Section 71(1) in The Drugs and Cosmetics Rules, 1945
(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).]
