Even though seven years have passed since Pharmacovigilance Programme of India (PvPI) started in India, a vast population in the country is yet to be covered under the drug safety programme.

PvPI was initiated in July 2010 by Central Drugs Standard Control Organization (CDSCO) under the aegis of Ministry of Health & Family Welfare (MoHFW), at the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordinating Centre (NCC) to safeguard health of Indian population. On April 15, 2011, the NCC was shifted from AIIMS to Indian Pharmacopoeia Commission (IPC) which has gained recognition as the first WHO collaborating centre for safety of medicines and vaccines in South East Asia region.

So far 210 adverse drug reaction (ADR) monitoring centres have been inducted under the PvPI which have reported 2.5 lakh adverse drug reaction cases to WHO monitoring centre at Uppsala. These 210 centres comprise of Revised National Tuberculosis Control Programme (RNTCP) centres, Antiretroviral therapy (ART) and Bedaquiline centres, ADR centres at medical colleges, public and private hospitals have covered only 20 per cent of the target population. Most of the centres are located in urban areas. Medical colleges and health facilities in rural areas need to be encouraged to have ADR monitoring centres for patient safety reporting which helps identify and analyse risk benefit ratio of marketed medicines, generate evidence on safety of medicines and support regulatory agencies in decision making, said Prof C Ramesh of IIHMR University, Jaipur.

He said that IPC, Medical Council of India and CDSCO have exhorted medical colleges to put in place ADR centres on their premises to improve drug safety monitoring but the response is not encouraging. Its high time the government makes it mandatory for public hospitals having 1000 beds to have ADR monitoring centres. It should also be made mandatory for private hospitals as well as medical colleges to set up ADR monitoring cells. Small scale industries especially startups also need to be encouraged to put in place ADR monitoring units.

India has a vast population that exhibits genetic and ethnic variability, there also exists a vast variation in disease prevalence. The ADR data so generated will help to make vital policy decisions regarding safe use of medicines in Indian population, he opined.

Prof Ramesh also emphasized the need for revamping the PvPI programme in line with global standards to streamline monitoring processes and improve surveillance, collection and analysis of an even broader body of drug safety data.

Human data extrapolated from animal studies does not give conclusive proof about adverse drug reactions. Clinical trial being conducted in minimum population in specific geographical locations can not produce conclusive evidence about ADR. Drug acceptance and toxic effects of drugs vary from country to country which can be attributed to difference in genetic pattern, food habit and cofounding disease factors. All these necessitate revamping of existing PvPI programme, he said.

Indian pharma industry aptly called pharmacy of world and is expected to reach USD 55 billion by 2020 and is driving force behind PvPI employing around 16,000 workforce. With the Indian drug manufacturers’ capability to develop and market new drugs out of their own research increasing, its important that pharmacovigilance standards are strengthened in line with global standards to monitor ADRs of products first launched in the country, he said.

Third party monitoring at pharmacovigilance departments of companies carried out by MHRA, USFDA needs to be adopted by Indian regulatory body under PvPI.

With the rapid technological advancements impacting pharmacovigilance obligations, he called for software upgradation of existing ADR monitoring units in respect of signal detection, quality review etc to improve ADR monitoring.

Signal detection and clinical assessment of Individual Case Safety Reports (ICSRs) is an inseparable domain of pharmacovigilance. The WHO defines a Signal as “Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously”.