Drug Regulation
Latest news, explainers and analysis on Drug Regulation. Tracking 4 stories on Arth Vani.
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Latest on Drug Regulation
Drug Regulator Seeks Answers on Unapproved Medicines in National Formulary of India
India's drug regulator, DCGI, has sought an explanation from the Indian Pharmacopoeia Commission (IPC) regarding the inclusion of several unapproved drugs in the latest edition of the National Formulary of India (NFI 2026). This discrepancy raises concerns about drug safety and official guidance for medical professionals, while stakeholders also note the unavailability of its online version.
CDSCO, Home Ministry Boost Efforts to Stop Illegal Pharma Drug Diversion
India's Central Drugs Standard Control Organisation (CDSCO) is stepping up measures to prevent the illegal diversion of pharmaceutical drugs, particularly those containing narcotic substances. This significant move follows a directive from the National Committee for Coordination on Drug Trafficking, with Union Home Minister Amit Shah emphasizing a united strategy to combat evolving drug trafficking challenges. The Drugs Consultative Committee will review existing regulations to recommend critical improvements.
Govt Bans Cough & Cold Medicine Combo for Children Under 4 Years
The Indian government has prohibited the use of fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age. Manufacturers are now mandated to display clear warnings on all product packaging.
Indian Pharma Alliance Urges Regularisation for Decade-Old Unapproved Drugs
The Indian Pharmaceutical Alliance (IPA) is pushing drug authorities to regularise numerous 'legacy drugs' that have been sold in the market for over a decade without central regulatory approval. This move aims to close long-standing regulatory gaps affecting common medicines like sodium valproate and carbamazepine tablets.
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