In its bid to take proactive action for reporting adverse drug reactions (ADRs) towards focused Pharmacovigilance (PV) for approved drugs in the country, the Union health ministry has come out with suspected ADR form for healthcare professionals and medicines side-effect reporting form for consumers besides a toll free helpline number in the interest of patient safety.

This comes at a time when the health ministry has also tasked 250 ADR Monitoring Centres (AMCs) existing in the country to establish clinical evidence between the drug and the adverse drug reaction through a robust system of causality assessment.

Central Drugs Standard Control Organisation (CDSCO) in collaboration with Indian Pharmacopoeia Commission (IPC) had in the past also started auditing healthcare institutions through assessment on aspects like SOPs and causality assessment in order to review the functioning of AMCs in the country.

The exercise was meant to generate awareness in medical institutions to put in place effective surveillance system for detection of ADRs. IPC under the union health ministry is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI).

CDSCO under the Union health ministry had initiated a nation-wide PvPI in July 2010. PvPI leads with 0.82 points as per quality completeness score of Individual Case Safety Reports (ICSR) as against the global average of 0.55 accounted on a quarterly basis for a total of 150 countries including India which contribute to the global PvP database.

ICSR as part of ADRs are reported from all over the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base.

To strengthen ADR monitoring, IPC had come out with draft guidelines focused on targeted drugs and events as a part of Intensive adverse drug reaction monitoring exercise under PvPI so that action could be taken on specific drugs involving adverse reactions.

The health ministry had in the past mandated based on the ADR monitoring protocol effective implementation of the projects related to Intensive adverse drug reaction monitoring with help from competent institutions in the country.

Based on the learnings of these projects, government will be equipped in taking regulatory decisions in a timely manner. The exercise has been initiated keeping in view the fact that data from spontaneous reporting of ADRs have generally been mis-spelt.

“Inference can be drawn from the diabetic drug Pioglitazone which was suspended and then revoked due to lack of India specific data in the country for adverse reactions leading to conditions like bladder cancer,” concludes a senior IPC official.