The efforts of government think tank Niti Aayog to improve transparency and quality within the medical sector includes a Rs 1 crore fine for firms who import or manufacture unsafe medical devices.
Per draft legislation, the Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019, a National Register of Medical Devices would be devised wherein each device is imprinted with a unique identification number. For the purposes of quality control, a medical regulator would be formulated outside of the Central Drugs Standards and Control Organisation (CDSCO) which presently regulates some medical devices in India that are classified as drugs.
For those who sustain harm as a result of unsafe medical devices, the Bill also prescribes provisions for availing compensation. Other breaches penalised by the law include fraud, improper conduct during clinical trials, and leaking of private information pertaining to the patient.
Ensuring quality of the medical devices sector has been a focus of Niti Aayog in recent weeks, with recently announced plans to bring all medical devices under the purview of the central government. Instituting such penalties for manufacturers and distributors of unsafe medical devices through legislation is one step towards this goal.
Niti Aayog has also suggested that a central body be devised similar to the United States Food and Drug Administration (USFDA) to oversee regulation of medicines, medical devices, and foodstuffs throughout the country. The proposal has reportedly been granted with enthusiasm by the Prime Minister’s Office.
“Undoubtedly a new regulatory agency with specialised expertise in medical devices would be a welcome move,” said Malini Aisola of the All India Drug Action Network in response to Niti Aayog’s proposal, quoted in The Times of India. “The [CDSCO] lacks the requisite technical competence and has not been up to the mark in regulating the limited devices currently notified as drugs.”
