India to extend drug reactions monitoring programme to all medical colleges

India is planning to expand its monitoring of adverse reactions and dangerous side-effects of medicines sold and used across the country into larger scale including more medical colleges into the programme.

India drug surveillance or pharmacovigilance programme launched in 2004 is currently rudimentary covering only 21 centres across the country.

These centres include two zonal centres at All India Institute of Medical Sciences, New Delhi covering north and east and the KEM Hospital in Mumbai monitoring the southern and western regions in India.

There are five regional Pharmacovigilance Centres at Kolkata, Pondicherry (JIPMER), Nagpur and Mumbai with two centres. There are several periphery centres including Bangalore at the Victoria Hospital, Goa, and Mysore within JSS College of Pharmacy.

The new pharmacovigilance programme, which is to be launched soon, will include 40 of the total 294 medical colleges in different parts of the country, as a pilot project initially  with a scope to expand all the medical colleges, according to India’s top drug regulator, the Drug Controller General of India (DCGI).

If the pilot progamme is found successful, it will be extended to all the medical colleges in the next phase of the programme, DCGI Dr Surinder Singh was quoted as saying.

A national level workshop will be conducted in the last week of December to discuss the details of the programme. The main agenda of the workshop will be to decide the target drugs which should be included in the pharmacovigilance programme. Top physicians and other medical experts are expected to participate in the workshop.

New pharmacovigilance programme will encompass several controversial medicines which are already banned in other parts of the world and still being sold in India such as popular non-steroidal anti-inflammatory drug nimesulide, anti-depression drug Deanxit, decongestant phenylpropanolamine, antibiotic gatifloxacine, etc, reports said.

Currently, Drugs Technical Advisory Board (DTAB) — the advisory council which provide technical information regarding drug products to the DCGI are examining some of the drugs which are being used for indications that are not approved by the authority.

USFDA, which has been helping the Indian regulatory authorities on improving the functioning of the Central Drug Standards and Control Organization (CDSCO), also identified pharmacovigilance as a key area of focus.

All the CDSCO -DCGI’s office – zonal offices has already created a separate pharmacovigilance cell in his office headed by a deputy drugs controller to coordinate and monitor the programme. These zonal offices will act as the peripheral centres of this programme.