Committee to reform drug regulatory system to table report in a month

With a view to reform the drug regulatory system, the Ministry of Health and Family Welfare (MoHFW) has constituted a committee, comprising senior health officials, scientists and representatives of the pharmaceutical industry. The committee, instituted on May 11, has met on May 19 and on May 22. It is slated to submit a report on it’s findings in about a month, MoHFW sources said.

“The issue of reforms in the drug regulatory system has been engaging the attention of the Government of India for quite some time now. Although requisite procedural changes have been carried out during the current Covid-19 pandemic and have worked quite well, it is felt that comprehensive changes in the drug regulatory regime should be carried out to reflect global best practices as well as domestic requirements and to streamline the Central Drugs Standard Control Organisation to make it more effective,” the MoHFW order said.

There has been a long pending demand to bring the CDSCO, also referred to as Drug Controller General of India (DCGI), under Department of Pharmaceuticals (DoP). However a senior DoP official told Businessline , “These are mere speculations at this stage. DoP, however, does want to be an umbrella body to bring together CDSCO under MoHFW, Pharmaceutical Export Promotion Council under Ministry of Commerce and Industry as well as the National Pharmaceutical Pricing Authority, which is under DoP. But how this arrangement will work out is not clear yet.”

Sources said the committee comprises 11 members — PD Vaghela, Secretary, DoP, or a nominated representative on his behalf; Balram Bhargav, Director-General of Indian Council of Medical Research, or a nominated representative; Sanjay Kumar Rai, Professor of Community Medicine at All India Institute of Medical Sciences; Pankaj Patel, Chairman of Cadila Healthcare for Indian Pharmaceutical Association; Adar C Poonawalla, CEO, Serum Institute of India and President, Indian Vaccine Manufacturers’ Association; Eswara Reddy, Joint Drug Controller, CDSCO, two scientists from the Department of Biotechnology, and one representative from Indian Pharmacopoeia Commission. It is headed by Rajesh Bhushan, currently Officer on Special Duty at MoHFW, and who is tipped to take over as Health Secretary from Preeti Sudan in a few months.

The committee will examine earlier reports of a Parliamentary standing committee, Professor RR Choudhary Committee on clinical trials and SN Mishra Committee on qualification of DCGI, the order said.

It further said: “While nominating a member, ministries, departments and institutions should keep in mind that the officer being nominated should have a flexible approach and willing to consider far reaching reforms with open mind.”

However, civil society members pointed out that having prominent pharmaceutical industry members sitting on a government committee that is looking at reforming drug regulatory regime is problematic.

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