Subsequent New Drug per se is not defined in the Drugs and Cosmetic Act 1940 and Rules 1945. However, it is an officially accepted term by the Indian Regulatory Authority, Central Drugs Standard Control Organization (CDSCO) in the context of approval of new drug products of same therapeutic class or of different therapeutic class for a new indication, new strength, new pharmaceutical dosage form or new route of administration. Hence, these drug products qualify for the definition of ‘New Drug’ of Drugs and Cosmetic Rules made there under and fall under subsequent new drug application. Subsequent term is used by the CDSCO in their work practice; however it is not included in the Drugs & Cosmetic Act 1940 and Rules 1945 and New Drugs and Clinical Trials Rules 2019.
CDSCO has categorized new drug in following category which can be called as Subsequent new drug (SND)
For Subsequent approval / permission for manufacture of already approved new drug, the list of data to be submitted along with the application (as per New Drugs and Clinical Trials Rules 2019 with indexing and page nos.) is listed below-
(1) Bio-availability / bio-equivalence protocol
(2) Sub-acute animal toxicity studies for intravenous infusions and injectables.
(3) Source of raw material (bulk drug substances) and stability study data.
(4) Chemical and Pharmaceutical Data
(B) Raw material (bulk drug substances)
(1) Manufacturing method
(2) Quality control parameters and/or analytical specification, stability report.
(3) Animal toxicity data
(C) Approval / Permission for fixed dose combination
(1) Therapeutic Justification (authentic literature in pre-reviewed journals/text books)
(2) Data on pharmacokinetics/pharmacodynamics combination
(3) Any other data generated by the applicant on the safety and efficacy of the combination.
(D) Subsequent Approval or approval for new indication – new dosage form
(1) Number and date of Approval/permission already granted.
(2) Therapeutic Justification for new claim / modified dosage form.
(3) Data generated on safety, efficacy and quality parameters.
(4) Animal pharmacological and toxicological data.
The above list is only an indicative list of documents required to be submitted, the regulatory authority may raise query which needs to be addressed by the applicant.