or Central License Approving Authority prior to the commencement of the Drugs and Cosmetics (Second Amendment) Rules, 1999.](ii)The applicant shall provide adequate space, plant and equipment for any or all the operations of blood collection or blood processing. The space, plant and equipment required for various operations is given in Schedule F, Part XII-B and/or XII-C.(iii)The applicant shall provide and maintain adequate technical staff as specified in Schedule F, Part XII-B and/or XII-C.(iv)The applicant shall provide adequate arrangements for storage of whole human blood, human blood components and blood products.(v)The applicant shall furnish to the licensing authority, if required to do so, data on the stability of whole human blood, its components or blood products which are likely to deteriorate, for fixing the date of expiry which shall be printed on the labels of such products on the basis of the data so furnished.122H. Duration of license.
- An original license in [Form 28-C or Form 28-E or a renewed license in Form 26-G or Form 26-I] [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).] unless sooner suspended or canceled shall be [valid for a period of five years on and from the date on which] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).] it is granted or renewed.122I. Inspection before grant or renewal of license for operation of Blood Bank, processing of whole human blood for components and manufacture of blood products.
- Before a license in [Form 28-C or Form 28-E is granted or a renewal of license in Form 26-G or Form 26-I is made, as the case may be] [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).], the licensing authority or the Central License Approving Authority, as the case may be, shall cause the establishment in which blood bank is proposed to be operated/whole human blood for components is processed/blood products are manufactured to be inspected by one or more inspectors, appointed under the Act and/or along with the Expert in the field concerned. The Inspector or Inspectors shall examine all portions of the premises and appliances/equipments and inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for operation of blood bank/processing of whole human blood for components/manufacture of blood products together with their testing facilities and also enquire into the professional qualification of the expert staff and other technical staff to be employed.122J. Report by Inspector.
- The Inspector or Inspectors shall forward a detailed descriptive report giving his findings on each aspect of inspection along with his recommendation in accordance with the provisions of rule 122-I to the licensing authority or to the Central License Approving Authority.122K. Further application after rejection.
- If within a period of six months from the rejection of application for a license the applicant informs the licensing authority that the conditions laid down have been satisfied and deposits an inspection [fee of rupees two hundred and fifty ] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).]the licensing authority may, if after causing further inspection to be made is satisfied that the conditions for the [grant or renewal of a license have been complied with, shall grant or renew the license in Form 28-C or Form 28-E:Provided that in the case of a drug notified by the Central Government under rule 68-A, the application, together with the inspection report and the Form of licenses (in triplicate to be granted or renewed), duly completed shall be sent, to the Central License Approving Authority, who may approve the same and return it to the licensing authority for issue of the license.] [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).]122L. Delegation of powers by the Central License Approving Authority.
- The Central License Approving Authority may, with the approval of the Central Government, by notification delegate his powers of signing license and any other power under rules to persons under his control having same qualifications as prescribed for controlling authority under rule 50-A, for such areas and for such periods as may be specified.122M. Provision for appeal to the State Government by a party whose license has not been granted or renewed.
- Any person who is aggrieved by the order passed by the licensing authority or Central License Approving Authority, as the case may be, may within thirty days from the date of receipt of such order, appeal to the State Government or Central Government, as the case may be, after such enquiry, into the matter as it considers necessary and after giving the said person an opportunity for representing his view in the matter may pass such order in relation thereto as it thinks fit.122N. Additional information to be furnished by an applicant for license or by a licensee to the licensing authority.
- The applicant for the grant of license or any person granted a license under this Part, shall, on demand furnish to the licensing authority, before the grant of the license or during the period the license is in force, as the case may be, documentary evidence in respect of the ownership or occupation, rental or other basis of the premises, specified in the application for license or in the license granted, constitution of the firm or any other relevant matter, which may be required for the purpose of verifying the correctness of the statement made by the applicant or the licensee, while applying for or after obtaining the license, as the case may be.122O. Cancellation and suspension of licenses.
122P. Conditions of license.
- .[A license in Form 28-C, Form 28-E, Form 26-G or Form 26-I shall be subject to the special conditions set out in Schedule F, Part XII-B and Part XII-C, as the case may be, which relate to the substance in respect of which the license is granted or renewed and to the following general conditions, namely:-] [Substituted by G.S.R. 245(E), dated 5.4.1999 (w.e.f. 5.4.1999).]Part XI – Exemptions
123. Exemptions.
- The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the rules made thereunder to the extent and subject to the conditions specified in that Schedule.Part XII – Standards
124. [ Standards of drugs. [Substituted by G.S.R. 19, dated 15.12.1977 (w.e.f. 7.1.1978).]
124A. [ [Omitted 'Standards for veterinary drugs. - For drugs intended for veterinary use, the standards shall be those given in the current edition for the time being in force of the British Pharmacopoeia (Veterinary)' by Notification No. G.S.R. 103(E), dated 2.2.2017 (w.e.f. 21.12.1945).]
* * *] .124B. [ Standards for patent or proprietary medicines. [Inserted by G.S.R. 665, dated 6.5.1977 (w.e.f. 28.5.1977).]
- The standards for patent or proprietary medicines shall be those laid down in Schedule V and such medicines shall also comply with the standards laid down in the Second Schedule to the Act.]124C. [ Standards for Surgical Dressings. [Inserted by G.S.R. 318(E), dated 1.5.1984 (w.e.f. 1.5.1984).]
- The standards for Surgical Dressings shall be such as are laid down in Schedule F(II).]124D. [ Standards for Sterilised Umbilical tapes. [Inserted by G.S.R. 1115(E), dated 30.9.1986 (w.e.f. 30.9.1986).]
- The standards for sterilised umbilical tapes shall be as laid down in Schedule F(III).]125. [ Standards for substances (other than food) intended to affect the structure or any function of human body-Contraceptives. [Substituted by S.O. 886, dated 8.3.1966 (w.e.f. 26.3.1966).]
125A. [ Standards for Medical Devices. [Inserted by G.S.R. 109(E), dated 22.2.1994 (w.e.f. 22.2.1994).]
- The standards for the Medical Devices shall be such as are laid down in Schedule R-I.]126. [ Standards for substances intended to be used for the destruction of vermin or insects which cause disease in human beings or animals- [Substituted by S.O. 400, dated 24.1.1964 (w.e.f. 1.2.1964).]
[* * *][Disinfectants. - The standards for disinfectants shall be such as are laid down in Schedule O.] [Substituted by S.O. 400, dated 24.1.1964 (w.e.f. 1.2.1964).]126A. [ Standards for ophthalmic preparations [including Homeopathic ophthalmic preparations.] [Inserted by S.O. 23, dated 23.12.1969 (w.e.f. 3.1.1970).]
- [The standards for ophthalmic preparations [including Homeopathic ophthalmic preparations] [Inserted by S.O. 23, dated 23.12.1969 (w.e.f. 3.1.1970).][shall be those laid down in Schedule FF, and such preparations shall also comply with the standards set out in the Second Schedule to the Act.] [Inserted by S.O. 23, dated 23.12.1969 (w.e.f. 3.1.1970).]127. [ List of colours permitted to be used in drugs. [Substituted by S.O. 289, dated 20.12.1972 (w.e.f. 3.2.1973).]
| Common name of the colour | Colour Index Number | Chemical Name |
| 1 | 2 | 3 |
| GREEN | ||
| Quinazarine Green SS | 61565 | 1, 4-bis (p-Toluino)-anthraquinone. |
| Alizarin Cyanine Green F | 61570 | Disodium salt of 1, 4-bis (O-sulfo-p-toluino) anthraquinone. |
| [Fast Green FCF[Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).]| [42053 [Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).] | [Disodium salt of 4-{[4-(N-ethyl-p-sulfobenzylamino(-phenyl-]-(4-hydroxy-2-sulfoniumphenyl)-methylene}[1-N-ethyl-N-p-sulfobenzyl-1-A 2,5-cyclohexadienimine] [Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).] | |
| [***] [Entries omitted by G.S.R. 753(E), dated 4.11.1999 (w.e.f. 4.11.1999).]YELLOW | ||
| Tartrazine | 19140 | Trisodium salt of3-carboxy-5-hydroxy-1-p-sulfogpheny 1-4-psulfophenyl asopyrazole. |
| Sunset Yellow FCF | 15985 | Discodium salt of 1-p-sulfophenyl-azo-2-naphthol-6-sulfonic acid. |
| [Quinoline Yellow WS[Substituted by G.S.R. 11(E), dated 7.1.1991 (w.e.f. 7.1.1991).]| [47005 [Substituted by G.S.R. 11(E), dated 7.1.1991 (w.e.f. 7.1.1991).] | [Discodium salt of disulfonic acid of 12-(2-quinolyl)-1,3-indandione.] [Substituted by G.S.R. 11(E), dated 7.1.1991 (w.e.f. 7.1.1991).] | |
| RED[***] [Entries omitted by G.S.R. 753(E), dated 4.11.1999 (w.e.f. 4.11.1999).] | ||
| Erythrosine | 45430 | Disodium salt of9-0-carboxphenyl-6-hydroxy 2,4,5,7-tetraiod-3-isoxanthone. |
| Eosin YS or Eosine G | 45380 | Disodium salt of 2,4,5,7-Tetrabrome-9-p-carboxphenyl-6-hydroxy-3-isoxanthone. |
| Toney Red or Sudan III | 26100 | 1-p-phenylazophenylazo-2-naphthol. |
| Ponceau 4 R | 16255 | Trisodium salt of 1-(4-sulpho-1-1naphthyazo)-2-napthol-6:8-disulphonic acid. |
| Carmoisine | 14720 | Disodium salt of 2-(4-sulpho-1-naph-thylazo)-1-naphthol-4-sulphonic acid. |
| ***BLUE | ||
| Indigo Carmine | 73015 | Disodium salt of indigotin-5:-5'Disulphonic acid. |
| [Brillium Blue FCF[Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).]| [42090 [Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).] | [Disodium salt of 4-{[4-(N-ethyl-p-sulphobenzylamino-phenyl-(2-sulphoniumphenyl)-methylene]-1-(N-ethyl-N-p-sulphobenzyl)-∆2,5-cycolhexa-dienomine.] [Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).] | |
| ***ORANGE | ||
| Orange G | 16230 | Disodium salt on 1-phenylazo-2-naphthol 6,8-disulfonic acid. |
| BROWN | ||
| Resorcin Brown | 20170 | Monosodium salt of 4-p-sulfophenylazo 2-(2,4-xylozo)-1,3-resorcinol. |
| BLACK | ||
| Naphthol Blue Black | 20470 | Disodium salt of 8-amino-7-p-nitrophenylazo-2-phenylazo-naphthol-3,6-disulfonic acid. |
