India to double drug inspectors to boost oversight

MUMBAI Wed May 21, 2014 9:32am EDT

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MUMBAI May 21 (Reuters) - India will spend 30 billion rupees ($511 million) and double the number of drug inspectors in the next three years to meet global manufacturing standards, the country's health regulator said on Wednesday.

A rash of import bans imposed by the U.S. Food and Drug Administration on leading Indian generic drugmakers due to lapses in production processes over the past year has triggered concerns about the quality of drugs sold in other markets, including in India.

The Indian government will increase the number of inspectors at the Central Drugs Standard Control Organization (CDSCO) to 1,000 from 500 now, Drugs Controller General of India G.N. Singh said in a statement on Wednesday.

The number of officials at state regulatory departments will be raised to 3,000 from 800 now, he said.

"India's reference system (for drug testing and intellectual property) will be at par with the top world standards in two to three years and will even match the U.S. in three to five years," Singh said.

In India, states regulate the manufacture and distribution of drugs, while CDSCO, which is the federal authority, handles approvals of new drugs and clinical trials, oversees drug imports and coordinates the activities of state regulators.

A chronic shortage of inspectors has made it difficult for regulators in India to monitor the more than 10,000 drug manufacturing factories in India, which supply to more than 200 countries.

Multiple state drug regulators told Reuters in April that skeletal staff and lack of enough drug testing laboratories had rendered their departments unequipped to carry out their duties.

($1 = 58.7600 Indian Rupees) (Reporting by Zeba Siddiqui in Mumbai; Editing by Prateek Chatterjee)

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