CDSCO clarifies regulatory pathway for combi-pack approvals of Lyophilized injections & diluents

The Central Drugs Standard Control Organization (CDSCO) has issued a clarification concerning the regulatory approval process for combi-pack products comprising lyophilized dry powder for injection or intravenous (I.V.) infusion, along with diluents used for reconstitution, such as Sterile Water for Injection or Sodium Chloride Injection.

The organization had received several representations seeking guidance on the appropriate regulatory pathway for such combinations. After a detailed examination of the matter, CDSCO has outlined the applicable procedure for granting permission for these combi-pack products.

According to the clarification, if the lyophilized dry powder for injection or I.V. infusion has been approved by CDSCO for more than four years and is already being used with a specific diluent as per its prescribing information, then a combi-pack that includes the same approved diluent will not be considered a new drug. In such cases, the State Licensing Authority (SLA) may grant the manufacturing or marketing license without requiring additional approval from CDSCO.

However, the notice also mentioned, if the approved injection or infusion is proposed to be combined with a different diluent not originally specified in its prescribing information, such a product will be treated as a new drug under Rule 2(1)(w) of the New Drugs and Clinical Trials (NDCT) Rules, 2019. In these instances, the applicant must obtain prior approval from CDSCO before a license can be issued by the SLA.

Furthermore, any other combi-pack formulations that fall within the definition of a new drug under the NDCT Rules, 2019, will similarly require new drug permission from CDSCO before a SLA can be granted.