India requires a robust pharmacovigilance programme going by the population size, ethnic variations, disease profiles and practice of different systems of medicine, stated Dr BR Jagashetty, Karnataka drugs controller.
Increasing availability of drugs, several irrational combinations, aggressive marketing practices, irrational practice, treatment without diagnosis, incorrect dosages, lack of documentation, etc lead to adverse drug effects. “This is where we need to do everything possible to ensure drug safety, and create post-marketing database,” stated Dr Jagashetty.
The country is also a preferred hub for clinical trials and there are an increasing number of Clinical Research Organizations (CROs) and hospitals carrying out human studies. This is where India will require a robust pharmacovigilance system, which will enable medical fraternity and CROs besides regulatory authority and decision makers to analyze safety data and take decisions without the need to depend on other countries, pointed out Dr Jagashetty.
Pharmacovigilance, which calls for Adverse Drug Reaction (ADR) monitoring, has 20 regional centres roped in under the National Pharmacovigilance Programme (NPP) after India joined the World Health Organization (WHO) Adverse Drug Reaction Monitoring Programme of Uppsala, Sweden.
The effort is to encourage a drug reaction reporting culture and information dissemination exercise involving pharmacists and medical experts.
Information on ADRs is required for any new formulation. In 2006, according to the Central Drug Standard Control Organization (CDSCO), 10,000 new drugs were introduced which doubled in 2009. The growing number of New Chemical Entities (NCEs) calls for compulsory pharmacovigilance. “This is where government hospitals and medical colleges should focus on ADR reporting because of the huge patient influx with varied disease patterns that would definitely provide a broad based data about drug efficacy and reactions,” he added.
Pharmabiz had earlier reported that Karnataka drugs controller has proposed to the Drugs Controller General of India (DCGI) for 18 Centre for Pharmacovigilance at government medical college hospitals in the state.
Going by India’s importance in the area of pharmaceutical research and manufacture, we need to adopt pharmacovigilance at a faster pace. Developed countries along with the Asian region including Singapore, Malaysia and Indonesia are way ahead of us. Therefore, from a state perspective, we have identified 12 government medical colleges hospitals and six government independent hospitals to establish the Centre for Pharmacovigilance spread across 16 districts to implement pharmacovigilance once the DCGI consents, stated the Karnataka drugs controller.
Currently, there are only two government approved centres in Karnataka: Drug Information Centre at Victoria Hospital supported by the Al Ameen College of Pharmacy and the JSS College of pharmacy, Mysore that are part of NPP.