{"slug":"in","tag":"in","variants":["in"],"description":"No description yet","count":3,"kinds":{"term":3},"related":[{"slug":"law","tag":"law","shared":3}],"records":[{"id":"india-new-drugs-rules-2019","kind":"term","name":"India New Drugs and Clinical Trials Rules 2019","route":"/terms/india-new-drugs-rules-2019/","tldr":"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."},{"id":"nexavar-compulsory-licence","kind":"term","name":"Nexavar compulsory licence (India, 2012)","route":"/terms/nexavar-compulsory-licence/","tldr":"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."},{"id":"novartis-glivec-ruling","kind":"term","name":"Novartis v. Union of India (Glivec, 2013)","route":"/terms/novartis-glivec-ruling/","tldr":"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."}]}