Lapses in India’s drug regulatory structure, what needs to change: Dr Kafeel Khan

A series of child deaths linked to contaminated cough syrup in Madhya Pradesh has reignited concerns about India’s drug safety system. The syrup, manufactured by Tamil Nadu-based Sresan Pharmaceuticals, was found to contain diethylene glycol (DEG), a toxic chemical that has caused similar tragedies in Gambia and Uzbekistan. The Federal spoke to Dr Kafeel Khan, senior paediatrician, about the lapses in India’s drug regulatory structure and what needs to change.

Do doctors have any system to verify if a drug like a cough syrup is safe before prescribing it?

There are two systems of regulation — one at the state level and the other at the central level under the Central Drugs Standard Control Organisation (CDSCO). But the problem is that doctors are not notified when a contamination alert or recall is issued.

There is no active recall mechanism that alerts every doctor in real time. Contamination is a testing failure — not something a doctor can detect in an outpatient setting. A paediatrician prescribing a syrup cannot possibly test it for diethylene glycol. The responsibility for this lies entirely with the Drug Regulatory Authority of India.

Also Read: Cough syrup deaths: CAG report already flagged regulatory lapses in TN last year

The Health Ministry has now advised against prescribing cough syrup to children under two years. What are the safe, evidence-based alternatives?

When we were trained in paediatrics, our professors would remind us that common cold and cough are natural occurrences in children under five. They happen four to six times a year as their immune system develops.

As I tell my students, “If you treat a cold, it will go in seven days; if you don’t, it will go in a week.” The duration remains the same. Instead of cough syrups — especially central suppressants or fixed-drug combinations — doctors should stick to simple remedies.

For children under two, I only recommend saline nasal drops, steam inhalation, keeping them warm and hydrated, and giving paracetamol if there’s fever or discomfort. Homemade remedies like honey (for children over one year), warm fluids, kadha, or neem leaves water are also effective.

But parents should watch for signs of breathing distress — if the child’s breathing rate crosses 60 per minute (under two months), 50 per minute (two to twelve months), or 40 per minute (one to five years). That’s when medical attention is urgently needed.

Also Read: Cough syrup deaths: SC rejects PIL seeking inquiry, nationwide drug safety review

Parents are now anxious about using over-the-counter syrups. How can they verify what’s safe?

Every bottle should have a scannable QR code so that parents can instantly access safety information — warnings, age restrictions, and recall alerts. In this digital era, this is entirely possible.

The government should also introduce a single national recall portal that lists all unsafe or contaminated drugs, updated in real time. There must be strict random market testing, but corruption among drug inspectors often undermines this.

Many medical shops, especially in rural areas of Uttar Pradesh, Bihar, Madhya Pradesh, West Bengal, and Rajasthan operate without qualified pharmacists. That’s dangerous. Also, nearly half of Indian parents buy cough syrups over the counter without a doctor’s prescription. Public awareness must improve along with regulation.

Also Read: Toxic cough syrup scare: Govt launches crackdown, notifies WHO of recall

What systemic gaps led to the current tragedy in Madhya Pradesh, and how can the drug control system be strengthened?

This is not the first case of DEG contamination. In 2019, a similar incident in Jammu and Kashmir killed several children. Indian-made syrups have also caused deaths in Gambia, Uzbekistan, and Cameroon — over 300 in total.

The WHO has already issued warnings, and India released fresh quality-control guidelines in June 2023. But ground implementation is weak due to corruption and lack of monitoring.

Random testing should be transparent and supervised nationally. A single, central recall system would prevent tainted drugs from staying on the market. Bottle-scanning technology can empower both doctors and parents to make safer choices.

Also Read: Cough syrup deaths: Centre to test, inspect, audit all manufacturers

Dr Praveen Soni, the paediatrician who prescribed the contaminated syrup, has been arrested. How do you see this in terms of accountability?

There’s a clear difference between medical negligence and criminal negligence. If a doctor knowingly prescribes a banned combination drug or gives it to a child under the wrong age group, that’s medical negligence.

But when a doctor prescribes a drug that’s later found to be contaminated — something beyond his control — that’s not criminal. Arresting a doctor for that is scapegoating. The accountability lies with the manufacturer and the regulatory authorities.

Also Read: Cough syrup deaths: TN govt not cooperating, it needs to take 'concrete steps', says MP CM Yadav

Finally, what precautions can parents take to reduce respiratory infections in children?

Parents should consider giving their children the influenza vaccine once a year. It may not prevent every infection, but it significantly reduces the frequency, severity, and duration of cold and cough episodes in children under five. It’s a safe and effective preventive step.

(The content above has been transcribed from video using a fine-tuned AI model. To ensure accuracy, quality, and editorial integrity, we employ a Human-In-The-Loop (HITL) process. While AI assists in creating the initial draft, our experienced editorial team carefully reviews, edits, and refines the content before publication. At The Federal, we combine the efficiency of AI with the expertise of human editors to deliver reliable and insightful journalism.)