Why India needs a comprehensive policy on OTC drugs

In 2016, India’s over-the-counter (OTC) market grew 8 percent to $2.7 billion, with a five-year compounded annual growth rate (CAGR) of 9 percent, according to Nicholas Hall’s global OTC sales database DB6 2017.

Perils of self-medication But the problem in India is that OTC drugs don't come with labels telling the consumer the purpose of the medicine, the active and inactive ingredients used in it, who should take the medicine and how to take it safely.

A lot of times the chemist who is prescribing the medicine isn't qualified to do so and has no understanding of the patient's medical condition. While an OTC drug should be used temporarily, many patients end up taking them for long periods of time.

Also, it is an open secret that practically any drug, even those that require a doctor's prescription, are available over the counter. Drugs like antibiotics were sold freely for a long time without prescription, before government tightened the screws in the face of anti-microbial resistance.

In 2016, the Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) alerted the Drug Controller General of India (DCGI) to the rampant misuse of creams containing steroids with antibiotics and anti-fungal agents causing serious side-effects such as extensive ringworm infection.

Lack of regulation Unlike countries like the US, UK and China, we don't have a well-defined legal and policy framework to either support or regulate distribution, marketing and consumption of OTC drugs. There is no defined list of OTC drugs.

Many would be surprised that the term OTC doesn't exist as per Indian law. Neither the Drugs & Cosmetics Act, 1940 nor the Drugs & Cosmetics Rules, 1945 (D&C) define OTC.

At its core, the Drugs & Cosmetics Act - which governs all products classified as drugs - is a series of Schedules containing specific drugs. Which Schedule a drug is listed under decides its regulatory status. Drugs under Schedule H, H1 and X cannot be sold without a doctor’s prescription. Therefore, from an OTC marketer’s perspective, drugs that fall outside these Schedules are considered to be non-prescription and by inference, free to be made available over the counter. However, the law does not explicitly state this.

This leaves a huge grey area, compounded by lack of labelling and drug monitoring.

Demand for OTC policy To be sure self-medication is nothing new in India. If regulated properly - armed by more patient education - OTC medications can be a useful tool to deal with the problems of rising out-of-pocket healthcare costs, inadequate doctor-patient ratio and weak and overburdened public healthcare system.

The Organisation of Pharmaceutical Producers of India (OPPI) along with a few members from the domestic pharmaceutical industry and consumer industry released a study titled: Shaping India’s OTC Policy 2018. The study calls for a well-regulated OTC framework that helps improve access to medicines and also supports responsible self-medication to achieve multiple health and economic objectives.

The study's important recommendations include suggestion to include a separate Rule and a separate Schedule to classify OTC products in the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.

The study asks for government to clearly define a pathway for prescription (Rx) to OTC switches, strengthen labelling and patient information, mandatory clinical trials and bioequivalence studies for OTCs, restrict distribution of prescription drugs as OTC, removal of OTC products from price controls and allow the market to determine prices.

The most evolved are the US and UK that have a substantial OTC market and allow OTC drugs to be advertised in the mass media and to be made available in non-pharmacy outlets such as general stores. They also have clearly defined requirements for switching drugs from prescription to non-prescription status, and clear guidelines on labelling and advertising claims. Regulatory implementation in these countries is rigorous.