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The country’s pharmaceutical market has long been waiting for a robust regulatory framework for over-the-counter (OTC) medicines. Such a framework would have enabled and facilitated the creation of a positive list of OTC medicines and ensured their widespread availability across the country, including in the remote areas. Even though a separate category for OTC drugs is common in many countries, including the developed countries like the US and the European Union, at present India does not have an OTC policy. In India, allopathic drugs which are even safe to be dispensed without prescription mostly fall under Schedule H and H1 and require a prescription. As per D&C Act 1940 and Rules 1945, these drugs should be sold against prescription only. It is a fact that a large percentage of people in the country are still not in a position to bear the cost of treatment and the doctor's fee. Once a schedule for OTC drugs comes out, the poor patients will have no botheration of visiting doctors for treating common ailments like acidity, indigestion, constipation, diarrhea, cold, cough, allergy, headache, to name only a few. A qualified pharmacist can then dispense OTC drugs for common ailments. A robust OTC policy, with clear guidelines for promotion and sale of OTC drugs, will be beneficial for both the industry as well as the patients. While it will help the 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.
Recently, the Drugs Technical Advisory Board (DTAB) of the Union Health Ministry has recommended to constitute a sub-committee to examine the issue of framing a separate category for OTC drugs with reference to various conditions based on which status of a drug as an OTC is decided and a detailed mechanism is to be developed for the drugs to be considered as OTC. Earlier in the year 2018, the Health Ministry had 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. After thoroughly examining the drugs marketed in the country vis-a-vis conditions for sale stipulated under various Schedules like H, H1, G, X and K, the panel submitted its recommendations to the ministry. However, instead of implementing the recommendations, the Ministry in 2019 formed another three-member sub-committee under the chairmanship of Haryana state drugs controller to define the OTC drugs that can be sold in the country without prescriptions and put in place a regulatory framework for these medications. This committee 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. The three-member sub-committee, under the chairmanship of Haryana state drugs controller N.K. Ahooja, came to the conclusion that there is an urgent need to define the OTC drugs and to lay down specific provisions for the regulation of OTC drugs in the country. The committee recommended to the government to promote self-care without compromising patient safety thereby reducing the treatment cost of the common people. Then in 2022, the Ministry issued a draft amendment in the Schedule K of the Drugs Rules, 1945. The DTAB has now recommended a comprehensive revisit of this draft notification. The fact is that minor ailments can, up to an extent, be treated without consulting a doctor if the country had an OTC drug policy. So, instead of constituting committee after committee, the Union Health Ministry should approach the issue with deserving seriousness as a robust OTC policy, in the long run, will prove to be a win-win situation for both the industry as well as the patients.
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