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The Organisation of Pharmaceutical Producers of India (OPPI) has come out with a slew of suggestions to be considered by the expert committee while framing over-the-counter (OTC) drugs regulation. The suggestions include keeping OTC medicines out of price control, allowing their advertisement and labelling as well as a clear process for switching from prescription (Rx)-to-OTC.
Based on the deliberations of 52nd meeting of drugs consultative committee (DCC), the government formed a sub-committee comprising of five state drug controllers to recommend the list of OTC drugs to be sold in pharmacies.
The term of reference of the panel is to look into the drugs marketed in country vis-a-vis conditions for sale stipulated under various Schedules like H, H1, G, X, K and suggest list of drugs which may be considered for marketing as OTC along with conditions to be followed.
Currently, Drugs & Cosmetics Act and Rules thereunder which regulates prescription drugs (Rx drugs) divided in Schedule H, H1, X has no provision to regulate the distribution, marketing, promotion and consumption of OTC drugs. Hence, the drugs which do not fall under prescription drugs category are generally considered as OTC drugs.
The panel had written to all stakeholders seeking suggestions from them.
Responding to the committee’s request, OPPI has come out with a slew of suggestions covering the key building blocks of OTC legislation such as an Rx-to-OTC switch pathway, the distribution/trade channels of choice, advertising, labelling, and pharmacovigilance, among other things.
The pharma industry lobby proposed that a separate Rule and a separate Schedule on OTC (proposed nomenclature Schedule “O”) should be included in the Drugs & Cosmetics Act 1940 and Rules 1945 to regulate OTCs which will improve timely access to medicines and to curb under the sales of Rx drugs.
Differential pricing treatment for OTC drugs would have to be considered in order to encourage investment. The DPCO does not make any distinction between Rx and OTC drugs. Aspirin and Vitamins, though OTC, are subject to pricing caps, it opined.
The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules, 1955 which controls the advertisement of drugs to treat a total of 54 ailments including fever, also put restriction on advertisement of OTC drugs. Due to ban on advertising and promotion of OTCs, consumers are deprived of important information on usage and side-effects of these drugs which abets risky behaviour among consumers, the industry body added.
In 2013, during a dengue outbreak, the Delhi government ‘banned’ the OTC sales of NSAIDS such as Voveran to dengue patients fearing life-threatening harm from indiscriminate consumption.
There are no specific laws that can ensure the labelling of OTC products with relevant information and comprehensible language to aid and guide the patient.
Self-medication is on the rise across the world as empowered consumers want the primary care benefits that OTC medicines offer and India is no different. Acidity, constipation and headache are some of the popular categories of self-medication in the country. Lack of time to visit a doctor, wanting to save on consultation fees and reliance on the Internet for solutions are the key reasons for this. Worsening state of public health delivery and the emergence of digital health have been significant drivers of this trend.
Said Kanchana TK, director general, OPPI, OTC medicines are a critical component in advancing consumer health because they allow people to treat or manage many health conditions conveniently and successfully. Because they enable people to self-treat, OTC medicines save health systems valuable resources and can save consumers time and money. OTC medicines have played a significant role in expanded access to safe and effective treatments in developing regions of the world.
In 2016, India’s OTC market grew 8 per cent to US$ 2.7 billion with a five-year Compounded Annual Growth Rate of 9 per cent, according to Nicholas Hall’s global OTC sales database DB6 2017.
However, lack of OTC drug regulation has boosted unchecked self-medication which poses a danger to patient safety and can negatively impact health outcomes. For instance, the easy availability of antibiotics without a valid prescription has contributed to rising antimicrobial resistance in the country.
Its high time, India needs to come out with well-defined OTC regulations, creating a more favourable environment for responsible self-medication, improvement in standards of public health and reduction in cost to the economy, said Nicholas Hall, chairman & CEO, Nicholas Hall Group of Companies.
Pharmaceutical industry is looking for support from government to bring the clear advantages of responsible self-medication to an eager population. OTC guideline could be the success formula to expand access to medicines in the country, said OPPI president Annaswamy Vaidheesh.
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