<img src="https://publish-01.obsidian.md/access/744ac39d33cabbc297b91373bfcac24d/bin/images/India_map.png" alt="India" class="page-header-sidebar-image"> India has provisions in its legislation relating to the granting of compulsory licences. These can be found in the Patents Act, 1970. A compulsory licence may be granted under the following grounds: - Non-working / unmet public requirements - After 3 years from grant, a compulsory licence may be sought where the reasonable requirements of the public with respect to the patented invention have not been satisfied, or the invention is not worked in India. - Refusal to grant licence on reasonable terms / failure to supply - Where the patent owner refuses to grant licences on reasonable commercial terms and conditions (or the patent is worked but not supplied to the public on reasonable terms). - Dependent (later) patent - If a later invention cannot be worked without infringing an earlier patent, and the later invention represents a substantial technical advance of considerable economic significance, a licence may be granted to the owner of the later patent to the extent necessary. - Public interest / national emergency / anti-competitive practice / government use - The law and related provisions allow compulsory licences or government use directions in cases of public health, national emergency or anti-competitive behaviour. Procedures differ (and some requirements may be waived in emergencies). - Export to countries lacking manufacturing capacity (Section 92A) - Section 92A provides for compulsory licences for the manufacture and export of patented pharmaceutical products to countries that lack sufficient manufacturing capacity, subject to conditions and exceptions (TRIPS-consistent export mechanism). More information can be found [here](https://ipindia.gov.in/writereaddata/Portal/IPOAct/1_113_1_The_Patents_Act__1970___incorporating_all_amendments_till_1-08-2024.pdf). ## Compulsory licences India has granted compulsory licence for: - [[Sorafenib Tosylate]] India has been requested to issue a compulsory licence for [[Saxagliptin]] by Lee Pharma. The compulsory licence has not been issued because it was rejected. India has been requested to issue a compulsory licence for [[Sunitinib, erlotinib]] by Natco Pharma Ltd. The compulsory licence has not been issued because it was withdrawn. India has been requested to issue a compulsory licence for [[Dasatinib]] by BDR Pharma. The compulsory licence has not been issued because it was rejected. India has been requested to issue a compulsory licence for [[Lumacaftor, tezacaftor, elexacaftor]] by Civil society. The compulsory licence has not been issued because the application is still pending. ## Generic manufacturers India has its own generic manufacturer: [Sun Pharmaceutical Industries, Ltd](https://sunpharma.com/ ).