The Union Health Ministry has constituted a committee for framing of New Drugs, Cosmetics and Medical Devices Act. As per the terms of reference of the order titled ‘Constitution of Committee for Framing of New Drugs, Cosmetics and Medical Devices Act’, 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 November 30, 2021. The newly formed eight-member panel is headed by the Drugs Controller General of India (DCGI) VG Somani. The composition of the committee as decided by the ministry is as follow:

• V.G. Somani, DCG (1) –  Chairperson
• Shri Rajeev Wadhawan, Dir (Drugs) – Vice-Chairperson
• S.E. Reddy, JDC (1) – Member
• Shri A.K Pradhan, JDC (1) – Member
• Drugs Controller, Haryana – Member
• Drugs Controller, Gujarat – Member
• Drugs Controller, Maharashtra – Member
• Shri N.L. Meena Member

The representations were made in the past dating as back as 1940 for the need of New Drugs, Cosmetics and Medical Devices as the current act is completely obsolete.

Last year, the union health ministry had brought medical devices within the regulatory ambit, treating them as a category of ‘drugs’ for the purpose of regulation.

The Drugs and Cosmetics (D&C) Act, 1940 regulates the import, manufacture, distribution and sale of drugs and cosmetics. Recently, it was amended to add medical devices with the notification of New Medical Device (MD) Rules 2017.

The terms of reference of the committee will be that the committee shall undertake pre-legislative consultations and examine the present Act, previously framed Drugs and Cosmetics Bills and submit a draft documents for a de-novo Drugs, Cosmetics and Medical Devices Bill by 30.11.2021.

Rajiv Nath , Forum Coordinator, 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 is not letting go – if Food can have  FSSAI we need something similar for devices which are engineering goods undergoing constant innovation .

NITIAayog 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 NITIAayog 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 “