DIPP has initiated discussions to lay down norms for the issuance of compulsory licensing (CL) in India. A paper in this regard highlights the issues which need to be addressed while formulating such a framework. While India became TRIPS-compliant starting 2005, grounds on which a CL can be issued are not
stipulated within TRIPS; thus allowing significant flexibility to member countries for issuing CLs. CLs have been an integral part of the patent regime with 52 countries issuing those. No CLs have been issued in India since the amended Patents Act was implemented in 2005. We examine below the key concern raised in the paper and developments leading to the concern.
If large Indian generic companies with the capability to manufacture drugs based on a CL are themselves taken over, then the regime of cheap and effective drugs may be threatened. There is also a concern that some of the Indian companies taken over were recipients of substantial grants — they were allowed to work patents owned by the CSIR at concessional prices.
While sales from patented products are still a miniscule proportion of domestic market currently, we think the long-term CL may be used as a mechanism not only to address affordability of medicines in categories such as anti-AIDS etc. where cheaper Indian generics are already available but more in the areas of anti diabetics/cancer where affordability remains a key issue and where newer innovative products will be introduced under product patents.
