A recent health ministry move to bar state drug regulators from granting manufacturing licences on brand names may be relaxed for pharma export certificates. This implies that the requisite export certificates issued to pharma companies by state drug regulators may continue to bear the brand names of their drugs even as these firms would be prohibited from sporting brand names on their domestic manufacturing licences.
These export certificates, such as certificate of pharma products (CoPP), are insisted upon by many countries across the globe, which don’t have their own robust regulatory system to independently assess the quality of drugs they are importing. An explanation citing this exception is likely to be issued by the Drug Controller General of India’s (DCGI) office in a few days.
“We are making this exception for export certificates, keeping in mind two things. First, while domestic sale of drugs is regulated by the Drugs & Cosmetics Act, exports are actually regulated by provisions laid down by respective importing countries. A blanket bar on brand name on export certificates may breach rules and requirements of some of the importing countries and prove to be imprudent in that context. Second, we do not, in any way, want to unnecessarily impede the growth of exports business the domestic industry is witnessing,” said a health ministry official.
This rethink follows a recent meeting of domestic drug industry representatives with DCGI officials.
A section of domestic drugmakers expressed concerns that regulatory agencies of countries which import their drugs may not allow them to export drugs carrying brand names that are not vetted by the regulator at home.
The CoPP serves as a proof of quality of the product for other countries. It is issued by the state drug regulators here for a period of two years after they hold joint inspections along with DCGI officials.
A recent notification issued by DCGI asked state drug regulators to not issue drug manufacturing licence on brand names and only use the generic or the salt name of the drug on such documents.
The move is essentially