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India's 2019 rules for approving new drugs and running trials set deadlines for the regulator, fixed compensation for trial injuries, and allowed waivers of local trials for drugs already approved abroad, a waiver widened in 2024 for cancer and orphan drugs.

In March 2012 India's patent office let Natco make a generic of Bayer's kidney and liver cancer drug sorafenib at about 3 percent of the branded price, paying a royalty, because Bayer had priced it beyond most Indians' reach; it remains the leading example of a compulsory licence on a cancer drug.

In April 2013 India's Supreme Court refused Novartis a patent on the crystal form of imatinib used in Glivec, ruling that a new form of a known drug must show improved therapeutic effect, a decision that kept Indian generics of the leukaemia drug legal and became the model for anti-evergreening laws elsewhere.