Not All Combipacks Are New Drugs: CDSCO Defines Approval Rules for Lyophilized Injections
Written By : Susmita Roy
Published On 2025-10-01 11:20 GMT | Update On 2025-10-01 11:20 GMT
Advertisement
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.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.