Booster dose: India inches closer to regulatory framework for OTC drugs

Business Standard

25-04-2025

India may soon have a streamlined regulatory framework around over-the-counter (OTC) drugs as the apex advisory board of drugs has approved the recommendations made by a special OTC sub-committee constituted by the drug regulator. Around 27-30 drugs, primarily analgesics, topical ointments for pain, cough-and-cold medications, etc., could be part of India's first comprehensive OTC drugs list, which would also enable pharma companies to advertise around these brands to create awareness. More drugs can be added to the list in future.
Sources in the Drugs Technical Advisory Board (DTAB) told Business Standard that on Thursday they had okayed the recommendations made by the eight-member OTC sub-committee in its report. 'Now, this would be taken up by the health ministry, and once its approval comes through, the framework and guidelines can be formalised. It is a move in the right direction as India lacks a clear and formal category of OTC and a comprehensive list of OTC drugs,' said one of the sources. He further elaborated that the OTC sub-committee had studied 126 drugs and then finalised around 30 of them that fit the OTC category after research and stakeholder consultation.
'This would make sure that for day-to-day ailments, patients could buy necessary medications. The duration for which these medicines can be used has been kept low to avoid misuse. We have suggested that instead of a five-day cap on dosage distribution, it could be kept a bit flexible for certain categories. For example, if you have a sprain, you may use a topical pain-management ointment for more than five days,' the source explained. He felt that it would raise demand for OTC medicines.
Dr Anupam Prakash, the OTC sub-committee chairman, said that the report is an attempt to bring in regulations for these drugs and create a mechanism for determining which medications would qualify as OTC drugs, incorporating suggestions from clinicians and other stakeholders. He said that around 27 drugs have been chosen to be dispensed as OTC.
Last year, the Central Drugs Standard Control Organisation (CDSCO) had formed the sub-committee to draw up a framework for OTC drugs, and also create a mechanism to determine which medicines can qualify as OTC.
The drugs of common use for day-to-day ailments will be available as OTC, and these medicines would have a good safety margin so as not to unduly compromise the health of the common man consuming the same.
'This includes medications that are part of the National List of Essential Medicines (NLEM) and are approved for distribution by the CDSCO,' Prakash added. Calling it the first attempt at bringing a separate rule for regularising OTC drugs since Independence, Prakash said that the sub-committee has recommended a proposal to accept applications for adding other drugs in the OTC list in the future.
'We have proposed that a protocol be enshrined for revision in the list if any stakeholder wants to apply, fulfilling certain guidelines,' he added.
Experts have cautioned against self-medication across categories, and, therefore, having a clear list of OTC medications will help reduce misuse.
Dr Tushar Tayal, consultant, internal medicine, at CK Birla Hospital, Gurugram, said that self-medication with drugs such as antibiotics, painkillers, and sedatives, commonly bought from chemists without a prescription, can lead to significant health risks and side effects.
'Antibiotics like amoxicillin, ciprofloxacin, and azithromycin are frequently used without medical guidance. Improper or incomplete use of antibiotics can lead to antibiotic resistance, making future infections harder to treat and spreading resistant bacteria in the community,' he added.
Tayal said painkillers, especially Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like ibuprofen, diclofenac, and naproxen are also commonly misused, which can irritate the stomach lining, leading to ulcers and bleeding, and in some cases cause kidney damage or raise the risk of heart attack and stroke.
Some analysts said that with a clear list of OTC drugs and an attempt to regulate this space, there can be some impact on volumes.
Nirali Shah, analyst with Ashika group, said that a clampdown on OTC drug sales could dent Indian Pharma Market (IPM) volume growth, especially in the acute therapy segment where self-medication is rampant in analgesics, antipyretics, and common cold medicines. 'IPM value may hold up in the short term due to price stickiness and a higher share of chronic therapies, but overall market growth could soften if consumer access is restricted or redirected,' she said.
Most analysts don't see much of an impact on volumes as such.
Sheetal Sapale, vice-president, commercial, Pharmarack, said that it is difficult to draw up the exact size of OTC medicines as there is no clear list. Typically, drugs like analgesics, antiseptics, contraceptives, some vitamins, laxatives, cough syrups, etc. are dispensed as OTC. Sapale does not think volumes would be impacted once OTC regulations come into place.