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Drug Authority Can Interview for Giving License

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 “Under which clause of Drugs and Cosmetics Act does Drug Authority get power to interview a manufacturer who eeks approval of newly manufactured injectibles, tablets, capsules, ointment,etc.

, even though he has 18 months experience as technical person/manufacturer.”

The Drugs and Cosmetics Rules 1945 provide in Rule 71 condition for the grant or renewal of a license in Form 25 or Form 25F. Before a license in Form 25 (or Form 25F) is granted or renewed, some conditions shall be complied. The manufacture of the drug shall be conducted under the active directions and personal supervision of competent technical staff consisting at least of one person who is a whole time employee and who is a graduate in Pharmacy or Pharmaceutical Chemistry and has had at least eighteen months’ practical experience after the graduation in the manufacture of drugs. This period of experience may, however, be reduced by six months if the person has undergone training in manufacture of drugs for a period of six months during his University course and also equivalent qualification for this purpose are mentioned in sub clause b, c and d of Rule 71.

The same norms are applicable to take a drug license specified in schedule C and schedule C1 under Rule 76(a). Schedule M in Para 6.1 provides that the manufacture shall be conducted under the direct supervision of competent technical staff with prescribed qualifications and practical experience in the relevant dosage from and or active pharmaceuticals product.

That as per Rule 76 after sub rule (e) the proviso added that any person who was approved by the licensing authority as expert responsible for the manufacture of the drug for the purpose of Rule 76 read with Rule 78. For a Manufacturing chemist approval is by the licensing authority as per Rule 76. The interview is a part and parcel of qualification. Interview is only to examine whether the person is competent to manufacture the drugs or examining his practical experience, because only required qualifications are not sufficient for this purpose. Even otherwise interview is an additional qualification for approval. Interview is only to test the ability, capacity and capability of the person. As interview is almost essential in all services, whether they are in Govt. services or in public sector.

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and Cosmetics Act (1940)