Licensing regime posing challenge to micro and small medical devices industry: SMTA
The Central government’s actions to mandate licensing of all medical devices is posing a challenge to the industry, especially the micro and small enterprises in the sector, says the Surgical Manufacturers and Traders Association (SMTA), the pan India organisation of manufacturers and traders of surgical equipment for healthcare services providers in the country.
The Association has recently approached the Supreme Court challenging an order of Delhi High Court, which refused to quash notification from the Union Government declaring all medical devices as drugs.
SMTA alleged that the government has not followed its own committee recommendation for creating specified manpower and space and laboratories to execute the regulations before proceeding to the mandatory registration phase on the roadmap.
The Central Drugs Standard Control Organisation (CDSCO) has mandated that all Class A and B medical devices, which are low and low to moderate risk devices respectively, have to undergo licensing regime from October 1, 2022 and the Class C and D medical devices which are of moderate high risk and high risk respectively, to complete transition to licensing regime from October 1, 2023.
The Association believes that the manpower is not even half of what is required and the government was to set up five to six labs in five years as per a Committee report in 2019, but not even one lab has been set up till date. Not even foundation stone for such a lab has been laid so far, it said.
“They have not only been notifying private labs and those labs too, can test only a handful of devices and that too, at an exorbitant cost that will drive the micro and small enterprises in medical devices out of business,” said Harpreet Singh, secretary of SMTA, when contacted.
Currently only 10 per cent of the applications have been processed and it takes three to six months to get a license after completing the documentation, he said.
There are several problems for each device segment to get the license and for import, a major factor is the high cost of license, which is around 30-150 times that of local license fee.
The Association filed a Special Leave Petition (SLP) with the Supreme Court in December and refiled the same early January and yet to receive a hearing date.
It may be noted that a Division Bench of the Delhi High Court last year dismissed two petitions filed by the Association, which sought an order to quash two notifications by the Union government including the one declaring all medical devices as drugs.
The Division Bench comprising Justice Rajiv Shakdher and Justice Tara Vitasta Ganju, in an order on September 1, 2023 said that there is no manifest arbitrariness or unreasonableness in the shift in policy of bringing all medical devices within the ambit of a regulatory regime.
The Association challenged a notification by the ministry of health and family welfare which brought four medical devices – nebuliser, blood pressure monitoring devices, digital thermometer and glucometer – under the ambit of drugs on December 3, 2018. In the second notification on February 11, 2020, which was also challenged, the Ministry spread the net to cover all medical devices.
The Court observed that the regulations show that the Central government has been given leeway to bring such devices within the ambit of the expression drugs after consultation with the DTAB and it has been taking such action from time to time in the past. The ministry of health and family welfare (MoHFW) has also granted sufficient time to manufacturers, importers, sellers and distributors to transition to a regulatory regime.
It observed that bringing all medical devices within the ambit of the expression ‘drug’ is a policy matter and the Ministry has the power to do so.
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