The list of drugs that will switch from being prescription only to over-the-counter (OTC) is likely to be made public soon with the sub-committee tasked with drafting guidelines for sale of drugs over-the-counter in the country set to submit its recommendations soon.
According to people familiar with the matter, the list includes certain antipyretics (fever drugs), analgesics (painkillers), antiallergic, antacids, nasal sprays, cough syrups, lactulose solution, and antiseptics.
“The earlier draft had some 16 categories of such drugs and from what we hear most of them have been retained in the final list. Final touches to the report are still being given and it should be submitted soon,” said a senior official familiar with the matter, requesting anonymity.
The people cited above also said that the list of over-the-counter drugs is likely to be further divided into sub categories and could include those that can be sold in pharmacies only and those that may be sold in general or departmental stores across the country as is the practice in western countries.
The term “over-the-counter” drugs currently is not explicitly classified in the Drugs and Cosmetics Act 1945. Countries such as US and UK have well-defined guidelines on drugs that can be sold without prescription, and this is India’s first attempt to arrive at a definition.
According to an explanatory document of the Organisation of Pharmaceutical Producers of India (OPPI), prescription drugs are categorized into Schedules H, H1, and X of the Drugs Rules, 1945 (DR, 1945).
“Newly approved drugs by the CDSCO are usually required to be sold only on prescription as a part of the drug approval condition. Drugs listed in Schedule G do not require a prescription but must carry a cautionary label. On the other hand, over-the-counter (OTC) drugs are not explicitly classified and can include allopathic drugs not listed in these schedules (OPPI),” read the document.
A formal process will ensure consistency and clarity in transitioning prescription drugs to over-the-counter status.
According to experts, any new active ingredients or fixed-dose combinations that the drugs regulator currently approves automatically is issued with a caveat that it will be sold only on prescription.
Last year, the central drugs control organisation (CDSCO) formed an eight-member sub-committee to look into the requirements for moving certain category of drugs from prescription to OTC that includes formulating dedicated guidelines for sale of OTC drugs, labelling and advertising requirements . The sub-committee was formed based on the recommendations made by the Drugs Technical Advisory Board (DTAB).
A drugs consultative committee (DCC) meeting held in 2019 deliberated upon sale of OTC drugs in the country.
The DCC sub-committee under chairmanship of NK Ahooja, the then drugs controller, Haryana, was of the opinion that there was an urgent need to define OTC drugs and lay down specific provisions for the regulation of OTC drugs in the country ‘to promote self-care without compromising patient safety thereby reducing the treatment cost.