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Increase in the medications under the CDSCO's radar

Content Editor: Dr.KH Reddy

February 21, 2024 at 1:30:00 PM

FDC, Drug regulation, Clinical Research, Drug control

Content Editor: Dr.KH Reddy

  • In its public notice issued in January, the CDSCO expert committee headed by Dr.M S Bhatia asked the stakeholders to generate data on the following three FDCs within 1 year:

  1. Paracetamol 500 mg + phenylephrine hydrochloride 10 mg + Caffeine anhydrous 32 mg

  2. Paracetamol 500 mg +phenylephrine hydrochloride 5 mg +caffeine anhydrous 15 mg, chlorpheniramine maleate 2mg

  3. Paracetamol 250mg + Propyphenazone 150 mg + Caffeine anhydrous 30 mg

  • The committee asked for data regarding the safety and efficacy of these FDCs from Phase IV clinical trials.

  • They also emphasized that these FDCs can only be sold to those with a prescription from a registered medical practitioner.

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