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The Tamil Nadu Pharmaceutical Traders Association has recently urged the Drugs Technical Advisory Board (DTAB) of the Union Health Ministry not to support the proposal for allowing sale of over-the-counter (OTC) medicines in non-pharmaceutical shops like super markets and general stores without prescription. A proposal is now under the active consideration of the DTAB that a few selected OTC drugs can be permitted to sell through super markets and general retail shops without prescription. Even though a separate category for OTC drugs is common in many countries, India at present does not have an OTC policy so that drugs for common ailments can be sold through general stores without prescription. For the last several years, the Union Health Ministry has been in the process of creating an exclusive Schedule for OTC drugs. The Ministry has been forming committee after committee to recommend a list of drugs which can be considered for marketing as OTC drugs. In 2018, the Ministry formed a sub-committee comprising of five state drug controllers to recommend the list of drugs which should be considered for marketing as OTC drugs along with conditions to be followed. Instead of implementing its recommendations, the Ministry in 2019 formed another sub-committee under the chairmanship of then Haryana state drugs controller N.K. Ahooja. The Ministry did not accept its recommendations too. Instead, in 2022, the Ministry issued a draft amendment in the Schedule K of the Drugs Rules, 1945. But, instead of issuing the final notification, the Ministry in early 2024 formed another sub-committee to go into the issue in detail. This sub-committee has now proposed that legal provisions should be enabled under Drugs Rules, 1945 along with manner of submitting application, prescribe the licensing requirements for the sale of OTC drugs which does not require the supervision of registered pharmacist, requirements for considering a drug as an OTC, labelling requirements, etc. and incorporation of a separate Schedule.
Quite understandably, the TN traders’ body has raised concern over the proposal now under the consideration of the DTAB. The traders are concerned over the fact that such a move can pose serious risks to public health as easy and unsupervised availability of medications such as painkillers, antipyretics, cough syrups, and certain scheduled and non-scheduled drugs can result in misuse, overuse, underuse, dependency and dangerous self-medication practices. Certainly, there is some merit in the arguments of the traders as at stake is nothing other than public health. The government should move with caution as a considerable section of patients in the country still requires to be educated on the use and side-effects of OTC drugs. Though the OTC drugs are generally those that are effective for minor ailments and extremely safe to use, there should be some mechanism in place to prevent the indiscriminate sale of these drugs. For this purpose, the point-of-sale should be clearly defined and the labelling norms will have to be adequately revised to make it easier for consumers to read and understand its contents. Then there is the issue of similar sounding brand names with different drugs, which should also be addressed by the government. It is common knowledge that minor ailments can, up to an extent, be treated without consulting a doctor if the country has an OTC drug policy. In fact, a robust OTC policy with clear guidelines for promotion and sale of OTC drugs will, in the long run, prove to be a win-win situation for both the industry as well as the patients. While it will help the pharma industry grow, for the patients their dependence on medical practitioners for minor ailments will drastically come down, thus saving a substantial amount of money and time.
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