Impact of COVID-19 and regulations for OTC segment

Over-the-counter (OTC) drugs are medications that are safe and effective for use by the public without seeking treatment by a health professional; for instance, pain relievers, cough suppressants and antihistamines. OTC designation is granted for a pharmaceutical product when enough safety and efficacy data is available, and the product is marketed for a very long time. Any specific help from medical professionals is not required to administer OTC products and it can be bought from pharmacies or online platforms without prescription. Despite being classified as safe, the following might be a few associated risks with the OTC:

◆ Dosage may vary for the paediatric population.
◆ There is a possibility of an allergic reaction.
◆ It may be risky to consume
during pregnancy.
◆ The medicine may interact with other medicines, supplements , food, etc.

COVID-19 and OTC

OTC is a growing market, and it is expected to grow with a Compound Annual Growth Rate (CAGR) of six per cent during the next few years, globally. The highest growth is expected from emerging markets like Latin America and Southeast Asia. When compared globally, India is expected to grow by 9.2 per cent and the COVID-19 pandemic has an important role in this forecast. Many pharma companies are inclined to capture the OTC market in India anyway due to the high consumer ratio, but COVID has shifted the attitude of people for self-medication as well. Impact of lockdowns, supply chain disruptions, etc., are also the key factors that will add surge in the OTC sales in upcoming years.

Regulation of OTC products

In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician’s care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.

◆ Europe: Article 74a of the Directive 2001/83/EC as amended by the Directive 2004/27/EC sets out switching drug products from prescription to OTC. European Medicine Agency (EMA) review certain criteria to switch from finished product to the OTC product.

◆ USA: The US Food and Drug Administration’s (FDA) review of OTC drugs is primarily handled by CDER’s office of non-prescription drugs. The Nonprescription Drug Advisory Committee meets regularly to assist the agency in evaluating issues surrounding these products. This committee has played a major role in the growth of prescription to OTC switches in recent years. There are over 300,000 marketed OTC drug products. FDA reviews the active ingredients and the labelling of over 80 therapeutic classes of drugs, for example, analgesics or antacids, instead of individual drug products. For each category, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of recipe book covering acceptable ingredients, doses, formulations and labelling. Many of these monographs are found in section 300 of the Code of Federal Regulations.

◆ Australia: The Therapeutic Goods Administration (TGA) Act requires that all medical products to be imported or exported from Australia must be included in the Australian Register of Therapeutic Goods (ARTG). For a medicine to be included in the ARTG, a sponsoring company is required to lodge an application to the TGA. The TGA has developed the Australian Regulatory Guidelines for OTC Medicines (ARGOM) to assist sponsors of OTC medicines to meet their legislative obligations. OTC medicines can be registered or listed on ARTG, depending on the level of risk associated with making the product available and accessible to consumers. The registered OTC medicines are considered to be of lower risk than prescription medicines, but they still require an appropriate level of scrutiny.

◆ The United Kingdom: The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. Apart from the prescription category, there are two following categories in the UK.

Pharmacy medicines: People can buy products classified as ‘pharmacy medicines’ (P) but only from a pharmacy and in the presence of a pharmacist. These medicines, also called ‘pharmacy-only medicines,’ are not usually displayed on open shelves. A rectangular box enclosing the letter P appears on the packaging of pharmacy medicines.

General sale medicines: People can buy general sale medicine packs from retail outlets such as corner shops and supermarkets. The medicines-also called ‘general sales list (GSL) medicines’- are also available for self-selection in pharmacies. General sale medicines are taken for common and easily-recognised ailments which usually last around two-to-three days. These medicines cause few troublesome side effects in normal use.

◆ India: Many drugs are sold over the counter without prescription, but the regulatory regime is grey in this regard, primarily because the term OTC has not been expressly defined under the Drugs & Cosmetics Act, 1940 (D&C Act) and the Drugs and Cosmetics Rules, 1945 (D&C Rules). Regulatory ambiguity is set to change, however, as the Central Government is now actively considering regulating the sale and distribution of OTC drugs. The Central government has formed a new three-member sub-committee to expedite efforts to define over-the-counter (OTC) medications that can be sold in the country without prescriptions and put in place a regulatory framework for those. The OTC committee of the Organisation of Pharmaceutical Procedures of India (OPPI) is currently working towards the promotion of responsible self-medication in order to promote the OTC market. It is also aiming on promoting the importance of responsible self-medication through awareness programmes and community education. The committee not only promotes OTC use, but also emphasises on safety. Besides promoting OTCs, establishing a balance between wider access to drugs and their safety should also be focussed on.

Major countries have defined pathways for the registration of OTC products and India needs to define regulation around it. A regulatory decision as to whether to increase the accessibility of drugs hinges on a determination of whether the benefit to be gained by doing so can be justified in light of any additional risk posed by self-medication. The ongoing COVID-19 pandemic has restricted the opportunities for formal medical intervention for patients in general and the OTC market is expected to be huge after the pandemic.