It is scheduled to submit draft document by Nov. 30
The 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.
According to the order issued by the Ministry of Health and Family welfare, dated August 27: “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 of the panel are Rajiv Wadhawan (director, Ministry of Health and Family Welfare), Dr. S.E. Reddy (member) A.K. Pradhan (joint drug controller), drugs controllers of Haryana, Gujarat, Maharashtra and IAS officer NL Meena. The committee is allowed to co-opt member(s) if it requires.
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’.
Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry, said medical devices have outgrown the joint family home shared too long with pharma.
‘A good step’
“The separate rules were a good step to allow us to have our own home but Central Drugs Standard Control Organisation [CDSCO] is not letting go. If food can have FSSAI, we need something similar for devices, which are engineering goods undergoing constant innovation,’’ Mr. Nath stated.
The NITI Aayog Bill to regulate devices separately from drugs and decriminalise minor non-compliances was in the right direction, he noted.
The composition of the committee was a serious conflict of interest and unprecedented. “Involving stakeholders like manufacturers, scientists, doctors and patient groups would have been beneficial,’’ he added.