128. Repeal of certain rules.
- The following rules are hereby repealed except as respects things done or omitted to be done under those rules, namely:-Andhra Pradesh Drugs Rules, 1945.Assam Drugs Rules, 1945.Bihar Drugs Rules, 1945.Bombay Drugs Rules, 1946.East Punjab Drugs Rules, 1945.C.P. & Berar Drugs Rules, 1945.Madras Drugs Rules, 1945.Orissa Drugs Rules, 1945.Rajasthan Drugs Rules, 1953.Saurashtra Drugs Rules, 1953.Travancore-Cochin Drugs Rules, 1953.United Provinces Drugs Rules, 1945.West Bengal Drugs Rules, 1946.[Mysore Drugs Rules, 1954.] [Added by Notification No. F.1-37/58-D, dated 21.7.1958.][Part XIII] [Inserted by G.S.R. 1183, dated 17.8.1964 (w.e.f. 22.8.1964).] [Import and Registration of Cosmetics] [Substituted for the words "Import of Cosmetics" by Notification No. G.S.R. 426 (E) dated 19.5.2010 (w.e.f. 1.4.2011)]129. [ Registration of cosmetic products imported into the country. [Substituted by Notification No. G.S.R. 426 (E) dated 19.5.2010 (w.e.f. 1.4.2011)]
- No cosmetic shall be imported into India unless the product is registered under the rules by the licensing authority appointed by the Central Government under rule 21 or by any person to whom such powers may be delegated under rule 22.129A. Form and manner of application for Registration Certificate.
129B. Registration Certificate for the import of cosmetics manufactured by one manufacturer.
- A single application may be made and a single Registration Certificate in Form 43 may be Issued in respect of import of one or more than one cosmetics manufactured by the same manufacturer:Provided that the cosmetics are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit.129C. Grant of Registration Certificate.
129D. Duration of Registration Certificate.
- A Registration Certificate, unless it is sooner suspended or canceled, shall be valid for a period of three years from the date of its issue:Provided that if application for a fresh Registration Certificate is made within six months before the expiry of the said certificate, the existing Registration Certificate shall be deemed to continue to remain in force until orders are passed on the application.129E. Suspension and cancellation of Registration Certificate.
- If the manufacturer fails to comply with any of the conditions of the Registration Certificate, the licensing authority may after giving him an opportunity to show cause why such an order should not be passed, by an order in writing, stating the reasons therefor, suspend or cancel the Registration Certificate for such period as it thinks fit either wholly or in respect of some of the cosmetics to which it relates:Provided that a person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government and the Central Government may after such enquiry into the matter as it considers necessary and after giving the said appellant an opportunity of being heard pass orders as it thinks fit.129F. Prohibition of import of certain cosmetic.
- No cosmetic, the manufacture, sale or distribution of which is prohibited in the county of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.129G. Standard for imported cosmetics.
- No cosmetic shall be imported unless it complies with the specifications prescribed under Schedule 5 and Schedule Q or any other standards of quality and safety, applicable to it, and other provisions under the rules. In case the cosmetic is not included under Schedule 5, it shall meet with specifications under the rules and standards applicable to it in the country of origin.129H. Labelling and Packing of Cosmetics.
- No cosmetic shall be imported unless it is packed and labelled in conformity with the rules in Parts XV. Further the label of imported cosmetics shall bear registration certificate number of the product and the name and address of the registration certificate holder for marketing the said product in India.]130. Documents to be supplied to the Collector of Customs.
- Before any cosmetics are imported, a declaration signed by or on behalf of the manufacturer or by or on behalf of the importer that the cosmetics comply with the provisions of Chapter III of the Act, and the rules made thereunder, shall be supplied to the Collector of Customs.131. Procedure for the import of cosmetics.
132. Exemption of cosmetics.
- Cosmetics as may be specified in Schedule D shall be exempted from the provisions of Chapter III of the Act and the rules made thereunder to the extent and subject to the conditions specified in that Schedule.133. Import through points of entry.
- No cosmetic shall be imported into India except through the points of entry specified in rule 43-A.134. [ Cosmetic to contain dyes, colours and pigments. [Substituted by G.S.R. 811(E), dated 14.11.1994 (w.e.f. 14.11.1994).]
- No cosmetic shall contain dyes, colours and pigments other than those specified by the Bureau of Indian Standards (IS: 4707, Part I as amended) and Schedule Q.The permitted synthetic organic colours and natural organic colours used in the cosmetic shall not contain more than-134A. [ Prohibition of import of cosmetics containing hexachlorophene. [Inserted by G.S.R. 116, dated 15.1.1975 (w.e.f. 25.1.1975).]
- No cosmetic containing hexachlorophene shall be imported.]135. Import of cosmetics containing lead or arsenic compound prohibited.
- No cosmetics shall be imported in which a lead or arsenic compound has been used for purposes of colouring.135A. [ [Substituted by Notification No. G.S.R. 56(E), dated 19.1.2017 (w.e.f. 21.12.1945).]
Regulation of import of cosmetics containing mercury. Cosmetics imported into India shall contain mercury in the following proportion, namely;| [135-A. Import of cosmetics containing mercury compounds prohibited. [Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).]- No cosmetic shall be imported which contains mercury compounds.] |
135B. [ Prohibition of import of cosmetics tested on animals. [Inserted by Notification No. G.S.R. 718 (E) dated 13.10.2014 (w.e.f. 21.12.1945)]
- No cosmetic that has been tested on animals after the commencement of the Drugs and Cosmetics (Fifth Amendment) Rules, 2014 shall be imported into the country.]136. Import of cosmetics for personal use.
- Small quantities of cosmetics the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions:Part XIV – Manufacture Of Cosmetics For Sale [Or For Distribution] [Inserted By G.S.R. 788(E), Dated 10.10.1985 (W.E.F. 10.10.1985).]
137. Manufacture on more than one set of premises.
- If cosmetics are manufactured on more than one premises, a separate application for each such premises shall be made and a separate license obtained for each such premises.138. Application for license to manufacture cosmetics [for sale or for distribution] [Inserted by G.S.R. 788(E), dated 10.10.1985 (w.e.f. 10.10.1985).].
- . [(1) Application for grant [*] [Substituted by G.S.R. 245, dated 3.2.1976 (w.e.f. 21.2.1976).] of [license to manufacture cosmetics for sale or for distribution] [Substituted by G.S.R. 788(E), dated 10.10.1985 (w.e.f. 10.10.1985).] [shall be made upto ten items of each category of cosmetics categorized in Schedule M-II to the licensing authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as licensing authority) in Form 31 and shall be accompanied by a license fee of rupees two thousand and five hundred and an inspection fee of rupees one thousand for every inspection thereof [*] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).].][* * *] [Proviso to sub-Rules (1), (2) and (3) omitted by G.S.R. 331(E), dated 8.5.1984 (w.e.f. 8.5.1984).][***] [Omitted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).][* * *] [Proviso to sub-Rules (1), (2) and (3) omitted by G.S.R. 331(E), dated 8.5.1984 (w.e.f. 8.5.1984).]138A. [ Application for loan license to manufacture cosmetics. [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).]
139. Condition for the grant [***] [Omitted 'or renewal' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).] of a license in Form 32.
- Before a license in Form 32 is granted [***] [Omitted 'or renewed' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).], the following conditions shall be complied with by the applicant:-139A. [ Form of license to manufacture cosmetics for sale [or for distribution] [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).][. [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).]
- A license to manufacture cosmetics for sale [or for distribution][against application in Form 31, shall be granted in Form 32.] [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).]139AA. [ Inspection before grant [***] [Inserted by G.S.R. 493(E), dated 9.6.1995 (w.e.f. 9.6.1995) as corrected by G.S.R. 184(E), dated 12.4.1996.] of license.
- Before a license under this Part is granted [***] [Omitted 'or renewed' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).] in Form 32, Form 32-A or Form 33, the licensing authority shall cause the establishment, in which the manufacture is proposed to be conducted or being conducted, to be inspected by one or more Inspectors appointed under the Act. The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardizing and testing the substances to be manufactured and inquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the requirements of plant and equipment as laid down in Schedule M-II read with the requirements of maintenance of records as laid down in Schedule U(I).139AB. Report by Inspector.
- The Inspector or Inspectors shall forward a detailed descriptive report giving his or their findings on each aspect of inspection along with his or their recommendations after completion of his or their inspection to the licensing authority.139AC. Grant or refusal of license.
