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Date: 2018-12-05 Category: Not Applicable State: Union Government Country: India

Public Notice for feedback on SUGAM Online Portal

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

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Executive Summary & Key Takeaways

What it means

  • The Central Drugs Standard Control Organisation (CDSCO) is seeking feedback from stakeholders on the SUGAM online portal to improve the system and enhance public confidence in the quality, safety, and efficacy of drugs marketed in India, as well as to satisfy the applicants.
  • The SUGAM portal has been in use for 2 years, and CDSCO is soliciting feedback to identify short, medium, and long-term measures for improvement.

Key Changes

  • CDSCO is requesting detailed feedback from all stakeholders regarding the SUGAM online system.
  • The feedback should be submitted within 2 weeks of the notice to feedback@cdsco.nic.in in both scanned PDF and Excel formats.
  • A detailed feedback form (Annex-I) is enclosed with the notice.
  • The SUGAM portal was launched in 2016 for Import & Registration and subsequently for Cosmetics, GCT, Biological and other divisions.
  • A separate Medical Device online portal has also been started in line with new Medical Device Rules-2017 for applications related to medical devices and IVDs.

Impact Analysis

Manufacturers

  • Suggested Action: Prioritize the review of the SUGAM portal and the preparation of comprehensive feedback. Engage relevant departments (regulatory affairs, IT, etc.) to ensure a thorough and well-considered response.

CDSCO

  • Suggested Action: Establish a clear process for receiving, analyzing, and acting upon the feedback received. Communicate updates and progress on SUGAM portal improvements to stakeholders.

General Public

  • Suggested Action: No direct action required, but public awareness of the SUGAM portal and its role in ensuring drug safety and quality can be beneficial.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. SUGAM Portal: Online portal developed by CDSCO for submission and processing of applications related to drugs, cosmetics, medical devices, and IVDs. Medical Device Rules, 2017: Regulatory framework governing the manufacture, import, sale, and distribution of medical devices and IVDs in India. Drugs and Cosmetics Manufacturing Associations: Industry associations representing manufacturers of drugs and cosmetics in India.
Official Source Record View Original Source →
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.­ · File No. X-11026/011/18-PRO Government of India Director General of Health Services Central Drugs Standard Control Organisation (PRO Division) 2 18 PUBLIC NOTICE Central Drugs Standard control Organisation (CDSCO), under e­ Governance has rolled out online services for filling of applications through "SUGAM" portal. The online system was launched in 2016 for Import & Registration and subsequently for Cosmetics, GCT, Biological and other divisions. A separate "Medical Device" online portal has also been started in line with new Medical Device Rules-2017 for applications related to medical devices and IVD's. Keeping in line with Govt of India's vision to promote Digital India and Ease of Doing Business, CDSCO thrives to strengthen this online SUGAM portal to enhance public confidence in quality, safety and efficacy of drugs marketed in India as well as to satisfy the applicants. As "SUGAM" online system (www.cdscoonline.gov.in) has completed 2 years and all stakeholders are well conversed, it would be appropriate to obtain feedback from the stakeholder to improve the system. A detailed feedback form is enclosed as Annex-I. All stakeholders are requested to provide their valuable feedback as per enclosed format with suggestions about short term, medium term and long term measures to be taken to improve the system. The feedback should be forwarded to feedback@cdsco.nic.in within 2 weeks of this notice in scanned pdf format as well as excel document format. 4d .,---- . (Dr. S. Eswara Reddy) Drugs Controller General (India) To, 1. All Drugs and Cosmetics Manufacturing Associations 2. CDSCO Website for public

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