New Delhi: The Drugs Controller General of India (DCGI) is planning to amend the Medical Devices Rules, 2017 to include a provision for quality requirement for non-sterile and non-invasive medical devices such as thermometers, stethoscopes, elastic bandages, and non-electrical wheelchairs.

Currently, there is a provision for licence exemption to manufacture and import Class A medical devices (non-sterile products) for marketing in the country and conformance to quality management system for manufacturing of such medical devices is not included in the existing rules.

The matter was discussed in a meeting of the Drugs Technical Advisory Board (DTAB), the country’s top technical advisory body on drugs and medical devices, held last month.

The board, which is a part of the Central Drugs Standard Control Organization (CDSCO), opined that a relevant clause under Medical Devices Rules, 2017 specifies the provisions for exemption of licence to manufacture and import Class A (non-sterile and non-measuring) medical devices for marketing in the country.

“It is observed that the scope for conformance of quality management system for manufacturing of such medical devices is not included in the above said rules,” the minutes of the DTAB meeting, reviewed by Mint, showed.

Therefore, it has been decided that a provision of undertaking stating that the manufacturing facility has complied with the quality management system, as specified in the Medical Devices Rules, 2017, will be incorporated in the existing rules.

Class A medical device is a low-risk device that has minimal or no invasiveness. These include measuring as well as non-measuring devices such as thermometers, stethoscope, elastic bandages, and non-electrical wheelchairs.

Queries sent to the health ministry spokesperson remained unanswered till press time.

Maintaining quality 

Quality management system is important for manufacturing of medical devices to ensure that the product meets relevant standards. Essential principles are applicable for medical devices and the firm shall adhere with the Quality Management System of Fifth schedule of Medical Devices Rules, 2017.

“So that the safety and performance of medical devices will be ensured, hence the undertaking stating that the manufacturing facility has complied with the Quality Management System as prescribed in the Fifth Schedule of Medical Devices Rules, 2017 may be included in the said rules,” the minutes said.

In India, the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and Medical Devices Rule, 2017 ensure the safety, rights and well-being of the patients by regulating the drugs, medical device and cosmetics.

Currently, the market size of India’s medical devices sector is approximately $11 billion, which is expected to grow to $50 billion by 2030.

Earlier, Mint reported that the drug regulator is planning to frame the required qualification criteria for medical device testing officers and increase the number of medical device testing laboratories in the country to ensure that safety parameters are adhered to.

New Delhi: India’s apex drug regulator is collating information on adverse events due to medical devices to take timely action against manufacturers and ensure appropriate measures to mitigate risks to public health as the number of such incidents rise.

The Drugs Controller of General of India has issued a prescribed format to collect information on undesired effects from medical devices and in-vitro-medical devices (IVDs), ensuring that the identity of the ‘patient’ or the ‘complainant’ will not be made public. The proforma has to be filled with details such as description of the medical device with details including the brand name, manufacturer, importer or distributor. 

The DCGI has urged people to send the duly filled form to the Indian Pharmacopoeia Commission, a body under the health ministry, which runs the government’s Materiovigilance Programme of India (MvPI) platform to monitor adverse events associated with medical devices in India.

The regulatory action is aimed at stricter surveillance of side effects from medical devices, a market that is estimated to expand from $11 billion to $50 billion by 2030. Mint earlier reported about DCGI directing all medical device licence holders and manufacturers to report any adverse events related to life-saving medical equipment on the MvPI platform.

Safety concerns

Unlike drugs, absolute safety in medical devices—which are engineering, not chemical, products — may not be possible, according to said Rajiv Nath , forum coordinator, AiMeD, an umbrella body of medical device manufacturers in India.

There needs to be post marketing surveillance of serious adverse events that lead to death or injuries requiring surgical intervention, he said. What’s important that such events have to be reported to manufacturers to enable faster and direct redressal or the Indian Pharmacopoeia Commission or the regulator, using the feedback for systemic reviews, he said.

Medical devices are therapeutic, diagnostic, therapeutic & diagnostic, implantable, non-implantable, invasive & non-invasive, single-use device, reusable, sterile & non-sterile, and for personal use and homecare.

Nath said the reports on adverse events from such devices should not result in witch-hunting and a trust factor needs to be created to persecute the one reporting—whether it’s a health care provider or patient or the manufacturer itself.

Lack of clarity

DCGI, in its public notice, said the submission of a Medical Devices Adverse Event (MDAE) does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the adverse event and also “does not have any legal implication on the reporter”.

 “The patient/reporter’s identity is held in strict confidence and protected to the fullest extent. Programme staff is not expected to and will not disclose the patient/reporter’s identity in response to a request from the public,” it said.

Citing regulations in the US and the European Union, Nath also stressed on clarity for “what’s reportable and what’s not—what’s a serious adverse event and what’s a non-serious adverse event”.

“Currently there’s a lot of confusion and lack of clarity at various levels, so either there’s under-reporting or an extreme of over reporting at some organizations or not reporting to manufacturer but reporting to regulators,” he said. “Webinars and public education will help to bring clarity and build a trust factor.”