-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...

-The Times of India All antibiotics, TB drugs and other habit-forming medicines may soon come with a label warning users about the dangers of taking them without medical advice. Recommending this to the health ministry as a way to address the problem of drug resistance, a task force has also suggested creating a new category, H1, for these drugs by amending the drugs and Cosmetics Rules, 1945. Health minister Ghulam Nabi Azad...

-The Times of India As many as 436 people died last year due to serious adverse events (SAE) during clinical trials. Investigations are now on to ascertain how many of the deaths were caused by drugs administered to the trial subjects. Union health minister Ghulam Nabi Azad said on Friday that deaths could be due to life-threatening diseases such as cancer, heart failure and stroke or side-effects of the drugs or their...

-Live Mint Developments a part of reforms initiated after apex court’s intervention to amend drugs and Cosmetics Act The health ministry has tightened the norms for clinical trials by making it mandatory for companies to compensate patients who may suffer injury or death while participating in the trials even if they have not been caused by the drugs being tested.   So far, the compensation has been restricted only to cases where the...