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Date: 2018-06-11 Category: Not Applicable State: Union Government Country: India

Filing of applications of New Drugs, FDC and SND through ‘SUGAM’ Portal only– Reg

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) is mandating the online submission of applications for New Drugs, Fixed Dose Combinations (FDC), and Subsequent New Drugs (SND) through the SUGAM portal.
  • This notification announces the transition to a fully online application process for New Drugs, FDC, and SND, eliminating the acceptance of physical applications.

Key Changes

  • Effective June 22, 2018, CDSCO will no longer accept physical applications for New Drugs, FDC, and SND.
  • All applications for New Drugs, FDC, and SND must be filed mandatorily through the SUGAM portal (www.cdscoonline.gov.in).
  • The online module for New Drugs, FDC, and SND was launched on April 27, 2018.
  • The SUGAM portal was initially launched on November 14, 2015, to implement e-Governance in CDSCO operations.

Impact Analysis

Pharmaceutical Companies

  • Action Items: Proactively address any technical issues or challenges encountered during the online application process.

CDSCO

  • Action Items: Monitor the implementation of the online system and address any issues or concerns promptly.

Pharmaceutical Associations

  • Action Items: Advocate for policies and procedures that facilitate a smooth transition to the online application process.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. SUGAM Portal: An online portal (www.cdscoonline.gov.in) launched by CDSCO to implement e-Governance and facilitate online submission of applications. New Drugs: Newly developed pharmaceutical drugs. FDC: Fixed Dose Combinations, which are combinations of two or more active pharmaceutical ingredients in a single dosage form. SND: Subsequent New Drugs MoHFW: Ministry of Health & Family Welfare, Government of India
Official Source Record View Original Source →
See Full Document Text
CDSCO / IT / 2018 - (09) Government of India Ministry of Health & Family Welfare Directorate General of Health Services Central Drugs Standard Control Organization FDA Bhawan, New Delhi Dated: 1 JU ,(1 1 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)on14.11.2015. 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 on 27.04.2018 and the stakeholders are requested to avail this facility which is intended to further reduce time and thereby the transaction cost. It is now decided that from 22.06.2018, no physical application for New Drugs, FDC and SNDwill be accepted and all applications should be mandatorily filed on the SUGAM portal. 4!b . (Dr. S. Eswara Reddy) Drugs Controller General (India) To All Pharmaceutical Associations Copy to 1. All]DC(I), DDC(I), ADCCI) and DIs of New drug, FDCand SNDdivisions. 2. PPS to AS & DG, MoHFW 3. PPS to ]S(R), MoHFW 4. Guard File 5. Website

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