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Centre wants to review safety, efficacy norms for 13 'very old' drugs

February 28, 2025

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Mint Hyderabad

The government body charged with setting quality standards for drugs has launched a review of the safety and efficacy norms for 13 commonly used but "very old" drugs and asked pharmaceutical companies to submit their manufacturing licence approval letters.

- Priyanka Sharma

The Indian Pharmacopoeia Commission (IPC), part of the Drugs Controller General of India, said the letter should be issued by either the Central Drugs Standard Control Organisation (CDSCO) or a state licensing authority.

The Commission is set to incorporate new standards into Indian Pharmacopoeia—the handbook that lists efficacy and safety standards for all drugs produced in the country that companies have to follow.

The 13 drugs include Clindamycin Lotion used for skin allergies, Nitrofurantoin Oral Suspension used to treat infections of the bladder and Dexamethasone, used to treat inflammation of the skin, joints, lungs and other organs. The details have to be furnished by Friday, 28 February.

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