New Delhi: India is preparing to launch its first national pharmacovigilance programme by the end of the year to study the adverse effects of drugs as well as formulate a policy on pharmaceuticals.
The Central Drugs Standard Control Organisation (CDSCO) in collaboration with the All India Institute of Medical Sciences (AIIMS) has prepared a draft of the programme, which will soon be sent to the health ministry for approval.
Pharmacovigilance aims at collecting, monitoring and reporting adverse drug reactions. While most countries have such a system in place, India has had to rely on data and action taken by other regulators such as the US Food and Drug Administration and European Medicines Agency.
“The programme was to start last year but got delayed. We will launch it this year and it will require over Rs12 crore by the end of five years,” said Surinder Singh, drugs controller general of India (DCGI).
The programme will be headed by AIIMS director R.C. Deka. “DCGI will receive the report from AIIMS and take action, if necessary, according to the data collected,” said Singh.
CDSCO is also collaborating with Sweden’s Uppsala University for collation and sharing of data. All the data collected in India from adverse drug reporting will be stored in Uppsala and can be shared with regulators from other countries. Similarly, India will also get access to the adverse drug reporting data of other countries.
“This concept of pharmacovigilance exists globally but was not there in India till now and is much needed,” said Ketan Desai, president, Medical Council of India (MCI).
In 2001, the World Federation of Medical Education had prepared international guidelines on medical education. “They recommended a few things, one of which was to have a pharmacovigilance cell in every medical college,” Desai said. This was in turn recommended by MCI to the Indian government in 2004. “We got approval to have these cells in the colleges in 2009 after the new government came into power,” Desai said.
“This will ensure that when medical students graduate from the college, they are already well-versed with pharmacovigilance and involve it in their practice as medical doctors,” Singh said, adding that MCI had approved the programme “in principle”.
The pharmacovigilance programme will start with cells at 40 medical colleges, rising to a total of 300 in four years. Some of these cells have already started functioning, though Desai said they need to be fine-tuned.