- In May 2019, Prime Minister Narendra Modi tasked all ministers with drawing up five-year vision plans for their ministries after taking office for a second term.
- The Health Ministry is expected to bring a vast majority of the medical devices sector under regulation as a priority under the five-year vision.
India’s medical device Industry
- Over 90 per cent of the country’s estimated $15 billion medical devices industry is unregulated. This includes over 6,000 devices like pacemakers, MRI machines and even tubes that collect blood samples.
- Currently, India is the fourth-largest medical devices market in Asia after Japan, China and South Korea. However, nearly 80% of the medical devices used in India are imported.
Drug Regulation in India
- Ministry of Health and Family Welfare (MoHFW) and the Central Drugs Standard Control Organization (CDSCO) are the main regulatory bodies that are responsible for overseeing pharmaceuticals and medical devices within India.
- The CDSCO exercises regulatory control over the import of drugs and devices, and approves new medical products and clinical trials.
- The CDSCO also oversees the Drugs Consultative Committee (DCC), the Drugs Technical Advisory Board (DTAB), and the Central Licensing Approving Authority (CLAA), the body responsible for ensuring medical device compliance.
The Drugs and Cosmetics Act
- The manufacturing, importing, sale, and distribution of pharmaceuticals and active pharmaceutical ingredients (APIs) in India are regulated under the Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945.
- Under the Drugs and Cosmetics Act, the regulation of the manufacturing, sale, and distribution of drugs and devices is primarily the concern of state authorities.
- Central authorities are responsible for approving new drugs, controlling the quality of imported drugs, coordinating the activities of state organizations, and providing expert advice in order to bring about a uniformity in the enforcement of the Drugs and Cosmetics Act.
The Medical Devices Rules
- Medical devices and in vitro diagnostics (IVDs) in India are regulated under the Medical Device Rules that came into effect in 2018. It provided guidelines for fundamental design and manufacturing requirements for 594 medical devices, and classified them into four categories (A,B,C and D) depending on their being high-risk or low-risk.
- But its regulation continues to be under the aegis of the Drugs and Cosmetic Act 1940.
- Majority of medical devices are completely unregulated in India.
- Presently, only 24 medical devices are notified as ‘drugs’. These devices are regulated under the Drugs and Cosmetics Act. For all other devices, there is no mechanism with the government to regulate quality or efficacy.
Need of regulating Medical Devices:
- There is a sense of urgency to address concerns related to medical device industry, under scrutiny over the last year after major health concerns and adverse reactions were highlighted with some high-risk devices.
Notifying all Medical Devices:
- The Drugs Technical Advisory Board (DTAB) (the country’s top drug advisory body) has recommended to notify all medical devices in a phased manner.
- The Ministry plans inter-ministerial consultations to implement a “detailed roadmap” for devices outlined by the Drugs Technical Advisory Board (DTAB) (the country’s top drug advisory body).
- This includes working out how to notify all medical devices under India’s Drugs and Cosmetics Act in a phased manner.
- This would be India’s first significant step towards holistic regulation.
- The Ministry is now planning stakeholder consultations to understand how to implement an expert advisory body’s recommendations to make sure medical device companies are accountable for the safety and quality of their products.
- This roadmap would be incomplete if it doesn’t address patient safety under a separate medical devices law and revamp CDSCO (India’s top drug regulatory body) to include a separate division for medical devices.
Need of a separate Medical Device Law:
- The government is currently using its 1940 drug laws to regulate the devices notified.
- Regulating medical devices under current drug laws may not effectively ensure patient safety because devices have issues different from medicines that need to be accounted for in legislation.
- Thus, the plan would be ineffective in the long run in the absence of a separate medical device law.
- To fulfill Medical device industry’s demand to have a new and separate act (from drugs and pharma) for medical devices as per global best practices, Medical Device Regulation Bill has also been proposed.
- This move is important for patient’s safety as with this notification, all implantable and diagnostic devices will come under the regulatory framework.