To be over-the-counter or not to be – That is the question: Reconsidering over-the-counter access – When convenience becomes a public health risk

INTRODUCTION

In our country, where a fast-paced life, desperation for conveniences, and craving for instant solutions are the norm, “over-the-counter” (OTC) medications have become everyday tools for self-care. They promise relief without a prescription, freedom from waiting rooms, and control over minor ailments. However, some drugs available “OTC” today arguably belong behind the pharmacy counter, “not to be OTC” – not to restrict, but to protect.^[1]

In India, with its vast, diverse, and one of the largest pharmaceutical markets (with more than 80,000 brands) and where access to healthcare is often uneven, the pharmacy counter has quietly become a surrogate clinic. With minimal regulation and oversight, often without any clear classification, a wide array of drugs – from cough syrups to antibiotics and painkillers – are sold OTC, often without a prescription.^[2] The pharmacies or what is colloquially called “Medical Shops” and their operators also called “Chemists” are often the first point of contact for healthcare. With the widespread availability of medicines and limited regulatory oversight, OTC drug dispensing is a prevalent and largely unmonitored practice. While convenient for patients, especially in rural and underserved areas, providing essential relief to them, the unrestricted sale of OTC medications, especially high-risk drugs, without proper guidance or documentation poses serious public health risks, such as misuse, resistance, addiction, and preventable hospitalizations.^[3] In addition, certain other occurrences such as excessive drug dosage, polypharmacy, drug abuse, and drug interactions also raise an uncomfortable public health question: “Should all these drugs really be available so freely, OTC?”^[4]

The very premise of OTC availability is that consumers can safely use these drugs without a healthcare professional’s oversight. For many medications – mild pain relievers, antihistamines, antacids – this holds true. However, “not all drugs are created equal, and some pose risks that outweigh the benefits of unrestricted access.”

THE OTC PARADOX

India’s pharmaceutical landscape is unique. Unlike countries with clear regulatory distinctions between prescription and non-prescription drugs, India lacks an officially codified and enforced list of OTC drugs. Instead, the market operates in a gray area, governed loosely by the “ancient” Drugs and Cosmetics Act, 1940 and its subsequent amendments. Although the Drugs and Cosmetics Act, 1940 classifies drugs into schedules, such as H, H1, and X, which require prescriptions, many prescription-only drugs are dispensed over the counter in community pharmacies. In addition, drugs such as antibiotics, anti-inflammatory agents, antitussives, and even opioid analgesics are commonly sold without a prescription, often at the discretion of the pharmacist or pharmacy assistant because enforcement of regulations is patchy and, in many cases, non-existent – particularly in semi-urban and rural areas.^[5]

The absence of a legally defined OTC category further dilutes the practice of prescribing. Most Western countries have systems in place that categorizes OTC drugs and prescription drugs based on safety and usage profiles and ensure adherence to these categories; however, India operates with a de facto OTC system that is vulnerable to misuse.^[1]

While OTC access promotes convenience and autonomy, it can come at the cost of safety, especially if:^[6]

• The drug has a high potential for misuse or abuse

• Side effects are serious or hard to self-manage

• The drug interacts dangerously with common medications or conditions

• Proper dosing or diagnosis requires professional guidance.

Here are some examples of drugs that arguably should not be OTC (or at least should have stricter controls):

Take codeine or dextromethorphan (Corex-DX^®)-based cough syrups, still available without a prescription in several countries. Codeine, an opioid, can cause addiction, respiratory depression, and in some cases, fatal overdose – particularly in children. The U.S. has already moved to restrict such products to prescription-only status, but globally, the picture is inconsistent. Abuse of these syrups has sparked public health crises in many countries, including India. When dealing with a drug like codeine or dextromethorphan, the line between medicine and narcotic is dangerously thin.