139AD. Further application after rejection.
- If within a period of six months from the rejection of an application for a license, the applicant informs the licensing authority that the conditions laid down have been fulfillled and deposits an inspection [fee of rupees two hundred and fifty] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).][, the licensing authority may, if, after causing further inspection to be made, he is satisfied that the conditions for the grant of license have been complied with, issue a license in Form 32, Form 32-A or Form 33.139AE. Appeal to the State Government.
- Any person who is aggrieved by the order passed by the licensing authority refusing to grant [***] [Omitted 'or renew' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).] a license under this Part may, within ninety days from the date of receipt of such order, appeal to the State Government and the State Government may, after such enquiry into the matter as is considered necessary and after giving the said person an opportunity for representing the case, pass such order as it thinks fit.] [Inserted by G.S.R. 493(E), dated 9.6.1995 (w.e.f. 9.6.1995) as corrected by G.S.R. 184(E), dated 12.4.1996.]139B. [ Form of loan license to manufacture cosmetics for sale [or for distribution] [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).][. [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).]
- A loan license to manufacture cosmetics for sale [or for distribution] [against application in Form 31-A shall be granted in Form 32-A.] [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).]140. [ Duration of licence. [Substituted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).]
| 141. Certificate of renewal.- The certificate of renewal of a license in Form 32 shall be issued in Form 33.141A. [ Certificate of renewal of loan license. [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).]- The certificate of renewal of a license in Form 32-A shall be issued in Form 33-A.141AA. Duration of a loan license.- An original loan license in Form 32-A or a renewed loan license in Form 33-A, unless sooner suspended or canceled, shall be[valid for a period of five years on and from the date on which][it is granted or renewed:Provided that if the application for the renewal of a license is made before its expiry, or if the application is made within six months of its expiry after payment of the additional fee, the license shall continue to be in force until orders are passed on the application. The license shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.] [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).] |
142. Conditions of license.
- A license in Form 32 shall be subject to the conditions stated therein and to the following other conditions, namely:-142A. [ Additional information to be furnished by an applicant for license or a licensee to the licensing authority. [Inserted by S.O. 2139, dated 5.6.1972 (w.e.f. 12.8.1972).]
- The applicant for the grant of a license or any person granted a license under this Part shall, on demand, furnish to the licensing authority, before the grant of the license or during the period the license is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises, specified in the application for license or in the license granted, constitution of the firm, or any other relevant matter, which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee while applying for or after obtaining the license as the case may be.]142B. [ Conditions of license in Form 32-A. [Inserted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).]
143. Cancellation and suspension of license.
143A. [ Inspection for grant of licence and verification of compliance. [Inserted by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).]
144. [ Prohibition of manufacture of cosmetics containing colours other than those prescribed. [Substituted by G.S.R. 811(E), dated 14.11.1994 (w.e.f. 14.11.1994).]
- No cosmetics shall be manufactured which contains dyes, colours and pigments other than the one specified by the Bureau of Indian Standards (IS: 4707 Part I as amended) and Schedule Q.The permitted synthetic organic colours and natural organic colours used in the cosmetic shall not contain more than-144A. [ Prohibition of manufacture of cosmetic containing hexachloro-phene. [Added by G.S.R. 116, dated 15.1.1975 (w.e.f. 26.1.1975).]
- No cosmetic containing hexachlorophene shall be manufactured:][Provided that in the case of soaps hexachlorophene may be used in concentrations not exceeding one per cent weight by weight:Provided further that the following cautionary note shall be printed and shall appear in a conspicuous manner on the wrapper of package of each soap, namely:-"Contains hexachlorophene-not to be used on babies".] [Inserted by G.S.R. 1049(E), dated 29.8.1986 (w.e.f. 29.8.1986).]145. Use of Lead and Arsenic compounds for the purpose of colouring cosmetics prohibited.
- The use of Lead and Arsenic compounds for the purpose of colouring cosmetics is prohibited.145A. [ Form of intimation for purposes of taking samples of cosmetics. [Added by S.O. 2139, dated 5.6.1972 (w.e.f. 12.8.1972).]
- Where an Inspector takes a sample of a cosmetic for the purpose of test or analysis, he shall intimate such purpose in writing in Form 17 to the person from whom he takes it.]145AA. [ Form of receipt of samples of cosmetics where fair price tendered is refused. [Inserted by G.S.R. 292(E), dated 29.5.1997 (w.e.f. 29.5.1997).]
- Where the fair price, for the samples of cosmetics taken for the purpose of test or analysis, tendered under sub-section (1) of section 23 has been refused, the Inspector shall tender a receipt therefor to the person from whom the said samples have been taken as specified in Form 17-A.]145B. [ Form of receipt for seized cosmetics. [Added by S.O. 2139, dated 5.6.1972 (w.e.f. 12.8.1972).]
- A receipt by an Inspector for the stock of any cosmetics seized under clause (c) of sub-section (1) of section 22 of the Act, shall be in Form 16.]145BA. [ Manner of certifying copies of seized documents. [Inserted by G.S.R. 89(E), dated 16.2.1985 (w.e.f. 16.2.1985).]
- The Drugs Inspector shall return the documents seized by him under clause (cc), or produced before him under clause (cca), of sub-section (1) of section 22 of the Act, within a period of twenty days of the date of such seizure or production, to the person from whom they were seized or, as the case may be, the person who produced them, after copies thereof or extracts therefrom have been signed by the concerned Drugs Inspector concerned and the person from whom they were seized, or, as the case may be, who produced such records.]145C. [ Form of order not to dispose of stocks of cosmetics. [Inserted by G.S.R. 1594, dated 28.10.1976 (w.e.f. 13.11.1976).]
- An order in writing by an Inspector under clause (c) of sub-section (1) of section 22 of the Act requiring a person not to dispose of any stock of cosmetics in his possession shall be in Form 15.]145D. [ [Substituted by Notification No. G.S.R. 56(E), dated 19.1.2017 (w.e.f. 21.12.1945).]
Regulation of use of mercury compounds in cosmetics. Cosmetics manufactured in the country shall contain mercury in the following proportions, namely,-| [145-D. Prohibition of manufacture of cosmetics containing mercury compounds. [Inserted by G.S.R. 1074, dated 19.8.1978 (w.e.f. 2.9.1978).]- No cosmetic containing mercury compounds shall be manufactured] |
Part XV – [LABELLING, PACKING AND STANDARDS OF COSMETICS] [Substituted by S.O. 3408, dated 1.11.1966.]
146. Prohibition of sale or distribution.
- Subject to the other provisions of these rules, no person shall sell or distribute any cosmetic unless the cosmetic, if of Indian origin, is manufactured by a licensed manufacturer and labelled and packed in accordance with these rules.147. [ Exemption of cosmetics not manufactured for consumption or sale in India from the provisions of this Part. [Substituted by G.S.R. 682(E), dated 5.12.1980 (w.e.f. 5.12.1980).]
- Labels on packages or containers of cosmetics not manufactured for consumption or sale in India shall be adapted to meet the specific requirements, if any, of the consignee:Provided that where a cosmetic is required by the consignee to be not labelled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the licensing authority mentioned in rule 21.]148. Manner of labelling.
- Subject to other provisions of the rules, a cosmetic shall carry-148A. [ Prohibition against altering inscriptions on containers, labels or wrappers of cosmetics. [Inserted by G.S.R. 351(E), dated 26.4.2000 (w.e.f. 26.4.2000).]
- No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any cosmetic:Provided that nothing in this rule shall apply to any alteration, inscription or mark made on the container, label or wrapper of any cosmetic at the instance or direction or with the permission of the licensing authority.]148B. [ Prohibition against false or misleading claims. [Inserted by G.S.R. 46(E), dated 22.1.2009 (w.e.f. 22.7.2009).]
- No cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user.]148C. [ [Inserted by G.S.R. 346(E), dated 21.5.2014 (w.e.f. 21.12.1945).]
prohibition of testing of cosmetics on animals - No person shall use any animal for testing of cosmetics.]149. [ Labelling of hair dyes containing dyes, colours and pigments. [Substituted by G.S.R. 811(E), dated 14.11.1994 (w.e.f. 14.11.1994).]
- Hair dyes containing Para-Phenylenediamine or other dyes, colours and pigments] shall be labelled with the following legend in English and local languages and these shall appear on both the inner and the outer labels."Caution . - This product contains ingredients which may cause skin irritation in certain cases and so a preliminary test according to the accompanying directions should first be made. This product should not be used for dyeing the eyelashes or eyebrows; as such a use may cause blindness."Each package shall also contain instructions in English and local languages on the following lines for carrying out the test:-"This preparation may cause serious inflammation of the skin in some cases and so a preliminary test should always be carried out to determine whether or not special sensitivity exists. To make the test, cleanse a small area of skin behind the ear or upon the inner surface of the forearm, using either soap and water or alcohol. Apply a small quantity of the hair dye as prepared for use to the area and allow it to dry. After twenty-four hours, wash the area gently with soap and water. If no irritation or inflammation is apparent, it may be assumed that no hypersensitivity to the dye exists. The test should, however, be carried out before each and every application. This preparation should on no account be used for dyeing eyebrows or eyelashes as severe inflammation of the eye or even blindness may result".149A. [ Special provisions relating to toothpaste containing fluoride. [Inserted by G.S.R. 223(E), dated 19.4.1991 (w.e.f. 19.4.1991).]
- (i) Fluoride content in toothpaste shall not be more than 1000 ppm and the content of fluoride in terms of ppm shall be mentioned on the tube and carton.]150. Report of result of test or analysis of cosmetics.
