India supplies the U.S. with 10% of its drugs and APIs, and some of India's largest drugmakers have felt the sting of FDA citations for quality lapses as the agency steps up inspections there. The Indian drug industry, in turn, gets 90% of its raw materials from China, but it has failed to open an inspection operation there despite that country's reputation for dumping low-quality products on India.
According to LiveMint, the government has pledged funding and was supposed to have an inspection office set up in China in March of this year. The publication did not get a response about the status of the effort from either India's health ministry or the ministry of external affairs, which was supposed to be doing the diplomatic groundwork so India could get inspectors established there.
Citing data from Indian reports, LiveMint said the Indian drug industry imported $4.6 billion worth of APIs from China in 2012, up from $2.9 billion in 2011. The publication says that poor quality ingredients that Indian drugmakers have gotten from China factor into the actions that the U.S. and Europe regulators have taken against Indian drugmakers. It claims that some of those ingredients came from unauthorized plants in China.
Concerns over the quality of products that come out of China and India led to the FDA actually getting its budget boosted last fiscal year so that it could expand local operations in those countries and its international inspection efforts in general. The U.S. FDA added 7 people to its office in India, which increased the number of people stationed there to 19--a nearly 60% bump. Ten of the 19 staff members handle pharma oversight while others are dedicated to medical devices or food.
Last month, the agency named Altaf Ahmed Lal, an Indian-born Ph.D., to take over management of its expanding office there. He has said that he sees his mission as threefold: to create trust by working closely with the FDA's Indian counterparts, to conduct prompt plant inspections and to "help industry and regulators understand that protecting the quality, safety and effectiveness of every product is essential." And Lal's boss, FDA Commissioner Margaret Hamburg, is slated to make her first visit to India either late this year or early next year.
The agency build-up comes as the FDA has taken tough actions against some of the key players in that country. Last month it issued an import alert against a third Ranbaxy Laboratories plant in India after finding a long list of quality and sanitary shortcomings. The company says it has begun to resolve the issues, but the FDA says its products will be banned from the U.S. until it is satisfied the plant is up to par. Two other Ranbaxy plants have been banned from shipping since 2009. The agency took the same action against a Wockhardt plant in May and two RPG Life Sciences facilities in June after discovering plant management at those operations had falsified some drug-testing data to cover up batch failures, among other problems. The U.K. has restricted imports from three Wockhardt facilities because of quality issues.
- read the LiveMint story
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