Section 71(4) in The Drugs and Cosmetics Rules, 1945
(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).]