- Test reports on samples of cosmetics taken for test or analysis under these rules shall be supplied in Form 34.150A. [ Standards for cosmetics. [Inserted by G.S.R. 510(E), dated 26.7.1982 (w.e.f. 26.7.1982).]
- Subject to the provisions of these rules, the standards for cosmetics shall be such as may be prescribed in Schedule S.][Part XV(A)] [Inserted by G.S.R. 1172, dated 23.8.1977 (w.e.f. 10.9.1977).] Approval Of Institutions For Carrying Out Tests On Drugs, Cosmetics And Raw Materials Used In Their Manufacture On Behalf Of Licensees For Manufacture For Sale Of Drugs/cosmetics150B. Application for grant of approval for testing drugs/cosmetics.
150C. Form in which approval to be granted for carrying out tests on drugs/cosmetics on behalf of licensees for manufacture of drugs/cosmetics and conditions for grant [***] [Omitted 'or renewal' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).] of such approval.
150E. Conditions of approval.
- An approval in Form 37 shall be subject to the following general conditions:-150F. Inspection before grant of approval.
- Before an approval in Form 37 is granted, the approving authority shall cause the institution at which the testing of drugs or cosmetics, as the case may be, is proposed to be carried out to be inspected jointly by the Drugs Inspectors of the Central Drugs Standard Control Organisation and the State Drugs Control Organisation who shall examine the premises and the equipment intended to be used for testing of drugs or cosmetics and inquire into the professional qualifications of the expert staff to be employed.150G. Report of inspection.
- The Drug Inspectors mentioned in rule 150-F shall forward to the approving authority a detailed report of the results of the inspection.150H. Procedure of approving authority.
150I. Further application after rejection.
- If within a period of six months from the rejection of an application for approval, the applicant informs the approving authority that the conditions laid down have been satisfied and deposits inspection fee of [rupees two hundred and fifty] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).], the approving authority may, if, after causing a further inspection to be made, he is satisfied that the conditions for grant of approval have been complied with, grant the approval in Form 37.150J. Renewal.
- On an application being made for renewal the approving authority may cause an inspection to be made and if satisfied that the conditions of the approval and the rules made under the Act are and shall continue to be observed, shall issue a certificate of renewal in Form 38.150K. Withdrawal and suspension of approvals.
151. Manufacture on more than one set of premises.
- If Ayurvedic (including Siddha) or Unani drugs are manufactured on more than one set of premises, a separate application shall be made and a separate license shall be obtained in respect of each such set of premises.152. Licensing authorities.
- For the purpose of this Part the State Government shall appoint such licensing authorities and for such areas as may be specified in this behalf by notification in the Official Gazette.153. Application for license to manufacture Ayurvedic (including Siddha) or Unani drugs.
- (i) An application for the grant or renewal of a license to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 24-D to the licensing authority alongwith [a fee of rupees one thousand] [Substituted by G.S.R. 79(E), dated 14.2.2005 (w.e.f. 18.2.2005).]:Provided that in the case of renewal the applicant may apply for the renewal of the license before its expiry or within one month of such expiry:Provided further that the applicant may apply for renewal after the expiry of one month but within three months of such expiry in which case [the fee payable for renewal of such license shall be rupees one thousand and two hundred plus an additional fee of rupees six hundred] [Substituted by G.S.R. 79(E), dated 14.2.2005 (w.e.f. 18.2.2005).].153A. [ Loan license. [Added by G.S.R. 376(E), dated 20.7.1978 (w.e.f. 20.7.1978).]
- (i) An application for the grant or renewal of a loan license to manufacture for sale of any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 25-E to the licensing authority alongwith [a fee of rupees six hundred].[ Explanation. - For the purpose of this rule, a loan license means a license which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but intends to avail himself of the manufacturing facilities owned by a licensee in Form 25-D:Provided that in the case of renewal the applicant may apply for the renewal of the license before its expiry or within one month of such expiry:Provided further that the applicant may apply for renewal after the expiry of one month, but within three months of such expiry in which case [the fee payable for renewal of such license shall be rupees six hundred plus an additional fee of rupees three hundred] [Added by G.S.R. 376(E), dated 20.7.1978 (w.e.f. 20.7.1978).].154. Form of license to manufacture Ayurvedic (including Siddha) or Unani drugs.
154A. [ Form of loan license to manufacture for sale of Ayurvedic (including Siddha) or Unani drugs. [Inserted by G.S.R. 376(E), dated 20.7.1978 (w.e.f. 20.7.1978).]
155. Certificate of renewal.
- The certificate of renewal of a license in Form 25-D shall be issued in Form 25-D.155A. [ Certificate of renewal of a loan license. [Inserted by G.S.R. 198(E), dated 7.3.2003 (w.e.f. 7.3.2003).]
- The certificate of renewal of a loan license in Form 25-E shall be issued in Form 26-E.]155B. [ Certificate of award of Good Manufacturing Practices of Ayurveda, Siddha and Unani Drugs. [Substituted by G.S.R. 79(E), dated 14.2.2005 (w.e.f. 18.2.2005).]
- The certificate of Good Manufacturing Practices (GMP) to manufacturers of Ayurveda, Siddha or Unani drugs shall be issued [for a period of five years] to licensees who comply with the requirements of Good Manufacturing Practices (GMP) of Ayurveda, Siddha and Unani drugs as laid down in Schedule T.]156. Duration of license.
- An original license in Form 25-D or a renewed license in Form 26-D, unless sooner suspended or canceled, shall be [valid for a period of [five years] [Substituted by G.S.R. 79(E), dated 14.2.2005 (w.e.f. 18.2.2005).] from the date of its issue] or renewal:Provided that if the application for the renewal of a license is made before its expiry or within one month of its expiry, or if the application is made within three months of its expiry after payment of the [additional fee of rupees five hundred] [Substituted by G.S.R. 79(E), dated 14.2.2005 (w.e.f. 18.2.2005).], the license shall continue to be in force until orders are passed on the application. The license shall be deemed to have expired, if application for its renewal is not made within three months of its expiry.156A. [ Duration of loan license. [Inserted by G.S.R. 376(E), dated 20.7.1978 (w.e.f. 20.7.1978).]
- An original loan license in Form 25-E or a renewed loan license in Form 26-E, unless sooner suspended or canceled, shall be [valid for a period of [five years] from the date of its issue][or renewal:Provided that if the application for the renewal of a loan license is made in accordance with rule 153-A, the loan license shall continue to be in force until orders are passed on the application. The license shall be deemed to have expired, if application for its renewal is not made within three months of its expiry.] [Inserted by G.S.R. 376(E), dated 20.7.1978 (w.e.f. 20.7.1978).]157. Conditions for the grant or renewal of a license in Form 25-D.
- Before a license in Form 25-D is granted or renewed in Form 26-D, the following conditions shall be complied with by the applicant, namely:-157A. [ Maintaining of records of raw material used by licensed manufacturing unit of Ayurveda, Siddha and Unani drugs in the preceding financial year. [Inserted by G.S.R. 512(E), dated 9.7.2008 (w.e.f. 9.7.2008).]
- Each licensed manufacturing unit of Ayurveda or Siddha or Unani drugs shall keep a record of raw material used by each licensed manufacturing unit of Ayurveda, Siddha or Unani drugs (sic as) the case may be in the proforma given in Schedule T-A in respect of all raw materials utilised by that unit in the manufacture of Ayurveda or Siddha or Unani drugs in the preceding financial year, and shall submit the same by the 30th day of June of the succeeding financial year to the State Drug Licensing Authority of Ayurveda, Siddha and Unani drugs and to the National Medicinal Plants Board or any agency nominated by the National Medicinal Plant Board for this purpose.]158. Conditions of license.
- A license in Form 25-D shall be subject to the conditions stated therein and to the following further conditions, namely:-158A. [ Conditions of loan license. [Inserted by G.S.R. 376(E), dated 20.7.1978 (w.e.f. 20.7.1978).]
- A license in Form 25-E shall be subject to the following further conditions, namely:-158B. [ Guidelines for issue of license with respect to Ayurveda, Siddha or Unani drugs. [Inserted by Notification No. G.S.R. 663 (E) dated 10.8.2010 (w.e.f. 21.12.1945)]
- I.(A) Ayurveda, Siddha Unani Medicines under section 3(a):-Ayurveda, Siddha or Unani drugs includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine, as specified in the First Schedule;| Serial number | Category | Ingredient(s) | Indication(s) | Safety study | Experience/Evidence of Effectiveness | |
| (1) | (2) | (3) | (4) | (5) | (6) | |
| Published Literature | Proof of Effectiveness | |||||
| 1. | (A) Ayurveda, Siddha and Unani drugs given in 158-B asreferred in 3(a) | As per text | As per text | Not Required | Required | Not Required |
| 2. | (B) Any change in dosage form of Ayurveda, Siddha and Unanidrugs as described in section 3(a) of the Drugs and CosmeticsAct, 1940 | As per text | As per text | Not Required | Required | Not Required |
| 3. | (C) Ayurveda, Siddha and Unani drugs referred in 3(a) to beused for new indication | As per text | New | Not Required | IF Required | Required |
| Serial number | Category | Ingredient(s) | Indication(s) | Safety study | Experience/Evidence of Effectiveness | |
| (1) | (2) | (3) | (4) | (5) | (6) | |
| Published Literature | Proof of Effectiveness | |||||
| 1. | Patent or Proprietary medicine | As per text | Textual rationale | Not Required | Of Ingredients | *Pilot study as per relevant protocol for Ayurveda, Siddhaand Unani drugs. |
| 2. | Ayurveda, Siddha, Unani drug with any of the ingredients ofSchedule E(1) of The Drugs and Cosmetics Act, 1940. | As per text | Existing | Required | Required | Required |
| SI.no. | Category | Ingredient(s) | Indication(s) | Safety study | Experience/Evidence of Effectiveness | |
| 1. | 2. | 3. | 4. | 5. | 6. | |
| Published Literature | Proof of Effectiveness | |||||
| 1. | (A) Aqueous | As per Text | As per Text | Not Required | Not Required | Not Required |
| 2. | (A1) Aqueous | As per Text | New indication | Not Required | Not Required | Required |
| 3. | (B) Hydro-Alcohol | As per Text | As per Text | Not Required | If Required | Not Required |
| 4. | (B1) Hydro-Alcohol | As specified | New Indication** | Required | If Required | Required |
| 5. | Other than Hydro/Hydro-Alcohol | As specified | As specified | Required Acute, Chronic, Mutagenicity and Teratogenicity | If required | Required |
