-Live Mint An investigation found DCGI cleared drugs without conducting mandatory clinical trials After five rounds of consultations in six months, a committee tasked with making recommendations on cleaning up India’s drugs-approval process and ending the cosy relationship between doctors, pharmaceutical companies and government officials had no suggestions to offer by way of a crackdown. It has, instead, suggested setting up 20 sub-committees. The report submitted to the health ministry in November is...

-The Hindu Bayer's plea dismissed by the Intellectual Property Appellate Board The Intellectual Property Appellate Board (IPAB) on Monday upheld the grant of compulsory licence (CL) to the Hyderabad-based Natco Pharma Limited, a generic drug maker, to produce and market Nexavar, a patented cancer drug of multinational pharma major Bayer Corporation. The order will pave the way for reduction in the prices of costly life saving drugs. Disposing an appeal filed by Bayer...

-Live Mint Court says legal, ethical issues involved; directs govt to monitor and regulate clinical trials of all experimental drugs  The Supreme Court directed the health ministry to monitor and regulate all clinical trials of experimental drugs in the country until further notice and observed that unregulated trials have caused “havoc”. The apex court order on Thursday revoked the power of the Central Drugs Standard Control Organization under the Drugs Controller General of...

-The Times of India The government is all set to crack the whip on India's shameful pharma-doctor nexus. The National Development Council (NDC), led by Prime Minister Manmohan Singh, will meet on December 27 to discuss bringing a legislation requiring drug companies to mandatorily disclose payments made to doctors for research, consulting, lectures, travel and entertainment. Doctors involved in ghost writing to promote pharma products will also be disqualified. The official NDC document...

-The Hindu Drugs Controller must be told of adverse events within 24 hours Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and...