Section 71A(4) in The Drugs and Cosmetics Rules, 1945
(4)[ The application for grant of license for a drug formulation containing single active ingredient shall be made only in proper name:] [Substituted by G.S.R. 926, dated 24.6.1977 (w.e.f. 16.7.1977).]Provided that the re-packing units, which, before the commencement of the [Drugs and Cosmetics (Second Amendment) Rules, 1977,] [These rules came into force on 16.7.1977 vide G.S.R. 926, dated 24.6.1977 ] [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 31st July, 1977:Provided further that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods the licensing authority may permit such test 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 G.S.R. 926, dated 24.6.1977 (w.e.f. 16.7.1977).]Explanation. - A person who satisfies the following minimum qualifications shall be deemed to be a "competent person" for the purposes of rule 71-A or 74-A of these rules, namely:-(a)a person who holds the Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (8 of 1948) or a person who is registered under the said Act, or(b)a person who has passed the Intermediate examination with Chemistry as one of the principal subjects or an examination equivalent to it or an examination recognized by the licensing authority as equivalent to it, or(c)a person who has passed the Matriculation examination or an examination recognized by the licensing authority as equivalent to it and has had not less than four years' practical experience in the manufacture, dispensing or repacking of drugs.
