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Panel to frame new drugs, cosmetics, and medical device laws

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’.

“The separate MD rules were a good step to allow us to have our own home but CDSCO is not letting go – if Food can have FSSAI we need something similar for devices which are engineering goods undergoing constant innovation. NITI Aayog Bill to regulate Devices separately from Drugs and decriminalise minor non compliances is needed to be taken forward. It’s not that the younger son who steps out to live on his own loves the family less – it’s being practical – but Mom won’t let go. 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 step backward moves,” commented Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry.
MB Bureau

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