Section 76(1) in The Drugs and Cosmetics Rules, 1945
(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.]
