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Drug regulator forms panel to evaluate OTC candidates

May 13,2024

New Delhi: India’s drug regulator has formed an expert panel to evaluate several currently prescription drugs that can be sold over the counter (OTC) after various pharmaceutical companies lobbied the regulator to make their drugs an OTC product, people in the know told ET.

The sub-committee, which includes various doctors from the country’s top government hospitals, representatives from Indian Council of Medical Research (ICMR), drug controllers from various states, will develop a mechanism for the drugs to be sold OTC, considering globally prevalent regulations and practices.

The sub-committee formed last week has been asked to submit the report within three months.

India’s drug regulator had earlier received representation from various companies that urged certain formulations be allowed to be sold as OTC.

These formulations include Diclofenac patches which helps reduce and alleviate pain caused due to osteoarthritis, sprain etc. Transdermal diclofenac, which is used to treat short-term pain due to minor strains, sprains, and bruises in adults and children 6 years of age and older. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).

Representations were also made for acetylsalicylic acid effervescent 500 tablets used for the treatment of pain and reduction of fever and has anti-inflammatory properties. Besides, Dextromethorphan used to temporarily relieve cough were also candidates for OTC sales.

Source: Healthworld

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