High-level panel formed to recommend reforms in India's drug regulatory system

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.

"The issue of reforms in the Drug Regulatory System has been engaging the attention of the government for quite some time now.

"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 Organization (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."