by Suman Gupta
Mumbai, 30th April 2019: 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, today said 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 make exports from India acceptable in global markets. A separate vertical in CDSCO, as proposed by DTAB, will curb the menace of unregulated garage manufacturing,” said Mr. Kaustav Banerjee, Director, MTaI.
The Drugs Technical Advisory Board (DTAB) 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 Mr. 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”.
About Medical Technology Association of India (MTaI) :Medical Technology Association of India (MTaI – pronounced as Em-tai) is a not-for-profit organization duly registered under sub-section (2) of section 7 of the Companies Act, 2013 and Rule 8 of the Companies (Incorporation) Rules, 2014.
MTaI is an association of research-based medical technology companies who have made remarkable investments in Manufacturing, R&D and Health Care Workers Training in India. MTaI represents a wide spectrum of the medical device industry with global experience in innovation and manufacturing. All the time stressing on the three hallmarks of healthcare – Quality, Consistency and Patient Safety, MTaI wants to be a responsible voice of the industry. The association is committed to improving access to affordable and quality healthcare for patients.
MTaI looks to partner with the Government of India in setting a roadmap for the growth of medical devices sector by bringing in even bigger investments in this sector, through ‘Make in India’ and through technology upgradation and dissemination in the provider space.