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US FDA to involve Indian regulators for inspections to create awareness about its inspection activities in India

Peethaambaran Kunnathoor, Chennai
Saturday, February 21, 2015, 08:00 Hrs  [IST]

The US FDA will invite Indian regulators for its inspections to create more awareness about its inspection activities in India. The US regulatory agency has also decided to increase its staff strength in India, said Dr Vijay Venkataraman, managing director of Oviya MedSafe, a pharmacovigilance consulting and drug safety services firm in Coimbatore.

Dr Venkataraman, who had attended the DIA-hosted conference on Pharmacovigilance and Risk Management Strategies--2015 in Washington from 26th to 28th January, quoting some reports said that the US FDA, which has offices in New Delhi and in Mumbai, will increase the number of their Indian officials from 10 to 19.

He said the government of India is initiating programmes to sensitise physicians on adverse drugs reactions (ADRs) to strengthen the pharmacovigilance programme in India (PvPI). The drugs controller general of India (DCGI), who monitors the ADR reporting, has authorised the 150 ADR monitoring centres (AMCs) in the country for  registration with the Vigiflow software which is meant to report adverse drug reaction data to World Health Organization.

Dr Vijay said that Oviya MedSafe will expand its pharmacovigilance activities and drug safety services to the North American region and reached an understanding with pharmaceutical companies and biotechnology firms there.

Dr Vijay has been awarded the Fellowship of the Pharmaceutical Information and Pharmacovigilance Association (PIPA) of the UK. This is first time a person from India receives this fellowship, he said. PIPA is the professional organisation for individuals who are involved in the provision and management of information and those involved in the fulfillment of regulatory requirements relating to drug safety.

In addition to the 150 AMCs, the union health ministry is planning to set up adverse drug reaction monitoring centres in over 380 medical colleges across the country. Ghaziabad based Indian Pharmacopoeia Commission (IPC) which is the national coordination centre for PvPI will serve as a nodal agency for the AMCs, Dr Vijay added.


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