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REGULATORY FRAMEWORK FOR OTC DRUGS

Ramesh Shankar
Wednesday, September 8, 2021, 08:00 Hrs  [IST]

Of late, there has been a clarion call by the healthcare experts in the country for creating a robust regulatory framework for over-the-counter (OTC) medicines that will enable and facilitate the creation of a positive list of OTC medicines and ensure their widespread availability across the country, including in the remote areas. Experts also stress that this framework should also work towards educating consumers and pharmacists on the judicious use of OTC medicines and the creation of a system of checks and balances regarding the safety, efficacy, promotion, and consumption of such medicines. It is true that OTC medicines have played a key role in expanding access to safe and effective treatments while advancing consumer health as they empower patients to treat or manage many health conditions conveniently and successfully. According to available data, 86% adults in the US believe that responsible use of OTC medicines helps lower individual healthcare expenditure. For every dollar spent on OTC medicines, the US healthcare system saved more than 7 dollars. Similarly, in European countries, 8 out of 10 individuals recognise that it is their responsibility to manage their own health and are willing to do so. Experts are of the view that with patients getting more and more involved in their health decisions, OTC medicines not only save valuable resources for healthcare systems but also save time for patients. But, these experts also hasten to add that in order to effectively ensure expanded access to health solutions, a set of robust OTC guidelines, aligned with the WHO’s objectives of educating people about self-medication, is crucial.
Obviously, there is merit in the arguments of the experts as the Indian healthcare ecosystem can benefit immensely from improved OTC system in the country. It can be mentioned here that a sub-committee, constituted by the Union Health Ministry to define the OTC drugs, in its report in 2019 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. The panel had come 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. The three-member panel asked the government to classify OTC drugs into OTC-1 and OTC-2 categories based on the extent of evidence of safety, therapeutic index, need for accessibility to patients, availability, non-habit forming nature, present supply chain mechanism and socioeconomic conditions of the country. Even though a separate category of OTC drugs is common in many countries, including several developing and developed countries, in India all the allopathic drugs including the drugs which are considered safe to be dispensed without prescription also fall under Schedule H and H1. As per D&C Act 1940 and Rules 1945, these drugs should be sold against prescription only. Because of these provisions, the patients with even common ailments are forced to consult a physician for treatment. It is high time the government acted on the recommendations of the panel. Of course, 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.

 

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