The most troubling example, especially in the northern states (Punjab and Haryana), is tramadol.^[7] In general, a naïve patient is coincidentally exposed to it, either in the immediate post-operative period by the surgical team or in the orthopedic/surgical or pain clinics for some chronic pain-related issues such as backache or knee pain. Whichever way, this, now “hooked” patient, starts drug-seeking at the local pharmacies, illicitly in connivance with the “co-operative” chemist. Whole generation after generation of productive youths has been utterly destroyed by this drug and now its successor “tapentadol.” A similar routine is being followed in the case of drugs such as gabapentin or pregabalin. Not surprisingly, all of these drugs are available, of course, OTC!

Then, there is pseudoephedrine (SudaFed^®), a common decongestant which is also a key ingredient in methamphetamine. While effective for colds, its misuse in the manufacturing of methamphetamine has led to tighter regulations in some jurisdictions, including ID tracking and purchase limits.^[8] Yet, it remains technically OTC in India. Convenience persists – so does abuse.

Even non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin, which are well and truly OTC, can be hazardous if abused chronically and without medical consultation – leading to numerous adverse effects such as gastrointestinal bleeding, increased risk of bleeding, and liver damage. Using OTC NSAIDs such as ibuprofen, acetaminophen, and diclofenac/aceclofenac as a self-prescribed band-aid for everyday symptoms can lead to masking of more serious medical issues; not to mention, these drugs have their own harmful side effects, to which most people are ignorant.

Perhaps more insidiously, proton pump inhibitors (PPIs) such as omeprazole (Omez^®) lull users into long-term dependence. Marketed for heartburn relief, they can mask symptoms of more serious conditions such as esophageal cancer and carry their own long-term risks – including osteoporosis, kidney disease, and vitamin deficiencies. Yet, they sit on the shelf, marketed for daily use.

Even benign-seeming drugs like diphenhydramine (Benadryl^®) have drawn concern. Misused as a sleep aid, it can cause next-day grogginess and confusion in older adults and has even been implicated in teenage overdoses through social media “challenges.” Its sedative properties and toxic dosage threshold make it a poor candidate for unrestricted use – yet it is often one of the first remedies people reach for.

Despite being classified under Schedule H, corticosteroids in any kind of oral, topical, and injectable formulations are widely sold OTC across the country. Pharmacy shelves carry dexamethasone, betamethasone, prednisolone, hydrocortisone, and potent steroid-antibiotic skin creams, which are readily handed over to patients seeking quick relief from symptoms such as itching, pain, swelling, cough, breathlessness, or even “feeling weak.” Of course, in many instances, neither the patient nor “pharmacist” is aware of the laundry list of adverse effects caused by these “wonder drugs.”

Probably the most abused drugs in healthcare, antibiotics have become more like “nutritional supplements” in any household. Not distinguishing whether their complaints are due to allergies or simple self-limiting viral infections, both the “pharmacist” and patient fervently believe that antibiotics are the “cure-all” for any disease. This, of course, has put India at the forefront of the list of countries with an established antimicrobial resistance (AMR) crisis.

The problem with loperamide (ROKO^®) is that the initial use is definitely for a medical condition – diarrhea. However, it is quickly abused and misused, in the name of convenience, leading to a physiological dependence that has long-term consequences (particularly cardiovascular). The dependence may not always be related to the central nervous system; in some individuals, the act of not having to go to the toilet itself becomes a compulsion.

Benzodiazepines, such as alprazolam (Alprax^®) and lorazepam (Larpose^®), have become household names in India. Dispensed without regulation or prescription, for any number of complaints ranging from “lack of sleep” (insomnia) to “tension” (anxiety) to just feeling good (euphoric), patients simply turn up at the chemist shop and demand a pack of these agents. The unregulated sale of alprazolam and other benzodiazepines without prescription in India is a silent public health threat, contributing to the growing burden of drug dependence, psychiatric emergencies, and preventable deaths.

