Centre forms 8-member panel for new Drugs, Cosmetics, Medical Devices Act

Committee will frame draft Bill and submit it by November 30

The Centre has formed a committee to frame new laws for framing new laws for drugs, cosmetics and medical devices. Medical devices are now ‘treated’ as drugs for the purpose of regulation by the Central Drugs Standard Control Organisation (CDSCO). But a new Act is the need of the hour as the existing Drugs and Cosmetics Act is one of 1940.

According to an internal order, seen by Business Standard, the eight member committee will prepare a new Drugs, Cosmetics and Medical Devices Bill so that a Drugs, Cosmetics and Medical Devices Act can be framed. The committee headed by Drugs Controller General of India (DCGI) V G Somani, will submit a draft by November 30.

The eight member panel includes Rajiv Wadhawan, director, Ministry of Health and Family Welfare), Eswara Reddy, joint drug controller, A K Pradhan, joint drug controller, IAS officer N L Meena followed by drug controllers of Haryana, Gujarat and Maharashtra.

“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,” said the order dated 27 August.

The Drugs and Cosmetics Act, 1940 now regulates the manufacture, distribution and sale, and also import of drugs and cosmetics now. Recently, this was amended to include medical devices in its ambit. Since 1940 the Act has undergone several amendments, but it now needs an overhaul.

“Medical Devices have outgrown the joint family home shared too long with pharma. The separate medical devices 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,” said Rajiv Nath, forum coordinator of medical devices lobby group Association of Indian Medical Device Industry (AiMeD).

Nath also felt that the composition of the committee is a serious conflict of interest and 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 pharma industry too feels a new Act is needed now. “Since the Act does not have rules to regulate the online sales of medicines and devices, there is confusion in that space. Even on matters like indemnity for new drugs and vaccines, compensation for adverse events once an approved drug is in the market, the Act is largely silent,” said a senior pharma executive.