The government has finally stepped in to curb the practice of paying variable or no compensation by pharma firms for deaths due to clinical trials. It has notified rules for granting relief in case of Serious Adverse Events like death or injuries.

The grant will depend on categories fixed by the government such as death, severe injury and minor injury. The minimum compensation amount would be notified soon. Recently the Supreme Court had directed the health ministry to monitor all clinical trials after stating that the government was in "deep slumber".

Issuing licence is totally compliant with multilateral agreements: Sharma

India, on Wednesday, conveyed to the U.S. that it had not violated any multilateral trade agreement by issuing compulsory licence for Bayer’s patented anti-cancer drug Nexavar to a local firm so as to make it affordable. It also asserted that such a move should not be seen as routine by the U.S. The message was conveyed by Commerce and Industry Minister Anand Sharma to U.S. Under Secretary for Economic Growth, Energy and Environment Rober Hormats, who raised concerns over the matter during a meeting here, according to an official.

The Lahore Chamber of Commerce and Industry (LCCI) will establish Green Productivity Cell that would work in collaboration with EU Switch Asia Programme and SMEDA to increase production efficiency

Cyrus Poonawalla?s Serum Institute of India to enter injectable polio vaccine market, undercut Glaxo

Billionaire Cyrus Poonawalla, founder of the world’s biggest maker of vaccines, will slash the price of polio immunisation and introduce shots for diarrhea and pneumonia, undercutting Pfizer and GlaxoSmithKline (GSK). Poonawalla, who set up the Serum Institute of India Ltd in 1966, will use last year’s acquisition of a Dutch vaccine business to add the injectable form of polio inoculation to the oral drops the Pune-based company supplies to organisations such as the United Nations Children’s Fund, he said.

The government's move to issue compulsory licences (CLs) for three more patented cancer drugs is a jolt to multinational pharmaceutical companies.

The plan is to issue CLs for Trastuzumab (or Herceptin, used for treating breast cancer), Ixabepilone (used for chemotherapy in breast cancer treatment) and Dasatinib (or Sprycel, for leukaemia). These cost an average of $3,000-4,500 (Rs 1.64-2.45 lakh) for a month's treatment.

Last March, the Hyderabad-based Natco Pharma had won the first ever CL, to manufacture its generic version of Bayer's patent-protected anti-cancer drug, Nexavar. With the licence, Natco sold the drug at Rs 8,880 for a pack of 120 tablets, a month's therapy, as against Rs 2.8 lakh, the cost at which Bayer sells Nexavar.

Each of the 3 drugs— Dasatinib Trastuzumab & Ixabepilone—costs 1L for a month’s dose

The government has appointed a panel to look into issues related to compulsory licensing of drugs and whether cheaper versions of cancer medicines Trastuzumab, Ixabepilone and Dasatinib can be launched under the provision, a person with knowledge of the development said. According to the person, the health ministry has sent its proposal regarding compulsory licensing for the three drugs to the Department of Industrial Policy and Promotion (DIPP), which in turn has sought the opinion of the department of pharmaceuticals. Srikant Jena, Minister of State for Chemicals and Fertilisers, however, denied having received any note.

Firms, foreign and Indian, reiterate they follow the rules fully earlier, SC had rapped govt for gaps in law and enforcement, including on compensation

Despite courts slamming the authorities over the monitoring of clinical trials in the country, the number of deaths caused by the adverse impact of drugs in these processes has risen. Data from the drug controller’s office, reviewed by Business Standard, show 12 drug-related deaths during clinical trials in the first eight months (till August) of 2012, as against 16 in all of 2011.

MNC Body Backs MCI Guidelines Banning All Kinds Of Gifts To Doctors In Clinical Trial

The Supreme Court on Monday sought the Centre’s response on a PIL accusing multinational pharma giant Glaxo Smithkline of having conducted unauthorised trials of its cancer vaccine on tribal girls.

A bench headed by Justice KS Radhakrishnan, while seeking reply from the health ministry, also directed the Christian Medical College, Vellore, to examine the medical records of the seven girls who have allegedly died during such trials, and submit a report to it.

The Supreme Court on Monday issued notice to the Centre on a public interest writ petition against licensing of and trials with the unproven human papillomavirus (HPV) vaccines, ostensibly to treat cervical cancer.

The petition, by Kalpana Mehta and other health activists, cited the Drugs Controller-General of India (DCGI), the Indian Council of Medical Research and others as respondents. It said Gardasil and Cervarix were hazardous HPV vaccines marketed in India by MSD Pharmaceuticals Pvt. Ltd. (a subsidiary of Merck) and GlaxoSmithKline Ltd.