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

The clarification on the approval process for lyophilized injection combi-packs follows multiple representations received by CDSCO seeking guidance on the regulatory pathway for such products. After reviewing the matter, CDSCO has laid out the applicable procedures for granting approvals.

The clarification follows multiple representations received by CDSCO seeking guidance on the regulatory pathway for such products. After reviewing the matter, CDSCO has laid out the applicable procedures for granting approvals.

As per the notice, if a lyophilized dry powder for injection or I.V. infusion has already been approved by CDSCO for more than four years and is being used with a specific diluent mentioned in its prescribing information, then a combi-pack containing the same diluent will not be treated as a new drug. In such cases, the State Licensing Authority (SLA) can issue manufacturing or marketing licences without additional approval from CDSCO.

On the other hand, if the approved injection or infusion is proposed to be combined with a diluent not specified in its prescribing information, it will be classified as a new drug under Rule 2(1)(w) of the New Drugs and Clinical Trials (NDCT) Rules, 2019. Applicants will then be required to obtain prior approval from CDSCO before the SLA can issue a licence.

The notice further emphasised that any other combi-pack formulations falling within the definition of a new drug under the NDCT Rules, 2019, will also require prior CDSCO approval before licensing by the SLA.