-The Telegraph
The Centre today asked a panel of doctors to outline measures to improve drug approval procedures, three days after a parliamentary standing committee said India’s drug regulators had broken laws, ignoring the interests of patients.
The panel announced by the Union health ministry has been asked to suggest steps to improve the procedural aspects of the Central Drugs Standards Control Organisation (CDSCO), the agency entrusted with approving medicines for sale in the Indian market.
The report tabled in Parliament on Tuesday had observed that the CDSCO has approved a large number of drugs either without any clinical trials in India or through irregular approval procedures.
The panel, which will also examine the guidelines adopted to approve drugs without clinical trials, has been given two months to submit its report. Its three members are P.N. Tandon, president of the National Brain Research Centre, Manesar, V.M. Katoch, director general of the Indian Council of Medical Research, New Delhi, and S.S. Agarwal, former director of the Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow.
The standing committee had also found that government doctors and private practitioners living in different cities had written near identical letters endorsing certain drugs or recommending that clinical trials be waived.
Medicines used to treat myriad illnesses — from infections to cancer, from liver disease to sexual dysfunction — had been approved by CDSCO officials through irregular procedures, at times even without any consultations with medical experts.
The ministry has asked the three-member panel to recommend steps to bring about “systemic improvements” in drug approval procedures and to “institutionalise improvements” in the procedural aspects of the functioning of the CDSCO.
A senior public health expert said the panel should ideally have included “representatives of civil society” who are familiar with these issues.