The much delayed national pharmacovigilance programme, which was postponed several times during the last some months due to the red-tapism in the union health ministry, will eventually become a reality by next week as the programme will begin in 10 select medical colleges across the country by mid-July this year.

To be rolled out in three phases, the pharmacovigilance programme for India (PvPI) will monitor a number of drugs including two H1N1 drugs - oseltamivir and zanamavir, the controversial sub-fertility drug letrozole, popular non-steroidal anti-inflammatory drug Nimesulide, decongestant drug phenylpropanolamine (PPA), antibiotic drug gatifloxacine, chronic constipation drug Tegaserod, type-2 diabetes drugs, pioglitazone and rosiglitazone in the first phase of the programme.

Dr Y K Gupta, professor and head, Department of Pharmacology, AIIMS, who heads the programme, said that in the first phase, 40 adverse drug reaction monitoring centres (AMC) will be rolled out in 2010 and will be expanded up to 140 MCI recognized medical colleges by 2011 in phase 2. Phase 3 would ultimately cover the healthcare system by 2013. Phase I will be further divided into phase Ia and Ib. Phase Ia will involve upgrading 10 centres in terms of infrastructure (computer and ancillaries). Phase Ib will include the rest of the 40 centres by end of 2010.

The coordinating centre of the Programme will be Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), New Delhi and will provide technical support to the CDSCO headquarter.

Though the programme is still in its infancy in the country, the concept is not new. It was not until 1986 that a formal adverse drug reaction (ADR) monitoring system consisting of 12 regional centres, each covering a population of 50 million, was proposed for India. In 1989, under the aegis of the Drug Controller of India, six regional centres were set up in Mumbai, New Delhi, Calcutta, Lucknow, Pondicherry and Chandigarh. In 1997, India joined the WHO Programme for International Drug Monitoring managed by the Uppsala Monitoring Centre, Sweden. The centre in New Delhi (at Department of Pharmacology, AIIMS) was identified as the national centre, while the centre in Mumbai (at KEM Hospital) was identified as the WHO special centre. Of the six centres, only the centres in Mumbai and New Delhi were active, yet spontaneous reporting of ADRs was poor. The monitoring centres were considered ad hoc and appropriate levels of funding were not, made available, which put severe constraints on them. Recognising the need for improved ADR monitoring in India, the Government of India sent a proposal to the World Bank for funding. The World Bank approved the proposal with an annual grant of US$ 0.1 million for five years and the National Pharmacovigilance Programme (NPVP) was launched in November 2004.

The NPVP had three broad objectives: the short-term objective was to foster a reporting culture, the intermediate objective was to involve a large number of healthcare professionals in the systems in information dissemination and the long-term objective was for the program to be a benchmark for global drug monitoring. However, the World Bank funding for the national programme ended in mid 2009 and the programme was temporarily suspended.