Govt forms panel to frame new drugs, cosmetics & medical devices
The central government has formed a panel to review the Drugs and Cosmetics Act, 1940 and come up with a new law to regulate drugs, cosmetics and medical devices in the country. The newly formed eight-member panel, headed by Drug Controller General of India (DCGI) Dr. VG Somani, is expected to submit the draft document by November 30.
According to the internal order, accessed by mojo4industry, “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 other members include Rajiv Wadhawan (Director, Ministry of Health and Family Welfare), Dr SE Reddy (Joint Drug Controller), AK Pradhan (Joint Drug Controller), NL Meena and the drug controllers of Haryana, Gujarat and Maharashtra.
The order titled ‘Constitution of Committee for Framing of New Drugs, Cosmetics and Medical Devices Act’ said, “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 by 30 November.”
Commenting on this, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) said, “Medical Devices have outgrown the joint family home shared too long with Pharma, the separate MD rules were a good step to allow us to have our own home but CDSCO (Central Drugs Standard Control Organisation) is not letting go – if Food can have FSSAI we need something similar for devices which are engineering goods undergoing constant innovation.”
He suggests, “NITI Aayog Bill to regulate Devices separately from Drugs and decriminalise minor non-compliances is needed to be taken forward. Also, the composition of Committee is a serious conflict of interest and unprecedented where they could have relied on MDTAG (Medical Devices Technical Advisory Group) created already and involving stakeholders like manufacturers, scientists, Doctors and patients’ groups to guide the Government. The NITI Aayog 2019 draft of a separate Bill to regulate Devices was in the right direction. Such confusing signals confuse potential investors of medical Devices and India will remain import dependent with one step forward two steps backward move.”