The government’s policy think tank, the Niti Aayog, is giving final touches to the medical devices bill that will bring a new law to regulate medical devices.
The bill, called as the Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019, has provisions to address patient safety concerns and punish companies making and selling faulty devices.
The proposed law brings all medical devices under one regulatory regime in a phased manner, and rigour and oversight will be dependent on risk-based classification of medical devices.
Niti Aayog had also tried to strike a balance by fostering ease of business and innovation without diluting patient safety concerns.
Niti Aayog, early this week, held consultations with various stakeholders that include patient advocacy groups, medical devices manufacturers, traders, state regulators, among others, before finalising the draft of the bill.
As part of the consultations, Niti Aayog made a presentation that gave an outline of the key proposals that would be contained in the bill.
Moneycontrol saw a copy of the presentation.
Medical Devices Authority
A major proposal is to set up of a Medical Devices Authority (MDA) that would function parallel to the Central Drugs Standard Control Organization (CDSCO), which currently regulates medical devices. The MDA would be under the Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare (MoHFW).
The MDA will have four divisions which include: a health and safety division that would grant permission for clinical trials, evaluate clinical evidence and collected and analyse post market surveillance; a conformity assessment division that would deal with issuing approvals and conducting audits of manufacturing facilities; an enforcement division that would deal with enforcing the law; and a testing division that would maintain a National Register of Medical Devices, grant a unique identification number to medical devices and coordinate product recalls.
As per the proposed bill, the MDA will have an Additional DGHS rank officer as chairperson, along with 11 members. The members would include four divisional heads, one member secretary and six ex-officio members from Bureau of Indian Standards (BIS), the Indian Council of Medical Research (ICMR) Co-Chairman, Indian Pharmacopoeia Commission (IPC), the Department of Biotechnology (DBT), Department of Science and Technology (DST), and the Department of Pharmaceuticals (DOP).
A National Register of Medical Devices for all devices would also be maintained. Each device would be granted a unique identification (UID), and have the information of manufacturers, distributors, importers, foreign manufacturers under one database.
According to the bill, the enforcement will be done in partnership with the state medical device officers and the reporting of adverse events would be carried out by patients, healthcare practitioners and manufacturers. Boost innovation in partnership with scientific and technological institutions.
According to the bill, to boost the ease of business, no manufacturing license is required to register the medical device or receive a certificate of compliance and the self-declaration for manufacturing low risk devices is allowed.
The proposed law includes provisions for patient safety, such as right to have access to a safe and effective medical device; access to information on the potential for harm to the user; receive timely safety advisories and alerts of adverse events from manufacturers and the administration; and protection of personal health information.
There penalty for offenders include a fine of Rs 1 crore and imprisonment of up to three years for non-compliance to essential principles of safety and performance, conditions of certificate of conformity and to protect personal health information of patients.Industry reactions
“We appreciate the wide ranging consultations which Niti Aayog has begun on the draft act. Our experts will study it for the impact it would have on patient safety, ease of doing business and making investments and innovation,” said Pavan Choudhary, Director General and Chairman of Medical Technology Association of India (MTaI). MTaI represents multinational medical device makers.
“We have also requested Niti aayog to evaluate if the improvements being aimed at need structural recipes or operational uplift alone would be enough i.e. we need a new agency or would it be more prudent to assign the existing agency some new jobs?,” Choudhary said.
Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD), welcomed the proposals of Niti Aayog.
“The Indian medical device industry is very hopeful the proposed Medical Devices Bill will be designed in time to make quality healthcare accessible and affordable for common masses, and that it would enable India to be placed among the top 5 medical device manufacturing hubs worldwide," said Nath
"The industry also hopes the bill would help end the 80-90 percent import dependence forced upon us and an ever increasing import bill of over Rs 38,837 crore to replicate success of India's pharmaceutical industry, which has now achieved the enviable status of pharmacy of the world,” he said.
“A pro-active policy formulation to regulate medical devices differently than drugs should permit free market dynamics to succeed and keep regulations simple, protecting consumers and incentivising Make in India,” he added.