The proposed new drugs, cosmetics and medical devices bill should align with Medical Devices Rules (MDR) 2017, say experts.
They note that an inclusive framework of industry experts and representatives is required and will help in a holistic understanding of all issues and perspectives while framing the new act.
Speaking about the move by the Central Government, Chairman of the Medical Technology Association of India Pavan Choudary said medical devices are currently governed by the MDR 2017 which were meticulously developed by Central Drugs Standard Control Organisation (CDSCO) after extensive consultations with stakeholders.
“These rules also follow the World Health Organisation Regulatory Framework for Medical Devices (including IVDs) and adhere to the step-wise approach to regulating medical devices based on guidance documents developed by the Global Harmonization Task Force (GHTF) and the International Medical Device Regulators Forum (IMDRF),” Mr. Choudary said.
Mr. Choudary added that the harmonised regulations also enable Indian manufacturers to get greater acceptability of their products in global markets, furthering the Make in India objective of the government and keeping India aligned to global supply chains.
“Therefore, it is imperative that any new laws that are framed are in line with the MDR 2017,” he said.
Stating that it is imperative that industry is included in the initial discussion to ensure a smooth transition to the new Bill, Sanjay Bhutani, country manager, Bausch and Lomb explained that the industry has worked extensively with CDSCO to strengthen the regulatory framework and would continue to do so to further patients’ access to quality medical devices.
“Organised and broad legal architecture for regulating activities of medical institutions, pharmaceutical companies, laboratories, clinical trials and medical equipment manufacturers will specify roles, responsibility and accountability of players in medical industry on micro level,” said Sudish Sharma, executive partner, Lakshmikumaran and Sridharan Attorneys.
“This will prevent non-compliance of regulatory frameworks by the hospitals, pharmaceutical companies, laboratories and other medical institutions and lead to better corporate governance which will advance the health care sector in India,” he added.
Managing Director of German medical and pharmaceutical device major B Braun Medical (India) Indranil Mukherjee said that over the last decade, and especially with the pandemic, the regulatory authorities and policymakers have realised the urgent need for establishing a well-defined and comprehensive framework for medical devices, diagnostics and equipment.
The current Act and Rules though more specifically for pharmaceuticals were archaic despite amendments, Mr Mukherjee said, adding that this led to the formulation of the new MDR, 2017 which were notified in 2020.
“It’s heartening to see that the Medical Device Technical Advisory Group (MDTAG), constituted under the aegis of Ministry of Health is led by the DCGI under CDSCO and is working towards framing of new Drugs, Cosmetics and Medical Devices Act. An inclusive framework of industry experts and representatives in this expert network is required and will help in a holistic understanding of all issues and perspectives while framing the new act,” he said.
