Union government has begun adverse drug monitoring to assess side-effects of drugs for H1N1 and Arteseminin for malaria in the country. It will be creating a data base on drugs of concern by reporting ADRs during immunization programmes, epidemic attacks, infectious and chronic diseases to ensure speedy causality assessment and audit the outcome of drug signal generation.

The objective is to improve the implementation of its existing pharmacovigilance programmes and to translate the data to indicate and prove ADRs.

In addition, the government is insisting Medical Council of India (MCI) to include pharmacovigilance not just in the MBBS syllabus but enforce the audit on drugs prescribed and administered at all medical college-hospitals.

“We need translational pharmacovigilance which transfers data from physicians to industry because no drug is totally safe. The outcome of ADR reporting will provide the ground reality. We will need to link pharmacovigilance with genomics, cohort monitoring and post marketing surveillance, stated Dr YK Gupta, department head, clinical pharmacology, All India Institute of Medical Sciences (AIIMS).

ADR is reported among urban and not rural population. On an average there is a consumption of 200,000 tablets a month with not a single exposure of ADR. A sample survey by AIIMS has shown that out of the 200 physicians in primary health centres only three were aware of ADR. In Uttar Pradesh and the Capital Region, of the 100 doctors only six had heard about pharmacovigilance. Even in AIIMS, 29 per cent doctors were unaware of ADRs.Therefore training and sensitizing physician are extremely important,” he stated in his address on’ Indian Pharmacovigilance Scenario –An Introspection’ during a seminar on ‘Future Perspectives of Pharmacovigilance’ organized by the Drug Information Association (DIA) India office.

There is reluctance in the reporting system and there is also no authority on similar lines like that of the Drugs Controller General of India (DCGI) to check on ADRs occurring across hospitals in the country.

Of the one lakh formulations marketed in India, there are several irrational drug combinations which calls for stringent control and regulation. The data on banned drugs in India is based on ADRs of patients in the US and Europe. There is no evidence on Indian patients for ADR with the banned drugs which makes Courts in India revoke the order, he pointed out.

“The irony is that India is recognized for its high quality and timely delivery of pharmaceutical products with drug data for the US and European companies and hospitals but similar expertise is not being done within the country,” he pointed out. The pharmacovigilance programme is not just a set of data but there is a need to convert this information to be put into practice.

“The country also requires massive capacity building and expand from its existing 22 centres of pharmacovigilance to at least 125 by the year end. Although 60 centres were planned last year at an investment of Rs.60 crore, nothing much has happened. Pharmacovigilance is not just a one-time effort it needs to be sustained to ensure drug safety,” stated Dr Gupta.