Cough syrup rules change: Mumbai docs explain why self-medication is dangerous 

​

The Ministry of Health and Family Welfare has made an amendment to the Drugs Rules, 1945 to exclude the word “Syrups” from Entry 7 under Serial No. 13 of Schedule K of the rules under the heading `Class of Drugs`. Schedule K of the 1945 rules provides exemptions from certain provisions of the Drugs and Cosmetics Act, 1940. 

It simply means that before the amendment, a provision allowed cough syrups to be sold in smaller villages with a population of less than 1,000, without requiring compliance with some retail sale licensing norms. However, now the sale will be required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules framed within it. 

The Health Ministry has said that the amendment has been done to strengthen regulatory oversight of syrup formulations and to align the exemption framework with contemporary public health and safety requirements. It further added that the measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country. 

While the amendment is timely, what does it mean and why is it necessary? mid-day spoke to three Mumbai doctors – Dr Manjusha Agarwal, consultant- Internal Medicine, Gleneagles Hospital, Dr Amit P Ghawade, consultant – Paediatrician and Neonatologist, Kharghar, Navi Mumbai, and Dr Jay Bhanushali, pulmonologist, Zynova Shalby Hospital, to understand more about what this means for not only the sale but also the consumption of cough syrup, not only for children but also parents, and adults too. 

The Mumbai doctors not only highlight why it is important but also break down common myths that people have about cough syrup, and why unregulated consumption can be harmful too. 

The Union Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, withdrawing a regulatory exemption that previously allowed the sale of cough syrups in villages. What does it mean for access to cough syrups? Does this also change for cities? 
Dr Agarwal: The amendment means cough syrups cannot be sold freely in villages without adhering to the same regulatory requirements applicable elsewhere. It aims to promote safer and more rational use of cough medicines, reducing misuse and self-medication. The rules in cities may remain unchanged, as these regulations were already being followed in urban areas.

Dr Ghawade: The amendment ensures that cough syrups are used more responsibly in children, reducing the risk of inappropriate self-medication and dosing errors. The change mainly affects rural areas where exemptions existed. 

Dr Bhanushali: This promotes more responsible use of cough syrups and reduces the risk of self-medication for respiratory symptoms that may require proper diagnosis. It ensures that persistent coughs are evaluated by the doctors rather than being repeatedly treated with over-the-counter remedies. The impact will be greater in rural areas. 

Why is it important for the sale of cough syrups to be regulated, and only available through prescriptions? 
Dr Agarwal: Regulating the sale of cough syrups helps prevent misuse, overuse, and accidental side effects, especially with formulations that may contain sedating or habit-forming ingredients. Prescription-based use ensures the underlying cause of the cough is properly diagnosed and treated. It also reduces the risk of masking serious illnesses and inappropriate self-medication. 

Dr Ghawade: In children, cough syrups can cause side effects if used unnecessarily or in the wrong dose, making medical supervision essential. Prescription-based use helps ensure the correct medicine is given for the child`s age, weight, and underlying condition, improving safety and effectiveness. 

Dr Bhanushali: Many respiratory conditions, such as asthma, tuberculosis, pneumonia, or chronic lung disease, can initially present as a cough, and self-medicating with cough syrups may delay proper diagnosis and treatment. Prescription-based use helps ensure that the underlying cause of the cough is identified and managed appropriately.

What are the common misconceptions that people have about cough syrups? 
Dr Agarwal: A common misconception is that cough syrups are completely harmless and can be taken without medical advice for any cough. This is not true, so don’t take any cough syrup on your own, as doing so can be dangerous to your health.  Many people also believe that higher doses provide faster relief, which can be dangerous. Another myth is that all coughs require syrup treatment, whereas some may resolve on their own or need treatment for the underlying cause. 

Dr Ghawade: A common misconception is that cough syrups are harmless and suitable for every child with a cough. Many parents also assume that all coughs need medication, whereas many are caused by viral infections that improve with supportive care and time. 

Dr Bhanushali: Many people believe that a cough syrup can cure every type of cough when treatment depends on the underlying cause. Another common misconception is that suppressing a cough is always beneficial, whereas coughing can sometimes be an important protective mechanism that helps clear the airways.

How do cough syrups affect children differently as compared to adults? 
Dr Agarwal: Children are more sensitive to the ingredients in cough syrups because their bodies process medicines differently from adults. Even small dosing errors can lead to side effects such as excessive sleepiness, breathing difficulties, irritability, or accidental overdose. This is why cough syrups should only be given to children under medical supervision and in age-appropriate doses. 

Dr Ghawade: Children metabolise medicines differently than adults, making them more susceptible to side effects such as excessive drowsiness, irritability, breathing difficulties, or accidental overdose. Even small dosing errors can have a greater impact on a child`s developing body. 

Dr Bhanushali: Children have smaller airways and different drug metabolism, making them more sensitive to the effects of cough syrup ingredients. Certain medications can cause excessive drowsiness, breathing difficulties, or other side effects in children that are less common in adults.

What makes cough syrup potentially risky? Why is correct doctor-advised dosage important? 
Dr Agarwal: Cough syrups can be risky because some contain ingredients that may cause drowsiness, allergic reactions, breathing problems, or harmful drug interactions if used incorrectly. Doctor-advised dosing is important to ensure the medicine is appropriate for the patient`s age, weight, and underlying condition. Correct use improves safety while reducing the risk of overdose, misuse, and unnecessary side effects. 

Dr Ghawade: Cough syrups can be risky in children because some ingredients may cause drowsiness, breathing problems, allergic reactions, or other side effects if not used appropriately. Doctor-advised dosing is crucial as it is based on the child`s age, weight, and health condition. Correct dosing helps ensure safety while avoiding overdose and unnecessary medication exposure. 

Dr Bhanushali: Some cough syrups can mask symptoms of serious respiratory illnesses or cause side effects such as drowsiness and drug interactions when used incorrectly. A doctor-recommended dose ensures the medication is appropriate for the patient`s age, condition, and the underlying cause of the cough.

Who should avoid taking cough syrup without a doctor`s advice? Are there any vulnerable populations to cough syrup?
Dr Agarwal: Young children, older adults, pregnant women, and people with chronic conditions such as asthma, liver disease, kidney disease, or those taking multiple medications should avoid using cough syrups without medical advice. These groups are more vulnerable to side effects, drug interactions, and dosing-related complications. 

Dr Ghawade: Children, particularly toddlers and infants, should never receive cough syrups without medical guidance, as their bodies are more sensitive to medication effects. Extra caution is also needed in children with allergies, asthma, or other chronic illnesses. A paediatrician can determine whether the cough requires medication at all and prescribes the safest option if needed. 

Dr Bhanushali: People with asthma, chronic lung diseases, sleep apnoea, liver disease, and those taking multiple medications should avoid using cough syrups without medical advice. Children, older adults, and individuals with underlying respiratory conditions can experience side effects.