Several drugs to come under regulatory scanner as national pharmacovigilance programme to begin in April
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 drug pioglitazone and rosiglitazone have been selected for the first phase of national pharmacovigilance programme which will begin in select 40 medical colleges across the country from April this year.
The much awaited pharmacovigliance programme for India has been designed by the central drugs standard control organisation (CDSCO), in collaboration with the Department of Pharmacology, AIIMS, for comprehensive drug safety monitoring with nationwide coverage. Inputs from scientific organizations like WHO and ICMR have been incorporated into this programme.
Dr Y K Gupta, professor and head, Department of Pharmacology, AIIMS, who heads the national programme, said that several criteria have been used for putting a drug on the watch list like restriction/withdrawal by any other regulatory agency in the world; reports in media; adverse reports published in WHO Newsletters; diseases of public health importance in relation to Indian population; drugs, vaccines for epidemics/pandemics; and signals generated from the spontaneous reports received under the NPV.
In the first phase, operative from April 2010, 40 medical colleges that have been identified as adverse drug reports (ADR) monitoring centres, will send ADR reports to the national coordinating centre at Department of Pharmacology, AIIMS, which will be involved in quality assurance, causality assessment and training. The programme also envisages to include all the medical colleges and corporate hospitals by 2012.
In addition to routine sponateous reporting, these ADR monitoring centres will also carry out focussed ADR monitoring on selected drugs of national importance, Dr Gupta said.
The 24 centres already identified for the pharmacovigilance programme are R G Kar Medical College, Kolkata; Postgraduate Institute of Medical Education & Research, Chandigarh; G.S.V.M. Medical College, Swaroop Nagar, Kanpur, U.P; C.S.M. Medical University (erstwhile KGMC), Lucknow, U.P; Pandit Bhagwat Dayal Sharma, Post Graduate Institute of Medical Sciences, Rohtak, Haryana; Gauhati Medical College and Hospital Guwahati, Assam; SMS Medical College, Jaipur; S.N. Medical College, Agra, U.P; Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P; Dayanand Medical College and Hospital, Ludhiana; Nizam's Institute of Medical Sciences, Hyderabad; Burdwan Medical College, Burdwan, West Bengal; LLRM Medical College, Meerut, U.P; Subharti Medical College, Subharti Nagar, Meerut, U.P; SGS Medical College and KEM Hospital, Mumbai; Govt Medical College, Srinagar, J&K; Santosh Medical College, Ghaziabad; V.P. Chest Institute, University of Delhi, Delhi; TN Medical College & BYL Nair Hospital, Dr. AL Nair Road, Mumbai; Seth G. S. Medical College & KEM Hospital, M. S. Building, Parel, Mumbai; Himalayan Institute of Medical Sciences, Jolly Grant, Dehra dun; RD Gardi Medical College, Ujjain (MP); KIMS University, Karad, Maharashtra; and National Institute of Malaria Research, Sec-8, Dwarka, New Delhi.
The remaining 16 centres will be identified soon.