Context: Recently, Central government has constituted a committee for framing/preparing new drugs, cosmetics and medical device laws. 

• The eight-member panel, headed by Drug Controller General of India V.G. Somani, is scheduled to submit a draft document by November 30.

Background

• According to India’s apex regulatory body, Central Drugs Standard Control Organisation (CDSCO), the Drugs and Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs and cosmetics.
• Recently, it was amended to add medical devices.
• The last amendment in the Act was made in 2008.

Key Points

• According to the order issued by the Ministry of Health and Family welfare, the government has decided to constitute a committee for framing/preparation of New Drugs, Cosmetics and Medical Devices Bill so that New Drugs, Cosmetics and Medical Devices Act can be framed.”
• The order further states that the committee shall undertake pre-legislative consultations and examine the present Act, previously framed Drugs and Cosmetics Bills and submit a draft document for a de-novo Drugs, Cosmetics and Medical Devices bill.
• The order is titled ‘Constitution of Committee for Framing of New Drugs, Cosmetics and Medical Devices Act’.

Why New Act is the need of an hour: Industry

• In 2020, the Ministry of Health and Family Welfare had brought medical devices within the regulatory ambit, treating them as a category of ‘drugs’ for the purpose of regulation.
• According to the pharmaceutical industry experts, a new Act is the need of the hour. “The Act is completely obsolete as it was formed in 1940. Since 1940, it has undergone multiple amendments. It has now become very confusing and unclear for the industry".
• If food can have FSSAI, we need something similar for devices, which are engineering goods undergoing constant innovation,’.

Key Challenge

• Thereis a huge conflict of interest to create such a committee without representation from other stakeholders like manufacturers, doctors, academia, scientists and consumer or patient bodies,”.