Context:

• Government think tank Niti Aayog has rejected the health ministry’s proposal to bring medical devices under the Central Drugs Standard Control Organisation (CDSCO), saying the body does not have the required expertise.
• NITI Aayog’s Draft bill proposes a separate regulator for medical devices on the lines of the Food Safety and Standards Authority of India (FSSAI), an autonomous body under the health ministry.

Health Ministry notification: 

• Facing a backlash after faulty medical devices risked lives, the government plans to bring “all medical devices and diagnostics in the country under the purview of the Drugs and Cosmetics Act, 1940. 
• Devices intended for use on human beings or animals should be treated as drugs with effect from 1 December 2019.
• If implemented, the country’s drug regulator will enforce standards to ensure safety and effectiveness of these products while its pricing regulator will monitor the prices.
• This notification runs contary to the assurances given to the medical devices industry by the MOH&FW in 2016.

Need for regulation of medical devices in India

• The recent ICIJ implant files or J&J incident, or the most recent ban on trans-vaginal pelvic mesh by USFDA points to the hazards of faulty medical devices.
• Patient safety is more complex with devices where the same are a shared responsibility of the manufacturer, medical practitioners, product user and the regulator.
• No quality parameters:At present only 24 out of over 6,000 medical devices are regulated by being notified as drugs. A considerable number of them are being exported from countries that do not regulate their exports.
• It's imperative to have a separate law as devices are engineering items and not medicines.

Benefits

• Patient safety and affordable devices.
• Investments: Medical devices manufacturers need to know the legal requirements, in a predictable manner. This will attract overseas and Indian investments. Presently, investors shy away from an unpredictable, incomplete and incorrect regulatory environment.
• A strong and fair regulatory environment will help the Make in India campaign by encouraging the growth of this industry.

Medical device regulations/bodies in India

• The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals and medical devices.
• The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of certain drugs (vaccines, large volume parenterals, blood products, r-DNA derived), specific medical devices, and new drugs.
• In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA). At present only 24 out of over 6,000 medical devices are regulated by being notified as drugs.

• The Medical Device Rules (2018): These rules have risk proportionate controls correlating to the risk classification of devices.
• The National Accreditation Board of Certification Bodies is already accrediting certification bodies for voluntary quality assurance (the Indian Certification for Medical Devices (ICMED) scheme) under the QCI (Quality Council of India).

Salient features of the NITI Aayog’s Draft Bill:

• The NITI Aayog has proposed a separate body to regulate devices stating that authorities handling it should also have special expertise, which the CDSCO doesn’t have.
• It has recommended that the government involve the IITs to check the safety profile of the medical devices. 
• The Aayog has advised the ministry to regulate only Category A devices such as pacemakers, heart and knee implants that are intrusive and are fit inside the human body.

Recommendations of Task Force on Medical devices 

• A task force on medical devices in 2015 recommended formulating a Medical Device Regulatory Act.
• Medical devices should be treated distinctly from drugs and a separate chapter for medical devices should be made in the existing Drugs and Cosmetics Act. 

Concerns with medical devices regulations:

• Devices are engineering items and not drugs: an MRI or CT scan machine by no stretch of the imagination can be called a drug, and, so, continued attempts to regulate devices as drugs is illogical.
• Negligence or  intentional wrongdoing by the manufacturer like J&J Hips implant case:
  • Since the manufacturer sold these devices to doctors and hospitals and not patients directly, it did not have a list of patients who had these devices implanted. 
• There is a lack of proper regulatory systems, harmonized standards, accreditation, legal requirements, proper guidance on quality and best practices in India. 
• India has no laboratories for checking the efficacy of medical devices.
• No penal provisions: Only Parliament can enact a law that creates new offences and penalties for wrongdoing. As a result, the Medical Device Rules 2017 contain no penal provisions. 
• Although the Drugs and Cosmetics Act does contain a penal provision for the manufacture of sub-standard drugs, it cannot be used to penalise manufacturers of sub-standard medical devices (although medical devices will now be legally defined as drugs) because legally binding standards recognised in the Second Schedule to the Drugs and Cosmetics Act covers only pharmacopeias for drugs.
• The Drugs Act itself needs reforms as it does not uniformly and equitably regulate quality from state-to-state in the absence of a national singular regulatory authority.
• At most, the ministry can prohibit the manufacture and sale of certain medical devices under Section 26A or cancel a license to prevent future harm.
• Foreign markets – Companies that make defective products will recall them from foreign markets and sell the same product in India, and comply with the law.  

Way forward:

• In the extensive work by the World Health Organization, there needs to be unique approach specific to medical devices and one cannot replicate the methodology used for medicines with medical devices.
• The government should stick to earlier assurance given to the industry by the MOH&FW in 2016 of four steps.
• Creating a confidential patient register that should be maintained by the government to record all details of implants.
• Essentiality of procedure: In order to promote access of medical devices to Indian patients, government should look at essentiality of procedure as a whole and not focus on a single component as patients are billed for whole procedure and not just the device.
• Incentivising ICMED certification by the QCI will help Indian manufacturers in capacity building for voluntary compliance to quality standards, thereby ensuring global competitiveness and enabling a smooth transition to mandatory compliance under the proposed draft Medical Devices Bill from Niti Aayog.
• Right from trade margin rationalisation to ensuring a separate set of legislations and regulatory frameworks to govern the medical device sector and everything in between needs to be looked at afresh to galvanise domestic manufacturing.

The final motive should be to make devices affordable, least intrusive and not mess with the industry and market.