To ensure that all medical devices meet certain standards of quality and efficacy, the Union Health Ministry notified medical equipment used on humans or animals as “drugs” under Section 3 of the Drugs and Cosmetics Act, with effect from April 1, 2020. The ministry, through a gazette notification, also released the Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices. The aim is to regulate all medical devices so that they meet certain standards of quality. Besides it will also make medical device companies accountable for quality and safety of their products. Once notified, the manufacture, import and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO). At present, only 23 categories of medical devices are regulated under the law.
Why there is a need to revise medical device policies?
- In spite of India’s global dominance with pharmaceuticals and vaccines, India continues to lag far behind in the medical devices sector. India imports over 70 percent of its domestic medical device requirements.
- Indian domestic manufacturing focusses on low cost segment of medical consumables lagging behind in mid tech segment.
- Indian domestic manufacturing is dominant mainly in high-volume and low-cost segment of medical consumables such as disposable syringes and gloves, which contribute to a large chunk of the country’s medical device exports.
- Success stories from Israel and Ireland should guide the governments at both the Centre and States in order to really spur the growth of the domestic industry.
- The implications of multiple labelling requirements under various new rules and the unclear influence under the GST regime seems to be adding up to the complexity of business.
- Without legislative backing, the regulator Central Drug Standard Control Organization was helpless to curb both the flood of substandard imports as well as the production of poor quality medical devices in the country.
- Lack of distinct identity for the medical device industry has acted as a substantial deterrent to the expansion of the sector
Significance and implications of this move:
- Majority of medical devices are completely unregulated in India. With this move, all devices will be brought into the regulatory framework which is important from a patient safety perspective.
- Apart from expanding the scope of regulation to ensure safety and efficacy, the move may pave the way for regulation of prices under the Drugs Price Control Order (DPCO).
- It will also make companies, in case of violations, liable to be penalised in a court of law.
- Companies will now have to seek approval from the drug controller to manufacture, import and sell any medical device in the country.
- The Drug Controller-General of India (DCGI) would regulate the import, manufacture and sale of these devices from January 1, 2020.
- All these devices will have to be registered under the quality parameters prescribed under Medical Devices Rules 2017 and other standards set by the Bureau of Indian Standard (BIS) certification.
- Also, companies which are engaged in the manufacture and import of these equipment, will have to seek the necessary permission or license from the Drug Controller-General of India.
- Medical devices shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation (CDSCO). Such registration is voluntary for a period of 18 months, after which it will be mandatory.
- The manufacturer of a medical device shall upload the information relating to that medical device for registration on the “Online System for Medical Devices” established by the CDSCO. Importers too will be required to do the same.
Laws governing MDI in India:
- Earlier, only notified medical devices were regulated in India.
- In India, medical devices continue to be regulated as “drugs” via the Drugs and Cosmetics Act, 1940, and that newly introduced Medical Device Rules, 2017, which came into effect on January 1, 2018.
- New rules classify medical devices based on risk, as is done by the Global Harmonization Task Force.
- The medical device industry is a unique blend of engineering and medicine.It involves the creation of machines that are then used to support life within the human body.Given this, it needs not only careful regulation but also the highest ethical standards.
- The notification issued has innumerable benefits , starting with settings qualitative standard of devices and to ensure the safety of patients
- It will attract FDI and increase our export.
- The new medical device rules were framed with the intention of making the domestic industry on par with global manufacturing practices. While the policy has the right intent for addressing multiple aspects of this paradigm shift encouraging domestic manufacturers, boosting innovation and R&D (research and development), the industry is looking for an assurance on follow-through at the basic level.
- Streamline the licensing process to ensure that manufacturers who already possess reputed international certifications can obtain the Indian mark easily. Currently, a domestic manufacturer with a CE mark must undergo nearly the same regulatory grind as a new manufacturer, a rather discouraging measure.
- The healthcare startups have gained tremendous private equity and venture capital attention over the past year and this trend is expected to intensify in the coming years. The state governments should set-up schemes to fund the medical device startups.
- It is vital for India to increase research funding for better execution through innovative, dedicated platforms.