A team of officials from the US Food and Drug Administration (FDA) will visit India to take stock of the progress made by the domestic drug regulator in ensuring quality of drugs, a top official in the Central Drugs Standard Control Organisation said.

The visit by the US official, which begins on Wednesday, is the second in just over a year. In February last year, the FDA Commissioner Margaret Hamburg visited India following import alerts issued against all the Ranbaxy plants in India, which effectively stopped the Indian manufacturer from exporting drugs to the US.

The US FDA and its Indian counterpart had signed a statement of intent during Hamburg’s visit last year, on exchanging expertise to ensure higher levels of compliance, concerns of the regulators, training, adoption of systems and procedures and other areas. During this year’s visit, the regulators are expected to sign a memorandum of understanding on information sharing, training and such subjects, the Government official said.

The US team would comprise Howard Sklamberg, JD, Deputy Commissioner for Global Regulatory Operations and Policy, Cynthia Schnedar, JD, Director, Office of Compliance, US FDA and Michael R Taylor, JD, Deputy Commissioner for Foods and Veterinary Medicine, US FDA. The delegation is set to travel to New Delhi, Goa, Chennai and Mumbai.

The US FDA and the Indian regulator had decided, last year, to meet on a regular basis. The US FDA had also extended the offer to train Indian drug inspectors in the systems and processes used by the US regulator.

A year since the last visit a number of Indian manufacturers have still been issued warning letters by the US body, mostly on data integrity issues. Some of the manufacturers, which came under scrutiny by the US regulator in 2014 include Sun Pharmaceuticals, Cadila Pharma and Orchid Pharma.

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