The national pharmacovigilance programme (PvPI), launched late last year at 20 centres across the country with an aim to ensure that the benefits of use of medicine outweighs the risks thus safeguarding the health of Indian population, will be extended to 20 more centres soon.

Some of the centres which have been selected for the expansion of the PvPI included: Grant Medical College & Sir J J Group of Hospital, Byculla, Mumbai; Lokmanya Tilak Municipal Medical College & General Hospital, Mumbai; Godavari Foundation's Dr Ulhas Patil Medical College, Jalgaon, Maharashtra; Padamashree Dr D Y Patil Medical College Hospital & Research Centre, Pimpri, Pune; BJ Medical College & Sassoon General Hospital, Near Pune railway station, Pune; BJ Medical College,  Ahmedabad; SMT NHL Municipal Medical College, Ahmedabad;  Government Medical College, Near ST Bus Stand, Jail Road, Bhavnagar, Gujarat; PDU Medical College, Rajkot, Gujarat; Indira Gandhi Government Medical College, Central Avenue Road, Nagpur; Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra; Goa Medical College & Hospital, Bambolim Premier Govt Based Hospital, Goa; and R D Gardi Medical College, Ujjain, Madhya Pradesh.

In fact, in the first phase of the programme itself, 40 Adverse Drug Reaction (ADR) monitoring centres were to be rolled out but the authorities could only launch the programme in only 20 centres that time.  The programme is scheduled to be expanded up to 140 MCI recognized medical colleges by 2011 end in phase II and the phase III would ultimately cover the entire healthcare system by 2015.

The Indian Pharmacopoeia Commission, Ghaziabad, is the coordinating centre of the Programme, while the CDSCO headquarters in Delhi is providing the technical support to the PvPI.

Pharmacovigilance has great significance in the country as India is now being recognized as the ‘Global pharmacy of Generic Drugs’ and has the distinction of providing generic quality drugs at affordable cost. India is also emerging rapidly as a hub of global clinical trials and a destination for drug discovery & development.

Further, more & more new drugs are being introduced into the country which include New Chemical Entities (NCE), high tech pharma products, vaccines as well as new dosage forms, new routes of drug administrations and new therapeutic claims of existing drugs.

Such rapid induction of NCEs and high tech pharma products in the market throw up the challenges of ADRs over large population base. All medicines  have side effects. Some of these side effects are known, while many are still unknown even though those medicines have been in clinical use for several years. It is important to monitor both the known and hitherto unknown side effects of medicines in order to determine any new information available in relation to their safety profile.

Since, there are considerable social and economic consequences of ADRs, there is a need to engage health-care professionals, in a well structured programme to build synergies for monitoring ADRs. The purpose of the Pharmacovigilance Programme of India is to collect, collate and analyze data to arrive at an inference to recommend regulatory interventions, besides communicating risks to healthcare professionals and the public.