Subsequent New Drugs

Subsequent new drug division deals with applications for approval of an already approved new drug (within 4 years) and A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration.

Subsequent new drug application can be made for the following cases:

  • Bulk Drug already approved in the country (approved within 4 years).
  • New drug (Formulation) already approved in the country (approved within 4 years).
  • A drug already approved and proposed to be marketed with new indication.
  • A drug already approved and proposed to be marketed as a ‘New Dosage Form/ New Route of Administration’.
  • A drug already approved and proposed to be marketed as a ‘Modified release dosage form’.
  • A drug already approved and proposed to be marketed with additional strength

Relevant Rules for Subsequent New Drug Application:

  • Rule 122-A -Application for permission to import new drug
  • Rule 122-B -Application for approval to manufacture new drug
  • Rule 122-DA-Mandatory requirement of permission from DCG (I) for conduct of clinical trial of new drug;
  • Rule 122 DAB -Provision for examination of serious adverse event (SAE) of injury and death and payment of compensation in clinical trial related cases. Provision for debarment of the applicant in case of failure to pay compensation;
  • Rule 122 DAC -Conditions of permission for conduct of clinical trial which includes mandatory requirement to follow Good Clinical Practice (GCP) guidelines, guidelines and requirements specified in Schedule Y of Drugs and Cosmetics Rules and other applicable regulations. Provision for debarment of applicant and investigator in case of non- compliance
  • Rule 122 E-Definition of new drug
  • Schedule Y-Detailed guidelines and requirements for conduct of clinical trial and approval of new drug
  • Good Clinical Practice Guidelines -issued by CDSCO, Directorate General of Health Services, Govt. of India
  • Processing of applications received for Subsequent New Drug Approval (Any drug approved less than 4 years,  Additional and /or new indication, Additional and /or new dosage form, additional strength, New or additional route of administration), review and approval as per Schedule Y, Rule 122 A, 122 B, 122 DA, 122 DAB, 122 DAC and 122 E (b) under Drugs & Cosmetics Rules 1945)

  • Processing of applications received for approval of clinical trials (Phase-I/II/III/IV) review and approval as per Schedule Y, Rule 122 A, 122 B, 122 DA, 122 DAB, 122 DAC and 122 E (b)under Drugs & Cosmetics Rules 1945)

  • Review of Academic Clinical Trials as GSR 313 E dated 16th March 2016.

  • Deliberation of proposals in Subject Expert Committee/Technical/Apex committee

  • Review/ Handling of RTI/Parliament questions

  • Review of notifications like Minor protocol amendments, Investigator's Brochure (IB), Informed Consent Form (ICD), Investigational Medicinal Product Dossier (IMPD), Development Safety Update Reports (DSUR), Change in Principal investigators/Co-investigators, Clinical Trial Agreements, Ethics committee approval of PI sites, Annual Status Reports, End of clinical trial notifications& Clinical Study Reports (CSR) etc.

  • Handling/Monitoring of safety of approved medicinal products for marketing in the country based on documents like PSURs, SAE reports, complaints received etc.

  • Handling and processing of documents submitted for updatation of Prescribing Information.

  • Handling and processing of Signal Review Panel (PvPI-NCC, IPC) recommendations for Regulatory Action.

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1 Notice Uploading of applications through Sugam Portal in accordance with New Drugs and Clinical Trials Rules 2019 2019-Apr-10 471 KB
2 Filing of applications of New Drugs, FDC and SND through ‘SUGAM’ Portal only– Reg 2018-Jun-11 359KB
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