A closer look at Over the Counter medicines in India

In India, patients and consumers have access to medicines from a pharmacy in two ways: access with a prescription or access without a prescription. Medicines, therefore, are categorized on the basis of their sale or supply to patients, into prescription controlled and decontrolled classes. They are prescription medicines and non-prescription medicines. A common term used to characterize non-prescription medicine is the over-the-counter (OTC) medicines.

OTC medicines mean medicines that are legally allowed to be sold over the counter without the prescription of a physician. The most important distinction between prescription and OTC medicine is based on the availability of adequate directions for use under which a layman can use the medicine safely and for the purposes for which it is intended. OTC medicines offer a wider margin of safety, in the event, they are used inappropriately. They are sold to treat minor, common, self-limiting illnesses and conditions like aches and pains, coughs and colds, fever, allergies, skin disorders, heartburns, and other digestive problems. For the most part, they are common medicines that everyone knows about. Acetaminophen (Paracetamol), Aspirin, vitamins, pain balms, digestives, antacids, cold rubs, cold tablets, antiseptic creams, glucose powders, cough syrups, throat lozenges, band-aids are some of the examples of OTC medicines. These medicines are mostly available in medical stores with easy access to consumers, and may also be located in non-pharmacy retail outlets such as supermarkets, convenience stores, and even grocery stores.

The OTC medicines are obviously less expensive than going to a doctor and perhaps paying for a costly prescription. The dark side of it – a recent report suggests that many who self medicate admit to taking more than the recommended dose or more frequently than the label indicates. This can be illustrated as follows:

Imagine you’re a patient or consumer regularly buying very common medicines from your neighborhood medicine store. An example is given of a consumer suffering from normal fever. He visits a pharmacy to get the most popular brand in India, a few CALPOLtablets. It relieves a symptom but doesn’t cure any disease. It’s considered safe in pregnant women also. At normal doses with a slight deviation, there are virtually no side effects.  Calpol is chemically acetaminophen, a safe medicine when used at appropriate doses, but highly toxic in overdose (2 to 3 times that the recommended dose).

Aspirin (acetylsalicylic acid) available in the market as SARIDON, DISPIRIN, with well-established benefits for a number of conditions, but also an impressive side effect profile, including stomach ulcers, multiple drug interactions, and associated risk of Reye’s syndrome when given to children. Many medicine consumer activists feel that there can be problems with OTC medicines, even if they are used correctly. Some medicines should not be taken with certain illnesses and some should not be combined with other medicines. Some countries have a sizable “behind the counter” (BTC) category, for medicines that can be purchased without a prescription but require a pharmacist’s authorization for sale.

These BTC medicines can be accessed or purchased behind the counter of a pharmacy without a prescription but require the intervention of a pharmacist before their sale. Proponents of BTC argue it offers greater consumer access to drugs that do not require physician consultation but benefit from pharmacist consultation. Many believe that OTC medicines that too unsafe for direct sales should be categorized as BTC where pharmacists would be able to provide education on proper use. They could also refer consumers to physicians when appropriate. 

Status of OTC medicines in India: The phrase ‘Over the Counter’ and its acronym ‘OTC’ medicines have no legal recognition in India and are customarily referred to as ‘household remedies’ and/or non-prescription drugs. OTC medicines are identified indirectly in the absence of an explicit definition. The current Indian drug legislation only has prohibition to sell medicinal products which must not be supplied without a prescription. The medicines which are not specified in lists of prescription drugs (Schedule H, Schedule H1, and Schedule X) are to be considered nonprescription (OTC) medicines in India and legally allowed to be sold over the counter in pharmacy retail outlets. However, it is clumsy and has no official status.

Benefits and risk: Used well and as directed, medicines can play an important part in keeping people healthy. There is a greater risk if a person has kidney, liver, or stomach problems; drink alcohol; pregnant or breastfeeding woman; and allergic to any of the substances in the medicines.

In India, several prescription medicines, listed in Schedules H, H1, and X, are easily available (illegally) without a prescription. For, Indian pharmacy outlets have been long known to sell drugs without a prescription. In addition, the OTC medicines are not only available freely in the Indian market but also they are promoted aggressively through all possible media

Balancing wider access and safety: The main objective of making legal OTC medicines category to widen the access of medicines without the prescription to larger sections of people especially rural areas. The availability of these medicines in general stores, without any restriction, is expected to bring down the medical costs. However, to protect public safety in using OTC medicines increasing restrictions like a warning, dosage size restrictions and directions of use are extremely important. An effort is also needed for controlling advertisements for certain categories of OTC medicines. All these safeguards call for a separate set of statutory controls for OTC marketing. In today’s modern health service, OTC medicines empower consumers to manage their own conditions where it is safe to do so. Prescription, OTC or BTC, they are merely intervening substances that provide benefit on appropriate use, but are never absolutely safe under all circumstances. The appropriateness of any medicine including OTC depends on balancing availability and safety.