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-](1)The manufacture will be conducted under the active direction and personal supervision of the competent technical staff consisting at least of one person who is a whole-time employee and who is-(a)a graduate in Pharmacy or Pharmaceutical Chemistry of [a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] [Substituted by G.S.R. 26(E), dated 19.1.2006 (w.e.f. 19.1.2006).] and has had at least eighteen months' practical experience after the graduation in the manufacture of drugs to which this license applies, this period of experience may, however, be reduced by six months if the person has undergone training in manufacture of drugs to which the license applies for a period of six months during his University course; or(b)a graduate in Science of [a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] [Substituted by G.S.R. 71(E), dated 30.1.1987 (w.e.f. 30.1.1987).] who for the purpose of his degree has studied Chemistry [or Microbiology] [Inserted by G.S.R. 245, dated 3.2.1976 (w.e.f. 21.2.1976).] as a principal subject and has had at least three years' practical experience in the manufacture of drugs to which this license applies after his graduation; or(c)a graduate in Medicine of a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose with at least three years' experience in the manufacture and pharmacological testing of biological products after his graduation; or(d)[ a graduate in Chemical Engineering of a University recognized by the Central Government with at least three years' practical experience in the manufacture of drugs to which this license applies after his graduation; or [Added by S.O. 1449, dated 13.6.1961 (w.e.f. 24.6.1961).](e)holding any foreign qualification, the quality and content of training of which are comparable with those prescribed in clause (a), clause (b), clause (c) or clause (d) and is permitted to work as competent technical staff under this rule by the Central Government:]Provided that any person who was approved by the licensing authority as an expert responsible for the manufacture of drugs for the purpose of rule 76 read with rule 78 as these rules were in force immediately before the 29th June, 1957, shall be deemed to be qualified for the purposes of this rule:[Provided further that for the drugs specified in Schedules C and C(1) meant for veterinary use, the whole-time employee under whose supervision the manufacture is conducted may be a graduate in Veterinary Science or General Science or Medicine or Pharmacy of a University recognized by the Central Government and who has had at least three years' experience in the manufacture of biological products:] [Added by S.O. 2889, dated 2.7.1969 (w.e.f. 19.7.1969).][Provided also that for medical devices, the whole time employee under whose supervision the manufacture or testing is conducted shall be -(i)a graduate in Pharmacy or Engineering (in appropriate branch) from a University recognized by the Central Government for such purposes and has had at least eighteen months practical experience in the manufacturing or testing of devices to which this license applies after his graduation; or(ii)a graduate in science, from a University recognized by the Central Government for such purposes, with Physics or Chemistry or Microbiology as one of the subject and has had at least three years practical experience in the manufacturing or testing of devices to which this license applies after his graduation; or(iii)a diploma in Pharmacy or Engineering(in appropriate branch) from a Board or Institute recognized by the Central Government or the State Government, as the case may be, for such purposes and has had at least four years practical experience in the manufacturing or testing of devices to which this license applies after his diploma; or(iv)having a foreign qualification, the quality and content of training of which are comparable with those specified in clause (i), clause (ii) and clause (iii) and is permitted to work as competent technical staff under this rule by the Central Government.](2)[ The applicant proposing to manufacture pharmaceutical products shall comply with the provisions referred to in Schedule M.(2A)The applicant proposing to manufacture medical devices and in-vitro diagnostics shall comply with the quality management system as referred to in Schedule M-III.(3)The applicant shall provide adequate space, plant and equipment for pharmaceutical products as referred to in Schedule M and for Medical devices and in-vitro diagnostics as referred to in Schedule M-III.] [Substituted by Notification No. G.D.R. 640(E), dated 29.6.2016 (w.e.f. 21.12.1945).](4)[ The applicant shall provide and maintain adequate staff, premises and laboratory equipment for carrying out such tests of the strength, quality and purity of the substances as may be required to be carried out by him under the provisions of Part X of these rules including proper housing for animals used for the purposes of such tests, the testing unit being separate from the manufacturing unit and the head of the testing unit being independent of the head of the manufacturing unit:Provided that the manufacturing units which before the commencement of the [Drugs and Cosmetics (Amendment) Rules, 1977] [Substituted by G.S.R. 926, dated 24.6.1977 (w.e.f. 16.7.1977).][, were making arrangements with institutions approved by the licensing authority for such tests to be carried out on their behalf may continue such arrangement up to the 30th June, 1977:Provided further that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods other than sterility the licensing authority may permit such tests to be conducted by institutions approved by it [under Part XV(A) of these rules] [Substituted by G.S.R. 926, dated 24.6.1977 (w.e.f. 16.7.1977).] for this purpose.] [Substituted by Notification No. G.S.R. 690 (E) dated 25.9.2014 (w.e.f. 21.12.1945)][(4-A) The head of the testing unit referred to in condition (4) shall possess a degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognized for this purpose and shall have experience in the testing of drugs, which in the opinion of the licensing authority is considered adequate.] [Inserted by G.S.R. 681(E), dated 5.12.1980 (w.e.f. 5.12.1980).](5)The applicant shall make adequate arrangements for the storage of drugs manufactured by him.(6)[ The applicant shall furnish to the licensing authority, if required to do so, data on the stability of drugs which are likely to deteriorate for fixing the date of expiry which shall be printed on the labels of such drugs on the basis of the date so furnished.] [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).](7)[ 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-(i)contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;(ii)are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in formulations, and under the conditions in which the formulations for administration and use are commended;(iii)are stable under the conditions of storage recommended; and(iv)contain such ingredients and in such quantities for which there is therapeutic justification;](v)[ have the approval, in writing, in favor of the applicant to manufacture drug formulations falling under the purview of new drug as defined in rule 122-E, from the licensing authority as defined in clause (b) of rule 21.] [Inserted by G.S.R. 311(E), dated 1.5.2002 (w.e.f. 1.5.2002).](8)[ The licensee of pharmaceutical products shall comply with the requirements of 'Good Manufacturing Practices' as laid down in Schedule M and the licensee of Medical Devices and in-vitro diagnostics shall comply with the requirements of "Quality Management System" as laid down in Schedule M-III.] [Substituted by Notification No. G.D.R. 640(E), dated 29.6.2016 (w.e.f. 21.12.1945).](9)[ The applicant shall make application for grant of license for a drug formulation containing single active ingredient only in proper name.] [Inserted by Notification No. G.S.R. 570 (E) dated 7.8.2014 (w.e.f. 21.12.1945)][ Explanation. - For the purpose of this rule, [Large Volume Parenterals Sera and Vaccines and Recombinant DNA (r-DNA) derived drugs,] [Inserted by G.S.R. 119(E), dated 11.3.1996 (w.e.f. 11.3.1996).][shall mean the sterile solutions intended for parenteral administration with a volume of 100 ml. or more (and shall include anti-coagulant solutions) in one container of the finished dosage form intended for single use.] [Inserted by G.S.R. 119(E), dated 11.3.1996 (w.e.f. 11.3.1996).][Added by G.S.R. 515, dated 24.3.1976 (w.e.f. 10.4.1976).](10)[ the applicant shall submit the result of bio-equivalence study referred to in Schedule Y, along with the application for grant of a licence of oral dosage form of drugs specified under category II and category IV of the bio-pharmaceutical classification system.] [Inserted by Notification No. G.S.R. 327(E), dated 3.4.2017 (w.e.f. 21.12.1945).]
