Patient groups, healthcare providers, and manufacturers associations have expressed their dismay as the Centre prepares to table the New Drugs, Cosmetics and Medical Device Bill, 2023 in Parliament, without adequately addressing their concerns, the concerned groups said in a statement issued on December 16.
While the proposed legislation is aimed at regulating the medical device sector, industry leaders argue that key issues such as regulatory complexities, the potential impact on innovation, and the need for a conducive business environment have yet to be adequately assured by redressal in the proposed Bill.
“Earlier industry stakeholders voiced their concern that their input has been overlooked despite intervention by the Health Ministry,” Association of Indian Medical Device Industry Forum coordinator Rajiv Nath said.
He added that no committee was formed to review the different tenets of the Bill on a clause-by-clause discussion to align it or as suggested to use earlier separate Bill drafted by NITI Aayog in 2019.
“The need of the hour is a progressive modern separate law for addressing patient safety concerns,” Mr. Nath said, adding that by keeping a chapter of penalties and punitive actions common with drugs, India is only reviving the Inspector Raj.
The group has noted that the proposed Bill is old wine in a new bottle as only the label is getting changed.
“The proposed Bill has been prepared largely through consultations within the governmental structures and only limited external inputs have been taken. This makes the entire process infructuous,” said the group.
Malini Aisola, co-convenor of the All India Drug Action Network, explained, “The proposed Bill has no clearly defined norms for conducting clinical investigations, particularly for high-risk devices that go into the body of a patient or have higher potential to cause harm, leading to some very poor study designs and insufficient or dubious data. There is a complete lack of transparency in the way the regulatory mechanism and expert committees provide recommendations and undertake assessments of the studies, and the data which is the basis for granting approval.”
“An inclusive process will help shape an appropriate Regulatory Policy that needs to impact the Medical Devices sector positively,” Prof. Bejon Misra, founder director, Patient Safety and Access Initiative of Foundation India, said. He added that collective voices of the entire stakeholders should be heard, especially of the consumer and patient safety groups as the law is built to protect them and who should also be allowed to participate in formulating the regulations, which will help in ensuring affordable access to innovative medical devices that are safe.
Discussing the potential negative impact of the Bill, Dr. Giridhar Gyani, director-general of the Association of Healthcare Providers India, expressed concern and said that if the Bill is passed as is, the healthcare providers sector, heavily reliant on medical devices and advocating for increased availability of affordable, high-quality, made-in-India medical devices, may once again face challenges in management of supply chain, leading to crisis and country wide lockdown similar to the onset of Covid. “Domestic manufacturers might lose their capacity to swiftly address domestic demand, especially in the event of a pandemic,” he warned.
The statement by the group also noted that treating medical devices at par with drugs for regulatory purposes is fraught with danger for various reasons including the fact that such an arrangement puts unnecessary burden on medical device manufacturers in terms of compliances and leaves out more vital aspects that are crucial for ensuring the safety and effectiveness of medical devices. They have also expressed their dismay that the Parliament Committee recommendations are being ignored along with the aligned concerns of health care providers, patient, and consumer groups as well as the domestic manufacturers.
“We hope that prior assurances are honoured,“ the group said.