In India, patients and consumers have access to medicines from a pharmacy by two ways: Access with a prescription provided by a registered medical practitioner or access without a prescription. Although many countries have this system of medicine classification, some countries have a third category of medicines (pharmacy only medicines) by which supply without prescription is limited under the supervision of a pharmacist. Medicines, therefore, are categorized on the basis of their sale or supply to patients, into prescription controlled and decontrolled classes. This classification is governed by various countries in accordance with the requirements of the respective laws and rules. Various countries with strong drug legislation embody a set of criteria for determining whether a medicine is to be restricted to prescription-only distribution. But the main criterion remains the same, direct or indirect danger to health if used without medical supervision.

OTC medicines
OTC is an acronym that stands for Over-the-Counter medicines. This pertains to medicines which are legally allowed to be sold over the counter without the prescription. They are, therefore, also called non-prescription medicines. OTC medicines are safe and are sold to treat minor, common, self-limiting illnesses and conditions.

In USA, the 1951 Durham-Humphrey amendment to the FD&C Act provides statutory basis and specific criteria for a medicine to be prescription restricted. Medicines that may be sold legally without a prescription must bear a seven point label related to mainly warning and adequate directions. The most important distinction between prescription and over-the-counter 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.
Australian regulatory guidelines for OTC medicines (ARGOM) decide to put a medicine an OTC status in accordance with Therapeutic Goods Act, 1989. Low risk registered products are non-prescription medicines. Products in this category are considered to be lower risk than prescription medicines. However, they require a high level of scrutiny to ensure adequate labelling for appropriate use. Under the UK Medicines Act 1968, General sale list medicines (GSL) are medicinal products which can, with reasonable safety, be sold or supplied without the supervision of a pharmacist.

Status of OTC medicines in India
The phrase ‘over-the-counter’ and its acronym ‘OTC’ medicines have no legal recognition in India as per Drugs and Cosmetics Act, 1940 and the Rules, 1945 there under (amended up to date) and are customarily referred to as ‘household remedies’ and/or non-prescription medicines. OTC medicines are identified indirectly in absence of explicit definition. The current drug legislation only has prohibition to sale medicinal products which must not be supplied without a prescription from a registered medical practitioner. Schedule H to the drug rules mentions a list of medicines that should be sold by retail on the prescription of physician. Schedule X specifies a list of habit forming drugs requiring prescription in duplicate. The medicines which are not specified in these lists of prescription drugs (Schedule H and X) are to be considered non-prescription (OTC) medicines in India. However, it is clumsy and has no official status and it has no safety guidelines. The medicines in Schedules H and X must carry the following statement on label of their packages, “Schedule H or Schedule X drug–warning: To be sold by retail on the prescription of registered medical practitioner only”. The left hand top corner of the label has to carry ‘RX’ symbol for Schedule H drug and ‘NRX’ (in red colour) for Schedule X drug.

Benefits and risks
Used well and as directed, medicines can play an important part in keeping people healthy. All medicines work best when combined with healthy diet and lifestyle. While using medicine (either prescription or non-prescription), there is always a risk that the medicine may cause unwanted effects. There is a greater risk if person has kidney, liver or stomach problems; drink alcohol; pregnant or breastfeeding woman and allergic to specific medicines.
The so called OTC medicines are not only available freely in Indian market but also they are promoted aggressively through all powerful media. Innumerable brands and combinations of drug products are available in the Indian market. In such a scenario pharmacists and other health care professionals must demonstrate that patients can take an OTC medicine safely without professional oversight and using information on the label.

Balance between wider access and safety
The good thing about OTC medicine is that patients may easily have access to medicines that could help them nurse themselves and their family without a medical authority. The main objective of making legal OTC medicines category within drug laws and increasingly include more number of medicines is to widen the access of medicines without prescription to larger sections of people especially rural areas in developing countries including India. An estimated 240 million people rely on OTC medicines for symptomatic relief in the USA that helps cost savings of billion of dollars due to avoided clinical visits. The United Kingdom has been leading in Europe in improving access to over-the-counter medicines for self care where it is safe to do so, providing greater choice and access for the public.

However, to protect public safety in using OTC medicines increasing restrictions like warning, dosage size restrictions and directions of use are extremely important. It is important to have labelling instructions in understandable words and in local languages. Dosage size restrictions are crucial for certain categories of medicines and can be supplied as single unit forms. An effort is also needed for controlling advertisements of certain categories of OTC medicines. All these safe guards call for a separate set of statutory controls for OTC marketing. In today’s modern health service, OTC medicines empower consumers to manage their personal healthcare management where it is safe to do so. Pharmacists can also make better use of their professional skills by the way of supervising OTC medicines sales. However, proper regulation is needed to balance the benefits of easier access against the potential harm from unsupervised or inappropriate use. The reality is the safety in using OTC medicines always remains the priority, but OTC marketing through a well defined regulation is not being materialized in India. It is a question of balance between safety and access.