Thousands of the pharmaceutical exporters in the country can heave a sigh of relief as 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.
Allaying the fears of the exporters, Drug Controller General of India (DCGI) Dr G N Singh said that the health ministry will not take any steps which will have an adverse effect on the pharma exporters in the country. The ministry's recent direction to all the states and union territories to instruct their respective drug licensing authorities to grant or renew licenses to manufacture for sale or for distribution of drugs in proper generic names only will not have any impact on the pharma exporters, he said and added that the ministry is well aware of the needs of the exporters.
Though the ministry has not taken any decision on coming out with a clarification on this issue, Dr Singh's clarification virtually meant that the ministry's directive, issued under Section 33 (P) of Drugs & Cosmetics Act 1940 to health secretaries of all states and union territories, will not be applicable to the exporters, as the ministry is well aware of the fact that the needs of the exporters are more or less dependent on the policies of the importing countries.
Ever since the health ministry issued the directive, there were apprehensions among the exporters about the impact of the directive on them. To drive home their apprehensions, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) had asked the health ministry to exclude the drugs meant for exports from the purview of its recent directive.
Pointing out the implications of the health ministry's directive on exports, Pharmexcil said that several overseas countries including developed countries, are granting product registrations for drugs by endorsing brand names as per their existing laws. In case, Indian drug regulatory authorities stop granting/renewing licences with brand names, Indian exporters will be in a disadvantageous position.
The exporters apprised the health ministry that there are about 3000 pharma exporters in the country and the companies are exporting drug formulations to almost all countries in the world. Most of the companies have established their markets with generic drugs sold in brand names. The state drug controllers have also issued CoPP (certificate of pharma product) to WHO GMP compliant companies by endorsing brand names for each product. Accordingly, small and big pharma companies have registered the drugs in various countries in brand names. Even the drug regulatory authorities like USA, UK, Japan, Australia etc. have also granted product registrations to Indian companies in brand names.