|
The medical devices industry wants the government to de-list Schedule M-III from Schedule M stating that there is lot of ambiguity and confusion within the given requirements. They also insisted that to overcome and properly address the needs of the sector, the government should amend the existing Schedule M-III to comply with IS 15579/ISO 13485 quality management system requirements for regulatory purposes.
Even though law clearly specifies Schedule M for pharma, Schedule M II for cosmetic and Schedule M III for medical devices, industry contends that the use of word ‘and’ is leading to unnecessary debate and avoidable conflict between the regulators and the industry. The Association of Indian Medical Device Industry (AIMED) pointed out that this is because most of the inspectors incorrectly insist additional compliance to Schedule M as well which is an overkill for terminally sterilised medical devices.
Rajiv Nath, forum coordinator of AIMED stressed that the most ironic fact is that the industry has to follow the inadequately defined rules for all their products even when Schedule M-III is applicable only on three medical devices out of the 14 notified under the Drugs and Cosmetics Act (D&C Act). Existing Schedule M-III specifies the requirement for the manufacture of sterile disposable perfusion and blood collection sets; sterile disposable hypodermic syringes and sterile disposable hypodermic needles only.
“The government must understand that the requirement of the medical device industry is very different from that of pharmaceuticals. They cannot impose good manufacturing practices (GMP) as followed by the pharma sector on sterile pharma products on medical devices. We strongly feel that the requirement of GMP compliance for medical devices should be as per IS: 15579: (ISO 13485) standards only, as it meets the needs of the industry,” Nath informed.
Experts feel that the government should take requisite action at the earliest as the delay in doing so will further affect the industry, which is already facing the brunt of unfavoured regulatory environment within the country.
|