High-level panel to recommend reforms in India’s drug regulations

The panel, chaired by Rajesh Bhushan, the OSD to the Union Health Minister, comprises top drug and vaccine entrepreneurs as well as nominees from DoP, DBT, Indian Pharmacopoeia Commission, Indian Pharmaceutical Alliance, ICMR and public health expert from AIIMS.

A high-level committee of experts has been formed by the government to recommend reforms in India’s drug regulatory system so that approval processes can be fast-tracked.

Faced with the ominous threat of the coronavirus infection, a number of steps such as fast-tracking the approval process for drugs, research and vaccine development were taken. A health ministry official said the aim of the panel is to identify and institutionalise these measures.

According to a recent Union Health Ministry order, the committee will study the current drug regulatory system and submit recommendations for reforms, so as to bring the system in line with global standards and make it more efficient.

“Although requisite procedural changes have been carried out during the 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 Central Drugs Standard Control Organisation (CDSCO) to make it more effective,” the order issued on May 11 stated.

The committee chaired by Rajesh Bhushan, the OSD to the Union Health Minister, comprises top drug and vaccine entrepreneurs of India along with officers nominated from the Department of Pharmaceuticals, Department of Biotechnology, Indian Pharmacopoeia Commission, Indian Pharmaceutical Alliance, ICMR along with public health expert from AIIMS.

The order stated, “While nominating a member, the ministries/departments/ institutions should keep in mind that the officer being nominated should have a flexible approach and willing to consider far-reaching reforms with an open mind.”

Dr Eswara Reddy, India’s Joint Drug Controller will assist the committee in their work on adopting global best practices. The committee, which has met twice till now, will submit its report within one month from the date of its formation.

The committee has been asked by the ministry to also study earlier reports given by the department-related Parliamentary Standing Committee on clinical trials and working of the CDSCO and address the unimplemented recommendations of the previous panels.