159. Cancellation and suspension of licenses.
160. Identification of raw materials.
- Raw materials used in the preparation of Ayurvedic (including Siddha) or Unani drugs shall be identified and tested, wherever tests are available for their genuineness, and records of such tests as are carried out for the purpose and the methods thereof shall be maintained.[Part XVI-A] [Inserted by G.S.R. 73(E), dated 31.1.2003 (w.e.f. 31.1.2003). Earlier it was inserted by G.S.R. 701(E), dated 27.9.2001 (w.e.f. 28.9.2001).] Approval Of Institutions For Carrying Out Tests On Ayurvedic, Siddha And Unani Drugs And Raw Materials Used In Their Manufacture On Behalf Of Licensees For Manufacture For Sale Of Ayurvedic, Siddha And Unani Drugs160A. Application for grant of approval for testing Ayurvedic, Siddha and Unani drugs.
- Application for grant or renewal of approval for carrying out tests for identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs or the raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of the said Ayurvedic, Siddha and Unani drugs, shall be made in Form 47 to the licensing authority appointed by the State Government for the purposes of Part XVI, XVII or XVIII of these rules, as the case may be, and referred to as the "approving authority" under this Part and shall be accompanied by an inspection fee of six thousand rupees in respect of the Ayurvedic, Siddha, Unani drugs specified in the books prescribed in First Schedule to the Act:Provided that the applicant shall furnish to the approving authority such additional information as may be required by it in connection with the application in Form 47:Provided further that if the applicant applies for renewal of approval after its expiry but within six months of such expiry, the inspection fee payable shall be six thousand rupees plus an additional inspection fee at the rate of one thousand rupees per month in the case of testing of Ayurvedic, Siddha and Unani drugs specified in First Schedule to the Act.Explanation. - For the purpose of this Part, the words "Ayurvedic, Siddha and Unani drugs" shall also mean and include the raw materials used in the manufacture of Ayurvedic, Siddha and Unani drugs, as the case may be.160B. Form in which approval to be granted for carrying out tests on Ayurvedic, Siddha and Unani drugs on behalf of licensees for manufacture of Ayurvedic, Siddha and Unani drugs and conditions for grant or renewal of such approval.
1. Alcohol determination apparatus complete set.
2. Volatile oil determination apparatus.
3. Boiling point determination apparatus.
4. Melting point determination apparatus.
5. Refractometer.
6. Polarimeter.
7. Viscometer (Outwalds, Redwood viscometer).
8. Tablet disintegration apparatus.
9. Moisture determination apparatus (IC filtrator).
10. U.V. Spectrophotometer.
11. Muffle furnace.
12. Electronic Balance.
13. Hot air oven(s) different range of temperature/vacuum oven.
14. Refrigerator.
15. Glass distillation apparatus/plant.
16. Water supply demineralised exchange equipment/Distillation equipment.
17. Air conditioner.
18. LPG Gas Cylinder with burners.
19. Water bath (temperature controlled).
20. Heating mantle (4) or as required.
21. TLC apparatus with all accessories.
22. Sieves 10 to 120 with sieve shaker.
23. Centrifuge machine.
24. Dehumidifier (where necessary).
25. pH meter.
26. G.L.C. with F.I. detector.
27. Silica crucible.
28. Tablet friability tester.
29. Tablet dissolution tester.
30. Other related equipment, reagents, chemicals and glasswares.
PHARMACOGNOSY SECTION1. Microscope binocular.
2. Dissecting Microscope.
3. Microtome.
4. Chemical balance.
5. Microslide cabinet.
6. Aluminium slide trays.
7. Hot-air oven.
8. Occular Micrometer.
9. Stage Micrometer.
10. Camera Lucida Prism type and mirror type.
11. Hot plates.
12. Refrigerator.
13. LPG Cyclinder with burners.
14. Other related equipments, reagents, glasswares, etc.
Note.- Instruments like HPLC, HPTLC, Atomic Absorption spectrophotometer could be arranged by tie up with other laboratories.MICROBIOLOGY SECTION1. Laminar air flow bench (L.A.F.)
2. B.O.D. Incubator.
3. Plaon incubator.
4. Serological water bath.
5. Oven.
6. Autoclave/Sterilizer.
7. Microscoper (high power).
8. Coloney counter.
9. Other related equipment and reagents.
160C. Duration of approval.
- An approval granted in Form 47 or renewed in Form 49 unless sooner suspended or withdrawn, shall be valid for a period of three years from the date on which it is granted or renewed:Provided that if an application for the renewal of an approval in Form 40 is made before its expiry or if the application is made within six months of its expiry after the payment of the additional inspection fee, the approval shall continue to be in force until orders to the contrary are passed on the application and the approval shall be deemed to have expired if the application for renewal is not made within six months of expiry.160D. Conditions of approval.
- An approval in Form 48 shall be subject to the following conditions, namely:-I. The Institution granted approval under this Part (hereinafter referred to as the approved laboratory) shall provide and maintain adequate staff and adequate premises and equipment as specified in rule 160-B.II. The approved laboratory shall provide proper facilities for storage so as to preserve the properties of the samples to be tested by it.III. The approved laboratory shall maintain records of tests for identity, purity, quality and strength carried out on all samples of Ayurvedic, Siddha and Unani drugs and the results thereof together with the protocols of tests showing the readings and calculation in such form as to be available for inspection and such records shall be retained in the case of substances for which date of expiry date is assigned; for a period of two years from such date of expiry and in the case of other substances, for a period of three years.IV. The approved laboratory shall allow the Inspector appointed under this Act to enter with or without prior notice the premises where the testing is carried out and to inspect the premises and the equipment used for test and the testing procedures employed. The laboratory shall allow the Inspectors to inspect the registers and records maintained under these rules and shall supply to such Inspectors such information as they may require for the purpose of ascertaining whether the provisions of the Act and rules made thereunder have been observed.V. The approved laboratory shall from time to time report to the approving authority any changes in the person-in-charge of testing of Ayurvedic, Siddha and Unani drugs or the expert staff responsible for testing, as the case may be, and any material alterations in the premises or changes in the equipment used for the purposes of testing which have been made since the date of last inspection made on behalf of the approving authority before the grant or renewal of approval.VI. The approved laboratory shall furnish reports of the results of tests or analysis in Form 50.VII. In case any sample of Ayurvedic, Siddha and Unani drug is found on test to be not of standard quality, the approved laboratory shall furnish to the approving authority and the licensing authority of the State where the manufacturer and/or sender of the Ayurvedic, Siddha and Unani drugs is located, a copy of the test report on the sample with the protocols of tests applied.VIII. The approved laboratory shall comply with the provisions of the Act and rules made thereunder and with such further requirements, if any, as may be specified in the rules made from time to time under Chapter IV-A of the Act of which the approving authority has given the approved laboratory not less than four months' notice.IX. The approved laboratory shall maintain an inspection book to enable the Inspector to record his impressions or defects noticed.160E. Inspection before grant of approval.
- Before an approval in Form 48 is granted, the approving authority shall cause the laboratory at which the testing of Ayurvedic, Siddha and Unani drugs, as the case may be, is proposed to be carried out to be inspected jointly by the Inspectors appointed or designated by the Central Government and State Government for this purpose, who shall examine the premises and the equipment intended to be used for testing of drugs and verify into the professional qualifications of the expert staff who are or may be employed by the laboratory.160F. Report of inspection.
- The Inspectors appointed by the Central Government as stated in rule 160-E shall forward to the approving authority a detailed report of the results of the inspection.160G. Procedure of approving authority.
160H. Application after rejection.
- If within a period of six months from the rejection of an application for approval, the applicant informs the approving authority that the conditions laid down have been satisfied and deposits inspection fee of two thousand rupees, the approving authority may, if, after causing a further inspection to be made and after being satisfied that the conditions for grant of approval have been complied with, grant the approval in Form 48.160I. Renewal.
- On an application being made for renewal, the approving authority shall, after causing an inspection to be made and if satisfied that the conditions of the approval and the rules made under the Act have been complied with, shall issue a certificate of renewal in Form 49.160J. Withdrawal and suspension of approvals.
161. [Labelling, packing and limit of alcohol ] [Substituted by G.S.R. 904(E), dated 2.11.1992 (w.e.f. 2.11.1992).]
