Although submission of post-marketing surveillance reports is a statutory requirement after granting marketing approval for new drugs in India for the last 5 years, none of the pharmaceutical companies has ever complied with this condition, it is learnt.
The office of the Drug Controller General of India, therefore, has no data of adverse drug reactions of any drug marketed in the country. With the result, India is fully dependent on international alerts to initiate action against any harmful drugs which are being marketed by pharmaceutical companies.
Sources in CDSCO said that pharmaceutical companies do not submit PMS data even after they were specifically instructed by the officials. The department, at the same time, has also not initiated any action against such companies for non-compliance, the sources said.
According to a leading medical expert, there is no effective system of ADR monitoring of drugs in the country despite 5 major and 12 peripheral ADR monitoring centers functioning directly under the DCGI. Still, India has to depend on international alerts to understand side effects or adverse reactions of drugs marketed here.
The office of DCGI, which is supposed to coordinate with these centers for collection and analysis of domestic data coming from across the country, does nothing but to follow the international reports to ban or withdraw the drugs approved and marketed in the country, experts complain.
"This is a paradoxical situation where the drug regulator is awakened to act in the country only when there is an international alert on drug ADR," said a Mumbai-based pharmaceutical scientist. Citing the instances of withdrawal of rofecoxib and cerivastatin in the country, he said the DCGI acted only when the innovator company decided to withdraw the drug voluntarily. However, it is ironical that the government is relying on the international reports to take necessary action as the adverse reaction of drugs varies depending on the physical nature, health and food habits of patient pool of different countries, the experts point out.