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Union of India - Section
Section 78 in The Drugs and Cosmetics Rules, 1945
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. |