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Date: 2018-04-27 Category: Not Applicable State: Union Government Country: India

Notice regarding SUGAM for New Drugs FDC and SND

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 launched a module on its online portal 'SUGAM' for New Drugs, Fixed Dose Combinations (FDC), and Subsequent New Drugs (SND).
  • This initiative is part of CDSCO's e-Governance implementation to reduce processing time and transaction costs.

Key Changes

  • A new module for New Drugs, FDC, and SND has been launched on the SUGAM portal (www.cdscoonline.gov.in).
  • Stakeholders are requested to use the online SUGAM portal for New Drugs, FDC and SND related transactions.
  • Stakeholders not yet registered on SUGAM are required to register to access the new module and other facilities. Registration instructions are available on the SUGAM homepage.
  • The launch of this module is intended to further reduce processing time and transaction costs for stakeholders.

Impact Analysis

Pharmaceutical Companies

  • Action Item: Update internal processes to align with the online submission requirements.

CDSCO

  • Action Item: Provide training and support to stakeholders on using the SUGAM portal.

Patients

  • Indirect Impact: Reduced drug development costs, which may translate to lower drug prices in the long term.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, responsible for regulating drugs and cosmetics in India. SUGAM: CDSCO's online portal (www.cdscoonline.gov.in) for e-Governance initiatives, providing various services related to drug regulation. New Drugs: New chemical or biological entities seeking approval for marketing in India. FDC: Fixed Dose Combinations, drugs containing two or more active pharmaceutical ingredients in a single dosage form. SND: Subsequent New Drugs, applications for new indications, dosage forms, or routes of administration for previously approved drugs.
Official Source Record View Original Source →
See Full Document Text
• CDSCD liT I 2018 - (09) Government of India Ministry of Health & Family Welfare Directorate General of Health Services Central Drugs Standard Control Organisation FDA Bhawan, New Delhi Dated: 27.04.18 Notice The Central Drugs Standard Control Organization (CDSCO) in pursuance to implementation of e-Governance has launched an online portal 'SUGAM' (www.cdscoonline.gov.in)onI4.11.20 15. Various services rendered by CDSCO are being rolled out in phases. In the latest phase, module for New Drugs, FDC and SND has been launched and all the stakeholders are requested to avail this facility which is intended to further reduce time and thereby the transaction cost. The stakeholders, who have not registered, first need to register on SUGAM to avail this facility. The process of registration is provided on the homepage of SUGAM. (fif.r. Reddy) Drugs Controller General (India) To All Pharmaceutical Associations Copy to 1. PS to DGHS 2. PS to JS (R) 3. All Zonal offices of CDSCO 4. Guard File

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