Dr. Dimbeswar Das, M.D.,F.I.D.
ILS Hospitals, Agartala

February 13, 2023, 09:27:43   


Over-the-counter (OTC) medicines are drugs you can buy without a prescription. In the United States, the Food and Drug Administration decides whether a medicine is safe and effective enough to sell over-the-counter. This allows you to take a more active role in your health care. But, the practice is not uniform across the world. There are differences in human behavior,level of awareness and ability to understand the mechanism of action of different molecules, it’s side effects profile etc., and most importantly,administrative control on such practice.

In India, lack of awareness of common people about different aspect of such practice is a strong factor for increasing and uncontrolled OTC purchase of medicines like pain killer tablets, different antacids, anti-allergic tablets,cough and cold medicine,anti-diarrhoeal,medicine for constipation, acid-suppressing preparations, different antibiotics, multi vitamins,energy booster etc. One can verify the facts and will be able to understand the depth of this matter observing  the things happening near the dispensing and billing counter of a pharmacy for some time and realise the way we are getting exposed to the risks related  to such practice.

Risks to taking OTC medicines:
Food and Drug Administration of USA states that:

•The medicine you are taking could interact with other medicines, supplements, foods, or drinks

•Some medicines are not right for people with certain medical conditions. For example, people with high blood pressure should not take certain decongestants.

•Some people are allergic to certain medicines

•Many medicines are not safe during pregnancy. In case of pregnancy, one must check with her health care provider before taking any medicine.

•One must be careful when giving medicines to childrenand to make sure that the child is given the correct dose. If you are giving your child a liquid medicine, don't use a kitchen spoon. Instead use a measuring spoon or a dosing cup marked in teaspoons.

•you also need to be careful to avoid mistakes. Make sure to follow the instructions on the drug label. If you don't understand the instructions, ask your pharmacist or health care provider.

•If you have been taking an OTC medicine but your symptoms don't go away, contact your health care provider. You should not take OTC medicines longer or in higher doses than the label recommends.
Regulation by country

Patients,specially in developing country like India, often approach a pharmacist instead of going to consult a doctor for minor ailments such as cough, cold, allergies, pain, fever, acidity, diarrhea, and skin-related conditions etc. Purchase of specific medicines over the counter is legally recognized in most countries. 'Over-the-Counter (OTC) Medicines' means drugs which are legally allowed to be sold by pharmacists without need for a proper doctor’s prescription. Unfortunately,the term does not have a legal definition in India. Technically, drugs are OTC unless they are specifically stated as prescription only drugs. OTC drugs undoubtedly allow faster and cheaper access to healthcare; but, their misuse and adverse effects cause concerns.

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 as per their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow companies the freedom to formulate ingredients, or to combine ingredients, into proprietary mixtures.In November 2016, India's Drug Consultative Committee declared that it was embarking on establishing a definition of drugs which could be dispensed without a prescription. But the legal definition is not yet complete and clear.

Transitions between prescription and OTC:

One can understand, over-the-counter drugs have to be used basically to treat a condition that does not require the direct supervision of a doctor and it is reasonably safe and well tolerated.OTC drugs are usually also required to have little or no abuse potential, although in some areas drugs such as codeine ,having addiction potential, are available OTC (usually in strictly limited formulations or requiring paperwork or identification to be submitted during purchase).

After continued use, often by 4-5 years, drugs that prove themselves safe and appropriate as prescription medicines may be switched from prescription to OTC. An example of this is diphenhydramine (Benadryl), an anti-histamine which once required a prescription but now is available OTC.It is usually not seen an OTC drug to be withdrawn from the market as a result of safety concerns, rather than market forces, though it does happen occasionally. For example, phenylpropanolamine was removed from sale in the United States over concern regarding strokes in some cases. A study has been done examining consumer's perceptions about the risk of and access to nonprescription medication,which concluded that a small percentage of consumers prefer having access to medication over potential risks of taking non-prescribed medication.Ranitidine was suspended in multiple markets due to concerns over the presence of the carcinogen N-Nitrosodimethylamine (NDMA).But the matter got diluted later.

In India, the medicines are listed under different schedules in the Drugs and Cosmetics Act and Drugs and Cosmetics Rule. Drugs listed in Schedules H, H1, and X should carry a label stating that these drugs are to be sold  only on prescription of a doctor. The drugs listed in Schedule G (mostly antihistamines) must carry a mandatory text on the label stating, “Caution: it is dangerous to take this preparation except under medical supervision.” Surprisingly, certain important drug categories such as diuretics and aminosalicylates (sulfasalazine, mesalamine) are not included under any drug schedule creating a confusion for pharmacists about selling these drugs as OTC or prescription medicines.

It needs to be stressed that in India, the phrase “OTC” has no legal recognition yet. It is used for the way drugs are sold (self-medication without prescription or allowed to be sold by pharmacists without the prescription) rather than being a recognized official category of medicines unlike other countries.

Schedule K of the Drug and Cosmetics Act and its Rules explain household remedies such as paracetamol, liquid paraffin, eucalyptus oil, tincture iodine, and various formulations for the treatment of cough and cold are the potential OTC drugs. Currently, nondrug-licensed stores (e.g., nonpharmacists) can sell a few medicines classified as “Household Remedies” in Schedule K of the D and C Rules in villages whose population is below 1000 subject to certain other conditions.

