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CDSCO issues clarification on approval of combi-packs of certain injections
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Gireesh Babu, New Delhi
October 01 , 2025
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The Central drug regulator has clarified that a combi-pack of lyophilised dry powder for injection or intravenous (IV) infusion approved by it for more than four years ago and used with particular diluents as per the prescribing information is not a new drug, while the drugs apart from this will fall under the definition of new drugs.
The clarification follows representations from the stakeholders seeking clarity on the regulatory pathway for approval of combi-product of lyophilised dry powder for injection or IV infusion and diluents for reconstitution such as sterile water for injection and sodium chloride injection.
Dr Rajeev Sing Raghuvanshi, Drugs Controller General (India) (DCGI), said that the Central Drugs Standard Control Organisation (CDSCO) has examined the matter and prescribed a pathway for grant of permission for combi-pack products.
"If the lyophilised dry powder for injection/IV 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 lyophilised dry powder for injection/IV infusion, then combi pack of such approved dry powder of injection/IV Infusion with the same diluents is not considered as a new drug and State Licensing Authority (SLA) may grant the permission," said the drug regulator.
However, combi pack of approved dry powder for injection or IV infusion with different diluents would be under the definition of new drugs as per Rule 2(1)(w) and permission from CDSCO is required as per the New Drugs and Clinical Trials (NDCT) Rules, 2019.
The drugs apart from the ones allowed to be approved by the SLA through the latest clarification, and which falls under the definition of new drugs as per the NDCT Rules, require new drug permission from CDSCO before grant of license by the SLA, it added.
"Accordingly, the applicants shall submit their applications as mentioned above for grant of permission/license for combi-pack products," said Raghuvanshi in a communication to all State and Union Territory drug controllers, CDSCO zonal and sub-zonal offices and all other stakeholders.
The Central drug regulator, earlier in a guidance document for post approval changes in biological products has advised that for changes such as addition of a dosage form or change in the formulation (e.g. lyophilized powder to liquid, change in the amount of excipient, new diluent for lyophilized product), and addition of new strength or concentration, the marketing authorisation holder should submit application in certain forms for manufacturing or import of such new drugs for sale or distribution.
The CDSCO has in the past also issued clarifications in various instances where the stakeholders seek clarity on defined pathways for approval of certain drugs.
Recently, it has clarified that the cocrystals of already approved active substances are considered as new drugs and for approval of such drugs, the company should submit an application as per the requirement prescribed in the NDCT Rules, 2019.The clarification was in the wake of representation from the stakeholders seeking a clarity on the regulatory pathway for the approval of cocrystals.
"If the solid state structure and properties as cocrystals are fulfilled by diffraction methods not limited to Single crystal XRD, powder XRD, electron diffraction, total scattering pair distribution function analysis as applicable, and spectroscopic analysis of the solid state cocrystals not limited to IR, Raman, near IR, NMR, then it will be defined as a pharmaceutical cocrystal/supramolecular complex drug, else the combination will be treated as FDC/mixture of APIs," said the drug regulator.
Cocrystals of already approved active substances may require validation of manufacturing process, stability studies, additional clinical and non-clinical studies, bioavailability/bioequivalence studies, to demonstrate its safety and efficacy.
Considering that the cocrystal of an already approved active substance is considered as a new drug, the applications for such new drug may be processed in accordance with this.
"Cocrystal of already approved active substance will be processed as a new active substance and requirements will be same as for any new active substance as prescribed in New Drugs and Clinical Trials Rules, 2019," clarified the regulator.
"Accordingly, applicant should submit application as per the requirement prescribed in the New Drugs and Clinical Trials Rules, 2019," it added.
Cocrystals are crystalline materials composed of two or more different molecules, typically active pharmaceutical ingredient (API) and cocrystal formers (coformers), in the same crystal lattice in a defined stoichiometric ratio associated by nonionic and noncovalent bonds.
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