The CDSCO has issued a regulatory clarification for combi-pack products comprising lyophilized dry powder for injection or IV infusion and diluents like sterile water or sodium chloride. If the drug is approved for over four years and used with specified diluents, SLA can grant permission. Otherwise, CDSCO approval is mandatory under NDCT Rules, 2019.
The Central Drugs Standard Control Organization (CDSCO) has clarified the regulatory pathway for combi-pack products involving lyophilized dry powder for injection or IV infusion and diluents such as sterile water or sodium chloride injection.
If the lyophilized product has been approved by CDSCO for more than four years and is used with the same diluent as per its prescribing information, it is not considered a new drug, and the State Licensing Authority (SLA) may grant permission.
However, if the diluent differs from the approved one, the product falls under the definition of a new drug as per Rule 2(1)(w) of the NDCT Rules, 2019, and requires CDSCO approval.
All other cases that meet the new drug criteria must also seek CDSCO permission before SLA licensing. Applicants are advised to follow the outlined procedure for combi-pack product approvals.