The Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with their footprint in manufacturing, and training in India, has said that the manufacturing companies preferring setting up of their units in countries like Vietnam and Malaysia could be based on a variety of factors including policies and tax regimes, which is beyond the control of drug regulatory authority in the country.

The Association was responding to the severe criticism raised by the Department-related Parliamentary Standing Committee on Health and Family Welfare in its recent report alleging that the delays and lack of transparency, among other issues in the current licensing process of the Central Drugs Standard Control Organisation (CDSCO) for the medical devices industry has resulted in various issues including units opting countries like Vietnam and Malaysia for their manufacturing operations.

"We believe that a more nuanced perspective is necessary when evaluating the functioning of CDSCO," said MTaI in a press statement.

"The preference of some companies for Vietnam and Malaysia as manufacturing destinations stems from a variety of factors beyond just CDSCO’s regulatory processes, such as policies, tax regimes, etc.," it added.

While the Parliamentary Standing Committee has perceptively identified the opportunities for improvement—such as ongoing training of CDSCO officials, the implementation of a fully digitized, time-bound, and trackable licensing system, minimizing frequent and delayed queries, lateral entry from the industry and the establishment of an industry advisory board to streamline operations— the Association added that certain aspects must also be considered in connection to the issues in the sector.

It also responded to the criticism of the Panel that centralisation of authority may result in creating a situation for arbitrary or discretionary decision making. The centralisation of intricate matters within CDSCO is largely due to the concentration of expertise at the organization, added the Association.

As reported earlier, the Panel recommended establishment of an independent Industry Advisory Board, comprising representatives from the industry.

MTaI said that the committee’s proposal to create a dedicated support team to assist applicants with queries—akin to a chaperone service—would be particularly beneficial, especially for startups, and should be taken up.

In its role as a regulator, CDSCO should continue to champion industry quality and ethical standards thus contributing to the sector’s enduring growth and global positioning, it added.

The Panel has recommended implementation of a  fully digitised, time-bound, and trackable licensing system which include clearly defined timelines for each stage of the licensing process, with automatic notifications to applicants; a standardised, publicly accessible database detailing all applications, queries, and approvals, allowing for real time tracking; and utilization of AI and automated systems to pre-screen applications for completeness, reducing the need for repeated queries and human intervention, especially for globally certified, non-invasive products.

It should also include a system that records all queries and the reason for the query along with the date of the query and the date of the reply.

Pharmabiz