11 member high-level committee under the chairmanship of Rajesh Bhushan formed to reform drug regulatory system in India

The centre has constituted a 11 member high-level committee to “simplify and expedite” the drug approval process in India. The committee chaired by Rajesh Bhushan, Officer on Special Duty, Ministry of Health was set up by the Ministry of Health and Family Welfare(MoHFW) on May 11 as a measure to reform the drug regulatory system in India. It comprises senior health officials, scientists and representatives of the pharmaceutical industry. The committee will submit its report within a period of one month from the date of its formation.

• The Ministry of Health & Joint Drug Controller of India Eswara Reddy will assist the committee to adopt global standards for drug and medical device regulation amid COVID-19 pandemic

Gist about the committee

Need 

There is a need to comprehensively change the drug regulatory regime to reflect global best practices & domestic requirements and to streamline the Central Drugs Standard Control Organisation(CDSCO), an arm of the health ministry that heads the regulatory system of drugs and medical devices in India to make it more effective.

Objective 

To study the current drug regulatory system and to submit recommendations for reforming the system to bring it in line with global standards and to deliver more efficiently

Work

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 &  address unimplemented recommendations suggested by these committees

Members

Balram Bhargav- Director-General of Indian Council of Medical Research(ICMR); Adar C Poonawalla- CEO, Serum Institute of India and President, Indian Vaccine Manufacturers’ Association; Pankaj Patel- Chairman of Cadila Healthcare for Indian Pharmaceutical Association; Eswara Reddy- Joint Drug Controller, CDSCO, PD Vaghela, Secretary- DoP,  2 scientists from the Department of Biotechnology, and one representative from Indian Pharmacopoeia Commission among others.

Meetings held– May 19 & 22

Key Points

i.In the nominating process of a member, ministries, departments and institutions, the  nominated officer must have a flexible approach and be willing to consider far reaching reforms with an open mind.

ii.There is a pending demand to bring  CDSCO, also referred to as Drug Controller General of India (DCGI), under the Department of Pharmaceuticals (DoP).

About MoHFW:

Union Minister–  Harsh Vardhan(Constituency- Chandni Chowk, New Delhi)
Minister of state– Ashwini Kumar Choubey(Constituency- Buxar, Bihar)

About CDSCO:

Headquarters– New Delhi, India
Drugs Controller General of India– Dr. V. G. Somani