The Drug Controller General of India (DCGI) will soon revive the much awaited national pharmacovigilance programme, which has been ignored for years after its launch in 2004. The pilot programme will be launched in 40 of the 294 medical colleges in different parts of the country soon.
"Once the pilot programme succeeds, it will be extended to all the medical colleges in the next phase of the programme," DCGI Dr Surinder Singh said. He said a national level workshop will be conducted in the last week of December to deliberate on the issue. Reputed doctors of the country will be invited for the workshop. The main agenda of the workshop will be to decide the target drugs which should be included in the pharmacovigilance programme. However, the date and venue of the workshop is yet to be finalised.
Dr Singh said that all the drugs which were included in the agenda of the recently concluded Drugs Technical Advisory Board (DTAB) meeting might find a place in the programme. Several controversial drugs, which are banned in the developed nations for adverse health effects were re-examined by the DTAB in its meeting on November 9. They included the controversial drug letrozole, popular non-steroidal anti-inflammatory drug Nimesulide, anti-depression drug Deanxit, decongestant phenylpropanolamine, antibiotic, gatifloxacine, etc.
Fund may not be a constraint for this national programme as the government has already allocated Rs 4 lakh for his year and Rs 1 crore for next year. All the CDSCO offices in different zones will act as the peripheral centres of this programme, Dr Singh said and added that he had already created a separate pharmacovigilance cell in his office headed by a deputy drugs controller to coordinate and monitor the programme.
Of late, the USFDA, which has been helping the Indian regulatory authorities on improving the functioning of the CDSCO, had also identified pharmacovigilance as a key area of focus.
India had launched the national pharmacovigilance programme in 2004 with the help of World Bank. Under the programme, there were 21 centres, including 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.