.-(1) There shall be conspicuously displayed on the label of the container or package of an Ayurvedic (including Siddha) or Unani drug, the true list of all the ingredients [with the botanical names of plant based ingredients along with plant part(s) and form of ingredients, in which, these are] [Inserted by Notification No. G.S.R. 844 (E) dated 26.11.2012 (w.e.f. 21.12.1945)] used in the manufacture of the preparation together with the quantity of each of the ingredients incorporated therein and a reference to the method of preparation thereof as detailed in the standard text and Adikarana, as are prescribed in the authoritative books specified in the First Schedule of the Act [and in respect of Patent or Proprietary Ayurveda, Siddha or Unani drugs, the true list of all the ingredients with the botanical names of plant based ingredients along with plant part(s) and form of ingredients, in which, these are used in the formulation, with their quantity:PROVIDED that if needed, standardized abbreviations prescribed for parties) and form of Ingredient(s) in the official Ayurveda, Siddha and Unani Pharmacopoeias and Formularies, may be used on the label] [Inserted by Notification No. G.S.R. 844 (E) dated 26.11.2012 (w.e.f. 21.12.1945)];Provided that if the list of ingredients contained in the medicine is large and cannot be accommodated on the label, the same may be printed separately and enclosed with the packing and reference be made to this effect on the label.| Name of the drug | Maximum size of packing | |
| (i) | Karpur Asava | 15 ml |
| (ii) | Aphiphenasava | 15 ml |
| (iii) | Margamadasava | 15 ml |
| Name of the drug | Maximum content of alcohol (Ethyl-alcohol v/v) | Maximum size of packing | |
| (i) | Mritsanjivani Sura | 16 per cent | 30ml. |
| (ii) | Mahadrakshava | 16 per cent | 120 ml. |
161A. [ Exemption in labelling and packing provisions for export of Ayurvedic (including Siddha) and Unani drugs. [Inserted by G.S.R. 787(E), dated 17.10.2000 (w.e.f. 17.10.2000).]
161B. [ Shelf life or date of expiry of medicines. [Substituted by Notification No. G.S.R. 789(E), dated 12.8.2016 (w.e.f. 21.12.1945).]
| S. No. | Dosage form | Shelf life or date of expiry with effect fromthe date of manufacture |
| (1) | (2) | (3) |
| (i) | Anjana | |
| a) Anjana made from Kasthaushadhi | 1 year | |
| b) Anjana made from Kasthaushadhi along withRasa/Uprasa/Bhasma | 2 years | |
| c) Anjana made only from Rasa/Uprasa/Bhasma | 3 years | |
| (ii) | Arka | 1 year |
| (iii) | Asava Arista | 10 years |
| (iv) | Avaleha, Khanda, Paka, Guda | 3 years |
| (v) | Churna, Kwatha Churna, Lepa Churna, Danta Manjan (Churna) | 2 years |
| (vi) | Dhoopan | 2 years |
| (vii) | Dravaka, Lavana, Kshara | 5 years |
| (viii) | Ghrita | 2 years |
| (ix) | Guggulu | 5 years |
| (x) | Gutika/Vati | |
| (I) Gutika or Vati containing Kasthaushadhi along with Rasa/Uprasa/ Bhasma/ Guggulu (including Lepa Gutika and GhanVati) | 5 years | |
| (II) Gutika or Vati containing only Kasthaushadhi (includingLepa Gutika and Ghan Vati) | 3 years | |
| (III) Gutika/ Vati containing only Ras/ Uprasa/ Bhasma exceptNaga, Vanga and Tamra Bhasma | 10 years | |
| (xi) | Karna/ Nasabindu | 2 years |
| (xii) | Kupipakva Rasayana | 10 years |
| (xiii) | Malahar | 3 years |
| (xiv) | Mandura-Lauha | 10 years |
| (xv) | Naga Bhasma, Vanga Bhasma and Tamra Bhasma | 5 years |
| (xvi) | Netrabindu | 1 year |
| (xvii) | Parpati | 10 years |
| (xviii) | Pishti and Bhasma except Naga, Vanga and Tamra Bhasma | 10 years |
| (xix) | PravahiKwatha | 3 years |
| (xx) | Rasayoga | |
| (I) Rasayoga Containing only Rasa/ Uprasa/ Bhasma except Naga,Vanga and Tamra Bhasma | 10 years | |
| (II) Rasayoga Containing Rasa/ Uprasa/ Bhasma along withKasthaushadhi/ Guggulu | 5 years | |
| (xxi) | Sattva (derived from medicinal plant) | 2 years |
| (xxii) | Sharkar/ Panak/ Sharbat | 3 years |
| (xxiii) | Shveta parpati | 2 years |
| (xxiv) | Taila | 3 years |
| (xxv) | Varti | 2 years |
| S. No. | Dosage form | Shelf life or date of expiry with effect fromthe date of manufacture |
| (1) | (2) | (3) |
| (i) | Curanam | |
| Kutinir Curanam/Adai Curanam/Kanchi Curanam/UtkaliCuranam/Pittu Curanam/ Podithimirthal Curanam/ Podi/ PattruCuranam/ Pottanam or Kizhi Curanam/ Ottratam Curanam/ VethuCuranam/ Pugai Curanam/Kali Curanam/ Thuvalai Curanam | 2 years | |
| (ii) | Mattirai/ Vatakam | |
| (I) Containing only Mooligai ingredients (including KudineerCuranam Mattirai) (eg. Nilavembu kutinir Mattirai) | 2 years | |
| (II) Containing Mooligai ingredients along with ThathuPorutkal/ Jeeva Porutkal/ Parpam/ Centuram/ Cunnam. (includingkutinir Curanam Mattirai) | 5 years | |
| (III) Containing only Thathu Porutkal /Parpam/Centuram/Cunnam/Kattu/Kalanku. | 10 years | |
| (iii) | Rasa-Paadana Marunthugal (All Mercurial Preparation) | |
| (I) Containing Mooligai ingredients along with ThathuPorutkal/Parpam/ Centuram/Cunnam /Kattu/Kalanku | 2 years | |
| (II) Containing only Thathu Porutkal/ Parpam/Centuram/CunnamKattu/ Kalanku | 10 years | |
| (iv) | Parpam/ Centuram | |
| (I) Containing only Mooligai ingredients (eg. KungiliyaParpam) | 2 years | |
| (II) Containing Mooligai ingredients with Thathu Porutkal/Parpam/ Centuram/Cunnam/ Kattu/Kalanku (eg. Aya Centuram) | 10 years | |
| (III) Containing Mooligai ingredients with Jeeva Porutkal(e.g. Sangu Parpam) | 10 years | |
| (v) | Karuppu | |
| (I) Containing only Mooligai ingredients (eg. Vasambu SuttaKari) | 2 years | |
| (II) Containing Mooligai ingredients with Thathu Porutkal(e.g. Sivanar Amirtham, Thalaga Karuppu) | 5 years | |
| (III) Containing Mooligai ingredients with Jeeva Porutkal(e.g. Kasthuri Karuppu, Pattu Karuppu) | 5 years | |
| (vi) | Patankam | |
| (I) Mooligai based Patankam (eg. Sambirani Patankam) | 5 years | |
| (II) Rasa based Patankam (eg. Rasa Centuram) | 10 years | |
| (vii) | Kulampu | |
| Based on process- | ||
| (I) Araippu Kulampu (eg. Agathiyar Kulampu) | 5 years | |
| (II) Erippu Kulampu (eg. Kumatti Kulampu) | 3 years | |
| (viii) | Meluku | |
| Based on process-(I) Araippu Meluku (eg. Linga Meluku) | ||
| 5 years | ||
| Based on Process-(II) Idippu Meluku (eg. Rasa Gandhi Meluku/ Idi VallthiMeluku) | 3 years | |
| Based on raw materials-(III) Mooligai Meluku (eg. Malaikudara Meluku) | 3 years | |
| (ix) | Karpam | |
| Based on raw materials-(I) Mooligai Karpam (eg. Karisalai Karpam, Thiripala Karpam) | 2 years | |
| Based on raw materials- | 5 years | |
| (II) Mooligai Thathu Karpam (eg. Aya Bringaraja Karpam) | ||
| Based on process- | 3 years | |
| (III) Araippu Karpam (eg. Irunelli Karpam) | ||
| (x) | Satthu | |
| (I) Satthu derived from Mooligai (eg. Seenthil Satthu) | 2 years | |
| (II) Satthu derived from Thathu Porutkal (eg. Aya Satthu, EyaSatthu,Thurusu Satthu) | 10 years | |
| (III) Satthu derived from Jeeva Porutkal (eg. Sembu Satthuderived from Poonagam, Mayiliragu) | 5 years | |
| (xi) | Ilakam/ Legiyam/ Iracayanaam | 3 years |
| (xii) | Kallikkam/ Mai/ Kalimbu/ Neer/ Venney | 1 year |
| (xiii) | Karam (Karanool) | 2 years |
| (xiv) | Kattu (Medicated bandage cloth)/Seelai/Varthy/ Thiri | 1 year |
| (xv) | Kattu/ Kalanku/ Cunnam | 10 years |
| (xvi) | Kutinir/ Kiyazham(with preservatives) | 3 years |
| (xvii) | Manappaku/ Panagam | 3 years |
| (xviii) | Nasiyathuli/ Kanthuli/ Sevithuli | 1 year |
| (xix) | Ney/ Ghirutham/Kadugu | 2 years |
| (xx) | Oothal/Nasigaparanam/ Thoopasarakku | 1 year |
| (xxi) | Pakkuvam, Thennoral | 1 year |
| (xxii) | Panda Vaippu | 10 years |
| (xxiii) | Peechu | 2 years |
| (xxiv) | Sutigai | 2 years |
| (xxv) | Tailam/ Ennai/ Poochu | 3 years |
| (xxvi) | Tinir | 1 year |
| (xxvii) | Tiravakam (derived from ThathuPorutkal) | 2 years |
| S. No. | Dosage form | Shelf life or date of expiry with effect fromthe date of manufacture |
| (1) | (2) | (3) |
| (i) | Arq (except Arq-e-Ajeeb) | 1 year |
| (ii) | Arq-e-Ajeeb | 5 years |
| (iii) | Ayarij/ Sunoon/ Zuroor/ Ghazah | 2 years |
| (iv) | Burood | 1 year |
| (v) | Shiyaf | 2 years |
| (vi) | Surma/ Kohal | 3 years |
