A December 2001 gazette notification, which introduced Form 44 in the Drugs and Cosmetics Act, is proving to be an Achilles’ heel for generic drugs in the country. Form 44 asks for information pertaining to patent status at the time of applying for permission to manufacture a drug.
The provision, in existence for 8 years, has lately been getting a lot of attention as multinational drugmakers seek to link patent status with marketing approval of generics. In fact, two MNC drugmakers dragged the Union of India and a generic drugmaker to court some months ago, to prevent registration of generic versions of their patented drugs.
Industry sources say Form 44, which was introduced without parliamentary debate, is leading to mixing up of two different issues —- intellectual property and drug regulation —- and making the drug controller act like a patent police.
Indeed, there are times when the controller asks not just for patent information as per Form 44, but subsequently also clarifications on whether the generic would infringe the patent, the sources say.
According to Anuradha Salhotra, managing partner of intellectual property law firm Lall Lahiri & Salhotra, the drug controller has absolutely nothing to do with patent status, trademarks, etc.
“The role of the controller, who is under the Ministry of Health and Family Welfare, is only to check whether the drugs are safe and effective before approving them. Patent related matters are for the patent office, which is under the Ministry of Commerce & Industry,” says a member of the National Working Group on Patent Laws,
“If the drug controller’s role has no connection with patent matters, why does he even require information pertaining to patent status?” asks Amit Sengupta, general secretary, All India People Science Network, a non-governmental organisation. “There is no clarity on why the drug controller needs any information on patent status.”
Industry experts also point out that Form 44 comes in the way of section 107A of the Indian Patent Act, which allows registration of generic versions of patented drugs and was introduced as a public health safeguard.
“It also hampers the compulsory licence (CL) provision of the Patent Act,” says a lawyer from an international humanitarian aid organisation. CL empowers the government to authorise generic production during the existence of a patent based on availability or supply of patented drugs or affordability.
According to the lawyer, even the World Health Organisation says that any effort to link or integrate patent and regulatory systems can have negative implications for access to medicines.“Drug controller lacks the expertise and resources to assess the validity of patents,” the lawyer says, adding, Form 44 is making the drug controller “look beyond his job.”
Efforts to establish contact over phone with Surinder Singh, the drugs controller general of India, were unsuccessful and emails remained unanswered at the time of this report going to the press.
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