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At a time when the Central government is drafting a combined legislation for Drugs, Medical Devices and Cosmetics, a Parliamentary panel has recently recommended to the government for a separate legislation for the medical devices industry in the country. In this regard, the panel has recommended that the government should come up with a ‘National Commission on Medical Devices’ to examine all aspects of the medical devices industry in the country in detail and bring forth a comprehensive law supported by a holistic policy and institutional infrastructure for the purpose. This Commission should study the aspect of centralizing the medical devices licensing with the central regulator so as to make the approval process easy. The Parliamentary panel further recommended that the blueprint for the new legislation must also include a 10-15 years roadmap with a clear policy plan and targets. It is obvious that with a 15-year roadmap with annual targets for the medical device industry, India would emerge as the world's biggest centre for manufacture and service of medical devices and thus also a leader in medical tourism. The Parliamentary Standing Committee on Ministry of Health and Family Welfare made this strong recommendation to the government in its 138th report on ‘Medical Devices: Regulation & Control’, which was presented to the Rajya Sabha and Lok Sabha on September 12 this year. It is a fact that while the Medical Devices Regulation-2017 mandated the Central Drugs Standard Control Organisation (CDSCO), which has primary focus on the regulation of drugs, to regulate the medical devices segment as well, the existing structure and expertise, which is more pharma-centric, of the workforce in CDSCO is falling short in effectively regulating the medical devices industry in the country.
The Parliamentary panel seems to have understood the pulse of the medical devices industry in the country as this sunrise industry has been clamouring for a separate Act, similar to the introduction of Food Safety and Standards Act for the food industry. Even though the Central government has recently released the draft New Drugs, Medical Devices and Cosmetics Bill with separate provisions for medical devices, the medical devices industry expressed its disappointment for not addressing its aspirations for a separate Act for the sector, while considering the new draft bill for the pharmaceutical and medical devices in the country. It is obvious that the medical devices industry has a huge potential of investment of over Rs. 50,000 crore to meet the market of over Rs. 1,00,000 crore and the government should have made separate Act for the medical devices industry in the country. The current approach of keeping the medical devices law under the drug regulations is restricting the industry in various levels as both are different in nature. The government should have heeded to the demands of the medical devices industry in the country. The medical devices industry is a sunrise sector in the country and the government should not have found wanting in acceding to the just demands of the sector. There are no two opinions about the fact that the medical devices industry in the country has been growing by leaps and bounds. So, the government cannot 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 appreciate the potential of the medical devices industry and formulate a separate legislation for medical devices which should have the provisions to transform the medical devices industry and bring about a medical device revolution in the country.
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