CDSCO has clarified the approval process for combipack products containing lyophilized dry powder for injection/IV infusion and diluents. If the drug is CDSCO-approved for over four years and used with the same diluent as per prescribing info, SLA may grant permission without CDSCO involvement. However, using a different diluent or any product falling under the “new drug” definition per NDCT Rules, 2019, requires CDSCO approval before SLA licensing. Applicants must follow these guidelines accordingly.
The Central Drugs Standard Control Organization (CDSCO) has issued a regulatory clarification regarding the approval pathway for combipack products comprising lyophilized dry powder for injection or IV infusion and diluents like sterile water or sodium chloride injection.
The guidance outlines three scenarios:
- If the lyophilized dry powder has been approved by CDSCO for over four years and is used with a specific diluent as per its prescribing information, then the combipack is not considered a new drug.
- In such cases, the State Licensing Authority (SLA) may grant permission without CDSCO involvement.
- If the combipack uses a different diluent than the one specified in the approved product’s prescribing information, it qualifies as a new drug under Rule 2(1)(w) of the NDCT Rules, 2019, and requires CDSCO approval.
- Any other combipack that falls under the definition of a new drug per NDCT Rules, 2019, must obtain CDSCO permission before SLA licensing.
Applicants are advised to follow these pathways when seeking approval for combipack products.