Practices as laid down in Schedule M.

Before a licence in Form 25-B is granted or renewed the following conditions shall be complied with by the applicant :____ (1) the repacking operation shall be carried out under hygienic conditions and under the supervision of a competent person; (2) the factory premises shall comply with the conditions prescribed in Schedule M; and (3) the applicant shall have adequate arrangements in his own premises for carrying out tests for the strength, quality and purity of the drugs at a testing unit which shall be separate from the repacking unit: Provided that the repacking units, which before the commencement of the Drugs and Cosmetics (Second Amendment) Rules, 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 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 for this purpose. 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 (VIII 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.