Indian medical devices industry expressed concern over government notification to regulate all medical devices as drugs, on grounds that the move may impose additional costs of compliance and could be detrimental for medium and small enterprises engaged in low-risk medical devices manufacturing.
The government on February 11 announced that all medical devices will now be considered as drugs, bringing them under the purview of regulation by the Central Drugs and Standard Control Organization (CDSCO) from April 1.
The notification comes in force from April 1, will be implemented in a phased manner.
For Class A and Class B – the low risk and low moderate risk devices like certain types of catheters, disinfectants, needles, syringes, among others, the government has given 30 months for mandatory compliance. For devices under Class C and Class D used to treat orthopedic implants, surgical dressings, cardiac stents, among others, the government has given 42 months for compliance.
“While manufacturers hav no problem coming under the Risk Proportionate Medical Devices Rules 2017, we are highly uncomfortable to be regulated under the very rigid and prescriptive Drugs Act as any non conformity can be treated as a criminal offence by any drug Inspector at his discretion and we can be taken to a court,” said Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD).
AiMeD is the domestic industry lobby that claims to have around 300 members.
“We have been seeking an assurance from Ministry of Health & Family Welfare (MoH&FW) that this is a temporary measure until the NITI Aayog drafted bill to regulate devices separately from drugs becomes a separate law,” Nath added.
The Medical Technology Association of India (MTaI), that represents multinational device makers, however, welcomed the government’s move.
“We welcome the government’s decision to regulate all devices, which has also been a long standing ask of the industry. These regulations, that are a continuation of the Medical Devices Rules 2017, which were launched after meticulous deliberations for 2 years, are in line with the government’s vision to provide equitable access to quality healthcare. We are also happy that the Health Ministry is recruiting competent resources to cater to the additional workload that these new regulations will bring,” said Pavan Choudary, Chairman and Director General, MTaI.
Need regulatory certainty
But analysts, while welcoming the decision to regulate medical devices sought more certainty on whether this will be a stop gap arrangement, as the government policy think tank is working on having a separate regulatory body for medical devices. They say that medical devices and drugs are different, as the nature of risk and product life-cycle of drugs is very different from medical devices that typically have varied risk and lower product life cycles.
“Rather than stop gap arrangements which increase regulatory uncertainty and ambiguity, the medical devices sector is desperately in need of a well thought out and balanced legislation which needs to be within the ambit of the law and caters to requirements of the industry and patients. Anything other than this would impact this a multi-billion dollar industry and also carries with it the danger of limiting access to quality healthcare for Indians,” said Ashwin Sapra, Partner – Pharma, Cyril Amarchand Mangaldas.
The medical device industry in India is valued at $5.2 billion and is growing at 12-15 percent.
Public health groups welcome the notification to cover all the devices, but said that it will be a long wait before all its higher risk devices are regulated. The expressed skepticism about the Indian drug regulator ability to regulate devices of such wide order.
“While this is positive, consumer groups remain skeptical about how the CDSCO’s current ability to regulate devices under the wider scope. We are particularly wary of the CDSCOs competence, expertise and most importantly its commitment towards patient safety given its dismal track record.
“We urgently need comprehensive reforms to strengthen the regulatory mechanism in relation to patients’ safety. These may include guidelines for the approval of devices including clinical investigation requirements, oversight of marketing and promotion, putting in place a robust and functioning system of adverse event reporting accessible to the public, rules for voluntary and statutory recalls, and patient compensation scheme,” said Malini Aisola, Co-Convenor, All India Drugs Action Network (AIDAN).
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