In a move considered long overdue, the government has initiated a major regulatory reform of the medical devices sector, notifying that all devices, equipment, and even software intended for medical use will now be treated as “drugs” for purposes of regulation and quality control. All devices for sale in India, whether manufactured locally or imported, will now require online registration with the Central Licensing Authority under the Central Drugs Standard Control Organization (CDSCO), the apex drug regulator in the country. Such registration is voluntary for a period of 18 months, after which it will be mandatory. With the inclusion of new published rules in 2020 under Drug and Cosmetics Act 1940, “Medical Device Ammendment rules” comes into picture. With this, the manufacturer/ importer has to undergo a stringent set of steps like uploading all the details related to product, certificate of compliance with respect to ISO 13485, clinical validation/accuracy certificate, showcasing free sale certificate from the country of origin, etc. The landmark reform promises to redefine the medical devices sector in India by ushering in an era of better quality control and boosting safety and regulation standards within the local manufacturing sector. It will also ensure that foreign companies do not market sub-standard products in India.
The regulatory reform comes at a time when the medical devices sector is poised for major growth. The Indian medical devices market is the fourth largest in Asia and is expected to grow to USD 50 billion in size by 2025[1]. The sector includes a wide array of devices, medical equipment, patient aids, remote care technology, diagnostic equipment, and implants. However, in the absence of a supervising regulatory authority, the sector stood largely unregulated. A study conducted by Anna University in Tamil Nadu threw up shocking facts last year. It found that just one in five ventilators in hospitals across the state had been certified safe by biomedical engineers, resulting in a large number of life-saving equipment short of credibility.
Indian importers, medical fraternity as well as consumers relied largely on foreign regulations like FDA, CE approvals for quality assurance. In the face of rapid growth and proliferation of devices, regulation standards must be strengthened and harmonized with international standards.
The need for better safety and quality assurance
This move has been a long time in the making. Last year, the Drugs Technical Advisory Board (DTAB) had recommended that all medical devices should be notified as “drugs” under the drug regulation law to ensure they maintain safety and quality standards. The government then made it mandatory for all medical devices — manufactured locally or imported – to get notified and get a CDSCO certification.
The series of developments have come after intense debate and discussion over the need for better quality assurance for Indian consumers for a long time. India’s medical devices sector is heavily dependent on imports, with almost 70% of the demand for devices met by imports[2]. Many of these imported equipment and devices do carry regulatory certificates in other countries, but many countries do not regulate their exports. This lack of regulation might allow certain manufacturers to take advantage of the loopholes and float low-grade devices and equipment in the market, which is a major worry for Indian healthcare. This is why regulating imports becomes extremely important to ensure quality and safety. The new amendment assures– that every medical device, either manufactured in India or imported, will have to have quality assurance before they can be sold anywhere in India.
Boost for local manufacturing
While the potential of the medical devices sector was duly acknowledged with its inclusion in the ‘Make in India’ initiative, several problems continue to hamper indigenous manufacturing and export potential. The absence of a concrete regulatory framework specific to medical devices was a leading factor that constrained investments in the market. Investors are discouraged by the lack of a concrete regulatory and legal framework to govern the sector. As mentioned above, almost 70% of the demand for medical devices in India is still met by imports. Hopefully, the introduction of the regulatory reform will change this. Apart from bringing radical improvements in standards of quality, safety and effectiveness in medical devices, the move will also act as a boost for the local manufacturing sector. The need for instituting strong quality controls will push manufacturers towards better compliance while gradually ensuring harmonizing of quality control protocols with international standards. Better regulatory mechanisms will, therefore, help Indian manufacturers produce globally competitive devices and equipment that are fitter for exports. In a nutshell, the harmonization of India’s regulatory structure with global norms will enable Indian manufacturers to ‘Make in India’ for the world. On a parallel note, a concrete regulatory framework will also boost investments, including from foreign players in the sector, and thereby help in reducing the gap between technology and research in India.
Need for building appropriate expertise
While the reform is much needed, it brings with it a major requirement of bolstering competency and auditory expertise. As regulatory standards become more stringent, regulatory bodies would require more specialized auditors and technical inspectors. On the other hand, all manufacturers – big or small – will also need to institute strong quality control checks internally. This will create major demand for competent bio-medical engineers, lab technicians, doctors and pharma experts to work closely with device manufacturers. This capacity building is an area that needs to be worked upon diligently to make the regulatory reform a success.
With the CDSCO also required to take up the regulatory role for devices along with drugs, it is also essential for the body to ensure it has the necessary capacity and expertise to conduct the process seamlessly. Greater investment in capacity building, skill enhancement, and recruitment of specialized auditors will be needed on a major scale. This comprehensive reform will benefit not only the medical devices sector but also the healthcare service consumer at large.
Need for separate regulatory bodies
Medical devices and equipment today are used for a wide variety of medical purposes. From diagnostic uses such as CT scan, MRI to Telehealth software platforms used for providing remote consultations, the use of medical equipment is widespread and versatile. The emergence of telemedicine as a major element in furthering the goals of Universal Healthcare has driven the production of devices, software, and equipment dedicated to improving telemedicine experience. Manufacturers are continually working to develop reliable devices and equipment to be able to deliver quality medical images and precision patient data, even from remote terrains. This calls for a broader rethinking of the regulatory approach. While the introduction of the regulatory process is highly welcome, it is imperative that as a country, we gradually move towards separate regulatory regimes for drugs and devices. Devices being engineering products cannot and must not be treated as drugs, and the government must take these efforts to the next level by establishing a separate body for regulating devices, equipment, and technology used for medical purposes.
The industry has so far reacted positively with the new move, though doubts remain about the ability of the Central Drugs and Standards Control Organisation (CDSCO) to effectively regulate both drugs and medical devices.The Govt needs to play a crucial role in making this new move implement successfully by helping provide certifying labs, manpower, technical & clinical assistance as way ahead for Quality Healthcare.
[2] https://2016.export.gov/industry/health/healthcareresourceguide/eg_main_108895.asp
Authored by Mr. Vikram Thaploo, CEO – TeleHealth
At Apollo Hospitals Enterprises Limited
