Govt forms panel to probe drug co-regulator nexus

Govt forms panel to probe drug co-regulator nexus

The Union Health Ministry on Friday has formed a probe panel to look into the nexus between drug manufacturers and the regulator Central Drug Standards Control Organisation (CDSCO ), which allowed entry of a large number of medicines in India throwing the rule book out of window.

The three member committee was created days after a panel under the Parliamentary Standing Committee on Health lifted the lid on the unholy alliance between manufacturers, regulators and a section of doctors for selling medicines in India without any medical need and clinical trials.

“There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of the CDSCO and some medical experts,” the panel stated.

The three members on the probe panel are Indian Council of Medical Research director general V M Katoch,  National Brain Research Centre president P N Tandon and Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow former director S S Agarwal. The committee would have to submit its report in two months, official sources said.

The committee has been asked to examine the validity of scientific and statutory basis adopted by the CDSCO for approval of new drugs without clinical trials. Its other tasks involve suggesting appropriate measures to improve the drug approval process and identify steps to institutionalise improvements to improve the CDSCO’s functioning.

Entry and sale of medicine in India is regulated by the Central Drugs Control Organisation under the health ministry and headed by the Drugs Controller General of India (DCGI).

The House panel reviewed its function and approval process for clearing new medicines.

A random scrutiny of 42 drugs approved by the DCGI in the last decade clearly highlighted the nexus between the regulators and manufacturers. Some doctors too are partners in crime. The unholy alliance was most explicit in the case of a clinical trial approval given to the fixed dose combination of aceclofenac with drotaverine, which is not permitted in North America, Europe and Australasia.

“In this case a CDSCO official advised the manufacturer, Themis Medicare Ltd, not only to select experts but get their opinions and deliver them to the office of the DCGI. No wonder that many experts gave letters of recommendation in identical language apparently drafted by interested drug manufacturer,” the panel said.

Themis was not an isolated case. The panel documented many approvals in which doctors situated thousands of miles away from each other draft identically worded letters of recommendation.

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