The world was horrified when 66 children died in the tiny African nation of Gambia. The deaths of these children were investigated by the WHO, who recently announced their finding of unacceptable levels of certain chemicals in a few cough syrups that were made in India, but used only in Gambia. It was indeed a tragic incident as most of the victims were below 5 years. The World Health Organization has said that the chemical contaminants found in cough syrup are known to cause kidney failure and subsequent death, and detailed investigations are to be done by relevant national regulatory authorities. The Government of India has announced an investigation.
Cough syrups are often sold as over-the-counter medicines and are easily available even without a doctor’s prescription. With the WHO’s announcement, there is concern among the lay public about the consumption of cough syrups.
Dr. Rajeev Jayadevan, senior gastroenterologist and former President of Kochi chapter of the Indian Medical Association explains what may have caused the death of the kids in Gambia and how to ensure the safety of the medicines that are regularly used.
The WHO has stated that cough syrups have been linked with the recent deaths of children in Africa. How do such deaths happen?
When deaths of people who belong to a certain age group happen in a particular region, it must be investigated for any common factor. In Gambia, children of a certain age group have lost their lives. The WHO has highlighted contaminated cough syrups after their investigation, even though it has not been directly proven that these children actually died after consuming these products.
When unnatural deaths happen, one of the first things that would be investigated is whether similar deaths have happened in the past. There are media reports that similar incidents have rarely occurred in various parts of the world over the past several decades.
Although very rare, deaths have previously happened due to contaminated ingredients in such medicines. For example, glycerine is a common ingredient that is used in cough syrups. Diethyl glycerol may sometimes contaminate glycerin. The solution to avoid such tragic incidents is to periodically inspect all the medicines produced.
Fake medicines and also poor-quality medicines apparently produced by licensed companies are available in the market in most countries, and India is no exception. It must also be kept in mind that there are many big and small companies that also produce good quality medicines of recommended international standards. Thus, all medicines available in the market do not have the same quality in India. For example, there will be dozens of companies that produce the same antibiotic. Although most will be of good quality, some need not be so. I don’t mean that all of them are bad. These medicines should be released into the market only after quality checks and proper testing.
In a 2016 study conducted by the Ministry of Health and Family Welfare, it was found that around 3% medicines sold in India are of low quality, while 0.02 -0.05% are spurious. Interestingly, most of the low-quality medicines found in that study were produced by just 10% of the pharma companies in the country.
It is also learned that the overall manufacturing standards in the country have steadily improved over the past years.
Governments must remain proactive in ensuring continuous quality control, and establish more labs for this purpose. Moreover, the doctor who prescribes the medicines and the patient who consumes them should also be able to test its quality if such a question arose. Assuring such facilities is the responsibility of our health system.
Quality testing should be done at proper intervals. Medications have multiple ingredients, each of which has to be of good quality. For example, if a medicine gets approval initially but five years later one or two of its ingredients deteriorated in quality, periodic testing would be able to detect it.
How can safety be ensured in cough syrup? What are the precautions?
Patients place their trust in their doctor or the healthcare facility. We must not forget that in the vast majority of instances, nothing goes wrong, and such adverse incidents are extremely rare. Doctors commonly recommend tried and trusted products in their own practice. However, new products also are occasionally introduced. In order to safeguard the patients’ trust, the government too should become part of it and try to bring about the above changes. When a patient comes to a doctor with the hope that he or she would be cured or comforted, it is a great responsibility. Quality testing of medicines plays an important role in preserving that responsibility and trust.
Ideally, there should be a tamper-proof seal of approval by the government on every medical product that reaches the consumer’s hands. That seal assures the consumer that the government has tested the ingredients in that product and ensured its quality. No matter what kind of medicine, it should have a seal of approval and an expiry date too.
It may not be possible to keep an eye on all the medicines that are produced in the country on a daily basis. If not all the batches, a large percentage of the medicines produced by each company should be tested for quality. Ideally, a universally approved seal of quality should be established in the country.
Such incidents are unimaginable in developed countries. There, the doctors need not worry about the brand or the company which produced the medicines, as those medicines are practically 100% safe. For instance, everyone knows that medicines produced in India need to be of high quality in order to export them to developed countries. If a medicine fails the quality test, then it cannot be sold there. Even minor imperfections are not tolerated, as is the case with other export products.
In India, although doctors are encouraged to prescribe generic medicines, some are reluctant because they are not always sure of their quality. Unfortunately, sometimes you do not know where or how such generic medicines are made, and whether they were quality-tested. In such situations, to avoid quality variation, many doctors prefer to go with manufacturers whom they trust, because their primary objective is for the patient to get better.
Cough syrup has been causing problems for a long time. How do such syrups affect the body?
It is not the cough syrup that actually causes the problem. The WHO in its report says that a substance called Diethyl Glycerol contaminated some samples of cough syrup sold in Gambia. Diethyl Glycerol could lead to severe stomach pain, vomiting, diarrhoea and kidney diseases that could even lead to death.
One might wonder how this could have happened. Let’s consider an example. Imagine that a certain brand of pickle has been really popular. The ingredients of the pickle are sourced from various vendors. Imagine now that the person who regularly supplies the chilly powder secretly decides to switch to cheaper quality. It would eventually affect the quality of the entire pickle. The problem might get noticed only when people begin getting sick after eating the pickle.
For the consumer, there would be labels on most of the medicines. From these labels, you could understand the ingredients, preservatives and colouring agents that have been added in the medicine.
Is it necessary to prescribe cough syrups to children?
Practising doctors often say that in most cases, cough syrups are not essential. However, patients who have a cough commonly ask the doctor to prescribe cough syrup. Even if the doctor tries to explain that they do not need a cough syrup, patients are relieved only if we prescribe one.
For example, in uncomplicated viral fevers, cough would subside naturally. In most cases, cough syrups only give psychological relief to the patients. The human mind has a special interest in consuming medicines in liquid form. When they taste the sweet or bitter flavour of the syrup, they may feel as if they have been cured.
That being said, cough syrups are required in certain situations. The medicines required for fever and cough are available in tablet form. It is difficult for small children to swallow tablets. Therefore, syrups are prescribed for them.
Cough is only a symptom. What matters is that the root cause is found and treated. For example, does the patient have tuberculosis or asthma that’s causing the cough? Or is it due to smoking? Available cough syrups target specific symptoms, such as fever, cough, wheezing, reducing phlegm or even allergies.
What are the points to keep in mind while buying over-the-counter medicines? How can you ensure the quality of such medicines?
Self-medication is not advisable. At the same time, one must not hesitate to seek proper treatment or medication when it is actually required.
Some people are not happy if doctors prescribe only a paracetamol tablet for viral fever. Doctors often prescribe supplements and antibiotics and then end up giving additional medicines to prevent their side effects. Thus, instead of just Rs 10, people may end up buying medicines for Rs 500. In most viral fever cases, the patient would get better with paracetamol tablets, adequate fluids and rest. Poly-pharmacy is a multifaceted problem that requires attention; awareness programs are ongoing.
People shouldn’t buy and consume the same medicine, the next time they have the same symptoms, without consulting a doctor. This is because the underlying disease condition could be different. Comparing prescriptions with another person is a bad idea because the person might have a different underlying condition which produced similar symptoms.