Prescription Not Needed? The Silent Epidemic of Over-The-Counter Medicine Use in India.

In India, it is not uncommon for people to walk into a pharmacy and walk out with medicines—all without ever seeing a doctor. Over-The-Counter (OTC) medicine use has become deeply entrenched in everyday health behaviour. While some OTC access makes healthcare more accessible, the scale, ambiguity, and risks of such non-prescribed medicine use are rising. This article delves into the landscape, regulatory gaps, risks, and what may need to change.

Understanding OTC Medicine Use in India

• What counts as OTC in India?

India does not yet have a fully codified or legally detailed category for OTC drugs in the Drugs & Cosmetics Act or Rules. Drugs that are not explicitly in the prescription-only schedules—Schedules H, H1, X—can often be dispensed without a doctor’s prescription. Some substances under Schedule G also don’t require prescriptions, though they carry mandatory caution labels. (SpringerLink)

• Regulatory moves & clarifications

The National Medical Commission (NMC) in August 2023 notified a list of therapeutic categories of drugs that can be sold without prescription: anti-hemorrhoid agents, topical antibiotics, cough suppressants, anti-acne drugs, NSAIDs, antacids, decongestants, antihistamines etc. However, it did not list specific drug names, which has led to ambiguity in practice.(The Hindu)

There has also been policy discussion via the Drugs Technical Advisory Board (DTAB) to formally define OTC rules. Draft proposals have included permitting certain medicines like analgesics, cough syrups, anti-fungals, and antiseptics to be sold without prescriptions. (PharmaTutor)

• Prevalence of self-medication

Multiple studies and articles note that self-medication is common across the country, often for mild symptoms such as coughs, colds, aches, fevers, or allergies. The reasons include cost, access issues, advice from family/friends or pharmacists, and convenience. (India Today)

Risks & Consequences

OTC access without proper oversight carries several risks:

1. Misuse and Incorrect Self-Diagnosis

Many ailments (e.g. cough, cold) are viral and resolve without medications. Using antibiotics or strong medicines unnecessarily can mask symptoms, delay correct diagnosis, and worsen conditions. (India Today)

1. Antibiotic Resistance

A major public health threat. When antibiotics are used without indication (especially for viral illness) or not used correctly (wrong dose/duration), resistance builds up. (India Today)

1. Adverse Drug Reactions / Toxicity

Drugs like painkillers/paracetamol may damage liver/kidney if overdosed. Some OTC cough syrups may contain harmful chemicals or be substandard. Recent public health incidents (child deaths linked to cough syrups) are reminders of this risk. (Reuters)

1. Dependency / Misuse of Certain Drugs

Some cough suppressants, sedating antihistamines, or combination syrups can lead to sedation, dependency, or harmful side effects, especially in children. (The Times of India)

1. Lack of Oversight, Quality & Counterfeit Risk

With many drugs being procured without prescription, quality control may suffer. Counterfeit/substandard or contaminated batches may enter the supply chain. The Coldrif cough syrup incident (toxic contamination) is a stark example. (Reuters)

1. Regulatory Ambiguity

Because India does not yet legally define OTC medicine categories clearly, there is confusion among pharmacies, regulators, and consumers about what can or cannot be sold. This leads to inconsistent enforcement. (SpringerLink)

Case in Point: Cough Syrups, Toxicity & Recent Outbreaks

Recent reports have revealed serious consequences tied to OTC/over-dispensed cough syrups:

• Child fatalities have been reported in Madhya Pradesh and Rajasthan allegedly due to consumption of a cough syrup (“Coldrif”) with dangerously high levels of diethylene glycol (DEG), a toxic solvent. Authorities have initiated inspections, banned certain batches, and in some states made prescription mandatory for cough syrups. (Reuters)
• In Kerala, a circular has been issued prohibiting sale of cough syrups without prescription, particularly for children under two. Pharmacists have been instructed to verify regulatory approval and dosage instructions. (The Times of India)

Why It Happens: Social, Economic & Structural Drivers

Several factors contribute to this “silent epidemic”:

• Cost and access: Seeing a doctor involves cost, travel, waiting time, and sometimes loss of daily wage. For many, pharmacies are closer/more affordable.
• Trust in pharmacists: Many people see the pharmacist as a de facto health advisor. For mild ailments, advice is often accepted without questioning.
• Cultural patterns: Use of home remedies, family advice, “know someone who used this” kind of solutions.
• Weak regulatory clarity: Because the law has gaps / ambiguity in what is “OTC” and what requires prescription, enforcement is uneven.
• Online commerce & quick delivery: Easier access to medicines via online portals, often with poor checks, exacerbates the issue. (The Hindu)

What Has Been Done – Regulatory Responses

• The National Medical Commission listing therapeutic categories allowed without prescription is a first attempt to clarify. (The Hindu)
• Several state governments have issued rules making certain medicine sales conditional on prescriptions (e.g. Kerala’s recent direction on cough syrups). (The Times of India)
• The chemists’ associations (e.g. AIOCD) have raised concerns about unregulated OTC expansion, especially about misuse, drug quality, and incorrect dispensing. (The Hindu)
• There is active policy discussion via bodies like DTAB to draft clearer definitions / rules for OTC medicines. (PharmaTutor)

What Needs to Change: Towards Safer OTC Use

To address this silent epidemic, multiple stakeholders need to act. Here are some suggestions:

1. Legal clarity / regulation
   • Formalize a clear OTC category of medicines via legislation or rules, with a defined list of specific drugs, not just therapeutic categories.
   • Define controls (dosage limits, label requirements, packaging, warning labels) for OTC drugs.
2. Pharmacist-led oversight
   • Pharmacists should be properly trained, and their role in advising / guiding OTC sales should be strengthened.
   • Enforce pharmacist responsibility: checking for contraindications, age limits (especially children), safe dose.
3. Public awareness & education
   • Educate consumers about risks of self-medication, dangers of misuse (especially in children), antibiotic resistance, side effects.
   • Promote use of teleconsultation or quick medical advice for mild ailments rather than relying solely on pharmacy advice.
4. Strengthened enforcement & quality control
   • Regular market surveillance, lab-testing of batches (especially cough syrups, combination products) for contaminants, toxic solvents, expiry etc.
   • Swift recall and transparency when any unsafe batches are found.
5. Prescription conditions for risky categories
   • For certain medicines (e.g. codeine-containing cough suppressants, strong sedatives, potent antibiotics), make prescription mandatory without exception.
6. Online regulation
   • Tighten regulation of online pharmacies and quick-commerce platforms to ensure prescriptions are verified.
   • Transparent labelling, batch numbers, digital verification (QR codes etc.).

Conclusion

OTC medicine use in India is a double-edged sword. On one hand, it offers accessibility, affordability, and serves health needs, especially for mild ailments. On the other hand, when medicines are used without adequate oversight—often with unverified information, ambiguous regulation, or absence of medical advice—it can lead to serious health risks, dependency, and even tragedies, particularly among vulnerable populations like children.

To navigate this balance, India needs clearer legal frameworks, better regulation, stronger pharmacist roles, and informed public behaviour. Without this, what begins as convenience can become a threat to public health—a silent epidemic in the making.