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State FDAs differ on use of brand names in licenses

Rajashtan, Maharashtra, Madhya Pradesh object; Gujarat and Karnataka fall in line

Usha Sharma

The issue of granting manufacturing licenses in the brand name refuses to die down. The Pharmaceutical Export Promotion Council of India (Pharmexcil) which was liaising with different state FDAs to convey the official notification dated November 9, with clarifications from the the Ministry of Health & Family Welfare (MoH&FW), Department of Health & Family Welfare has been approached by some state FDAs with concerns.

The notification No. 11011/1/2011-DFQC dt. 9.11.2012 categorically states that the directive issued on 1.10.2012 is not applicable to the issue of Certificates of Pharma Product (CoPPs), GMP Certificates, and free sale certificates as the October directive was issued under the Drugs & Cosmetics Act, 1940, which does not apply to certificates required for drug exports. Drug exports do not fall under the purview of the Drugs & Cosmetics Act, 1940 and instead have to comply with regulatory requirements of importing countries which require such certificates.

However, some state FDAs have now reverted with concerns, pushing for the use of brand names while granting/renewing drug manufacturing licenses even for consignments meant for the domestic market. Pharmexcil has shared these concerns with the MoH&FW and is awaiting to hear on the same.

Giving more details, Dr PV Appaji, Director General, Pharmexcil said, “While states like Karnataka and Gujarat have already started acting on the said clarified notification, other states namely Rajashtan, Maharashtra and Madhya Pradesh raised concerns over the impact on domestic trade.”

He continued, ”We understand the raised concerns and to discuss this we have already shared this issue with Ministry of Health. Few of our members are in favour of the issued notification but there are few members who still feel that brand endorsement is required for the domestic market as well. We are happy with the fact the MoH has considered the issues raised by us and now there will be no adverse effect on the pharma exports.”

Considering that the MoH&FW had issued these clarifications in order to encourage pharma exports and looking at the requirements from importing countries, the clarified notification stated that the drug regulator's office can give COPP and can give GMP certificates in the brand name to an exporter. It has also mentioned that whenever there is a request for a free sale certificate, the drug regulator can provide these as well.

While commenting on the outcome of raised concerns from the members, Appaji said, “I am not sure whether the Government will address this concern or not. But we have put it forward to them.”


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