Monday 2 June 2014

India To Up Drug Inspection Efforts To Address Quality, Regulation Concerns

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



A number of import bans imposed by the Food and Drug Administration U.S. in major generic drug manufacturers in India due to failures in the processes of production in recent years have given rise to concerns about the quality of the drugs sold in other markets, particularly in India.

The government of India the number of inspectors from the Organization of Central Drug Standard Control (CDSCO) 500 1000 now, Drug Controller General of India will increase GN Singh said in a statement Wednesday.

The number of officials from state departments of regulation was increased to 3,000 from 800 now, he said.


“Reference System India (for drug testing and intellectual property) will be at par with global standards the most important two or three years and will even match the U.S. in three to five years," Singh said.

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

The chronic shortage of inspectors has made it difficult for regulators to monitor Indian factories over 10 thousand drug manufacturing in India, catering to more than 200 countries.

Multiple state drug regulators told Reuters in April that the skeleton staff and the lack of sufficient drug testing laboratories had surrendered their departments equipped to carry out their duties.

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