Self-medication is not new to India. A 2015 survey conducted by Lybrate among 20,000 people across 10 cities showed that 52% of people practised self-medication. But the country lacks a well-defined regulation for over the counter (OTC) medicines, important for patient safety.
The government is in the process of finalising an OTC drug policy, which may bring more clarity on the drugs that a wider population can access. The Organisation of Pharmaceutical Producers of India (OPPI), a body of multinational drug companies, has worked with the government over the past one year by providing inputs to the draft of the OTC policy.
The Hindu spoke to OPPI president Annaswamy Vaidheesh about the need for such guidelines and the changes they will bring about in healthcare.
What role did OPPI play in creating the OTC policy draft?
We brought experts together to help develop the guidelines. We also invited companies like Cipla, Glenmark, Sun Pharma and others who are not members of OPPI, but their inputs were valuable. Additionally, we got international experts to bring in perspective. The government has hailed the inputs and is seriously considering taking them forward. We have looked at the best practices in various economies and highlighted what we can take from them, the kind of drugs that should be included in the OTC list and the ones that should not.
How will an OTC policy help?
First of all, when you widen access to OTC drugs, it automatically releases the government’s time and resources, which can be focussed on drugs that need to be stringently prescribed. We are saying that drugs that are known to have negligible side effects and don’t require much explanation can be classified as OTC so that access to them becomes easy and wide. These drugs can be made easily accessible in small towns as well. The idea is to make sure that the right product rests in the right place. Society has learnt that OTC medicines are those that don’t have major side effects but help improve health. Many countries have brought more products under the OTC category to focus on drugs that need to be strictly regulated.
We also face the threat of antibiotics resistance. Will bringing more drugs under the OTC category lead to overuse or misuse?
An antibiotic is a drug meant to treat a bacterial infection. But people who have viral infections, fever and so on are taking antibiotics, causing the resistance. However, when drugs for common viral infections, sore throat, acidity, indigestion, nausea, vomiting, stomach pain, injury, cuts, wounds, burns, acne etc are made available under OTC, people will get access to the right medication. Many people are using such drugs without prescription anyway. But an OTC policy will improve access to drugs that are okay to be sold as OTC and restrict access to other drugs. Besides antibiotic resistance, steroid use is also a big problem. There are people who use steroid creams for skin whitening. But we are working with the government to spread awareness about the responsible use of antibiotics and steroids.
What stage is the policy in?
The submission has gone; we have crossed three-fourths of the passage. The government may take six months or a year. It is in the process of finetuning it and converting it into a legislation.