medical-devices-regulation-in-india

The government thinks 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.

 

About CDSCO

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.

Major functions of CDSCO:

1. Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters.

A medical device is any instrument, apparatus or appliance used specifically for diagnosis, prevention, alleviation of diseases or wellness purposes.

Medical Devices are segregated into six major segments, out of which diagnostics imaging constitutes the largest chunk (from a global perspective).

The Medical Devices industry in India

  • Currently, India is counted among the top 20 global medical devices market and is the 4th largest medical device market in Asia after Japan, China, and South Korea.
  • Up to 100% of Foreign Direct Investment is permitted in Medical devices through the automatic route.
  • The medical devices industry is principally import-driven, with about 75% of equipment being sourced from other countries. 

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 the safety and effectiveness of these products while its pricing regulator will monitor the prices.
  • This notification runs contrary to the assurances given to the medical devices industry by the MOH&FW in 2016.

Assurance was given to the industry by the MOH&FW in 2016 of four steps — 

  1. starting with the Medical Devices Rules (MDR), 
  2. initially experimenting with a few electronic devices under the MDR, 
  3. the MDR to be amended as per experience gained after six months of introduction and 
  4. the simultaneous drafting of a Medical Device Bill to be reviewed stakeholders and passed by Parliament and the MDR to accordingly be tweaked in order for it to migrate to an eventual Medical Devices Law.

Need for regulation of medical devices in India

  • The recent ICIJ implant files or J&J incident, or the most recent ban on the transvaginal pelvic mesh by USFDA points to the hazards of faulty medical devices.
  • Patient safety is more complex with devices where the same is 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 parenteral, blood products, rDNA 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 Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture, and distribution of drugs in India. 
  • The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
  • 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 offenses 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 recognized 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.  

A recent proposal to cap prices of stents was on hold for long as there was pressure to create a separate law for medical devices. Moreover, the department of pharmaceuticals plans to come up with a National List of Essential Medical Devices.

What is NELM?

  • The NLEM is a dynamic list and reviewed every three years to include or exclude drugs as relevant to the newest medical innovations and aligned to the current market competition.
  • National list of essential medicines (NLEM), a list from which the Delhi high court struck out condoms last year.
  • Social activists demand: The cost of medical equipment in the country is higher. Considering the increasing cost of treatment for heart diseases in the private sector, this is a welcome move to include it in the list of essential medicines.
  • Stent-makers say the inclusion in the NLEM and the consequent price cap could stop the introduction of technologically advanced stents in India.
  • Rather than a price cap, there should be a dynamic regulatory process. 

Way forward:

Best practices

WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices

  • The Model recommends guiding principles, harmonized definitions and specifies the attributes of effective and efficient regulation, to be embodied within the binding and enforceable law. 
  • Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF).

A global harmonization task force (GHTF)

  • The Global Harmonization Task Force (GHTF) was founded in 1993 by the governments and industry representatives of Australia, Canada, Japan, the European Union, and the United States of America. 
  • The purpose of the GHTF is to encourage convergence in standards and regulatory practices related to the safety, performance, and quality of medical devices. 
  • In the extensive work by the World Health Organization, there needs to be a unique approach specific to medical devices and one cannot replicate the methodology used for medicines with medical devices.
  • The government should stick to the 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, the government should look at the essentiality of the procedure as a whole and not focus on a single component as patients are billed for the whole procedure and not just the device.
  • Incentivizing 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 rationalization 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 galvanize domestic manufacturing.

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