The Union health ministry's recent directions to the state drug licensing authorities to grant or renew drug licenses in proper generic names only will not be applicable to the exporters in the country as the ministry has issued a clarification in this regard in which it has clarified that the direction will not be applicable to the exporters.
In the clarification issued by the ministry, it has been clarified that the direction is applicable only for the manufacturing licenses issued by the drug licensing authorities under the provisions of the Drugs and Cosmetics Act, 1940. The direction does not apply to the various types of certificates, namely CoPP, GMP certificate, Free Sale Certificate, etc required for the purpose of exports of drugs as these are not issued under Drugs and Cosmetics Act, 1940. The exports have to comply with the regulatory requirements of of the importing countries which require such certificates, the ministry's clarification further said.
The clarification also says that the direction is not applicable to grant/renewal of licenses for import of drugs.
The ministry's clarification comes in the backdrop of confusion that prevailed in the country over the issue of granting or renewal of manufacturing licenses of drug formulations under brand names by the state drug licensing authorities for the purpose of exporting. Thought the senior health ministry officials have been maintaining that the ministry's recent directions to the state drug licensing authorities to grant or renew drug licenses in proper generic names only will not be applicable to the exporters, most of the state drug licensing authorities stopped issuing licenses in brand names, even for the purpose of exports.
The state drug licensing authorities refused to issue licenses in brand names even for the purpose of exports, citing the reason that there was no written directive from the ministry in that regard.
Now that the ministry has come out with a clarification on exports, the exporters in the country are feeling relieved.