Section 76(4) in The Drugs and Cosmetics Rules, 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).]
