Reporting adverse drug reactions will be mandatory

India will make reporting of adverse drug reactions mandatory for medical colleges across the country. All the 289 medical colleges -- both private and public -- in the country will be required to monitor the effect of medicines given to their patients and report whether there was any adverse drug reaction.

The central government also intends to provide financial support to institutions to run such monitoring centres. The health ministry has asked the finance ministry to introduce a budgetary head specifically for ADR monitoring, to ensure sustained government funds for the project.

The move comes in the backdrop of the failure of the health ministry's World Bank-sponsored National Pharmacovigilance Programme to generate sufficient ADRs from select medical colleges.

While individual clinicians were given charge of such centres earlier, the new mechanism will make the institutional heads responsible for managing ADR centres within the hospitals.

According to sources, the union health ministry will ask the Medical Council of India to ensure that functional ADR centres are made mandatory for recognition of medical colleges in the coming months.

Pharmacovigilance or ADR reporting is essential to understand the harmful effects of administering a medicine after it has been approved for use by human beings. While India is still taking its decisions to ban medicines based on such ADR data generated outside the country, developed nations have strict post-marketing surveillance systems in place.

A functional ADR monitoring system is important for India, as it is fast becoming a market place for newer drugs from multinational pharmaceutical companies.