Govt doctors to provide suggestion on over-the-counter drug sale in 3 months
NEW DELHI : In order to come up with more clarity about provisions for drugs to be declared as over-the-counter (OTC), the centre has set a three months timeframe for an all doctor's expert committee to provide with suggestion, according to officials aware of the matter. The expert committee consists of eight members including doctors from LHMC, Safdarjung Hospital, PGIMER, SMS Medical College to examine matters regarding amendment of the Drugs Rules in line with recommendations from the Drugs Technical Advisory Board (DTAB).
According to the apex drug regulatory body, all experts appointed to the subcommittee needs to adhere to the concept of confidentiality and cannot have any conflict of interest. The Directorate General of Health Services (DGHS) stated that various clinician committees have been formed on the OTC issue, and these committees will provide advice to the sub-committee for its consideration.
The Central Drugs Standard Control Organisation (CDSCO) has also suggested that the sub-committee may co-opt subject experts as and when required. According to the Drugs Controller General of India (DCGI), the development follows representation from some companies for certain drugs formulations to be sold OTC, including diclofenac diethylamine transdermal patch 200 mg, acetylsalicylic acid effervescent 500 tablets, dextromethorphan HBr lozenges 50 mg and mometasone furoate nasal spray 50 mcg, among others.
Also Read: India plans central online drugs registry to avoid medication errors Additionally, the CDSCO has recommended that the sub-committee can co-opt for experts on subject matters as needed. According to the DCGI, the development is in response to requests from a few companies for the OTC sale of specific drug
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