Why Are Codeine-Based Cough Syrups Regulated? Safe Use, Side Effects And Red Flags Explained

In recent weeks, drug regulatory and enforcement agencies in India have launched widespread raids and filed cases against illegal suppliers of codeine-based cough syrups, highlighting both their therapeutic uses and the risks associated with misuse. The Enforcement Directorate conducted raids at 25 locations across Uttar Pradesh, Jharkhand and Gujarat in a crackdown on a large trafficking network involving these syrups, leading to an Enforcement Case Information Report (ECIR) against 67 individuals. Separately, a medical supply firm in Bareilly, Uttar Pradesh was charged by the Food Safety and Drug Administration (FSDA) for selling codeine cough syrup without proper documentation and records, indicating ongoing efforts to clamp down on illegal pharmaceutical distribution.

So, what's the big deal about codeine-based cough syrups, and why are these heavily regulated by authorities? Codeine is an opioid medicine traditionally used in cough syrups to quiet severe coughing when other treatments fail, but its narcotic effects also make it susceptible to misuse and addiction. This has drawn regulatory scrutiny in India under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985.

Here's a closer look at what codeine is, how cough syrups containing it are meant to be used, their correct dosage, common side effects, safety precautions and more.

What Is Codeine And How Does It Work?

Codeine is a member of the opioid family, the same class of drugs that includes morphine and other pain relievers. It works by acting on the brain's cough-control centre and suppressing the reflex that triggers coughing, making it useful for moderate to severe coughs that do not respond to first-line treatments. Codeine is also used as a mild pain reliever. 

In cough syrups, codeine is typically combined with other agents such as guaifenesin (an expectorant) and sometimes antihistamines to reduce cough severity. Because it affects the central nervous system like other opioids, codeine has narcotic properties, which is why its distribution is regulated and it's usually available only by prescription.

The US Food and Drug Administration (FDA) notes that codeine is metabolised in the liver into morphine, and a portion of the population, especially children, may convert it rapidly, leading to dangerously high morphine levels. For this reason, its use in certain age groups and conditions is restricted.

Also Read: What Hit India's Health Hardest In 2025? Toxic Cough Syrups, Antibiotic Resistance And More

Approved Medical Uses Of Codeine-Based Cough Syrups

Codeine-based cough syrup is prescribed for:

• Severe cough due to upper respiratory infections when other treatments have failed
• Cough suppression in palliative or chronic conditions, under strict supervision
• Sometimes used for pain relief, though less common with cough syrup formulations

Because its benefit must outweigh its risk of sedation and respiratory depression, codeine syrup is not a first-choice for ordinary coughs and colds. Regulatory agencies in many countries have tightened guidelines around its use, especially in children, due to safety concerns.

Dosage: How Codeine Syrup Is Used in Medicine

The correct dose of codeine depends on the patient's age, weight and overall health, and should always be determined by a doctor. According to professional drug information sources, codeine cough syrup doses are generally kept as low as possible to achieve relief and minimise addiction risk.

• For adults in cough suppression: 10-20 mg orally every 4-6 hours, not exceeding 120 mg in 24 hours.
• Codeine is not recommended for children under 12 years old for cough treatment because of the elevated risk of serious breathing problems.
• Because codeine can cause drowsiness and impair coordination, patients are often advised not to drive or operate heavy machinery until they know how it affects them.

Common Side Effects And Risks Of Codeine-Based Cough Syrups

Despite therapeutic use, codeine-based syrups have several side effects, even at appropriate doses:

• Drowsiness and sedation
• Constipation
• Nausea and vomiting
• Dizziness or confusion
• Dry mouth

More severe reactions can occur, especially with misuse or higher doses:

• Respiratory depression, like slowed breathing, which can be life threatening
• Dependence and addiction due to its opioid nature
• Withdrawal symptoms if stopped suddenly after long-term use
• Overdose risk when combined with other depressants like alcohol or benzodiazepines

Because of these risks, medical authorities emphasise the smallest effective dose for the shortest duration to reduce the likelihood of dependence.

Also Read: Toxic Cough Syrup, Deadly Fallout: Here's How The Public Health Crisis Unfolded

Safety Precautions: What You Must Know

Patients prescribed codeine cough syrup should follow these precautions:

• Use Only With a Valid Prescription: Codeine is a controlled substance, and selling or buying it without proper medical supervision is illegal under the NDPS Act in India.
• Avoid in Children: Because of unpredictable metabolism and risk of respiratory depression, children are at particular risk. Most regulatory agencies strongly advise against codeine in children under 12 years.
• Discuss Medical History: Inform your doctor about these problems before they prescribe - Asthma or breathing problems, liver or kidney disease, history of substance misuse, use of other sedatives or CNS depressants. This is important because co-use with other depressants can dangerously slow respiration. 
• Avoid Alcohol: Alcohol amplifies sedation and respiratory depression risks when taken with codeine. Avoid alcohol during treatment.
• Monitor for Dependence: Prolonged use can lead to tolerance and physical dependence. Do not increase doses without doctor guidance.

Why Codeine Syrup Misuse Has Become a Law Enforcement Issue

While medically useful, codeine cough syrups have also been diverted into recreational misuse due to their opioid properties, leading to sedation and, in some cases, dependence or addiction. This non-medical use has prompted crackdowns in several Indian states.

In Uttar Pradesh, the Enforcement Directorate's raids across 25 sites targeted a large illegal trafficking network suspected of diverting codeine syrups outside legal supply chains. Similarly, an FSDA inspection in Bareilly uncovered a supplier selling tens of thousands of codeine syrup bottles without proper records, leading to FIRs under the Bharatiya Nyaya Sanhita.

These actions underscore the dual reality that while codeine syrups have a therapeutic role, unregulated sale and misuse pose public health and legal risks.

Codeine-based cough syrups are legitimate medicines for specific, severe coughs, but their opioid nature, potential for misuse and side effect profile require strict medical supervision. Appropriate dosing, adherence to prescription instructions, and awareness of safety precautions are essential to prevent adverse outcomes.

The recent enforcement actions in India highlight systemic problems of illegal diversion and abuse, not the medicine's inherent value when properly used. Understanding both the therapeutic role and risks of codeine cough syrups can help patients use them safely while authorities work to curb misuse.

Disclaimer: This content including advice provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.