Medical Device Regulations In India

Medical Device Regulations In India

Updated on 6 December, 2019

Target 2020 GS3 Health and Family wellfare
medical-device-regulations-in-india

The Ministry of Health and Family Welfare, Government of India has proposed a draft Medical Device RegulationsThe NITI Aayog has rejected its proposal to bring medical devices under the Central Drugs Standard Control Organisation (CDSCO). 

Need for the Medical Device Regulations: 

  • 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. The manufacturers did not have a list of patients who had these devices implanted. 
  • Patient safety is more complex with devices where the same is a shared responsibility of the manufacturer, medical practitioners, product user, and the regulator.
  • Very few medical devices are regulated under the current regulatory regime.

Present Status of the Medical Device Regulation:

  • India is among the top 20 global medical devices market. It is the 4th largest medical device market in Asia after Japan, China, and South Korea.
  • Up to 100% of Foreign Direct Investment (FDI) 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. 
  • 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.
  • Both imports and exports of medical devices grew at more than 10% between 2011-12 and 2014-15 (A report by the department of pharmaceuticals).
  • The country’s medical devices industry has grown from $2.02 billion in 2009 to $3.9 billion in 2015, at a compounded annual growth rate (CAGR) of 15.8%.
  • At present, there is no mechanism for reporting the malfunctioning of non-notified medical devices.

The proposed rules and a draft notification related to medical devices regulations:

  • It is a roadmap that the health ministry has chalked out in consultation with the department of pharmaceuticals, Niti Aayog, the department of biotechnology, the Indian Council of Medical Research, the Bureau of Indian standards and industry experts and associations.
  • The roadmap mandates every manufacturer and importer of medical devices to report serious adverse events to the drug regulatory authority and the material-vigilance program. 
  • The CDSCO will be the nodal authority to investigate the quality, safety-related issues, and complaints.
  • The CDSCO can suspend the registration based on the outcome of its investigation.
  • Certification of devices will be on a voluntary basis up to 18 months from the date of notification, and thereafter it will be made mandatory.
  • All imported and locally-made medical devices will have to meet certain standards of quality and efficacy to enter the Indian market.

The Benefits of the Draft Rules:

  • Patient safety and affordable devices.
  • A huge chunk of Overseas Investments. 
  • It will help  Make in India campaign by encouraging the growth of this industry.
  • It will inspire the domestic industry for further research and innovation in medical devices.
  • Foreign markets: Companies that make defective products will recall them from Indian markets and comply with the law.  

NITI Aayog’s Concern over the proposal:

  • The Department has prepared a draft proposal without having expertise
  • Notifying medical devices as ‘drugs’ is an unhealthy way of regulating the segment that is growing by leaps and bounds. It’s a temporary solution.
  • The Niti Aayog has also highlighted CDSCO’s lack of ability to check the safety and efficacy of medical devices.
  • The CDSCO’s specialization is in drugs that are chemical-based whereas the medical devices are purely technological inventions
  • It argues: “From band-aid, cotton, stretcher, head mirror, dressings to gauze — everything is a medical device. Why does all of this need to be regulated?”
  • There is no clinical trial system for devices like we have for medicines. 
  • 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.
  • One size does not fit all as the Medical Devices are not drugs: An MRI or a CT scan machine by no stretch of the imagination can be called a drug, and, so, continued attempts to regulate devices as drugs are illogical.

A Proposal by NITI Aayog:

  • A separate body to regulate devices stating that authorities handling it should also have special expertise.
  • It has recommended that the government should 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.
  • The Aayog recommended that it's imperative to have a separate law as devices are engineering items and not medicines.

Current Standard of Drugs Regulation in India:

  • The drug is in the concurrent list of the Constitution.
  • It is governed by both Centre and State Governments under the Drugs & Cosmetics Act, 1940
  • 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, 1940
  • CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.

A National List of Essential Medical (NLEM) Devices.

  • The department of pharmaceuticals plans to come up with the NLEM list.
  • 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.

 

Medical Devices:

  • Medical Devices are notified as DRUGS under the Drugs and Cosmetics (D&C) Act. 
  • Section 3 (b) (iv) defines, Medical Devices as “Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals” 
  • GMP Requirements are specified under Schedule M III 
  • Rule 109-A Labeling of Medical Devices 
  • Rule 125-A Standards for Medical Devices 
  • Currently, 24 medical devices have been notified as Drugs.
  • Segments of Medical Devices: 
    • Devices that do not require any external energy source. 
    • Devices that require an external energy source to be operational (powered). 
  • Powered devices are further divided into three product categories: 
    • Equipment, 
    • Implants, 
    • Disposables. 
  • Phases in the lifespan of Medical Devices:

  • Ideal Conditions for ensuring Safety and Performance of Medical Devices

 

Factors driving the growth of the medical devices sector:

  • Market Factors – Growing population, ageing, income base and associated disposable income, increasing socio-economic inclusion of rural and deprived in mainstream economy, heightened manufacturing innovation to create customized products to meet the needs of all income segments, changing disease prevalence pattern (e.g. early onset of diabetes and heart diseases) and growing awareness among the middle class to focus on early detection and disease prevention. 
  • Non-market Factors:  Development of infrastructure, favorable regulations, FDI inflow, outsourcing of manufacturing and R&D activities to India, government initiatives to improve healthcare access through insurance schemes such as RSBY (Rashtriya Swasthya Bima Yojana), Aarogyasri, Aayushman Bharat, etc. 

