The government of India has issued an order to prohibit the use of a common anti-cold drug combination for children below the age of four years, citing safety concerns and lack of therapeutic justification. The drug combination, known as fixed-dose combination (FDC), consists of two ingredients: chlorpheniramine maleate and phenylephrine. The order, which was issued on December 18 and made public on Wednesday, requires drug manufacturers to label their products accordingly and stop selling them to the pediatric population.
FDC linked to child deaths
The ban on the anti-cold drug combination comes as India learns from a series of child deaths since 2019 that authorities linked to toxic cough syrups made in the country. According to a report by the National Commission for Protection of Child Rights (NCPCR), at least 17 children died in Jammu and Kashmir in 2019 after consuming a cough syrup containing diethylene glycol, a toxic substance used in antifreeze. The report also found that the cough syrup was manufactured without proper quality control and testing, and was sold without a prescription.
The NCPCR report recommended that the government should ban the use of FDCs for children, as they pose a risk of overdose, adverse reactions, and drug interactions. The report also suggested that the government should regulate the manufacture, sale, and distribution of cough syrups and other pediatric medicines, and ensure that they are safe and effective.
No therapeutic justification
The government’s order to ban the anti-cold drug combination was based on the recommendations of an expert committee, which examined the safety and efficacy of the FDC. The committee found that there was no therapeutic justification for the FDC, and that it may involve risk to human beings. The committee also noted that the FDC was not approved by the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority for drugs in India.
The committee observed that the FDC was irrational and unscientific, as it combined two drugs with different pharmacological actions and indications. Chlorpheniramine maleate is an antihistamine, which is used to treat allergic reactions and reduce nasal congestion. Phenylephrine is a decongestant, which is used to relieve nasal congestion caused by colds, allergies, or sinusitis. The committee stated that the FDC did not offer any additional benefit over the individual drugs, and that it may increase the risk of side effects such as drowsiness, dry mouth, insomnia, and hypertension.
The committee also pointed out that the FDC was not in accordance with the World Health Organization’s (WHO) guidelines on the use of cough and cold medicines for children. The WHO advises against the use of antihistamines and decongestants for children under the age of 12 years, as they have no proven efficacy and may cause harm. The WHO also recommends that cough and cold medicines should not be used for children under the age of six years, and that they should be used with caution and under medical supervision for children between six and 12 years.
Public interest and consumer awareness
The government’s order to ban the anti-cold drug combination is a step towards ensuring the safety and well-being of children in India. The order also reflects the public interest and consumer awareness that have been raised by various civil society groups and activists, who have been campaigning against the irrational and harmful use of FDCs for children. One of the prominent voices in this campaign is the All India Drug Action Network (AIDAN), a coalition of NGOs working on health and drug issues.
AIDAN has been advocating for the rational use of drugs and the regulation of FDCs in India for several years. AIDAN has also challenged the legality and validity of several FDCs in the courts, and has demanded that the government should ban all irrational and unsafe FDCs in the country. AIDAN has welcomed the government’s order to ban the anti-cold drug combination for children, and has called it a “most welcome news”. AIDAN has also urged the government to take further action to ban other irrational and harmful FDCs, and to ensure that the drug regulatory system in India is transparent, accountable, and responsive to the public health needs of the people.