A recent health ministry move to bar state drug regulators from granting manufacturing licences on brand names may force companies to queue up before the registrar of trademarks. In the process, several brands resembling popular brands and at times even misrepresenting their contents may get weeded out, too.
Estimates suggest 75-90% of drug brands in India, including some of the top sellers, may be unregistered trademarks. This, despite the fact that the R68,000-crore pharma market consists largely of branded generics as doctors write brand names rather than generic names in prescriptions.
The government through this move wants to limit the abuse of brands and misuse of the law (the Drugs and Cosmetics Act) to cover up such instances, an official told FE.
Currently, state controllers give licences to companies on brand names without verifying whether it is a registered trademark or whether a similar brand exists. This has made it difficult for the owner of the original and registered brand to challenge those who misuse the brand names. This is because in the courts, the smaller company might furnish the drug manufacturing licence sporting the brand name to argue that its brand is legitimate. It is this sort of embarrassment the government is trying to avert by omitting brand name from licences.
While a company can market its product under a trademark irrespective of it being registered or unregistered, it has no legal protection if the trademark is unregistered.
Not everyone thinks companies will rush to register their brands, for the simple reason that in India it is a tedious process that may take up to seven years. Smaller drug makers might not opt for this route. On the pattern of the RNI (Registrar of Newspapers for India) website, we should have a website for all drug brands used in country registered or unregistered which pharma manufacturers can check to avoid duplication of brands, said CM Gulhati, a drug regulatory expert.
The move may also spare the government embarrassment of another sort. Many identical brands are being used for different medicines by various manufacturers in different states. For instance, Lona is a brand used by two different companies to market two therapies low sodium salt as well as anti-epilepsy drug clonazepam. Similarly, the AZ brand is used for different therapies like azithromycin (antibiotic), albendazole (deworming) and alprazolam (anti-anxiety). This happens because one state drug regulator is unaware of the details of the licences issued by another. While the latest move may guard against such blunders, it doesnt address the real problem of different drugs being marketed under identical names.
As of now, the notification, seen more as a push towards a brand-less generics market by many, has spawned confusion. While large players remain unfazed, medium and small players are worried. As I understand, the directive has a limited objective of ensuring that manufacturing licence is not used to give legitimacy to a brand name. Hence, the state licensing authorities are advised not to issue licences under a brand name. This in no way prohibits companies from selling their products under brand names, provided they comply with the labelling requirements, said DG Shah, secretary general, Indian Pharmaceutical Alliance.
Smaller firms fear regulatory agencies of countries buying their drugs may not allow them to export drugs carrying brand names not vetted by the domestic regulator. If some unscrupulous drug inspector wants to exploit this to harass us saying we do not have the permission to market a drug under a brand, how do we tackle it, a small drug maker wondered.
* Ministrys move may force pharma firms to queue up before trademarks registrar
* 75-90% of brands, including some top-selling ones, may be unregistered trademarks
* Branded generics form a large chunk of the R68,000-cr domestic pharma market
* Registering drug brands in India is a tedious process that may take up to 7 years