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

• 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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