The FDA in the last couple of years has banned production from some of India's largest drugmakers, raising questions in warning letters about faked data and shoddy manufacturing. The actions have knocked the legs out from under market growth in the country's generic drug industry and caught the attention of some lawmakers. Thinking it needs to change the spin on the story, an industry group has hired a Washington, DC, consulting firm which is launching a campaign it hopes can do that.
According to BusinessWorld, the Indian Pharmaceutical Alliance (IPA) has hired Ron Somers' India First Group, known for its work on behalf of U.S. interests in India's civilian nuclear industry. The IPA counts among its members Ranbaxy Laboratories, Sun Pharmaceutical, Lupin, Dr. Reddy's Laboratories and Zydus Cadila. Ranbaxy and Sun both have had plants banned by the U.S. in recent months.
Somers' firm has created the Coalition for Affordable Care, a group made up of his clients, but which will invite insurers, pension funds, large employers and healthcare professionals to support market-based pricing and the protection of intellectual property in line with global norms. The U.S. Chamber of Commerce, PhRMA and Big Pharma, which have complained about India's treatment of drug patents, is among the targets of Somers' PR campaign.
He accused them in a press release of "tar-brushing" the Indian generic industry "in order to maintain market share and destroy competition." PhRMA could not be reached for comment.
India manufactures about 40% of the generic and over-the-counter drugs sold in the U.S., and concerns have been building for several years as the FDA has banned plants operated by Ranbaxy, Sun, Wockhardt and others for faking analytics and for sanitation and manufacturing lapses. An FDA warning letter posted two weeks ago for a now banned Sun Pharmaceutical plant in India said employees routinely deleted records of batch failures then retested drugs, reporting they met the standards that they previously couldn't hit. In fact, FDA inspectors fished torn and partially destroyed raw data cGMP records out of the trash.
During a trip to India in February, FDA Commissioner Margaret Hamburg said that many drugmakers there were top-notch, but that a failure to focus on quality was costing India its reputation in the eyes of the world. The bans have taken a significant toll on India's drug industry. Growth in drug exports fell to 2.6% in the year ending March 31, about $15 billion, after reaching a growth rate of 23% two years ago. The campaign is intended to help India restore its industry to its former glory.
"The time has come to let the truth be known on Capitol Hill, in the halls of government, and across America, that Indian and U.S. manufacturers of generic drugs are producing high quality medicines at a fraction of the price of branded pharmaceuticals," Somers said in his release.
- read the announcement
- here's the BusinessWorld story