Radical drug rule changes hit buffers in India

A parliamentary panel in India has slammed a proposed bill seeking to radically alter the way drugs are regulated in India. The panel’s report has essentially put reform of medicines in the country on ice, according to observers.

The bill was introduced in parliament in August last year. A parliamentary committee  investigating the bill severely criticised several of its clauses, most notably one that would have led to the setting up of a central drug authority for drug regulation, licensing and exports.

Currently, the entire drug regulation process, including approval of new drugs, withdrawal of harmful medicines and clinical trial regulation, is handled by the Central Drugs Standard Control Organization (CDSCO), which falls under the umbrella of the health ministry and is headed by the Drug Controller General of India (DCGI). The CDSCO has attracted a lot of bad publicity in recent years for poor regulation of clinical trials. Morever, last year it was also criticised for the controverial ban and then revocation of diabetes drug pioglitazone.

The bill proposed a Central Drug Authority (CDA) to replace the CDSCO. The CDA would have had representatives from seven ministries, as well as other technical and administrative officers, including the DCGI. But the panel complained that the new body was studded with ‘bureaucratic heads’.

C M Gulhati, editor of Monthly Index of Medical Specialities, India, backs the panel. ‘The very purpose of creating a “regulator” is that it should be independent of the politicians and bureaucrats of the government on one hand and entities to be regulated on the other,’ he says. ‘It should be fair and transparent in its decision making process. The proposed authority will subjugate the Drugs Controller General of India who will be reduced to saying “yes sir” to his superiors.’

The panel has instead recommended setting up a Central Drug Administration. ‘The proposed administration should be given adequate autonomy to discharge its functions enumerated under the act,’ it noted in the report. The committee also suggested that this administration should be periodically reviewed by a set of independent experts. The administration, it recommended, should have three sepearate divisions for drugs, medical devices and clinical trials.

T R Gopalakrishnan, an adviser for the Indian Drug Manufacturers’ Association, says the bill’s fate now looks uncertain. ‘It will probably be shelved for a long time now. The government will have to go for a complete re-drafting because of the response of the parliamentary standing committee,’ he says.