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CDSCO to begin regulatory action on ADRs reported under PvPI soon

Suja Nair Shirodkar, Mumbai
Friday, September 21, 2012, 08:00 Hrs  [IST]

With a view to safeguard the health of the patients in the country, the Central Drugs Standard Control Organisation (CDSCO) is soon planning to take regulatory action based on the adverse drug reactions (ADRs) reported under the Pharmacovigilence Programme of India (PvPI). This will be the first time that the Indian regulators will be referring to the data documented on the drug safety profile by reviewing the case reports of various drug monitoring centres submitted to the national coordinating centre (NCC) at Indian Pharmacopoeia Commission (IPC).

This also highlights the growing importance of the PvPI programme in streamlining monitoring function of the drug regulatory system of the country as per the Indian requirement. As of now, the Indian regulators refers to other international ADR reports for taking necessary regulatory steps for safeguarding the interest of the Indian patients.

According to a top senior official from the CDSCO, the health ministry in a recently concluded meeting on the working of the PvPI programme in Delhi, acknowledged the growing role of the PvPI programme in the country as a useful mechanism to stimulate adverse reporting as well as to disseminate information on suspected adverse reactions to health. It is also understood that they have pledged their full support to further strengthen this programme to get indigenous evidence based data that will help the regulators in monitoring the drug movement in the country.

This is huge initiative aimed at regulating and monitoring the drugs that are running in the Indian market, especially since the result is generated out of the ADR report on the indigenous population. To further discuss and deliberate on the modalities of this project, top regulatory officials plan to have regular meeting with the NCC committee officials soon.


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