Medical devices aren't drugs, they need a separate law

To keep pace with the changing needs, times and technology, the central government is coming out with a new bill 'New Drugs, Medical Devices and Cosmetics Bill' which will replace the pre-independence legislation of the Drugs and Cosmetics Act, 1940. The Union Health Ministry has already released the draft of the bill recently. It is true that the D&C Act, 1940 has been amended over a period of time to include new clauses, in view of the changes happening in the pharmaceutical and medical devices industries over a period of time. The Rules, framed in 1945, also underwent several changes over the period, in the wake of the technological changes happening in the pharmaceutical and medical devices sectors in the country. But the government wanted to make the laws more contemporary.

Hence, it has come out with a new bill. The new Bill is a comprehensive legislation with provisions to regulate medical devices, clinical trials and online pharmacy, among others in order to keep pace with changing needs of the pharmaceutical industry in the country. It has several features which will go a long way in doing ease of business in the country. Apart from the provisions to form Drugs Technical Advisory Board (DTAB), the Bill proposes constitution of Medical Devices Technical Advisory Board (MDTAB) to advise the Central Government and the State governments on technical matters pertaining to medical devices arising out of administration of the proposed Act.

Besides, a Drugs, Medical Devices and Cosmetics Consultative Committee (DMDCCC) shall also be constituted by the Centre to advise the Central Government, the State Governments, the DTAB and MDTAB on any matter tending to secure uniformity in the country in the administration of the proposed Act and the rules made thereunder.

While the central government is making all efforts to have a single Act for the pharmaceuticals, medical devices and cosmetics through the new Bill, a Parliamentary panel has strongly recommended to the government for a separate legislation for the medical devices industry in the country. The Parliamentary Committee, in its 138th report on 'Medical Devices: Regulation & Control', which was presented to the heads of Rajya Sabha and Lok Sabha on September 12, said that the Committee, while welcoming the initiative of the Ministry to set up a panel to make the new Drugs, Medical Devices and Cosmetics Bill with separate provisions for Medical Devices, strongly recommends that instead of drafting a combined legislation for Drugs, Medical Devices and Cosmetics, the Ministry should appreciate the potential of the Medical Device industry and formulate a separate legislation for Medical Devices. The Parliamentary Committee has also recommended to the government to come up with a 'National Commission on Medical Devices' to examine all aspects of the industry in detail and bring forth a comprehensive law supported by a holistic policy and institutional infrastructure for the purpose.

There can be no two opinions about the fact that the medical devices industry is growing by leaps and bounds in the country. So this Commission should study the aspect of centralizing the Medical Device licensing with the Central regulator so as to make the approval process easy. The Ministry should also focus on guaranteeing transparency by designing this legislation so that the citizens and experts get a right to participate in decision making.

The legal provisions should be such that citizens and experts can participate in the regulatory process and register their objections. The new legislation should set up a new set of regulators at different levels for regulating the Medical Devices industry. Unlike the present structure, the proposed regulator should license the manufacturing of all classes of medical devices i.e. Class A, B, C, and D. This would help harmonise the regulation process throughout the country as it would do away with different regulating procedures employed by different States. This step would greatly help the manufacturers and will reduce the time required to start a manufacturing unit thereby facilitating ease of doing business.

As the medical devices industry is growing exponentially in the country, the government should not afford regulation of medical devices by pharma experts and it is time that at ground level the medical device regulations are dispensed with by qualified and well-trained Medical Device Officers to give a fillip to the Medical Device industry in the country. The government should pay heed to the recommendations of the Parliamentary panel.

(The author is freelance journalist with varied experience in different fields)