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Issue of Drug Licenses without Brand names - Clarifications issued by Government
 
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PHARMACEUTICALS EXPORT PROMOTION COUNCIL OF INDIA
(Set up by Ministry of Commerce & Industry, Govt. of India)
 
Ref: PXL/H.O./CIR-104/2012-13 Date: 12.11.2012

Issue of Drug Licenses  without Brand Names – Clarifications issued by Government

To
All the Members of Council,

Dear Member,

Subject: Issue of Drug Licenses  without Brand Names – Clarifications issued by Government

We refer to our circular No. PXL/HO/CIR-100/2012-13 dt. 7.11.2012, wherein we have informed members that Council is following up with  DCGI/Department of Health & Family Welfare to modify their notification issued on 1.10.2012, which caused lot of hurdles in export of pharmaceuticals.   We are glad to inform the members that Government has issued another directive to State Drugs Controllers certain  clarifications  relating to exported / imported  medicines, vide notification No. 11011/1/2011-DFQC dt. 9.11.2012 (copy enclosed).

The communication  provides the following important clarifications relating to exports:

a) The directive issued on 1.10.2012 is not applicable to issue of CoPPs, GMP Certificates, and Free sale certificates.

b) The Notification has prospective effect only.

We understand that in view of Govt.'s considered view that endorsement of brand names is not the responsibility of licensing authorities under Drugs & Cosmetics Act and with a view not to have adverse impact on exports, the above clarification was issued.    We hope, the above clarifications will help the members to continue their exports without any hassles with respect to issue of CoPPs, GMP Certificates, Free Sales certificates etc., with brand names.

In case, members find any problem, kindly inform us and the same would be compiled and  taken up with the Government.

Thanking you and assuring our best services to the members.

 Yours sincerely,

 

Dr. P V Appaji
Director General

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