To address the regulatory vacuum and concerns of patient safety in medical devices, Niti Aayog is likely to circulate a draft of the Medical Devices Bill for stakeholders review to frame a separate medical devices Act much on the similar lines as drugs Act.
This according to experts will clear the ambiguity in terms of regulating drugs and devices separately as both have different shelf life and product life cycle in the context of efficacy, performance and patient safety.
A stakeholder review meet took place in December last year and then in January earlier this year with representatives from the domestic medical device industry and other stakeholders including some regulators to discuss on the need to regulate medical devices separately and having a regulatory division parallel to what the Union health ministry has in the form of Central Drugs Standard Control Organisation (CDSCO).
The meet was aimed at having a predictable road map for the development of Indian medical device sector with the help of separate regulatory framework having effective and rationale medical device regulations as stipulated in the national health policy.
Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMed) explains, “There is a need for a separate regulatory framework to address the regulatory vacuum and concerns of patient safety in medical devices.
However, the industry has been surprised with the reluctance of Union health ministry to initiate framing a separate Law or now sharing a clear view point on the proposal for the new bill medical device bill.
This lack of clarity is making the policy environment unpredictable and is being interpreted that possibly Union health ministry is not supporting a separate act for medical devices or in the form that’s being drafted by Niti Aayog.
First priority is to have a separate Act. Then comes the question about who will regulate? Whether there would be a separate division under Union health ministry as is the case with CDSCO and Food Safety and Standards Authority of India (FSSAI) currently or CDSCO will be revamped with separate divisions for drugs and devices and separate team of competent regulatory experts as professionals.”
An attempt to self regulate the Indian medical device industry was initiated when Quality Council of India (QCI) introduced on March 15, 2016 the Indian Certification for Medical Devices Scheme (ICMED)- the first indigenously developed international class certification scheme for medical devices in India.
ICMED was launched to bring credibility for medical devices manufacturers in India to reduce time and cost-run for obtaining globally accepted certification thus eliminating malpractices of sub-standard or fraudulent certification or quality audits.
It is also intended to help manufacturers get preference in public healthcare procurement scheme. ICMED is also aimed at enhancing patient safety and will serve as the much needed product credential for manufacturers to build confidence among buyers and users.
This move motivated the Union health ministry into introducing a revised Schedule M-III delinking quality management system (QMS) from pharma good manufacturing practices (GMP) and expedited drafting of new medical devices rules separate from drugs.