Not All Combipacks Are New Drugs: CDSCO Defines Approval Rules for Lyophilized Injections
New Delhi: The Central Drugs Standard Control Organization (CDSCO) has issued a notice clarifying the regulatory pathway for approval of combipack products of lyophilized dry powder for injection/ I.V. infusion and diluents for reconstitution such as sterile water for injection or sodium chloride injection.
The notice states that if the lyophilized dry powder for injection (I.V. infusion) is already approved by CDSCO for more than 4 years and uses the same diluent as per approved prescribing information, the combipack is not considered a new drug and State Licensing Authorities can grant permission.
For combipacks of approved dry powder for injection/ I.V. infusion with different diluents attracts the definition ot New drugs as per Rule 2(1)(w) and permission from CDSCO is required as per the NDCT Rules, 2019.
This came after representations has been received seeking clarification for regulatory pathway for the approval ol Combi-pack product of Lyophilized dry powder for injection/ I.V. infusion and diluents for reconstitution such as Sterile water for injection lsodium Chloride Injection.
The matter was examined and it was decided to follow the following pathway for the grant of permission for Combi-pack products:
1. If the Lyophilized dry powder for injection/ I.V. infusion is approved by CDSCO for more than 04 years and it is being used with particular diluents as per prescribing information of said approved Lyophilized dry powder for injection/ I.V. infusion, then combi pack of such approved dry powder for injection/ I.V. infusion with same diluents is not considered as new drug and State Licensing Authority (SLA) may grant the permission.
2. Combi pack of approved dry powder for injection/ I.V. infusion with different diluents attracts the definition ot New drugs as per Rule 2(1)(w) and permission from CDSCO is required as per lhe NDCT Rules 2019.
3. The drugs apart from (1) as mentioned above and which falls under definition of New Drugs as per NDCT Rules, 2019 require new clrug permission from CDSCO before grant of license by SLA.
In accordance with the above, the Directorate General of Health Services directed that the applicants shall submit their application as mentioned above for grant of permission/License for Combi-pack products.
To view the official notice, click the link below:
