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Date: 2023-11-10 Category: Not Applicable State: Union Government Country: India

Corrigendum to Notice inviting Expression of Interest for development of Digital Drugs Regulatory System

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 Organization (CDSCO) has issued a notice inviting Expression of Interest (EoI) from Software Services Providers (SSPs) for the digital transformation of CDSCO, IPC (Indian Pharmacopoeia Commission), and NIB (National Institute of Biologicals) through the development and maintenance of a Digital Drugs Regulatory System (DDRS).

Key Changes

  • CDSCO is seeking a Software Services Provider (SSP) to develop and maintain a Digital Drugs Regulatory System (DDRS) for an expected period of 8 to 10 years.
  • The DDRS aims to be a unified digital ecosystem, replacing all existing portals with a single window, single sign-on, and unified portal for all regulatory activities.
  • The system will serve as India's DPI (Digital Public Infrastructure) for regulatory systems, ensuring quality medicines.
  • The system development should use a platform design approach, open-source technology stack, and open standards.
  • The last date for EOI submission is December 7th, 2023.
  • A pre-bid conference was held in hybrid mode on November 29th, 2023.
  • Queries regarding the EOI were to be submitted by November 22nd, 2023.

Impact Analysis

Software Services Providers (SSPs)

  • Action Item: Interested SSPs should review the EoI document, prepare their Expression of Interest with necessary documents, and submit it by the deadline.

CDSCO, IPC, and NIB

  • Action Item: Internal teams should prepare for the transition to the new DDRS system and decommissioning of existing portals.

Pharmaceutical Industry

  • Action Item: Monitor the development and implementation of DDRS and prepare for the transition to the new platform.

Patients and Public Health

  • Action Item: No immediate action required, but the public should benefit from a more robust and efficient drug regulatory system.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the National Drugs Regulatory Authority of the Government of India. IPC: Indian Pharmacopoeia Commission NIB: National Institute of Biologicals DDRS: Digital Drugs Regulatory System, the unified digital ecosystem to be developed. Drugs and Cosmetics Act: The legislation enforced by CDSCO.
Official Source Record View Original Source →
See Full Document Text
NOTICE INVITING EXPRESSION OF INTEREST FOR Selection of Software Services Provider (SSP) for Digital Transformation of Central Drugs Standard Control Organization, IPC & NIB (Digital Drugs Regulatory System) Corrigendum to EoI IT-13011(17)/1/2023-CDSCO Dated 10th November 2023 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION Ministry of Health and Family Welfare Government of India November 2023 FDA Bhawan, Kotla Road, New Delhi-110002Invitation of EoI for Selection of Software Services Provider (SSP) for Digital Transformation of Central Drugs Standard Control Organization, IPC & NIB (Digital Drugs Regulatory System) Central Drugs Standard Control Organization (CDSCO) is the National Drugs Regulatory Authority of the Government of India and is responsible for laying down the standards for Drugs, approval for Clinical Trials and New Drugs, control over the quality of imported Drugs, coordination of activities of State Drugs Control Organizations, enforcement of the Drugs and Cosmetics Act, granting and renewal of licenses for specified critical categories of Drugs such as blood and blood products, Vaccine and Sera, r-DNA products. The regulatory landscape is continuously evolving, striving for alignment with global standards, while ensuring affordability and accessibility for its vast population. India's with its vast population and diverse health challenges, ensuring the availability of safe and effective medicines is not just a commercial imperative but also a significant public health concern. To build a robust yet enabling digital regulatory ecosystem in India, CDSCO invites Expression of Interest from interested Software Services Provider for the Development and Maintenance of Digital Drugs Regulatory System (DDRS) of Central Drugs Standard Control Organization, IPC & NIB for an expected period of about 8 to 10 years. The aim is to develop DDRS as a unified digital ecosystem. Once operational, all existing portals will be discontinued, and DDRS will serve as a Single Window, Single Sign On, and Unified Portal for all regulatory activities. This platform is envisioned to serve as a new approach to regulatory system in the form of India’s DPI for regulatory systems, thereby ensuring quality medicines for India and the world. The system needs to be developed using a platform design approach, open-source technology stack, and open standards. For overview of the existing system, scope, pre-qualification criteria, other terms and conditions and suggested response formats, please refer to specific sections of this EoI document. Interested Service Providers who meet the pre-qualification criteria may furnish their Expression of Interest with all the necessary documents on or before 16:00 hours on Wednesday, 7th December 2023 at the email admn@cdsco.nic.in. CDSCO, New Delhi, IndiaSchedule of events & bid details S No Particular Details 1 Start date of issuance of EOI 2nd November 2023 document 2 Last date for Submission of Queries 22nd November 2023 (by email only) 3 Pre-Bid Conference (In hybrid mode) Date and Time: 29th November 2023 at 2:00 P.M. Meeting link: https://cdscofda.webex.com/cdsc ofda/j.php?MTID=m8f94101f113 eb8acfee63387705895d3 Address: Central Drugs Standard Control Organization, FDA Bhawan, Kotla Road, New Delhi-110002 4 Last date and time for EOI Submission 7th December 2023 CDSCO, New Delhi, India

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