Adding to the festive cheer of the Deepawali, the festival of lights, the Ministry of Health & Family Welfare (MoH&FW), Department of Health & Family Welfare has thrown light on a matter which had seemed to darken the prospects of future pharmaceutical exports.
The Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) has received word back from the MoH&FW clarifying that its letter dated 1.10.2012 giving directions under section 33 (P) of Drugs and Cosmetics Act 1940 for grant / renewal of manufacturing licenses of drug formulations in proper/generic name only. This is the promised formal notification after verbal assurances from Ministry officials along the same lines.
In an email, Dr P V Appaji, Director General, PHARMEXCIL reveals that the latest communication categorically clarifies that the directive issued on 1.10.2012 is not applicable to the issue of 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.
The notification also clarifies that this direction is not applicable to grant / renewal of license for import of drugs or to the grant / renewal of license for manufacture and import of medical devices. The communication also clarifies that the notification has prospective effect only.
Dr Appaji appreciates the Government’s stand that the endorsement of brand names is not the responsibility of licensing authorities under Drugs & Cosmetics Act and the above clarification was issued so that there was no adverse impact on exports. He hoped that these clarifications would help pharma exporters continue exports without any hassles with respect to issue of CoPPs, GMP Certificates, Free Sales certificates etc., with brand names. Any problems faced by exporters could be directed to PHARMEXCIL so that the same can be compiled and taken up with the Government.
EP News Bureau