Rooting for medical devices regulation

The medical devices market is the most unregulated market in the country vis-à-vis the healthcare sector. There are no prescribed ‘gold standards’ for manufacturing in India, no data on Indian studies for ‘safety standards’, no studies showing efficacy and even indications of use in India, no MRP is ever fixed and even the variations in cost prices is very wide. This scenario is made worse by unscrupulous vendors and manufacturers offering incentives to doctors for use of their products. Medical tourism too, is now looking to boom in India, which will bring in patients from across the world; to maintain international standards of healthcare and earn our healthcare industry an international reputation. We need to follow international standards in use of medical devices.

Hence to consolidate laws related to medical devices and for establishing and maintaining a national system of controls relating to quality, safety, efficacy and availability of medical devices that are used in India, whether produced in India or elsewhere, a regulatory body under the regulatory law is a must.

Having considered paramount the safety of the public in the use of medical devices, and the fact that the content and scope of the present laws of the country including the regulations and administrative provisions in force do not extend to and cover adequately the safety, health protection and performance characteristics of medical devices, the regulatory body is essential. Also, even in the amendments to the Drugs and Cosmetics Act, 1940, the scope of the definition of the expression ‘drugs’ has not been extended to cover the entire spectrum of ‘devices’ fully and does not adequately cover all the products which are covered by the current internationally accepted definition of ‘medical devices’.

Thus, the regulatory body will cover the aspects of medical devices broadly covering the design, manufacture, packaging, labelling, import, sale, usage and even disposal of medical devices in India.

Along with the regulatory body it is essential that a law should be in place for regulating medical devices to give teeth to the body. The following aspects also show the need of the regulatory body:

It is clear from international experience in the regulation and use of medical devices, that the optimum assurance of medical device safety has several essential elements, viz.:

• Absolute safety cannot be guaranteed
• It is a risk management issue
• It is closely aligned with device effectiveness/ performance
• It must be considered throughout the life span of the device
• It requires shared responsibility among the stakeholders

A diverse range and multitude of medical devices are in use, which are manufactured using a wide variety of technologies with the result that for ensuring the safety of the public in the use of medical devices an entirely different system and method of regulation from the current national and international practices that are being applied for the regulation of drugs and cosmetics is required.

Also, the national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonized with global provisions in order to guarantee the free movement of such devices within the country and into the global market.

There is a need to ensure that medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; it is necessary to improve, the level of regulation, supervision and control over medical devices manufactured in or imported into the country.

Therefore, it is found expedient in the larger public interest, that the Parliament should enact a law to bring under its control the safety and performance of all medical devices which will be administered through the regulatory body.

The objective of the regulatory body should be to regulate and monitor the design, testing and evaluation, manufacture, packaging, labelling, import, sale, usage and disposal of medical devices, to ensure availability of safe medical devices for human use in the country.

With a view to the implementation of the objects specified above, the regulatory body should:

• Provide for notification of essential principles of safety and performance of a medical device and the requirements for design and manufacturing
• Provide for risk-based classification of medical devices
• Notify the standards and guidelines in relation to medical devices and specify an appropriate system for enforcing various standards notified under this Act;
• Provide for a mechanism for conformity assessment using direct or third party notified bodies
• Notify the method of conformity identification by assigning marks or other means
• Specify the requirements pertaining to conformity assessment of imported medical devices, refurbished devices, date expired devices, custom made devices and other special cases
• Stipulate the procedure and guidelines for testing laboratories and referral testing laboratories and notification of the same;
• Provide for the exchange of information among the notified bodies and other enforcement authorities;
• Prescribe methodology for implementing and operating a vigilance and post-market surveillance system and taking preventive and pro-active measures
• Provide for enforcement of the various provisions stipulated in the law and those relating to offences
• Stipulate the manner and procedures for risk management and risk benefit analysis.

The duty of the regulatory body should also be to:

• Provide scientific advice and technical support to the Central Government and the State Governments in matters of policy and principles in areas which have a direct or indirect bearing on medical device safety and efficacy;
• Search, collect, collate and analyse relevant scientific and technical data particularly relating to:

• hazards with the use of medical devices
• the exposure of individuals to risks related to the use of medical devices;
• incidence and prevalence of risks associated with medical devices;
• identification of emerging risks; and
• introduction of effective alert system;

• Promote, co-ordinate and issue guidelines for the development of risk assessment methodologies and monitor, conduct and forward messages on the risks associated with medical devices to the Central Government, State Governments and other enforcement agencies;
• Provide scientific and technical advice and assistance to the Central Government and the State Governments in implementation of crisis management procedures with regard to medical device safety and to draw up a general plan for crisis management and work in close co-operation with the crisis units set up by the Central Government in this regard;
• Promote networking of national and international organisations within and outside India with the aim of facilitating scientific co-operation, co-ordination of activities, exchange of information, implementation of joint projects and exchange of expertise;
• Provide scientific and technical assistance to the Central Government and the State Governments for improving co-operation with international organisations;
• Take all such steps to ensure that the public, medical professionals and interested parties receive rapid, reliable, objective and comprehensive information through appropriate methods and means;
• Provide, whether within or outside their area, training in medical device safety and standards for persons who are or intending to become involved in medical device businesses, whether as entrepreneurs or employees or otherwise;
• Contribute to the development of national/international technical standards for medical devices;
• Contribute, where relevant and appropriate, to the development of agreements, national or international, aimed towards standardisation of metrology relating to medical devices;
• Support international efforts to improve and harmonise standards relating to medical devices and regulatory practices;
• Promote consistency between international technical standards and national medical device standards while ensuring that the level of protection adopted in the country is not reduced; and
• Promote general awareness as to medical device safety and medical device standards.
• Provide guidance and support to industry to understand and comply with the regulatory requirements

To sum up, a regulation in this area of healthcare will help patients and the doctors alike.