India’s drug regulator has banned the use of the famous cough syrup, which is mainly used among children. This ban on cough syrup regulates its use among children, which is not permitted for consumption by children. Know about which cough syrup is banned as we detail everything here.
Highlights Of The Article.
Why The Cough Syrup Ban Happened?:
Central Drugs Standard Control Organisation(CDSCO), a drug regulator in India, has banned the “Fixed Dose Combination syrup” as it is not suitable for consumption by children. This ban comes after the hard-hitting death of 153 children aged below 4 years. 141 Children from Gambia, Uzbekistan, and Cameroon, along with 12 children from India, were reported as dead, and 4 children have been affected by disabilities since 2019 due to consumption of this FDC Cough Syrup that you might be using for your children.
What Is FDC Cough Syrup:
Fixed Dose Combinations (FDCs) contain two or more pharmaceutical ingredients with a fixed ratio in a single drug. In this cough syrup, we have a combination of drugs with chlorpheniramine maleate IP 2mg and phenylephrine HCL IP 5mg per ml. Here, chlorpheniramine maleate is used as an allergic, and phenylephrine is used as a Decongestant(provides short-term relief from cough after consumption). This cough syrup is not approved yet, but it is being used.
Except for standard drugs, this kind of FDC is not permitted for consumption under 4 years. The FDC drugs have a high risk for health among children aged less than 5 years. However, the CDSCO lost control to give permissions in 2016.
This is due to the previous court decision of the health ministry in 2012 about the state authorities giving permissions for the production of medicines. This led to different combinations of FDCs over the years in different forms without proper testing and clearance, causing many unapproved drugs on the market.
State Authorities Involvement In FDC Approval:
In 2015, the FDCs came into effect, by which a committee evaluated all the combinations of FDCs and gave approval by a ‘no-objection’ certificate only upon meeting safety standards. However, the anti-cold drug(cough syrup) has few concerns concerning children. It is approved on an “18-month policy,” where the renewal of medicine takes only after its success without any side effects.
However, the companies challenged this situation in court in 2016. They got approval from the court through the health ministry’s decision in 2012 about state authorities giving all the required permission without the need for the center.
Cough Syrup Ban In India:
The center has decided to ban these FDCs among children and label them accordingly on all the FDC drugs after a meeting was held on June 6th, 2023, by the Subject Expert committee.
“The committee said the Fixed Dose Combinations should not be used among children younger than 4. “
The FDCs have been produced in India and have also been exported to other countries for usage, but due to no proper clearance, this cough syrup led to deaths in children. From June 6th, the committee has started the proper testing of FDCs for the safety of all and with more attention towards the drugs that are used for children below 5 years after it gained its power back in 2023.
List Of Banned Cough Syrups:
- Nimesulide, paracetamol dispersible tablet
- Amoxicillin, bromhexine
- Pholcodine, promethazine
- Chlorpheniramine maleate, dextromethorphan, guaiphenesin, ammonium chloride, menthol
- Ammonium chloride, bromhexine, dextromethorphan
- Chlorpheniramine maleate, codeine syrup
- Bromhexine, dextromethorphan, ammonium chloride, menthol
- Dextromethorphan, chlorpheniramine maleate, guaiphenesin, ammonium chloride
- Paracetamol, bromhexine, phenylephrine, chlorpheniramine, guaiphenesin
- Salbutamol, bromhexine
- Chlorpheniramine, codeine phosphate, menthol syrup
- Phenytoin, phenobarbitone sodium
- Ammonium chloride, sodium citrate, chlorpheniramine maleate, menthol syrup
- Salbutamol, hydroxyethyl theophylline, bromhexine
Center Warning To Companies:
On December 18th, 2023, the Center issued warning letters to all the companies that are preparing the FDCs and to label them as FDCs should not be used for children under 4 years. The warning will be labeled as “FDC should not be used in children below 4 years of age” on the packaging. This usage is banned only among children under 5 years old due to its high efficiency, but for children above 5 years, this combination can suit properly.
The government has also banned tablets that are unapproved FDCs (Off-label: Medicine 70% of Antibiotics in the Market are Fake!) recently. The center has been regulating and testing every drug for proper clearance before its release in the market for the safety of patients since June 2023.
What WHO Say About FDC Cough Syrups And Medicines:
The World Health Organisation(WHO) does not suggest the usage of FDC’s drugs that are consumed by children less than 5 years old due to the risks and concerns that are associated with children. The FDC cough syrups and cold medicines, these syrups contain high dosages that children below 5 years cannot sustain.
Even though it is dangerous to use, the companies don’t care about the factors concerned; they mainly focus on profits. These cough syrups and cold tablets are primarily prepared from FDCs only to treat colds,s, but it is not suggestable until the doctors prescribe them for children below 5 years.
Conclusion:
Since June 2023, the center has stepped up and has been testing all the unapproved FDCs and then releasing them into markets for usage. The center has made the approval mandatory if needed to export or release in the market.
It has also banned several FDC’s medicines earlier. The companies are denying the deaths caused by FDCs. A few popular companies that received the warning regarding the FDCs are Glenmark, GlaxoSmithKline, and IPCA Laboratories.
Be sure of what kind of cough syrup you are using for your children because it might cause problems in the future, and never give cough syrup to children below 5 years old without a doctor’s prescription.
FACT: India is known as “WORLD’S PHARMACY due to its supply of medicines at low cost.