Who banned my cough syrup? And why?

PT Jyothi Datta | Updated on January 20, 2018

Informed buy With combination drugs under lens, patients must be assured that individual medicines are not off shelves (file photo)

The drug regulator should be vigilant, and keep consumers fully informed

Over the weekend, Corex, Vicks Action 500 Extra, Saridon, D’cold and Phensedyl went from being household names to becoming outlawed products.

And that’s because they featured on the Health Ministry’s list of 344 combination products banned for posing a risk to humans besides having “no therapeutic justification”. But even before the week ran out, a clutch of companies secured interim injunctions from the Delhi High Court against the ban on their products. The hearings begin next week. So where does that leave the consumer, who has just been told by the government that several medicines available till the other day are now unsafe?

The 288-page notification certainly holds no answers. There is no advisory to consumers on why these medicines are unsafe or what patients need to do if they have been taking any of these combination medicines.

Contrast this with regulatory action, say, from the US Food and Drug Administration. Information on the medicine is written in simple language, the chemical or generic name and the brandname under which it is sold are mentioned. Also mentioned are the names of the company selling it, and the reason for caution — whether it affects the liver or causes heart attacks or so on. The patient can access all this information on the FDA website.

A fixed dose combination (FDC) involves two or more drugs combined into one pill. There’s little disagreement that irrational and unsafe combinations need to be weeded out.

What patients need to be assured of is that individual drugs are not off the market, says Leena Menghaney, who works on public health and access. The Centre is not targeting all combinations — those that treat HIV/AIDS and tuberculosis work. But antibiotic combinations can increase drug resistance, says Menghaney, drawing attention to a serious problem that has global health authorities worried. Medicines are seen to be becoming increasingly less effective due to excessive and indiscriminate exposure.

The FDCs targeted are just the tip of the iceberg, says S Srinivasan of Locost (a maker of inexpensive medicine) and the All India Drug Action Network. FDCs are pegged at about ₹40,000 crore, nearly half the medicine market in India. Of these, only about ₹15,000 crore are supported scientifically, he says. The rest are “irrational” or unsafe. For example, a diabetes drug should never be combined with a hypertension drug, as each medicine affects the body differently, and the doctor may want to change the dosage of one of the drugs, he explains.

Years don’t matter

Puncturing the argument that a product has been selling for 30 years ought to be safe, he says, governments across the world routinely review decisions and take out bad products. The key point is whether the drug has a scientific reason to be in the market, he points out.

CM Gulati, Editor with drug journal MIMS, says the regulator needs to also look at combinations approved by the Centre, and not just outlaw those approved by the States. People who approved these “irrational combinations” are the “culprits”, and should also be held accountable, he says.

Published on March 18, 2016

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