The Central Drugs Standard Control Organization (CDSCO) has issued a clarification on the regulatory pathway for approving combipack products consisting of lyophilized dry powder for injection/I.V. infusion and its diluents. The guidance distinguishes between standard and altered combipack formulations, determining whether they require approval as a new drug. This notice was issued on September 29, 2025.
Standard Combipacks: State Licensing Authority (SLA) Approval
A combipack of an approved dry powder injection with its standard diluent is not considered a new drug and may be approved directly by the State Licensing Authority (SLA) if the following criteria are met:
- The lyophilized dry powder for injection/I.V. infusion has been approved by CDSCO for more than four years.
- It is being packaged with the same diluent (such as sterile water for injection or Sodium Chloride Injection) that is already listed in the prescribing information of the approved dry powder product.
Non-Standard Combipacks: CDSCO Approval Required
Any combipack that deviates from the approved or standard combination attracts the definition of a New Drug under the New Drugs and Clinical Trials (NDCT) Rules, 2019, thus requiring prior approval from CDSCO.
The following scenarios require new drug permission from CDSCO:
- Different Diluents: A combipack of an approved dry powder injection with a different diluent than what is specified in its original prescribing information.
- Other New Drugs: Any other drug product that falls under the definition of a New Drug as per the NDCT Rules, 2019.
Applicants are advised to adhere to these classifications and submit their applications either to the SLA or to CDSCO as specified for the grant of permission or license.