Pharma & drug development War on drugs

Defining OTC drugs

India has decided to rethink which medicines can and can’t be sold without prescriptions, in an attempt to create a definition for over the counter drugs. Abi Millar takes a closer look at this categorisation of drugs

In November 2016, India’s drug regulator announced it was creating a definition for over the counter (OTC) medicines. This change will create some much-needed clarity around which medicines are safe for general purchase.

Although India already has a definition for drugs that require prescription, the existing regulations do not lay out which drugs can be sold without it.

“Generally, people presumed drugs not in Schedule H, H1, X, etc., do not require a prescription. Now, the regulator will list separately which drugs can be sold without a prescription,” a government official told the Economic Times.

It is thought the new category will include drugs for fevers, colds, emergency contraception and certain types of allergies. Through creating a legal demarcation for these drugs, the government will be better able to regulate the sector. The move will also help them curb the unlicensed sales of prescription-only drugs, like antibiotics.

The need for OTC drugs

Globally, OTC drugs are an important class of medicines. Referring to any drug that can be sold directly to the general consumer, the term can be further subdivided into various categories, with the specifics varying widely from place to place.

Rather counterintuitively, the name does not indicate that the drugs are literally sold over a counter. Oftentimes, they can simply be taken off a shelf, and paid for with your other shopping.

According to the Consumer Healthcare Products Association (CHPA), 81% of US adults use OTC medicines as a first-line treatment for minor illnesses. The average consumer makes 26 trips a year to purchase OTC drugs, compared with just three visits to their doctor. And there are more than 750,000 retail outlets that sell OTC products, compared to 54,000 pharmacies.

As the CHPA website explains: “Without affordable and accessible OTCs, underserved populations would depend more heavily on the highest cost medical care for minor ailments.”

Varying definitions

Typically, OTC drugs are defined in distinction to prescription-only. In the UK, for example, medicines fall into three categories: prescription only (available from a pharmacist to a specific patient), pharmacy medicines (which can be sold by a pharmacist without prescription) and general sales list (which can be sold anywhere, including supermarkets). The latter group includes painkillers like paracetamol, as well as skin creams and anti-allergy drugs.

It is easy to see the purpose of this kind of categorisation. Since OTC drugs are safe for the vast majority of people, and are used to treat minor ailments, it wouldn’t make commercial or medical sense to restrict their availability. Conversely, since prescription drugs are generally quite powerful, and suited only to specific patients, they are not appropriate for retail sale.

However, this is not to say the division is set in stone. It is not unusual for a prescription medicine to be reclassified as OTC or vice versa, in light of new evidence, and laws do not entirely line up around the world.

India’s OTC problem

Despite the classifications in place elsewhere, India has never given OTC drugs legal recognition. Its OTC drug market, estimated at around $4bn, is a somewhat murky category. It is also growing fast, as new chemists open up in rural areas and an influx of new products hit the shelves.

The lack of regulation is troubling, in that it heightens the risk that OTC drugs will be taken inappropriately. A 2016 study by the India Pharmacopoeia Commission found a growing incidence of adverse reactions, concluding: “The present study reveals that safety of OTC drugs is a matter of grave concern. Therefore stringent safety monitoring and regulations are needed.”

On top of this, a number of ‘prescription-only’ drugs are easily available over the counter. Many of these drugs, like paracetamol, are low-risk, and will likely be recategorised as OTC. But it also includes some higher-risk products that should never be administered in this manner.

For example, antibiotics are often acquired without prescription, contributing to the growing problem of antibiotic resistance. The government has lately been pressing for more cautious use of antibiotics.

When illegal drug sales proliferate, this is likely to hit poorer communities the hardest. According to a recent cross-sectional Indian study: “When there is a perceived poor access to health care, OTC medication use becomes a low-cost alternative… People who are economically weak are less likely to consult a medical practitioner for a medical condition.”

It has also created a market for drugs tourism, demonstrated most chillingly by the young English couple found dead in their Agra hotel in 2014. The couple, who had overdosed on prescription medication, had earlier tweeted: ‘Codeine under the counter here. With Valium, Xanax and Lyrica. Winning’.

Such incidents, of course, are mercifully rare, but they do point towards a greater need for oversight.

Changes ahead

At the time of writing, India’s Drugs Consultative Committee, which is part of the health ministry, is drawing up a legal framework for OTC drugs, using international models for reference. Not only will it define which medications truly are OTC, it will make it a prosecutable offence to sell drugs that aren’t on the list.

As an official told the Times of India: “The sub-committee will submit its report within three months. Once we have a notified list of OTC drugs, it will be easier to track those selling ‘prescription only’ drugs without a prescription from registered medical practitioner. This will also help us create more awareness among consumers.”

The move is thought to be related to the recent wave of OTC product launches. At present, it is not clear which of these new drugs are appropriate for retail sale.

As Sujay Shetty, a partner at PwC India, explains, the move to define OTC drugs will have important ramifications for India’s pharma sector.

“We are also waiting to see a clearer spelling out of the definition as currently India does not have one,” he says. “It is a largely catch all term for any consumer health care product, vitamins, cough, colds and the like. It would certainly be a step in right direction to define OTC as distinct from prescription. This would be great both for customers and companies planning their strategies in this very important segment.”

This article appears in the February 2018 edition of Pharma Technology Focus

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