India to introduce compulsory submission of new drug data

A system to be introduced by the Indian Central Government will require drug companies to submit comprehensive data on newly introduced drugs to the Drugs Controller General of India (DCGI), including reports of any adverse side-effects.

Currently submission of such data is voluntary and a drug is removed from control by the regulator when marketing approval is given.

The DCGI, Ashwini Kumar, said: 'Provision of mandatory surveillance of new drugs in the market had been included in the rules related to new drug approvals released last year. We will now set up a pharmacovigilance committee with the DCGI's office which will take up the surveillance and any consequent action thereupon.'

Although post-marketing surveillance lasts for the entire life of a drug, it requires to be more stringent in practice during the initial few months following marketing approval. Data would be generated by the drug companies themselves based on a drug's therapeutic action on about 1,500-2,000 patients who take the drug initially.

But Dr R. Roy Choudhri, chairman of the Toxicology Review Panel under the Indian Council of Medical Research (ICMR), said there was a drawback to the new system. 'Drug companies have a free hand in generation of data, while scrutiny of the same and consequent action is vested with the DCGI. The government feels that concealment of data will not help the companies ultimately, as the system will be competent to show up unreported adverse effects of a drug. The number of new drugs is on the rise. There is now little time lag between the first introduction of a drug and its launch in India.'

In 2002, the DCGI approved 53 new drugs for marketing, the highest ever. Among the new drugs approved were Mihefosine, a drug developed indigenously for treating kala azar, and Thalidomide, which despite its former dubious global reputation, is one of the most effective pain alleviators for cancer and leprosy patients.