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A robust regulatory framework for over-the-counter (OTC) medicines has been long overdue in the country. It is almost nine years since the Union Health Ministry constituted a subcommittee on the issue. The Ministry in 2017 constituted a subcommittee under the chairmanship of Dr. Ravi Shankar, Drugs Controller, Andhra Pradesh to examine drugs marketed in India vis-à-vis conditions for sale stipulated under various schedules, i.e. Schedules H, H1, G, X, and K, and recommend the list of drugs that may be considered for marketing as OTC along with conditions to be followed. The Shankar Committee submitted its report in 2019 containing recommendation on definition, characteristics, classification of OTC drugs, preparation of initial list of OTC drugs, regulation of Rx drug to OTC drug switch process, regulation of new OTC drug approval, manufacturing, labelling, distribution and sale of OTC drugs, their advertisement and pricing, etc. In February 2019, the ministry set up another subcommittee under the chairmanship of NK Ahooja, Drugs Controller, Haryana to look into the report submitted by the Shankar Committee and submit its recommendations for further consideration. The Ahooja Committee stressed on the need to define OTC drugs in the D&C Rules and laid down specific provisions for the regulation of OTC drugs. It recommended promotion of self-care without compromising patient safety thereby reducing treatment costs. Of course, the subcommittee had made some sweeping recommendations to the government on OTC drugs. It recommended to the government to classify the OTC drugs into two separate categories - one for those drugs that can be sold in retail outlets and the second category for those drugs that can be sold under the supervision of a registered pharmacist.
Of course, creation of an exclusive schedule of OTC drugs will prove to be beneficial as it will improve accessibility and affordability of healthcare in the country, especially to the poor patients and those who reside in the remote areas. In India, a large percentage of people are still not in a position to bear the cost of doctor's fees. Once schedule of OTC drugs comes out, patients will have no botheration of visiting doctors for treating common ailments. A qualified pharmacist can then dispense OTC drugs for common ailments such as anti-allergies, antipyretic (for fever), antiemetic (for vomiting and nausea), muscle relaxants, decongestants (for cough and cold), anti-inflammatory, antacids, etc. But, the government should move with caution as a considerable section of patients in the country still require 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 labeling norms will have to be adequately revised to make it easier for consumers to read and understand its contents. No doubt, there is a dire need to create a robust regulatory framework for OTC medicines in the country by incorporating a separate schedule in the Drugs and Cosmetics Act. Obviously, a robust OTC policy with clear guidelines for promotion and sale of OTC drugs will 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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