Intellectual Thoughts by Sanjay Panda


Another Block buster bites the dust

Yet another milestone on pharma's journey away from the mega blockbuster era: Plavix (the world's second-best-selling medicine) goes off patent. And unlike Pfizer BMS plans to back off Plavix marketing immediately. Thanks to the monopoly Plavix enjoyed, USD 9 Billion on its peak and it brought in $6.6 billion in net U.S. sales last year and the drug has generated an estimated $42.8 billion for the company during its 15 years on the market.

FDA said it gave seven companies permission to sell generic Plavix or clopidogrel in the standard 75-milligram dose. According to the FDA, 75-milligram generic Plavix can now be sold by Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxanne Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals.

The larger dose of 300 mg will be sold by Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan and Teva.

India To Probe Alleged Irregularities Within Drug Regulator

The government of India announced an inquiry on the functioning of the main drug regulator, after a parliamentary report exposed dysfunction within the agency and serious irregularities in the drug approval process.

The government said in a statement that it had appointed three experts to look at the scientific basis of approving new drugs without clinical trials and recommend ways of improving the procedures of the Central Drugs Standard Control Organisation (CDSCO).The parliamentary panel accused some officials of the CDSCO of colluding with multinational and Indian drug firms to bypass normal approval procedures.


(Reuters)