24-04-2025
Paracetamol, Ibuprofen May Soon Be Available At General Stores As India Reviews First List Of OTC Drugs
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A committee has proposed that India needs to develop legal provisions, eligibility for considering drug as OTC and special labelling similar to those for prescription medicines
A total of 27 prescription-only medicines, including levocetrizine, ibuprofen and paracetamol will soon be sold at medical and general stores as over-the-counter (OTC) drugs, News18 has learnt.
The list of 27 drugs includes the names of generic formulations and the strength of doses allowed to be sold without a prescription.
Currently, India lacks a comprehensive set of regulations governing the distribution, marketing, and consumption of OTC drugs. In May, drug regulator Central Drugs Standard Control Organisation (CDSCO) constituted a sub-committee to examine matters regarding the amendment of the Drugs Rules to incorporate necessary provisions for drugs to be declared as over-the-counter (OTC), in line with a recommendation of the Drugs Technical Advisory Board (DTAB) meeting. Now, the panel has submitted the report, and DTAB will deliberate to move on moving forward.
'The subcommittee has finely balanced and submitted the report containing almost 27 generic names of formulations for the top therapeutic segment. These formulations are top-selling and best in the safety profile of that category. For instance, Levocetirizine is best to treat allergies, ibuprofen is best for painkillers and paracetamol for anti-pyretic use," a senior official at the Ministry of Health and Family Welfare, privy to the development, told News18.
The sub-panel has also mentioned the strength of the medicines which should be available in the OTC category. 'It would be damaging if people end up popping painkiller ibuprofen in higher doses. Hence, the idea is to keep the moderate or mild dose available without prescription."
'Legal provisions to be enabled under Drugs Rules, 1945 along with the manner of submitting application, requirements for considering a drug as an OTC, Labelling requirements, etc and incorporation of a separate Schedule as enumerated under section 7 of the report," said the government document containing agenda for discussion on upcoming DTAB meeting.
The DTAB meeting is expected to convene in April. However, the final decision may take several meetings as the central government needs to design a full plan before it decides to shift prescription medicines into the OTC category.
The sub-committee was headed by Dr Anupam Prakash, Director and Professor of Medicine, Lady Hardinge Medical College, Delhi. The panel has other members including as Dr Umesh D Suranagi from Director General of Health Services (DGHS), Paediatrician Dr Ratan Kumar Gupta from Vardhman Mahavir Medical College & Safdarjung Hospital and Dr Bikash Medhi, Department of Pharmacology, Post Graduate Institute of Medical Education & Research (PGIMER).
