Parl Panel Demands Faster Turnaround on Creation of a Comprehensive National Standard for Medical Devices

The committee expressed concern for the absence of any standard or regulation for over 6,000 medical devices in the market.

The Department-related Parliamentary Standing Committee on Chemicals and Fertilizers, in its 50th report on the Promotion of the Medical Device Industry, urged the Department of Pharmaceuticals (DoP) and the Bureau of Indian Standards (BIS) to expedite the creation of National Standards for all types of medical devices.

The committee emphasizes the use of a 'National Mark' for medical devices conforming to BIS/IEC standards. The absence of national standards for domestically produced medical devices is seen as a hindrance to exports and limits opportunities for Indian manufacturers.

Reportedly, the committee has expressed concern about the absence of standards for over 6,000 medical devices in the market. While BIS has laid down standards for medical devices, it is noted that there is a growing variety of devices, and complying with WHO/American/European standards can limit exports.

The committee, which interacted with industry representatives in Goa and Kochi in May 2023, highlighted the challenges faced by domestic manufacturers due to the lack of national standards. It suggested that BIS's 5-year Standards National Action Plan (SNAP) for 2022-2027, which identifies sector-wise priority areas for standardization, needs acceleration.

National Mark & Ease of Doing Business

The committee recommended using a 'National Mark' for medical devices complying with BIS/IEC standards to ease procurement-related concerns and facilitate exports. It emphasized the importance of creating a Single Window System or Unified Application Portal for the medical device industry to enhance the ease of doing business.

The absence of such national standards forces manufacturers to follow international standards, limiting their export opportunities. The committee urged the DoP and BIS to expedite the process to safeguard the interests of domestic medical device manufacturers.

It recognized the challenges posed by different testing standards and procurement agencies, hindering manufacturers, even for low-risk class medical devices.

Regulatory Landscape & Single Window Clearance

The committee acknowledged the complex regulatory landscape for medical devices governed by various legislations, guidelines, and policies. Multiple regulators, including the Central Drugs Standard Control Organisation (CDSCO) and the National Pharmaceutical Pricing Authority, contribute to a challenging regulatory environment.

It was observed that the National Medical Devices Policy, 2023, aims to establish a Single Window Clearance System for the medical devices sector. The policy aligns with the National Single Window System (NSWS) for the sector, integrating all regulators in the medtech sector.

The Ministry of Health & Family Welfare is in the process of incorporating various departments and ministries into the Medical Device Portal.

The proposed system for licensing medical devices is expected to minimize duplication of efforts and compliance burdens. The committee expressed hope that the system would streamline the licensing process and reduce complexities for manufacturers.

The focus on creating a Single Window System aligns with industry demands for a simplified and more efficient regulatory process. Implementing these recommendations is crucial for fostering growth in the medical device industry, encouraging exports, and improving the ease of doing business in this sector.

The observations made by the committee underscore the challenges faced by manufacturers and the potential benefits of streamlining standards and regulations.

In another development, just days back, the Parliamentary Panel recommended the Department of Pharmaceuticals (DoP) to include medium and high-end medical devices essential for critical care into the National List of Essential Medicines (NLEM).

This recommendation was made in collaboration with the Ministry of Health and Family Welfare (MoHFW), focusing on public interest. The Department-related Parliamentary Standing Committee on Chemicals and Fertilizers, in its 50th report, focused on promoting medical devices.

The report explored the National Pharmaceutical Pricing Authority's (NPPA) plans. These plans aim to expand price regulations to cover other medical devices widely used in government hospitals.