Even as the Central Drugs Standard Control Organisation (CDSCO) in India has launched the much delayed national pharmacovigilance programme (PvPI) at 20 centres across the country, no specific drugs have been brought under the programme so far for monitoring its adverse reaction among the patients.
Though several controversial drugs including the controversial sub-fertility drug letrozole and popular non-steroidal anti-inflammatory drug Nimesulide were to be brought under the radar of the PvPI, the authorities seem to have changed track at the eleventh hour.
“We have so far launched Adverse Drug Reaction (ADR) monitoring centres at 20 centres across the country. Among this, 12 centres have become fully functional while the remaining eight centres will become operational very soon. No specific drug has been selected for monitoring and it is spontaneous monitoring for all the drugs”, a senior official said. “As on 30.01.11, a total of 4696 ADR forms have been entered in the ADR database (Vigiflow) through the ADR monitoring centres (AMCs) under PvPI”, the official said.
To be rolled out in three phases, the PvPI was to 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, to name only a few, in the first phase of the programme.
In fact, in the first phase 40 AMCs were to be rolled out in 2010 but the authorities so far could only launch it in only 20 centres. It 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 2013. The Department of Pharmacology at All India Institute of Medical Sciences (AIIMS), New Delhi is the coordinating centre of the Programme, while the CDSCO headquarters in Delhi is providing the technical support to the PvPI.
The 20 ADR Monitoring Centres (AMC) where the PvPI has been launched include: All India Institute of Medical Sciences, New Delhi which is the National Coordinating Centre (NCC); Govt. Medical College, Bakshi Nagar, Jammu; PGIMER, Chandigarh; R.G. Kar Medical College, Kolkatta; Lady Hardinge Medical College, New Delhi; Seth GS Medical College & KEM Hospital, Parel, Mumbai; School of Tropical Medicine, Chittaranjan Avenue, Kolkata; JIPMER, Pondicherry, JSS Medical College Hospital, Mysore; Gauhati Medical College, Guwahati; Madras Medical College, Chennai; SAIMS Medical College, Indore, Madhya Pradesh; GSVM Medical College, Kanpur; Pandit Bhagwat Dayal Sharma PG Institute of Medical Sciences, Rohtak, Haryana; Dayanand Medical College and Hospital, Ludhiana; Sher-i-Kashmir Institute of Medical Sciences, Srinagar; Himalayan Institute of Medical Sciences, Dehradun, Uttrakhand; Santosh Medical University, Santosh Nagar, Ghaziabad; SMS Medical College, Jaipur; and Christian Medical College, Vellore, Tamilnadu.