Home› India› Ministry of Health and Family Welfare› Public Notice for comments on proposed notification...
Date: 2018-06-25 Category: Not Applicable State: Union Government Country: India

Public Notice for comments on proposed notification

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

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

What it means

  • The Drugs Controller General (India) (DCG(I)) has issued a public notice regarding a proposal to include several medical devices under the purview of Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940, effectively defining them as drugs.
  • The proposal stems from recommendations made by the Drugs Technical Advisory Board (DTAB) during its 79th meeting held on May 16, 2018.
  • Stakeholders are invited to submit comments and suggestions on the proposal within 21 days of the notice's issuance.

Key Changes

  • The following medical devices are proposed to be specified under the definition of drug:
  • All implantable medical devices
  • CT scan equipment
  • MRI equipment
  • Defibrillators
  • Dialysis machine
  • PET equipment
  • X-Ray machine
  • Bone marrow cell separator
  • The notification will be published in the official Gazette of India and will come into force twelve months after its publication.

Impact Analysis

Manufacturers of Medical Devices

  • Action Items: Manufacturers should assess their current operations and quality control systems to ensure compliance with the Drugs and Cosmetics Act. They should also prepare for increased regulatory scrutiny and potential changes to their manufacturing and distribution processes. Engage with CDSCO to seek clarification and provide feedback during the consultation period.

Healthcare Providers

  • Action Items: Healthcare providers should review their procurement policies and vendor contracts to ensure compliance with the new regulations. They should also train staff on the proper handling, maintenance, and reporting of adverse events related to these devices.

Patients

  • Action Items: Patients should be informed about the regulatory changes and their rights regarding the safety and quality of medical devices. Patient advocacy groups should monitor the implementation of the regulations and provide feedback to the government.

Regulatory Bodies

  • Action Items: CDSCO should develop clear guidelines and procedures for the regulation of these medical devices. They should also invest in training and infrastructure to effectively monitor and enforce compliance.

Importers and Distributors

  • Action Items: Importers and distributors should obtain the necessary licenses and ensure that the medical devices they import and distribute comply with the regulatory standards. They should also establish systems for tracking and tracing devices and reporting adverse events.

Key Entities Referenced

Drugs and Cosmetics Act, 1940: The primary legislation governing the regulation of drugs and cosmetics in India. Section 3(b)(iv) defines drugs to include devices intended for internal or external use in the diagnosis, treatment, mitigation, or prevention of disease or disorder in human beings or animals. Drugs Technical Advisory Board (DTAB): A statutory body constituted by the Central Government to advise on technical matters related to drugs and cosmetics. Central Drugs Standard Control Organization (CDSCO): The national regulatory authority responsible for regulating drugs and medical devices in India. Drugs Controller General (India) (DCG(I)): Head of the CDSCO and responsible for approving licenses for specified categories of drugs.
Official Source Record View Original Source →
See Full Document Text
F No. 18-13/2018-DC (Part-1) Directorate General of Health Services Central Drugs Standard Control Organization FDA Bhawan, Kotla Road, New Delhi (O/o DCG (I)) 2 JUN 2018 Dated: ? PUBLIC NOTICE FOR COMMENTS ON PROPOSED NOTIFICATION Subject: Proposal to include all implantable medical devices and other high end equipment under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 as Medical Devices-regarding. In pursuance of sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), Drugs Technical Advisory Board (DTAB) in its 79th meeting held on 16.05.2018, deliberated and recommended for the proposal to specify the following medical devices under the definition of drug. 1) All implantable medical devices 2) CT scan equipment 3) MRI equipment 4) Defibrillators 5) Dialysis machine 6) PET equipment 7) X-Ray machine 8) Bone marrow cell separator This will be notified in the official Gazette of India and it will come into force after a period of twelve months from the date of its publication. All the stakeholders are requested to forward their comments/suggestions within 21 days of issue of this notice prior to finalization of the notification, through email at dci@nic.in and dccdtab@cdsco.nic.in or in hard copies to the O/o DCG(I), CDSCO, FDA Bhawan, Kotla Road, New Delhi-110002. (Dr. S. Eswara Reddy) Drugs Controller General (India)

Continue your research

Related Documents from Ministry of Health and Family Welfare