NEW DELHI : The Central Drugs Standard Control Organisation (CDSCO) has assured that the government will regulate all medical devices in a phase wise manner to ensure safety, quality and performance of medical devices. This will also include diagnostic kits manufactured and imported in the country.
Speaking at a conference organized by the Association of Indian Medical Device Industry (AiMeD), Dr. V.G Somani, Drugs Controller General of India and CDSCO, said, “Regulations need to encourage – Make in India and Made in India. To improve brand value, credibility and acceptance of Made in India Medical devices, all Medical Devices need to be regulated at one go and not item by item.”
Dr. Vinod Paul, Member, NITI Aayog emphasized on the need for integrated efforts to promote innovations and development of indigenous medical devices for having a vibrant domestic medical devices industry for the society.
He assured full support of NITI Aayog to ensure that the intent of domestic industry to provide access to safe, effective and quality medical devices to the patients are kept in all Government policies.
Mr. Rajiv Nath, Forum Coordinator AiMeD, pointed out the need to regulate all Medical Devices under a Patients’ Safety Medical Devices Law to protect patients and aid responsible manufacturing.
He said “We have been specifically seeking Trade Margin Caps on Devices notified as Drugs but from 1st point of sale in Supply Chain, which as per us is when 1st sale takes place and GST is applied 1st time e.g. when goods enter country. “This will maintain parity between Indian & overseas manufacturers,” he further added.
“Government needs to take policy decisions to give at least a level playing field, if not a strategic advantage to domestic manufacturers while safeguarding consumers,” he explained.
“The manufacturers have been confused with informally choosing of products and notifying them as drugs. They seek a predictable and comprehensive regulatory framework that allows for adequate transition. Only then will investments speed up as they get discouraged to be regulated as drugs,” said Mr. Gurmit Chugh, Jt. Coordinator (AiMeD).
The technical session on Comprehensive Regulation of Medical Devices highlighted the current state of the beleaguered Indian Medical Devices industry.
The panel discussion during the first technical session raised the issues of patient safety, quality concerns and compensation mechanism.
The second technical session dealt mainly with Excessive MRP: Stifling India’s Medical device growth Story.