Under the provision of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules, 1955, the advertising and misleading promotion of some drugs/classes is kept under control to avoid self-medication by people.Topical or external use of certain schedule G and H category drugs (except ophthalmic and ear/nose preparations containing antibiotics and/or steroids) is exempt from the schedule. For example, topical diclofenac is not a schedule H drug though diclofenac is included in schedule H.So,things are not very clear and confusion exists.

The State Government of Delhi announced in 2015, that aspirin which was earlier included in the list of household remedies (Schedule K) should be sold only with a prescription in Delhi. This was because of the fact that there were increased number of deaths in dengue patients who bought aspirin OTC.

Overall, 52% Indians were estimated to self-medicate in India according to a web portal-based survey of 20000 people across 10 cities. The reasons given were lack of time, need to avoid doctors' fees, and dependence of internet.One Indian study reported that more than 90% of the qualified pharmacists interviewed in their study were aware about the concept of OTC drugs, 96.5% asked the patients their complaints when they were approached for purchase of OTC drugs, but only 51% counselled the patients regarding instructions for use.

The Indian pharma market generated total revenues of 1.8 billion in 2009 from the drugs presumed to be OTC with an annual growth rate of 10.7%. Organisation for Pharmaceutical Producers of India (OPPI) has proposed that policies should be developed for drug classification, labeling, licensing, distribution, and pricing of OTCs.

Common concerns about OTC medications: Inappropriate use and adverse effects
The concerns about misuse, adverse effects including dependence (especially to sedatives, painkillers, antacids, laxatives), drug resistance, and delayed diagnosis of underlying conditions due to use of OTC medicines pose formidable challenges.

As per the National survey data submitted by Substance Abuse and Mental Health Services administration (SAMHSA) in US, about 3.1 million people aged 12 years and older have misused OTC medications at least once in their lifetime (3.7% in < 18 years old).A meta-analysis by Frei et al., threw light on the fact that over half a million Australians use analgesics over the counter for non medical purpose and OTC medicines are the third most common form of substance abuse in Australia. Similarly, in Canada, it was found that OTC medicines were widely abused.In India, abuse of OTC medicines is not well documented. One report mentions that cough syrups and antihistamine medications sold over the counter are a prevalent form of drug abuse in India.

Despite their importance, instructions for use printed on the labels of OTC medicines are often inadequate, filled in small space and are in such a format, often missed by patients. Astudy from India assessed whether labels of 100 nonprescription medicines complied with the requirements mentioned in the US FDA guidelines. It was found that 87% of the labels lacked information regarding contraindications. In 90% of the labels, adverse effects and in 96% information about their use during pregnancy and breastfeeding were missing. Overall, the label instructions were inadequate and had the potential of harming the patient’s health.Even though antimicrobials belong to the category of prescription drugs in India, they are dispensed without a prescription raising the concern regarding antimicrobial resistance as dosing and duration of such medicine courses are not properly guided or maintained.The ready availability of OTC drugs places the weakest individuals of our country at greatest risk—these are the patients from low socioeconomic strata, the elderly and others taking multiple medications, and some illiterate individuals who are not capable of evaluating safety information mentioned on the drug label. 

Optimising use of OTC medicines
Actions should be initiated under the following heads:

Prescription monitoring programs 

Prescription monitoring programs (PMPs) are useful which collect, monitor, and analyse electronically transmitted prescribing and dispensing data submitted by pharmacies and dispensing practitioners. But this will need a good infrastructure supported by govt. agency.

Spreading awareness through news and electronic media is an effective method to optimize the use of OTC medicines.

Adequate labeling 

Due to the diversity in languages spoken throughout India, apart from English, it will be appropriate to have labels in local languages for OTC drugs. Label instructions should be simple and understandable by common and less educated people. Doses specification, especially for children, is most important. It is also important to clearly mention the indications, warnings, and directions for use since the drugs are administered without medical guidance.

Distribution and delivery of OTC drugs 

India is still struggling to provide essential health care to remote places. New ways to deliver the OTC drugs to the rural population have to be conceived. India has almost 1,50,000 post offices and 9,00,000 pharmacy shops. If the services of post offices are used, the reach will dramatically increase.Conversely if the drugs are provided in places other than the pharmacy shop, then conditions necessary for proper storage need to be strictly followed.

Establishment of a subcommittee to categorize OTC drugs 
The Drugs Consultative Committee (DCC) on 18th September 2017 recommended the creation of a separate category for OTC drugs which can be legally sold over the counter. This was an important step to have a proper system to clarify all the doubts.


We need to recognise OTC medicines as a separate category of drugs in India.Earlier is better.But, at the same time,we have to understand that OTC medicine can act as a double-edged sword and due consideration has to be given to safety, abuse, and patient education in this regard. Appropriate regulation for classification, distribution, and sale of OTC medicines is the need of the hour. Strategies should be developed by the Govt. Authorities  to enhance awareness of all concerned.The pharmacists can be asked to take a strong role in this movement. Manufacturers can use pictorial description to allow safe use of such products especially by the less educated population. Surveillance for reporting of adverse effects of OTC drugs needs to be strengthened. All stakeholders must join hands to rationalise use of OTC medicines in India.

(while writing this article help taken from study materials available online and expert’s opinions published in PubMed/nida.nih.gov/MedlinePlus.gov/www.fda.gov)