It is not the purpose of this editorial to criticize the use of these OTC and/or prescription drugs; however, to point out that the indiscriminate and unregulated use of either class of drugs can be detrimental and must be “checked.”

THE IMPLICATIONS OF UNCHECKED ACCESS

The harms of unregulated OTC drug sales are not theoretical – they are real, ongoing, and escalating. Self-medication often leads to delayed diagnosis, adverse drug reactions, and interactions with other medications. The casual sale of antibiotics has turned India into one of the epicenters of AMR, threatening the very foundation of modern medicine.

The economic burden is also considerable. Misuse leads to more hospitalizations, longer treatments, and higher out-of-pocket expenses – particularly devastating for low-income households. Moreover, then, there is the social cost: The growing misuse of codeine and other sedative agents has fed into addiction crises, especially among the youth.

THE CHEMIST CONUNDRUM: LACK OF TRAINING, UNETHICALITY AND IMMORALITY

A significant contributor to unsafe OTC dispensing practices is the widespread lack of formal training, ethical values, and regulatory accountability among retail pharmacy personnel. Although legal mandates require a registered pharmacist to be present at retail counters, in reality, many outlets are staffed by untrained assistants or sales personnel lacking even basic pharmacological knowledge.

• Pharmacological Illiteracy: Many chemists dispense drugs based on anecdotal experiences or commercial incentives, rather than evidence-based recommendations or therapeutic guidelines.

• Malpractice and overreach: In rural and peri-urban India, it is common for pharmacy staff (often not registered pharmacists) to act as informal prescribers – advising on dosages, substituting drugs without medical consultation, and in some cases, selling combinations of medications without any documentation.

• Incentivized Dispensing: Pharmaceutical companies often offer incentives to chemists to push specific brands, further undermining rational drug use. This commercial influence often trumps patient welfare and clinical appropriateness.

• Prescription recycling and duplication – In the absence of electronic health records and e-prescriptions, many a time, patients will reuse the same prescription for months together or fulfill the same prescription at different pharmacies to get more pills – usually in an effort to get their “fix.”

• Neglect of Counseling: Patient education – on dosage, duration, side effects, and contraindications – is virtually absent in most retail settings.

This ecosystem of informal and profit-driven dispensing results in irrational polypharmacy, patient harm, and wider public health fallout.

UNDERLYING CHALLENGES

• Lack of Enforcement: Although Schedule H and H1 drugs require prescriptions, enforcement at the pharmacy level is minimal.

• Pharmacist Shortages: Many retail outlets operate without a qualified pharmacist on site or with pharmacists who are not actively involved in patient counseling.

• Consumer Perceptions: Patients often equate accessibility with safety, believing that easily available drugs are inherently safe.

• Absence of Awareness Campaigns: Public health messaging around rational drug use is limited or nonexistent in most regions.

WHAT NEEDS TO BE DONE URGENTLY? - STRENGTHENING OTC DRUG DISPENSING PRACTICES IN INDIA

To reform the prevailing OTC drug dispensing practices and ensure safe, rational medicine use, India needs a multi- pronged strategy involving policy, enforcement, education, and legal action.

CAN DOCTORS DO PITCH IN TO THWART OTC DRUG MISUSE IN INDIA?

EPILOGUE

While India’s OTC drug dispensing culture stems from a need for accessibility in a resource-limited setting, the current unregulated practices are unsustainable and hazardous. Balancing patient access with public safety requires thoughtful policymaking, robust enforcement, and systemic education. A reformed OTC framework can be a cornerstone of rational pharmacotherapy and a bulwark against the mounting threat of AMR.

Doctors must act not just as prescribers but as educators, advocates, and stewards of rational drug use. By reinforcing ethical dispensing practices and empowering patients with accurate information, clinicians can significantly reduce the misuse of OTC drugs and unregulated dispensing of prescription-only drugs in India. Their collective action can form the backbone of a culture shift toward safer, more accountable medicine use.