Cough Syrup banned in India

Cough syrups containing codeine phosphate as an active pharmaceutical ingredient has been banned to prevent the addictive effect. Over the weekend, Sumo, Zerodol P, Ace Proxyvan, Corex, Saridon, D’cold, Phensedyl, and Vicks Action 500 Extra went from being household names to becoming outlawed products. Before going into details of why cough syrup banned in India, we will discuss what is fixed-dose combinations (FDC).

What is Fixed Dose Combination (FDC)?

A fixed-dose combination (FDC) involves two or more drugs combined into one pill. The FDA put their highest warning on these fixed-dose combinations medicine, saying that the risks are greater than the potential benefits. Due to this risk, the Health Ministry’s banned 344 combination products for posing a risk to humans.

Why Phensedyl & Corex Cough Syrup banned in India?
Why Phensedyl & Corex Cough Syrup banned in India?

The government has issued a notification to ban the manufacture, sale, and distribution of 344 fixed dose combination drugs including deadly combinations of Paracetamol, on March 10’2016. A few of these drugs include Vicks Action 500, Phensedyl, and Corex.

Codeine-based cough syrups (banned cough syrup in India) are among the 344 fixed-dose combinations (FDCs) banned by India in February.

How Cough Syrup Works?

Cough is a natural phenomenon to throw out dust and any other particle, which can be germs or foreign bodies. Coughing is a life-saving mechanism devised by the body for its protection. By giving cough syrup, we are trying to hinder this natural mechanism, and in fact, making the person more prone to infections.

The cough syrup should work by going to the lungs. It even increases the heart rate in children. All cough syrups have sedatives and hence, are addictive.

High courts in the country have been banning cough syrups but physicians, as well as pediatricians, have been prescribing these to adults and children as well. India’s doctors to understand that cough syrups are banned in most of the developed countries and no doctors there prescribe it.

Why Corex Cough Syrup banned in India?

A drug is usually taken off the market because of safety issues with the drug that cannot be corrected. Codeine (an Opium derivative) based cough syrup brands like Phensedyl & Corex which have caused addiction on a large scale in India and other countries.

Although Codeine based cough syrups are effective in suppressing cough. But their misuse (consumed there in large quantities, against the recommended small doses, to get a kick) emerged as a major problem. The active ingredient Codeine is a narcotic belonging to a class of chemicals called opioids. Opioids can be highly addictive when taken in more than the recommended quantities.

Cough syrups contain sedatives, anti-histamines, increase heart rate, and reduce breathing rate which is very bad. Not just Corex but Phensedyl that also contains the same drug combination Phenylephrine, Paracetamol, and caffeine has been banned from 10 of March 2016. Identifying the pathogen causing the cough is better than giving syrups. In fact, Indian remedies like turmeric milk, Giloy juice, ginger, honey, and turmeric are better to minimize coughing.

“US pharmaceutical giant Pfizer India unit said, it had stopped selling its popular Corex cough syrup after regulators banned it saying it was likely to pose a risk to humans.”
Read: Is Combiflam Banned? – Combiflam Side Effects, Substitutes & Precautions

Phensedyl Banned in Bangladesh:

Abbott Pharmaceuticals, which sells another popular cough syrup Phensedyl contain the narcotic codeine. Codeine, one of the primary active ingredients in Phensedyl, is a strong opiate. Phensedyl was already banned in Bangladesh due to its high codeine content and so it is highly addictive. However, it has been routinely smuggled into the country from India.
According to a report, The Border Security Force (BSF) has seized 3,045 bottles of banned Phensedyl near the India-Bangladesh border. The bottles were to be smuggled into Bangladesh, where these cough syrups are banned, and selling them is punishable.

Is cough syrup safe for children?

Cough syrup is especially dangerous for kids with a rapid metabolism gene. Medicines with codeine are banned for children below 12 in many developed countries.

Why Phensedyl & Corex Cough Syrup banned in India?
Why Phensedyl & Corex Cough Syrup banned in India?

In 2013, the United Kingdom, United States, European Union, Australia, Canada, and New Zealand banned codeine-based medicines (codeine, which is nothing but a chemical derived from opium) for children under 12. But are still being sold in India as popular cough syrups such as Benadryl, Corex, Phensedyl, and Teddy cough to name a few.

Major companies and their drugs that could be affected:

Not just Corex, there are hundreds of drugs that are banned in many countries, here is the list:

1) Ascoril range of cough syrups, manufacturer: Glenmark

2) Zedex cough syrups, manufacturer: Wockhardt

3) Vicks Action 500 Extra, manufacturer: Procter and Gamble (P&G)

4) 32 FDA Recalls Prescription Drugs

Source: AIOCD AWACS(a pharmaceutical market research organization)

India is one of the world’s largest markets for medicine but has a notoriously poor implementation of drug regulations that let thousands of drugs that are banned in the US, Europe, or other developed countries slip through the monitoring process.

Painkiller Medicines Banned Around the World, But not in India