To
All the Members of Council,

Dear Member,

Sub: Directive of Central Government to State Drugs Controllers to issue Drug Manufacturing license for formulations under Proper/Generic name only.

We would like to inform all our member companies that Ministry of Health & Family Welfare, Govt. of India, issued a direction u/s 33 (P) of the Drugs and Cosmetics Act, 1940 vide letter dt. 1st October, 2012 (copy enclosed) to all States/Union Territories Health Secretaries to instruct their respective Drug Licensing Authorities to grant/renew licenses to manufacture for sale or for distribution of drugs in proper/generic names only.

Our Council has received calls/mails from members bringing the above directive to the notice of the Council and expressed severe apprehensions that the exports of formulations would be adversely affected, if the above directive is implemented by State Drug Control Authorities.  It is also informed that the formulations in general, are being exported with brand names to various countries.

In view of the above, the Council is actively considering to submit a representation to the Government on this subject.  We therefore, request our members to please study the directive issued by Central Govt. and send their comments/remarks to  rd@pharmexcil.com immediately. Pharmexcil will compile all important observations of the members and would submit a representation to the Government, if considered necessary.

Thanking you,

Dr. P.V. Appaji
Director General

Encl:
Drug License Notification

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