The Central Drugs Standard Control Organisation (CDSCO) is falling short in effectively regulating the medical devices industry, observed the Department-related Parliamentary Standing Committee on Health, headed by Prof. Ram Gopal Yadav, M.P., Rajya Sabha stating that the organisation in its existing structure and expertise is more pharma centric.
He presented 138th Report on the subject “Medical Devices: Regulations and Control” to Rajya Sabha earlier this week.
It has recommended for more certified medical devices testing laboratories, robust IT enabled feedback driven post-market surveillance system and medical device registry, particularly for implants to ensure traceability of patient who has received the implant in order allowing assess the performance of the implant.
The Committee observed that the CDSCO was originally set up to regulate pharma, related segments and medical devices. It has recommended that the new legislation should set up a new set of regulator at different levels for regulating the medical devices industry.
The Committee observed that the country has only 18 certified Medical Device Testing Laboratories that have been approved by CDSCO and that is grossly insufficient keeping in view the size of the country. The Committee is of the considered opinion that having adequate common infrastructure including accredited laboratories in various regions of the country for standard testing would significantly encourage local manufacturers to get their products tested for standards and such measures undertaken would also help in reducing the cost of production which ultimately will improve the availability and affordability of medical devices in the domestic market.
The Committee noted that there is a dire need for developing a robust IT enabled feedback driven post market surveillance system for Medical Devices to evaluate the efficiency of specific Medical Devices. A medical device registry, particularly for implants should also be made to ensure traceability of patient who has received the implant in order to assess the performance of the implant and ascertain upto what extent the implant has made the life of the patient comfortable and also to seek feedback of functional capacity of medical devices. Such measures would ensure that patients get access to good quality and approved medical devices.
“The Committee recommends the Ministry to work in synergy with State governments and impart the necessary skills to the local medical device officers and also devise a mechanism to regularly designate State Medical personnel as Medical Device/Medical Device Testing Officers so that the mandate of the legislation can be implemented effectively. The Committee believes that with industry growing by leaps & bounds, the government should not afford regulation of medical devices by pharma experts and its time that at ground level the medical device regulations are dispensed with by qualified and well-trained Medical Device Officers to give a fillip to the Medical Device industry in the country,’’ said the report.
It has recommended that the Ministry should allow the new regulator to involve institutions such as IISC, CSIR, DRDO and network of IITs to test medical devices for safety and efficacy. The Committee is of the firm view that these institutes have high-tech labs and thus can be used to test medical devices for their electronic, electromagnetic, biochemical-run aspects. The Committee further recommends that additional investments should be made to raise the standards of these labs as per the requirements.
It has also highlighted the multiplicity of regulations and said that a single window clearing platform for application of license for manufacturing, export, import shall also integrate all these bodies involved in the regulation of medical devices.
“A single window clearance for all the Department/Ministries would significantly boost investment in R&D in the field of medical devices and would also reduce the time required for obtaining approvals from different Departments/Ministries. The Ministry must incorporate such an all-encompassing “single window clearing/approval system” in the proposed new separate Act for the regulation of Medical Devices,’’ said the report.
The Committee also discussed that quality and affordability are two vital factors regarding medical devices.
“Indian Medical Devices Industry presently lacks research ecosystem and infrastructure for manufacturing of high tech, advanced medical devices (Class C&D) and Indian Medical Devices Industry doesn’t have facilities to produce such medical devices comparable to global standards,’’ it said while advocating for invigorating a culture of research and development in medical devices in institutions such as IITs, NITs and other academic institutions. “The Committee recommends the Department to start a Research Linked Incentive (RLI) Scheme in Line with the PLI scheme. The Department should facilitate academia-industry partnership for undertaking research projects on industry challenges and incentivise the successful outcomes,’’ notes the report.