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:-(1)the manufacture shall be conducted under the active direction and personal supervision of 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. 71(E), dated 30.1.1987 (w.e.f. 30.1.1987).] and has had at least eighteen months' practical experience after the graduation in the manufacture of drugs. This period of experience may, however, be reduced by six months if the person has undergone training in manufacture of drugs 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 as a principal subject and has had at least three years' practical experience in the manufacture of drugs after his graduation; or(c)a graduate in Chemical Engineering or Chemical Technology or Medicine 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).] with general training and practical experience, extending over a period of not less than three years in the manufacture of drugs, after his graduation; or(d)[ holding any foreign qualification the quality and content of training of which are comparable with those prescribed in clause (a), clause (b) or clause (c) and is permitted to work as competent technical staff under this rule by the Central Government:] [Added by S.O. 1449, dated 13.6.1961 (w.e.f. 24.6.1961).]Provided that any person who was immediately before the 29th June, 1957, actively directing and personally supervising the manufacture of drugs and whose name was accordingly entered in any license granted in Form 25 [or Form 25-F ] [Inserted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).]as it existed before that date shall be deemed to be qualified for the purposes of this rule:[Provided further that for drugs other than those specified in Schedules C, C(1) and X and meant for veterinary use, the whole-time employee under whose supervision the manufacture is conducted shall be a graduate in Veterinary Science or Pharmacy or General Science or Medicine of a University recognized by the Central Government and who has had at least three years practical experience in the manufacture of drugs excluding graduate in Pharmacy who shall have at least eighteen months' practical experience in the manufacture of drugs:] [Inserted by G.S.R. 93(E), dated 24.2.1995 (w.e.f. 24.2.1995).][Provided [also] [Added by S.O. 3868, dated 26.10.1968 (w.e.f. 2.11.1968).] [that the licensing authority may, in the matter of manufacture of disinfectant fluid, insecticides, liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of pairs and surgical dressings, for the manufacture of which the knowledge of Pharmaceutical Chemistry or Pharmacy is not essential, permit the manufacture of the substance under the active direction and personal supervision of the competent technical staff, who, although not having any of the qualifications included in clause (a), (b) or (c) of this rule, has, in the opinion of the licensing authority, adequate experience in the manufacture of such substance.] [Added by S.O. 3868, dated 26.10.1968 (w.e.f. 2.11.1968).](2)The factory premises shall comply with the conditions prescribed in Schedule M.(3)The applicant shall provide adequate space, plant and equipment for the manufacturing operations; the space, plant and equipment recommended for various operations are given in Schedule M.(4)[ The applicant shall provide and maintain adequate staff, premises and laboratory equipment for carrying out tests of the strength, quality and purity of the substances at the testing unit, which shall be separate from the manufacturing unit and head of the testing unit shall be 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 arrangements 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.][(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.] [Substituted 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, 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 the formulation and under the conditions in which the formulations for administration and use are recommended;(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).](7)[ The licensee shall comply with the requirements of "Good Manufacturing Practices" as laid down in Schedule M.] [Inserted by G.S.R. 735, dated 24.6.1988 (w.e.f. 24.6.1988).][Substituted by G.S.R. 515, dated 24.3.1976 (w.e.f. 10.4.1976).](8)[ 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)]