Issues Related to Medical Device Regulations in India:

  • The government does not have an exact figure for how many non-notified medical devices are available in the country. 
  • 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.
  • 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.
  • There have also been complaints of refurbished imported equipment making their way into the country.
  • There is a lack of proper regulatory systems, harmonized standards, accreditation, legal requirements, proper guidance on quality and best practices in India. 
  • Mushrooming medical laboratories with faulty medical devices

Best Practices across the World:

  • In the United States: The Federal Food Drug and Cosmetic Act regulate the medical deviceDevices are classified into a 3-tiered system (Class I-lowest risk; Class II-intermediate risk; Class IIIhighest risk). Humanitarian use devices (HUDs) are marketed for a limited population in an entirely separate process termed a Humanitarian Device Exemption (HDE). 
  • In the EUROPEAN UNION:  Medical Device Directive (MDD) regulates the safety and marketing of medical devices in Europe since the 1990s. Devices are classified into class I (including Is and I'm), IIa, IIb, and III. Class III is ranked as the highest and higher the classification the greater the level of scrutiny. Medical devices cannot be marketed in the European Union without adhering to the stringent regulations of the European Union.
  • In Australia: The medical devices are regulated by the Therapeutic Goods Administration (TGA). Before being launched in the Australian market the medical devices must be recorded in the database of the Australian Register of Therapeutic Goods (ARTG). In Australia, medical devices are classified into following classes; class I, class I- supplied sterile, class I- incorporating a measuring device, class IIa, class IIb, class III and Active Implantable Medical Devices (AIMD).

Way Forward:

  • The government should expedite steps to end the 80-90% import dependence forced upon the medical device industry. 
  • The GST on medical devices is in favor of imports and is detrimental to Make in India.

RECOMMENDATIONS OF THE TASK FORCE ON THE MEDICAL DEVICES SECTOR IN INDIA - 2015

  • Policy support 
    • Create necessary bodies to drive the policies
    • Preferential treatment in government procurement
  • Infrastructure 
    • Set up manufacturing hubs/ clusters in PPP mode.
    • Set up Medical device parks 
    • Financing support: Low-cost funding like interest subsidy to MSME
    • R&D should be supported/ coordinated by agencies like ICMR, DBT, CSIR, DIETY & DoP through the single window facilitating body. 
    • Other support like Concessional power tariff for up to 5-10 years
  • Facilities for efficacy and safety testing 
    • Medical device testing centers should be set up, preferably in the PPP mode 
    • Designate “Centers of Excellence” (CoE) for supporting product development and validation.
    • Strengthen a made in India marking (BIS) specific to Medical devices in line with international standards like CE and FDA
  • Skill development
    • Set up a Skill development committee with representatives from the Medical devices industry, academia (NIPERs) and Healthcare Sector Skill Council (HSSC) under the National Skill Development Council (NSDC)
  • R&D capability 
    • Set up a system for IP exchange 
    • Set up/ promote Incubation centers through appropriate incentive structure/ cost-sharing.
    • Provide requisite financing support 
    • Promote industry-specific “independent software vendor” by extending similar benefits
  • Policy for pricing 
    • Separate price control order for medical devices 
    • Price control body Empower NPPA for fixation and monitoring of prices under a separate vertical.
    • Pricing & reimbursement policy
  • Regulatory 
    • Formulate the “Medical Device Regulatory Act”.
    • Designate regulatory bodies for medical devices
  • Duty structure 
  • Discounts on import duties 
  • Restrictions on imports of second-hand diagnostic equipment/ tools 
  • Incentivize and promote exports in the medical devices sector. 
  • Taxes should be levied with reference to MRP. 

Conclusion 

A proactive policy formulation to regulate medical devices should permit free market dynamics to succeed. The regulations should be simple which will help in protecting consumers and incentivising Make in India. Synchronising the expertise from various agencies, including NITI Aayog, to formulate the policy will be essential steps in this regard. 

 


Categories : newcategory,
Read Also
...
GOVT GOES FOR 100% DISINVESTMENT IN AIR INDIA
...
Plea for judicial probe in custodial violence cases(TH)
...
European Parliament’s resolution on the CAA(TH)
...
Govt inks peace pact with Assam militant group NDFB