Medical Device Regulations In India

Medical Device Regulations In India

The Ministry of Health and Family Welfare, Government of India has proposed a draft Medical Device Regulations. The 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.

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

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 device.  Devices 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.