The Subsequent New Drug Division deals with applications for approval of an already approved new drug (within four years of its first approval) and drugs falling under the definition of a 'new drug' as per Rule 2(w)(iv) of the New Drugs and Clinical Trials Rules, 2019, i.e., drugs already approved by the Licensing Authority under Rule 21, which are proposed to be marketed with modified or new claims relating to indications, dosage, dosage form [including sustained-release dosage forms, Novel Drug Delivery Systems (NDDS), Extended Release (ER), Sustained Release (SR), Gastro-Retentive (GR), Prolonged Release (PR), Delayed Release (DR)] or 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’ like NDDS (Novel Drug Delivery Systems), ER (Extended Release), SR (Sustained Release), GR (Gastro-Retentive), PR (Prolonged Release), DR (Delayed Release).
• A drug already approved and proposed to be marketed with additional strength

• Processing, review and approval of applications received for Subsequent New Drug Approval (Any New 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), as per New Drugs and Clinical Trials Rules 2019 under Drugs and Cosmetic Act 1940.
• Processing, review and approval of applications received for approval of clinical trials (Phase-I/II/III/IV) and Active post marketing surveillance study as per New Drugs and Clinical Trials Rules 2019 under Drugs and Cosmetic Act 1940 and Rules made thereunder.
• Processing, review and approval of applications received for grant of permission to manufacture or import in first time in country of an Active Pharmaceutical Ingredients (APIs) whose New Drug finished formulation for import and marketing is already approved.
• Deliberation of proposals of Subsequent New Drug Application for New claims, indications, dosage, dosage form and route of administration in Subject Expert Committee/Technical/Apex committee.
• Review/ Handling of RTI/Parliament questions/PG etc.
• Conduct onsite evaluation at manufacturing site (Formulation and API) with respect to New Drug application for verification of CMC data submitted with application.
• Handling and processing of application for post approval changes, Amendment in clinical trial protocol and related update/notification etc.
• Handling and processing of applications for updation of Prescribing Information of drugs already approved by SND division, safety update in Prescribing Information based on PSUR, SAE, etc.

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