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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 invited 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).
  • The DDRS aims to create a unified digital ecosystem, acting as a single window, single sign-on, and unified portal for all regulatory activities, replacing existing portals.
  • The system will be developed using a platform design approach, open-source technology, and open standards.

Key Changes

  • CDSCO is seeking a Software Services Provider (SSP) for the development and maintenance of the Digital Drugs Regulatory System (DDRS) for an expected period of 8 to 10 years.
  • The DDRS will integrate the functions of CDSCO, IPC, and NIB into a single digital platform.
  • All existing portals will be discontinued once the DDRS is operational.
  • The last date for EOI submission is December 7th, 2023.
  • A pre-bid conference was held on November 29th, 2023, in hybrid mode.
  • The EOI document was issued on November 2nd, 2023.

Impact Analysis

Public Health

  • Action Item: No direct action required but will benefit from the overall improvements to the regulatory system.

Software Service Providers (SSPs)

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

CDSCO, IPC, and NIB

  • Action Item: CDSCO, IPC, and NIB should prepare for the integration of their respective systems into the DDRS platform and the eventual decommissioning of existing portals.

Pharmaceutical Industry

  • Action Item: Pharmaceutical companies should monitor the development and implementation of the DDRS platform and prepare to integrate their systems accordingly.

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, a unified digital ecosystem for drug regulation in India. Drugs and Cosmetics Act: The law 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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