MTaI has requested CDSCO that a seperate new vertical be set-up so that ‘garage manufacturing’ can be kept in check according to industry regulations
Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies having a large footprint in manufacturing, R&D and healthcare training in India, has stated that creation of a separate vertical in Central Drugs Standard Control Organisation (CDSCO) exclusively to govern medical devices will check ‘garage manufacturing’.
“Capacity building is always a good initiative and has been long overdue. Regulators should build capacity and capability to prevent inferior products from entering the market which was happening through a large number of unregistered garage manufacturing in India, particularly in orthopedic industry. Global innovators are not just operating in India but in several developed countries across the globe, and they follow global regulation and are accountable. These globally accepted standards of quality are also complied by several domestic manufacturers, which makes exports from India acceptable in global markets. A separate vertical in CDSCO, as proposed by the Drug Testing Advisory Board (DTAB), will curb the menace of unregulated garage manufacturing,” said Kaustav Banerjee, Director, MTaI.
The Drugs Technical Advisory Board has proposed creation of a vertical in CDSCO specifically for medical devices to enable the latter regulate all medical devices sold in the country in phases. As per the proposal, CDSCO will hire 754 officers for the vertical.
MTaI Chairman and Director General Pavan Choudary said: “The proposal of DTAB to have a separate vertical in terms of manpower and infrastructure in CDSCO for medical devices is welcome. It is reflective of the understanding that new categories of skill-set are required to regulate this sector. The fact that this vertical will be under the CDSCO, sensitively uses the umbrella of the body which has the maximum expertise and experience in governing the medical device universe. As new devices are coming under regulation in line with government’s objective of ensuring patient safety, it will be great if the recruitment begins soon so that this additional workload is efficiently handled.”