| (vii) | Habb | 3 years |
| (viii) | Halwa | 3 years |
| (ix) | Itrifal | 3 years |
| (x) | Jauhar/ Jawahir | 5 years |
| (xi) | Jawarish | 4 years |
| (xii) | Khamira | 3 years |
| (xiii) | Kushta | 10 years |
| (xiv) | Laboob | 3 years |
| (xv) | Laooq | 3 years |
| (xvi) | Majoon/ Dawa | 3 years |
| (xvii) | Marham/ Zimad/ Qairooti | 2 years |
| (xviii) | Mufarreh | 3 years |
| (xix) | Murabba | 1 year |
| (xx) | Nabeez | 10 years |
| (xxi) | Qurs | 3 years |
| (xxii) | Qutoor | 1 year |
| (xxiii) | Raughaniyat/ Tila | 3 years |
| (xxiv) | Sharbat/ Sikajabeen | 3 years |
| (xxv) | (I) Sufoof (Without Salt) | 2 years |
| (II) Sufoof (Containing salt) | 1 year | |
| (xxvi) | Tiryaq | 3 years] |
| 161B. [ Shelf life or date of expiry of medicines. [Substituted by Notification G.S.R. 897(E), dated 24.11.2015 (w.e.f. 21.12.1945).]- (1) The date of expiry of Ayurveda, Siddha or Unani medicines shall be conspicuously displayed on the label of container or package of Ayurvedic, Siddha or Unani medicine, as the case may be, and after the said date of expiry, no medicine shall be marketed, sold, distributed or consumable;Provided that this sub-rule shall apply to Ayurvedic, Siddha and Unani medicines seeking license or renewal of license for manufacturing after the date of notification of the rules.(2) Every person applying for license or renewal of license for the manufacturing of Ayurveda, Siddha or Unani medicines defined under clause (h) of section 3 of the Act shall submit to the State Licensing Authority scientific data based shelf life or date of expiry of the medicine based on the studies of medicines in accordance with the guidelines prescribed in the Ayurvedic, Siddha and Unani Pharmacopoeia.Provided that this sub-rule shall be applicable after three years from the date of notification of the rules.(3) The State Licensing Authority shall, before granting license or renewal of license for an Ayurvedic, Siddha or Unani medicine, ensure validity of the data submitted by the manufacturer in support of the claimed shelf-life of that medicine.(4) The State Licensing Authority may at any time direct the manufacturer to provide the samples of the medicine and any other related information; and may share it with the Pharmacopoeial Laboratory for Indian Medicine, Ghaziabad for analysis or independent validation.(5) Where the manufacturer fails to comply with direction of the State Licensing Authority under sub-rule (4), the license for the manufacturing of the medicine shall be liable for suspension after giving a reasonable opportunity of being heard.(a) The shelf life or date of expiry of an Ayurveda, Siddha or Unani medicine defined under clause (a) of section 3 of the Act shall, unless otherwise determined on the basis of scientific data, be as follows:-(a) Ayurvedic medicines:{| | ||
| S. No. | Dosage form of Ayurvedic medicines | Shelf life or date of expiry with effect from thedate of manufacture |
| (i) | Arka | 1 year |
| (ii) | Asava Arista | 10 years |
| (iii) | Avaleha, Khanda, Paka, Guda | 3 years |
| (iv) | Churna, Kwatha Churna, Lapa Churna, Dant Manjan (Churna) | 2 years |
| (v) | Dhoopan | 2 years |
| (vi) | Dravaka, Lavana, Kshara | 5 years |
| (vii) | Ghrita | 2 years |
| (viii) | Guggulu | 5 years |
| (ix) | Gutika | |
| (I) | Gutika or Vati containing Kasth Aushadhi along with Rasa/Uprasa/ Bhasma/ Guggulu (including Lepa Gutika and Ghan Vati) | 5 years |
| (II) | Gutika or Vati containing only Kasth Aushadhi (including LepaGutika and Ghan Vati) | 3 years |
| (III) | Gutika/ Vati containing only Ras/ Uprasa/ Bhasma | 10 years |
| (x) | Karna/ Nasa bindu (Ear/Nasal drop) | 2 years |
| (xi) | Kupipakva Rasayana | 10 years |
| (xii) | Malahar | 3 years |
| (xiii) | Mandura-Lauha | 10 years |
| (xiv) | Naga Bhasma, Vanga Bhasma and Tamra Bhasma | 5 years |
| (xv) | Netra bindu (Eye drop) | 1 year |
| (xvi) | Parpati | 10 years |
| (xvii) | Pisti and Bhasma | 10 years |
| (xviii) | Pravahi Kwatha (Decoction with preservative) | 3 years |
| (xix) | Rasayoga | |
| (I) | Rasayoga Containing only Rasa/ Uprasa/ Bhasma | 10 years |
| (II) | Rasayoga Containing Rasa/ Uprasa/ Bhasma along with KasthAushadhi/Guggulu | 5 years |
| (xx) | Sattva (derived from medicinal plant) | 2 years |
| (xxi) | Sharkar | 3 years |
| (xxii) | Shveta parpati | 2 years |
| (xxiii) | Taila | 3 years |
| (xxiv) | Varti | 2 years |
| S. No. | Dosage form of Siddha medicines | Shelf life or date of expiry with effect from thedate of manufacture |
| (i) | Curanam | |
| Kutinir Curanam/ Adai Curanam/ Kanchi Curanam/ Utkali Curanam/Pittu Curanam/ Podithimirthal Curanam/ Podi/ Pattru Curanam/Pottanam or Kizhi Curanam/ Ottratam Curanam/ Vethu Curanam/ PugaiCuranam/ Kali Curanam/ Thuvalai Curanam | 2 years | |
| (ii) | Mattirai/ Vatakam | |
| (I) Containing only Mooligai ingredients (including KudineerCuranam Mattirai) (eg. Nilavembu kutinir Mattirai) | 2 years | |
| (II) Containing Mooligai ingredients along with ThathuPorutkal/ Jeeva Porutkal/ Parpam/ Centuram/ Cunnam. (includingkutinir Curanam Mattirai ) | 5 years | |
| (III) Containing only Thathu Porutkal/ Parpam/ Centuram/Cunnam/ Kattu/ Kalanku. | 10 years | |
| (iii) | Rasa-Paadana Marunthugal (All Mercurial Preparation) | |
| (I) Containing Mooligai ingredients along with ThathuPorutkal/ Parpam/ Centuram/ Cunnam/ Kattu/ Kalanku | 3 years | |
| (II) Containing only Thathu Porutkal/ Parpam/ Centuram/ CunnamKattu/Kalanku | 10 years | |
| (iv) | Parpam/ Centuram | |
| (I) Containing only Mooligai ingredients (eg. KungiliyaParpam) | 4 years | |
| (II) Containing Mooligai ingredients with Thathu Porutkal/Parpam/ Centuram/ Cunnam/ Kattu/ Kalanku (eg. Aya Centuram) | 10 years | |
| (III) Containing Mooligai ingredients with Jeeva Porutkal(e.g. Sangu Parpam ) | 10 years | |
| (v) | Karuppu | |
| (I) Containing only Mooligai ingredients (eg. Vasambu SuttaKari) | 2 years | |
| (II) Containing Mooligaiingredients with Thathu Porutkal(e.g. Sivanar Amirtham, Thalaga Karuppu) | 5 years | |
| (III) Containing Mooligaiingredients with Jeeva Porutkal(e.g. Kasthuri Karuppu, Pattu Karuppu) | 5 years | |
| (vi) | Patankam | |
| (I) Mooligai based Patankam (eg. Sambirani Patankam) | 5 years | |
| (II) Rasa based Patankam (eg. Rasa Centuram) | 10 years | |
| (vii) | KulampuBased on process- | |
| (I) Araippu Kulampu (eg. Agathiyar Kulampu) | 5 years | |
| (II) Erippu Kulampu (eg. Kumatti Kulampu) | 3 years | |
| (viii) | Meluku | |
| Based on process-(I) Araippu Meluku (eg. Linga Meluku) | 5 years | |
| Based on Process-(II) Idippu Meluku (eg. Rasa Gandhi Meluku/ Idi VallthiMeluku) | 3 years | |
| Based on raw materials-(III) Mooligai Meluku (eg. Malaikudara Meluku) | 3 years | |
| (ix) | Karpam | |
| Based on raw materials-(I) Mooligai Karpam (eg. Karisalai Karpam, Thiripala Karpam) | 2 years | |
| Based on raw materials-(II) Mooligai Thathu Karpam (eg. Aya Bringaraja Karpam) | 5 years | |
| Based on process-(III) Araippu Karpam (eg. Irunelli Karpam) | 3 years | |
| (x) | Satthu | |
| (I) Satthu derived from Mooligai (eg. Seenthil Satthu) | 2 years | |
| (II) Satthu derived from Thathu Porutkal (eg. Aya Satthu, EyaSatthu, Thurusu Satthu) | 10 years | |
| (III) Satthu derived from Jeeva Porutkal (eg. Sembu Satthuderived from Poonagam, Mayiliragu) | 5 years | |
| (xi) | Ilakam/ Legiyam/ Iracayanaam | 3 years |
| (xii) | Kallikkam/ Mai/ Kalimbu/ Neer/ Venney | 1 year |
| (xiii) | Karam (Karanool) | 2 years |
| (xiv) | Kattu (Medicated bandage cloth)/ Seelai/ Varthy/ Thiri | 1 year |
| (xv) | Kattu/ Kalanku/ Cunnam | 10 years |
| (xvi) | Kutinir/ Kiyazham (with preservatives) | 3 years |
| (xvii) | Manappaku/ Panagam | 3 years |
| (xviii) | Nasiya thuli/ Kan thuli/ Sevi thuli | 1 year |
| (xix) | Ney/ Ghirutham/ Kadugu | 2 years |
| (xx) | Oothal/ Nasigaparanam/ Thoopa sarakku | 1 year |
| (xxi) | Pakkuvam, Thennoral | 1 year |
| (xxii) | Panda Vaippu | 10 years |
| (xxiii) | Peechu | 2 years |
| (xxiv) | Sutigai | 2 years |
| (xxv) | Tailam/ Ennai/ Poochu | 3 years |
