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  • Writer's pictureChetan Chadha


Recently, the Government of India has proposed a change to the Drugs & Cosmetics Rules, 1945 seeking to introduce changes to the present provisions relating to data exclusivity. The Department of Industrial Policy and Promotion, (working under the aegis of the Ministry of Commerce) which is the nodal agency for patent matters in India, is inclined to extend the four-year period for which a new drug shall continue to be considered as new drug (given at the time of drug approval) to 10 years, extending the protection of exclusivity to the drug.

This proposed amendment seeks to enlarge the scope of the already existing provisions of IP protection, viz. the patents regime for the original product, to include an extra layer of protection for clinical data.

In India, in the atmosphere of emerging recognition of the need to extend stronger protection of Patent rights to big pharmaceutical companies, the proposed amendment is a welcome move for such innovator companies. Adding to the stimulation that the amendment would give to Patent rights in India, it is noteworthy that it would impede the entry of generic companies into the market.

A significant impact of the proposed data exclusivity provision would be that the grant and use of compulsory licenses would no longer be a thing of routine and would be resorted to only in instances of actual public requirement, thereby, recognising the efforts and costs involved on part of drug manufacturers. Further, such an amendment would apply not only to patented medicines, but even to the off-patent medicines introduced for the first time and also, to medicines whose patents have been invalidated.

Therefore, the amendment is a positive step in the direction of IP protection in India thereby, signalling a bright future of IP regime in India.

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