Time to read the fine print of consumer law to punish unfair trade practices

New Delhi: The hospitalisation of 16 children and the death of three of them, following administration of a cough syrup containing dextromethorphan during September-October this year in Delhi and another equally tragic incident involving 15 children and the death of nine of them in Jammu and Kashmir last year from an adulterated cough expectorant, throw up serious questions about the safety and efficacy of cough medications for children

New Delhi: The hospitalisation of 16 children and the death of three of them, following administration of a cough syrup containing dextromethorphan during September-October this year in Delhi and another equally tragic incident involving 15 children and the death of nine of them in Jammu and Kashmir last year from an adulterated cough expectorant, throw up serious questions about the safety and efficacy of cough medications for children. It also brings to the fore the need to hold pharmaceutical companies accountable under the Consumer Protection Act too and force them to pay hefty compensation and punitive damages to the victims, in addition to prosecution under the Drugs and Cosmetics Act.

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I will discuss the safety and efficacy of these cough medications in another column, but this week, I wish to emphasise the urgent need for payment of adequate compensation to the families, whose children suffered the consequences of consumption of these cough preparations - both in J&K and in Delhi. And I would urge the consumer affairs ministry in both the states (or at the Centre) which are empowered to take up such class action suits on behalf of consumers, to immediately seek the intervention of the consumer courts. In fact the Consumer Protection Act provides for just such contingencies by defining a ‘consumer’ as not just an individual consumer or a voluntary consumer organisation, but also the central government, any state government and the central authority.

Unfortunately, most state governments are not even aware of this provision , that paves the way for such petitions to be filed by governments on behalf of victims of unsafe products and services. This compensation is very different from what the governments may give as ex-gratia and is basically meant to hold the wrong doer accountable for violations of the rights of consumers, particularly the right to safe goods and services. It is for this reason that the law also provides for award of punitive damages. The compensation package of course should be worked out in such a way that it should serve as a deterrent to companies that take consumer safety lightly and play with the lives of children.

In the Udhampur case, for example, the cough syrup Coldbest –PC manufactured by Digital Vision, Himachal Pradesh, was found to be contaminated with the nephrotoxic chemical Diethylene Glycol, leading to the recall of the drug from eight states in the beginning of last year. Subsequently in August, 2020, another cough syrup-Cofset AT manufactured by the same company was ordered to be recalled following a case of renal failure in a child.

What is most shocking here is that the pharmaceutical company did not do due diligence before releasing the cough syrup into the market. And this is inexcusable given the fact that the extreme toxicity of Diethylene Glycol is well documented. In fact there have been mass poisoning cases from this chemical around the world. In the United States, the death of over 100 patients in 1937 from consumption of Elixir Sulfanamide containing diethylene glycol, led to the birth of their law on drug safety. India too has had its share of DG deaths, perhaps the last one being in 1998, when 36 children aged between two months and six years were admitted to two hospitals in Delhi with symptoms of acute renal failure caused by Diethylene Glycol contamination of a cough expectorant . As many as 33 children died as a result.

In the Delhi cough syrup tragedy, the Delhi government is inquiring into whether the incidents were caused on account of sub-standard cough syrup or it was a case of drug overdosing. The Director General of Health Services, union health ministry, in the meanwhile has recommended that the cough suppressant Dextromethorphan manufactured by Omega Pharma be withdrawn in larger public interest. It has also warned that cough syrup dextromethorphan should not be prescribed for children below four years of age.

Here again, depending on the report of the inquiry, those responsible for the suffering of the sixteen children will have to be held accountable under the consumer protection law too and made to pay hefty compensation.

Meanwhile, parents have to be educated on the side effects of these medications. We in India have for long used natural remedies for cough and cold, particularly in children. These need to be nurtured, propagated and practised.