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| FDA Commissioner Margaret Hamburg |
FDA Commissioner Margaret Hamburg, during a visit to India this year, urged the country to get its regulatory house in order and make sure all of its companies are meeting the highest standards. India, without any reference to Hamburg's plea, says it is doing just that, making a $500 million investment to vastly expand its inspection team.
Drugs Controller General of India G.N. Singh said Wednesday that India will invest more than half a billion dollars over three years to make improvements.
"While following a zero tolerance policy for any laxity, the government will more than double the number of regulators in three years and set up state-of-the-art testing labs at ports to ensure the pharmaceuticals and drugs exports shipments meet global quality standards," Singh told reporters, according to the Economic Times.
The Indian system is a dual process, with the central government approving and overseeing manufacturing facilities for the first four years and then giving that responsibility over to state authorities. The 30 billion rupees ($511 million) will be spent to increase the number of inspectors in the central government to 1,000 from 500 today, and as many as 3,000 at the state level, Singh explained.
The top regulator was speaking at iPHEX 2014, an industry event supported by the government. Regulators from around the world were invited to attend and visit production plants in the country to see for themselves that things are better than reports suggest. The newspaper said Singh and his colleagues were meeting with regulators from about 40 other countries.
The industry hopes to use the meeting to counter the impression that it has failed to meet international expectations in recent years. That impression has been growing amidst highly publicized FDA actions against a number of India's largest drugmakers. Those actions have taken a toll on the country's important drug export business. Growth in drug exports from India fell to 2.6% in the year ending March 31, about $15 billion. Two years ago it reported a 23% rise in drug export value.
During her February trip there, Hamburg said, "We think this is a critical moment in time, when we have to think and act in new ways, and that requires real commitment of national regulators to work as a coalition of global regulators." She said of the country that makes 40% of U.S. generic and OTC products that "it is so important that the Indian regulator really joins us at the table, because they are so important in the global marketplace for medical products."
- read the Economic Times story