the Drugs Controller General of India (dcgi) is preparing guidelines for linking the drug regulatory authority and the Indian patent office. The system called 'patent-registration linkage' will deny marketing approval to generic drug manufacturers for drugs patented in India. Public health organizations warn that the system will reduce access to cheap, life-saving drugs and goes against the Indian Patent Act, 1970.
At present, a generic manufacturer gets marketing approval from dcgi even before the patent for the drug is expired. The Bolar provision in the Indian Patent Act allows this. If there is a violation of patent rights, the patent holder can appeal in the court. But under patent linkage, even if the patent is wrongly granted--which is often the case--the generic manufacturer cannot get marketing approval. It will have to wait for the patent to expire. There will be a time lag between the expiry of the patent and market approval of the generic drug and this will delay access to cheap drugs for patients.
The linkage system also implies that dcgi will have to cross check if any patent has been issued in India for a drug before considering the marketing request. "dcgi's office has neither the capacity nor the mandate to judge violations of patent law. dcgi's mandate as a government official is to ensure that the drugs available in the market are safe and of acceptable quality. Why is the dcgi becoming the patent police?" asked Leena Mengahaney of Mdecins sans Frontires (msf). International public health organizations, including msf, fear that the patent linkage system will affect supply of cheap drugs to countries in Africa because India is the source of generics for other developing nations.
Patent linkages are not required under the Trade and Related Aspects of the Intellectual Property Rights.
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