Drug trials: Panel to look into practices of CDSCO

Almost a year after a parliamentary committee pointed out irregularities in grant of approvals to certain drugs without mandatory clinical trials on Indians, a fact-finding committee has been set up to review practices and procedures adopted by the drug controller and fix responsibilities.
The four-member expert committee headed by former Director of Institute of Medical Sciences, Banaras Hindu University, Varanasi, T M Mahapatra will review the procedure and practices followed by the Central Drugs Standard Control Organisation (CDSCO) for granting marketing approval and clinical trials on new drugs including fixed dose combinations.
The Committee will have former scientist Satyawan Singh of Central Drug Research Institute, Lucknow, former Kerala Drug Controller Venkat Krishnan and a representative of the Chief Vigilance Officer of Union Ministry of Health and Family Welfare as its members.

The CDSCO had approved new drugs on scientific and statutory basis without Phase-III clinical trials on Indian population.
The panel will see that the scientific requirements and the regulatory compliance was adhered to by the CDSCO, as recommended by the Parliamentary Standing Committee.
The Parliamentary panel had pointed out that certain drugs were approved illegally by the drug controller in violation of Indian laws and in contravention of laid procedures.

It also recommended that the Drug Controller General of India (DCGI) is expected to take action against those CDSCO functionaries who colluded with private interests and got the drugs approved in violation of laws.

The panel also wanted the DCGI to enquire into all such cases and fix responsibility and take appropriate action against the guilty involved.
It had pointed out that the CDSCO had gone out of the way to unlawfully and wrongly certify that some drugs were not new drugs, which helped the manufacturer to market the drug.
It also said that many experts gave letters of recommendation in identical language apparently drafted by the interested drug manufacturer before approving the drug.
The government had earlier set up a high-powered committee headed by Secretary Medical Research and Director of ICMR, V M Katoch, but it did not fix any responsibility and made general recommendations on the issue.