Regulatory Editor

The release of a regulatory framework specific to medical devices in India was generally well received, but the Association of Indian Medical Device Industry (Aimed) told Medical Device Daily that at least one provision of the final rule could damage the prospects for makers of high-risk devices manufactured by domestic firms.

India's Central Drugs Standard Control Organization (CDSCO) finalized its regulatory framework for medical devices and diagnostics, providing a much-needed break from the drug regulations the agency had previously used to govern medical devices. The CDSCO made several key changes to the draft version, including that device makers will have until Jan. 1, 2018, to obtain marketing licenses for their products rather than the initially announced deadline of 180 days after the final version was published. There were several ambiguities in the final version, however, including that of the frequency with which a device company must review its own quality system. (See Medical Device Daily, Feb. 3, 2016.)

Rajiv Nath, forum coordinator for Aimed, told Medical Device Daily that industry is "delighted with release of the latest medical devices regulations," as it offers a framework distinct from pharmaceutical regulation, and because the rule allows third-party certification for low-risk devices, such as wheelchairs and syringes.

Still, Nath said high-risk devices did not fare as well. Nath said high-risk devices are not eligible for third-party certification, and thus the regulation "may result in closure of some units of domestic manufacturing and drive jobs out of India as more manufacturers of high-risk/high-technology devices will switch to imports." He said that while the rule allows the government to "seek expert input for inspection[s]" of facilities making high-risk devices, those provision could prove to be "a double whammy to satisfy the inspector and the expert, as we have experienced in joint inspections" conducted jointly by state and federal inspectors.

Nath said device makers in India had consistently backed third-party certification programs for device manufacturing sites as an alternative to government inspections, but he also remarked that the Ministry of Health and Family Welfare has refused to recognize inspections conducted under the Indian Certification of Medical Devices Scheme (ICMED), a program engineered by the Quality Council of India.

Aimed members, Nath said, were also disappointed at the absence of a ban on re-used device imports, as well as the failure to stipulate that the device label declare the nation of origin. He said the association has been assured that these considerations are part of legislation that is under development. The failure of the rule to require inspections of overseas facilities making high-risk devices also drew fire, and Nath commented, "let's hope the government addresses this in the Medical Devices Bill and walks the entire mile" in its efforts to put manufacturers in India on the same regulatory footing as its overseas competitors.

Sundar Kumar Mainampati, director of business development for Emergo's office in India, gave Medical Device Daily some insight into some of the details of the final rule, including that the overarching ambition is to not only foster domestic manufacture for domestic use, but also to boost med-tech exports from India.

The final rule seemed ambiguous on the point of substantial equivalence and predicate devices, but Mainampati explained that there may be a reason that most of the text regarding substantial equivalence was located in a section dealing with clinical studies. He said those provisions deal with classes C and D devices – the two higher-risk categories in India's four-tier risk system – that lack certificates of export from the U.S., the European Union, Canada, Australia and Japan.

Mainampati said import licenses will be issued to such devices "only if they find the comparative analysis to prove substantial equivalence to the claimed predicate device(s) satisfactory in addition to the clinical investigation," which may be the reason CDSCO explained its substantial equivalence policy in the section on clinical studies (the final rule had declared that a device that is deemed investigational in India may nonetheless be eligible for a marketing license if that device has been on the market for at least two years in any one of the jurisdictions mentioned by Mainampati).

The rule offers no specific number for the limit to the number of devices manufactured as custom devices, but the agency will likely use the limit as described in the existing Medical Device Directives in the European Union. The final rule stipulates that notified bodies can inspect plants making class C and D devices only if that NB has two years' experience, and Mainampati said that while the rule is not explicit as to the jurisdiction where that NB has derived two years of experience, the most plausible interpretation is that the rule applies to experience in India.

Mainampati said it is not clear how frequently a company must undertake management reviews of the quality system, which is not spelled out specifically in the rule. He also remarked that the term "investigational medical device" applies to devices that are under investigation for a new intended use and devices that are under investigation for the first intended use.

No Comments