The Union government has removed cough syrups from the list of medicines that receive certain exemptions in manufacturing and sale, such as availability in general stores in smaller villages. This comes after a spate of recent incidents where children have died after consuming contaminated syrups.

The Union Health Ministry, in a gazette notification, removed the word “syrup” from Schedule K of the Drug Rules.

Even before this notification, a doctor’s prescription was required for almost all cough syrup formulations. The removal from Schedule K removes just one exemption that allowed general stores in smaller villages with a population of less than 1,000 to sell these syrups.

In other areas, cough syrups can only be sold at licensed medical stores with a pharmacist on site.

Why was the step taken?

It comes after several incidents of children dying because of contaminants in cough syrups. The oversight measure was first discussed in a meeting of the apex drug regulator’s Drug Consultative Committee (DCC) last November, after the deaths of at least 22 children in Madhya Pradesh’s Chhindwara.

The step, however, has been described as “too little, too late” by experts in drug regulation. “This exemption was meant only for cough syrups that do not contain any Schedule H or X drugs (which are to be sold on the prescription of a Registered Medical Practitioner only). But almost all cough syrups contain at least one component that is regulated. This meant that they should not have been sold without a prescription anyway, but, in practice, they are widely available over the counter,” said a former drug regulator, on condition of anonymity.

They added: “The only cough syrups that do not contain any of the regulated substances are herbal remedies, and they are not governed by these norms… despite some of them using propylene glycol (PEG), which is usually the source of the contaminant.”

Contamination with diethylene glycol and ethylene glycol usually happens in syrups when non-pharmaceutical grade PEG is used as a solvent in its manufacturing, without appropriate testing.

How can regulation happen?

Experts say certain measures are likely to better prevent contamination.

One, as discussed in the meeting, is using solvents that carry a lower risk of contamination. Two, while PEG is needed as a solvent for syrups, companies can manufacture suspensions of the same drug (which contain insoluble particles) without using it. An industry expert said, “Syrups are just sweeter and better tasting, suspensions can be equally efficacious and stable.”

Three, as the industry discussed with the drug regulator in the aftermath of the deaths in MP and other global cases linked to India-made syrups, was to ensure smaller packs of PEG are available.

The industry expert said, “PEG is usually sold in big barrels, which is good for the big companies. But cough syrups are manufactured in very small units as well. They do not buy PEG by the barrel, they instead procure it from the open market. Their containers do not carry the company seal, and there is no way to track where the contamination enters in the supply chain.” At times, suppliers could sell cheaper, industrial-grade PEG as pharmaceutical-grade.

What precautions should you take?

Experts advise that people should only buy cough syrups from established brands to reduce the chances of contamination.

Every cough needs to be treated differently, and patients do not need to take cough syrups for most of them. Dr Suranjit Chatterjee, senior consultant for internal medicine at the Indraprastha Apollo Hospital in New Delhi, says, “In most cases, people are likely to get better on their own without a cough syrup, and, in some cases, taking a cough syrup when the cough lasts for long can lead to misdiagnosis of the underlying condition.”

When it comes to the type of syrup, he says, a cough suppressant can be used by people experiencing a dry, hacking cough. However, in case of phlegm build-up in the chest, no syrup should be used. “We want the phlegm to come out and not remain in the lungs. But some cough syrups that contain anti-allergic medicines can actually dry out the phlegm inside the lungs,” he said.