| (xxvi) | Tinir | 1 year |
| (xxvii) | Tiravakam (derived from Thathu Porutkal) | 5 years |
| S. No. | Dosage form of Unani medicines | Shelf life or date of expiry with effect fromthe date of manufacture |
| (i) | Arq (except Arq-e-Ajeeb) | 1 year |
| (ii) | Arq -e-Ajeeb | 5 years |
| (iii) | Ayarij/ Sunoon/ Zuroor/Ghazah | 2 years |
| (iv) | Burood/ Surma/ Kohal/shiyaf | 5 years |
| (v) | Habb (Pills) | 3 years |
| (vi) | Halwa | 3 years |
| (vii) | Itrifal | 3 years |
| (viii) | Jauhar/ Jawahir | 5 years |
| (ix) | Jawarish | 4 years |
| (x) | Khamira | 3 years |
| (xi) | Kushta | 10 years |
| (xii) | Laboob | 3 years |
| (xiii) | Laooq | 3 years |
| (xiv) | Majoon/ Dawa | 3 years |
| (xv) | Marham/ Zimad/ Qairooti | 2 years |
| (xvi) | Mufarreh | 3 years |
| (xvii) | Murabba | 1 year |
| (xviii) | Nabeez | 10 years |
| (xix) | Qurs (Tablets) | 3 years |
| (xx) | Qutoor | 1 year |
| (xxi) | Raughaniyat/ Tila | 3 years |
| (xxii) | Sharbat/ Sikajabeen | 3 years |
| (xxiii) | (1) Sufoof (Without Salt) | 2 years |
| (2) Sufoof (Containing salt) | 1 year | |
| (xxiv) | Tiryaq | 3 years] |
162. Duties of inspectors specially authorized to inspect the manufacture of Ayurvedic (including Siddha) or Unani drugs.
- Subject to the instructions of the controlling authority, it shall be the duty of an Inspector authorized to inspect the manufacture of Ayurvedic (including Siddha) or Unani drugs-162A. [ Qualifications for State Drug Licensing Authority for licensing of Ayurveda, Siddha and Unani drugs. [Inserted by G.S.R. 76(E), dated 3.2.2003 (w.e.f. 3.2.2003).]
163. Procedure for despatch of sample to Government Analyst and its receipt by the Government Analyst.
163A. Functions.
- The Pharmacopoeial Laboratory for Indian Medicine at Ghaziabad shall function as a Central Drugs Laboratory for the purpose of testing or analysis Ayurveda, Siddha and Unani drugs.Its functions shall be:-163B.
The functions of the Central Drugs Laboratory in respect of Ayurvedic, Siddha and Unani drugs shall be carried out at the Pharmacopoeial Laboratory for Ayurvedic, Siddha and Unani medicine, Ghaziabad (Uttar Pradesh) and the functions of the Director in respect of the said drugs shall be exercised by the Director of the said laboratory.163C. Despatch of samples for test or analysis.
163D. Recording of condition of seals.
- On receipt of the packet, it shall be opened by an officer authorized in writing on that behalf by the Director, Pharmacopoeial Laboratory for Indian Medicine, who shall record the condition of the seal on the packet.163E. Report of result of test or analysis.
- After test or analysis, the result of the test or analysis, together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2-A of as specified in the said Schedule.163F. Fees.
- The fees for test and analysis shall be as specified in Schedule B-1.163G. Signature on certificates.
- Certificates issued under these rules by the Pharmacopoeial Laboratory for Indian Medicine, shall be signed by the Director or by an officer authorized by the Central Government to sign such certificates.]164. Method of test or analysis to be employed in relation to Ayurvedic (including Siddha) or Unani drugs.
- The method of test or analysis to be employed in relation to an Ayurvedic (including Siddha) or Unani drugs shall be such as may be specified in the Ayurvedic (including Siddha) or Unani Pharmacopoeia, or if no such pharmacopoeias are available or if no tests are specified in such pharmacopoeias, such tests as the Government Analyst may employ, such tests being scientifically established to determine whether the drug contains the ingredients as stated on the label.165. Qualifications of Government Analyst.
- A person who is appointed as a Government Analyst under section 33-F of the Act shall be a person possessing the qualifications prescribed in rule 44 or a degree in Ayurveda, Siddha or Unani system, as the case may be, conferred by a University, a State Government or Statutory Faculties, Councils and Boards of Indian Systems of Medicine recognized by the Central or State Government, as the case may be, for this purpose and has had not less than three years' post-graduate experience in the analysis of drugs in a laboratory under the control of (i) a Government Analyst appointed under the Act, or (ii) a Chemical Examiner to Government, or (iii) the head of an institution specially approved for the purpose by the appointing authority.166. Duties of Government Analyst.
167. [ Qualifications of Inspector. [Substituted by G.S.R. 376(E), dated 20.7.1978 (w.e.f. 20.7.1978).]
- A person who is appointed an Inspector under section 33-G shall be a person who-168. Standards to be complied with in manufacture for sale or for distribution of Ayurvedic, Siddha and Unani drugs.
-| Class of Drugs | Standards to be complied with | |
| 1. | [Drugs] [Substituted by G.S.R. 422(E), dated 11.6.2002 (w.e.f. 12.6.2002).]included in Ayurvedic Pharmacopoeia | The standards for identity, purity and strength as given in the editions of Ayurvedic Pharmacopoeia of India for the time being in force. |
| 2. | Asavas and Aristas | The upper limit of alcohol as self generated alcohol should not exceed 12% v/v excepting those that are otherwise notified by the Central Government from time to time. |
169. [ Permitted Excipients. [Substituted by G.S.R. 755(E), dated 23.10.2008 (w.e.f. 27.10.2008).]
- Permitted Excipients along with their standards, i.e., additives, preservatives, antioxidants, flavouring agents, chelating agents, etc., permitted in the Indian Pharmacopoeia (IP), Prevention of Food Adulteration Act, 1954 and Bureau of Indian Standard Act, 1986 are permitted for use in Ayurveda, Siddha and Unani drugs with the following conditions, namely:--1. The above excipients shall be used in the permissible limits as prescribed in the Indian Pharmacopoeia/Prevention of Food Adulteration Act, 1954/Food Product Order/Bureau of Indian Standard Act, 1986 and they shall comply with the respective quality specifications, not exceeding any specified limits of usage therein, and except Hydrogenated vegetable oil.
2. Only Natural coloring agents as permitted under rule 26 of Prevention of Food Adulteration Rules, 1955 will be used for Ayurveda, Siddha and Unani drugs and additionally, colors permitted under rule 127 of Drugs and Cosmetic Rules, 1945 shall be used for Proprietary Ayurveda, Siddha and Unani drugs as defined in sub-clause (i) of clause (h) of section 3 of Drugs and Cosmetics Act, 1940, not exceeding any specified limits of usage therein.
3. Preservatives and Colouring agents shall be mentioned on the label for the information of the consumer as required under rule 161 of the Drugs and Cosmetics Rule, 1945.
4. Additives used in various processes and in formulating dosage forms shall be mentioned clearly with quantities used, in the application for licenses and the record for the same shall be maintained by the manufacturers.
5. Manufacturers shall be responsible to ensure rationality, safety and quantity used of various excipients in the formulation.
6. If any excipients or additive or preservative, etc., referred in Indian Pharmacopoeia/Prevention of Food Adulteration Act, 1954/Food Product Order/Bureau of Indian Standard Act, 1986 is deleted at a particular point of time, this will also be deleted simultaneously for the use in Ayurveda, Siddha and Unani drugs.
7. Following artificial sweeteners as per maximum limit indicated below may be used in various dosage forms of Ayurveda, Siddha, Unani Proprietary Medicines:-
Artificial sweeteners may be used only in proprietary ASU products and the label of such products should carry a statutory warning stating the name and quantity of the artificial sweetener used.The recommended Acceptable Daily Intake (ADI) of these sweeteners as laid down by US FDA is as follows:-| SI. No. | Sucralose | Aspartame | Saccharin | Acesulfame K |
| 1. | 5mg/kg body weight | 40mg/kg body weight | 5mg/Kg body weight | 15mg/kg body weight |