Last month, the Central government restricted use of a common cold drug combination for children under the age of four, and also asked manufacturers to include a warning on the label and package insert or the promotional literature of these drugs in this regard.
This fixed drug combination (FDC), present in several popular brands of cough syrups for children, consists of chlorpheniramine maleate and phenylephrine hydrochloride. While chlorpheniramine is an antihistamine, used to relieve allergy-like conditions such as a runny nose, watery eyes and sneezing, phenylephrine is a decongestant that works by narrowing small blood vessels, providing temporary relief from inflammation.
In a gazette notification issued on April 15, the Union Ministry of Health stated that this FDC was likely to involve risk to children below four years of age and safer alternatives to this drug are available. The matter was examined by a Subject Expert Committee, following which the restrictions were imposed.
Good news for paediatricians
For paediatricians across the country, the ban is a welcome move. Rajath Athreya, lead neonatologist and senior consultant paediatrician at Rainbow Children’s Hospital, Sarjapur Road in Bengaluru said the combination of a sedative antihistamine like chlorpheniramine maleate along with phenylephrine was irrational in the first place. “Phenylephrine, which is a decongestant, can also have effects on heart beat and blood pressure. These effects are unpredictable in young children and hence, there has been concern about the use of the drug in this age group,” he said.
T.U. Sukumaran, a specialist in paediatric pulmonology and behavioural medicine from Kerala, pointed out that first-generation antihistamines – drugs that block the action of histamines that can cause a fever, itching, runny nose, and watery eyes – such as Chlorphenaramine should not be given to children aged less than four in any case, as they could produce complications in this age category.
Explaining further, Vibhu Kawatra, pediatrician, pulmonologist and allergy specialist based in New Delhi said that the main issue with first generation antihistamines is that of respiratory depression and apnoea. Many over-the-counter syrups and drops however, contain chlorpheniramine due to its antihistamine properties as well as its side effect of drowsiness to calm the child, despite the risk of sudden death that could occur with its use. Over a period of time, he said, a newer generation of antihistamines evolved making chlorpheniramine redundant.
Paediatricians pointed out that second-generation antihistamines such as cetirizine and fexofenadine were safer alternatives.
Unclear communication, say pharmacists
For pharmacists however, some amount of confusion has prevailed over whether or not prescriptions can be honoured and what can be done with existing stock. This was complicated by petitions moved by several pharma companies in the Delhi High Court praying for the quashing of the gazette notification. The Court however ruled on April 24 that the restriction would apply prospectively, and not retrospectively, and also directed the pharma companies to issue notices in national newspapers and issue advisories to doctors, chemists and retailers with regard to the ban. However, no coercive action would be taken with respect to the stock manufactured and/or in circulation on or before April 15, the Court stated.
B. Thirunavukkarasu, president, Bangalore District Chemists and Druggists Association, raised serious concerns over the communication of the ban to pharmacies, “While we welcome the government’s move to protect children’s health, the way this ban has been communicated and managed has caused widespread confusion and risk within the pharmaceutical supply chain,” he said. Pointing out that there was a lack of formal communication from manufacturers and wholesalers to retailers, Mr. Thirunavukkarasu said retail chemists, who are expected to comply immediately, have not even received circulars from many companies or the State Drugs Controllers’ office. As a result, stocks are still available in pharmacies.
“It is the responsibility of manufacturers to collect the banned stock through their medical representatives or to officially instruct their authorised distributors to retrieve the same. Retailers cannot bear the financial or legal brunt for holding stocks they procured legally before the ban,” he added.
A.N. Mohan, president, All Kerala Chemists and Druggists Association, however said that chemists have been allowed to sell their existing stock of this FDC, in line with the Delhi High Court judgement. M. Anandan, general secretary of Tamil Nadu Pharmacists Welfare Association, pointed to a wider problem: inadequate drug inspectors to enforce regulations. In T.N., for instance, where there are 90,000 pharmacies, the State has just 200 drug inspectors, he said. He also noted that many pharmacies were not run by qualified pharmacists which contributed to the problem of proper drug dispensation.
Aggressive medical treatment warranted?
Paediatricians said it is important to know what is causing the cough or cold rather than rushing to medicate the child.
Mohandas Nair, professor, department of pediatrics, Government Medical College Hospital, Kozhikode, explained that the most common type of cough in children is associated with viral upper respiratory tract infections that only last for a few days. In such cases, symptomatic treatment was not essential – the FDC would only add to the cost of treatment apart from its undesirable potential side effects, he said.
Other causes of a cough could be: asthma, gastro-oesophageal reflux, or post-nasal drip – secretion in the back of the throat or nose. For asthma, doctors recommend inhaled salbutamol, while occasionally inhalers or nebulisers are prescribed, while for post-nasal drip, proper positioning while sleeping could help. Across the board doctors say simple home remedies such as warm water and honey can go a long way.
Colds too, could be caused by viral infections, and in most cases, do not require aggressive treatment, they said. As a senior paediatrician in Chennai noted: “The coughing disturbs the parent more than the child. We have tried to reduce prescribing medicines wherever possible.” Dr. Kawatra said that parents must also be responsible: they must refrain from buying cough syrups without prescriptions and must not medicate their children without consulting a doctor.
Disseminating information
While the restriction has been welcomed, doctors also point to the need for widely disseminating information about it. Madap Karuna, a paediatrician based in Hyderabad said that professional bodies should use their continuing medical education programme platforms to share updated protocols and it was essential for information to be circulated to all associations of doctors and pharmacists. “If well-informed groups like us are not kept in the loop, how can we expect the general public to follow safe practices?” she asked. She also noted that there needed to be stringent protocols in place to ensure no banned medications were available in the market at all.
(With inputs from Afshan Yasmeen in Bengaluru, A.S. Jayanth in Kerala, R. Sujatha in Chennai, Bindu Shajan Perappadan in Delhi and Siddharth Kumar Singh in Hyderabad.)
Published – May 16, 2025 08:30 am IST