India – Clarity emerges on Indian health ministry’s pharma trademarks directive

Towards the end of last year, reports emerged from India suggesting that regulatory authorities in the country might be planning to restrict or even ban the use of brand names in the sale of pharmaceutical products. However, as more detail has emerged it is apparent the move is not the threat to trademarks that some speculated.

This weekend the Times of India reported on a directive issued by India’s federal Ministry of Health & Family Welfare late last year. The order calls on regional regulators to grant drugs manufacturing licences under a formulation’s generic name only, as opposed to the hitherto commonplace practice of using brand names on licences. Writing to health departments in the Indian states, the Ministry says that:

“Under the provisions of the Drugs & Cosmetics Rules 1945, applications in various forms for grant/renewal of a license to manufacture for sale or distribution of various categories of drugs as well as various forms for grant/renewal of such licenses require the name of the drug to be specified. Such forms for application as well as grant/renewal of the licenses do not require any mentioning of any Trade Name/Brand Name.

In view of the above, the grant of drugs manufacturing licenses under a trade or brand name is not in accordance to the spirit of the legislation. Therefore, manufacturing license for the drug formulation should be granted in proper/generic name only.”

The directive goes on to state that, for drugs containing multiple ingredients (eg, multivitamin supplements), licence applications should state the ‘name of categories of product’ (eg, ‘Multivitamins Capsules’), as well as the strength and generic names of active ingredients, rather than a brand name for the product. In a subsequent letter to state governments, the Ministry emphasised that its order does not apply to certifications required for the export of drugs, applications for licences to import drugs or applications for licences to import or manufacture medical devices.

Up until now, many drugs controllers at the individual state level have accepted licence applications from pharmaceutical companies that submit a trademark or trade name for a drug alongside the formulation’s generic name. “Thus, once marketing approval is granted, it could be seen as an ‘endorsement’ of the brand name by the drug authority,” says Ranjan Narula of Ranjan Narula Associates. “Endorsement of brand names is not the responsibility of licensing authorities under Drugs & Cosmetics Act. The Ministry of Health order rightly acknowledges that grant of drugs manufacturing licenses under a trade or brand name is not in the spirit of the legislation.”

Some brand owners had expressed anxiety that the directive could lead to restrictions on the use of trademarked brand names for marketing drugs. However, now that the situation has been suitably clarified, Narula thinks that trademark owners should not be too concerned about the Health Ministry’s proposals. “The order nowhere stipulates that a drug manufacturer is barred from using a brand name,” he says. “In my view the interpretation that this order will not allow any drug manufacturer to market the drug in its own brand name is inherently flawed as the restriction is only confined to mentioning brand name in the drug approval application. The risk – if any – on choice of brand name will have to be determined as usual by carrying out a search of the trademark registry database, as well as common law searches, to check what is actually available in market under an identical or similar mark.”