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Date: 2018-11-27 Category: Not Applicable State: Union Government Country: India

Public Notice for proposal to include surgical gowns and drapes under the purview of section 3(b)(iv) of Drugs & Cosmetics Act, 1940

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • This public notice from the Directorate General of Health Services, Central Drugs Standard Control Organisation (CDSCO) proposes to include surgical gowns and drapes under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940, classifying them as Medical Devices.
  • The notice solicits comments and suggestions from all stakeholders regarding this proposal.

Key Changes

  • The key change being considered is the inclusion of surgical gowns and drapes as medical devices under the Drugs and Cosmetics Act, 1940.
  • Currently, 15 notified medical devices are regulated under the Drugs and Cosmetics Act, 1940, as per the Medical Devices Rules 2017.
  • Stakeholders are given 45 days from the date of the notice to submit their comments and suggestions.
  • The proposal originated from a meeting held on 05.10.2018, following decisions made by the Committee of Secretaries (Cos) on Technical Textiles.

Impact Analysis

Manufacturers of Surgical Gowns and Drapes

  • Action Items: Assess current manufacturing processes and quality control systems to identify gaps in compliance with medical device regulations. Prepare to submit necessary documentation and applications to CDSCO if the proposal is approved. Submit comments/suggestions to CDSCO within the stipulated 45-day period.

Hospitals and Healthcare Providers

  • Action Items: Evaluate current suppliers of surgical gowns and drapes. Monitor regulatory developments and prepare for potential price increases. Participate in the consultation process by providing feedback to CDSCO.

Patients

  • Action Items: No immediate action required. However, patients can stay informed about the regulatory changes and their potential impact on healthcare costs.

Central Drugs Standard Control Organisation (CDSCO)

  • Action Items: Prepare for an increase in workload related to the regulation of surgical gowns and drapes. Develop guidelines and standards for these products. Review stakeholder feedback and make informed decisions regarding the proposal.

Key Entities Referenced

Directorate General of Health Services (DGHS): The DGHS is a government organization under the Ministry of Health & Family Welfare responsible for public health matters. Central Drugs Standard Control Organisation (CDSCO): The CDSCO is the national regulatory authority for pharmaceuticals and medical devices in India. Drugs and Cosmetics Act, 1940: This act regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India. Medical Devices Rules, 2017: These rules, notified vide G.S.R. 78(E) dated 31.01.2017, govern the regulation of medical devices in India. Ministry of Health & Family Welfare: The government ministry responsible for health policy in India. Committee of Secretaries (Cos) on Technical Textiles: A committee that made decisions related to technical textiles, leading to the proposal to include surgical gowns and drapes as medical devices.
Official Source Record View Original Source →
See Full Document Text
No. 29/Misc/03/2018-DC (331) Government of India Directorate General of Health Services Central Drugs Standard Control Organisation (Medical Devices and Diagnostics Division) 2 7 N V 20 PUBLIC NOTICE Subject: Proposal to include surgical gowns and drapes under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 as Medical Devices-regarding. Ministry of Health & Family Welfare, Government of India has notified the Medical Devices Rules 2017 vide G.S.R. 78(E) dated 31.01.2017 under the provisions of the Drugs and Cosmetics Act, 1940. At present, 15 notified medical devices are regulated under the said act. In the meeting held on 05.10.2018 at Nirman Bhawan, New Delhi under the chairmanship of DGHS w.r.t. the implementation of the decisions taken by Committee of Secretaries (Cos) on Technical Textiles, it proposed that surgical gowns and drapes can be considered for notification under the said Act. In this connection , all the stakeholders are requested to forward their comments/suggestions within 45 days of issue of this notice through email at dci@nic.in and ddcimd-cdsco@nic or in hard copies to the % DCG(I), CDSCO, FDA Bhawan, Kotla Road, New Delhi-110002. ~ (Dr. S. Eswara Reddy) Drugs Controller General (India) Copy to: PPS to JS (R ), Ministry of Health & Family Welfare

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