Death by Cough Mixture: Global Scandal Exposes India’s Weak Drug Regulations
Patients wait to be treated at Shri Maharaja Hari Singh (SMHS) Hospital. Doctors report a surge in heart attacks that may be linked to cough mixture.

The deaths of children and young people related to contaminated cough syrups made by Indian companies have exposed India’s lack of regulation, which is also enabling the over-consumption of over-the-counter cough syrups in the country.

After completing her household chores, 42-year-old Shameema Akhter was tending to a cow outside her home in Shangas village in southern Kashmir. It was drizzling but the January sun had started to come out after a heavy snowfall. Akhter crossed the apple orchard through a narrow lane that connected to her house and greeted me. 

She led me inside her house and offered me a kangri (an earthen fire pot used by Kashmiris to keep warm). As she sat down to talk about her son who died of a heart attack, she sighed heavily and took a few moments to compose herself.

“I do not know what happened to him, you tell me who dies of a heart attack at 18?” asked Akhter. “I have called him Raja (king) since the day the nurse put him in my lap… When the doctors said he had died of a heart attack, I could not believe it. Those words are still ringing in my head.”

On 6 January, Akhter’s son, Muneer Ahmed, had played cricket all day in a nearby field with his friends. In the evening, he complained of a headache. The family thought he had caught a cold during the day while playing outside. “I gave him some lukewarm water, food, and medicine (paracetamol),” said Akhter.

During the night, Ahmed complained of chest pain and family members rushed him to the nearby district hospital but doctors declared him dead on arrival. 

While there is no proof that cough medicine was the cause of Ahmed’s death, there is mounting evidence that anti-cold medicines and syrups can exacerbate conditions leading to death – and anti-cold medicines are sold in Kashmir and elsewhere across India without any checks.

Even opioid-based cough syrups are sold without a doctor’s prescription. These medicines, especially cough syrups, have caused deaths in Jammu and Kashmir as well as in other Indian states such as Himachal Pradesh, Uttar Pradesh and Bihar. 

Shameema Akhter is not the only mother who has such a story to share. Dozens of others in Kashmir share the same ordeal. 

Twenty-five-year-old Basit Ashraf, an advocate by profession, reached his home in the Rawalpora area of Srinagar on 24 January at around 7pm. He too complained of sudden chest pains and passed away before his family get medical help or rush him to the hospital.

Doctors warn against cough syrups

SMHS hospital in Srinagar, Kashmir.

Doctors attend to 18 to 20 cardiac arrest cases every day at each of Kashmir’s capital city of Sringer’s two main hospitals, Shri Maharaja Hari Singh (SMHS) Hospital and Sher-i-Kashmir Institute of Medical Sciences (SKIMS).

Dr Irfan Ahmad Bhat, a senior cardiologist at SMHS Hospital, told The Kashmir Monitor that heart attack victims were getting younger and believes that over-use of cough mixture could be a cause. These medicines can trigger high blood pressure, kidney failure, and heart attacks.

While India is the world’s biggest producer of generic medicine, its regulatory system is out of date, harming Indians as well as people in lower-middle-income countries (LMICs) who receive its exports.

And possible death by cough syrup is one of the most vivid examples.

Contaminated syrup

The WHO issued warnings of contamination against these paediatric cough syrups distributed in Gambia.

When paracetamol syrup, cough syrup, or anti-cold syrup is manufactured, it needs a solvent to dissolve all its active ingredients, add sweetness, and act as a lubricant. The solvents used are either glycerine or propylene glycol, a clear, faintly sweet, and viscous liquid.

Glycerine  Indian Pharmacopoeia (IP) grade is used in drugs and medicines, while industrial glycerine, which can contain diethylene glycol and ethylene glycol, is used in chemicals and cosmetics, according to the good manufacturing practice framed by the WHO. 

Between December 2019 and January 2020, 12 children in Udhampur aged between the ages of 11 months and four years died after consuming Cold Best-PC cough syrup, while 10 children died in Himachal Pradesh. The cough mixture had been diluted with diethylene glycol. 

This issue gained international attention last year when Indian-made cough syrups were linked to the deaths of 66 children in Gambia. After a Gambian parliamentary enquiry and a World Health Organization (WHO) investigation, the WHO announced on 5 October 2022, that four cough syrups made by Maiden Pharmaceuticals Limited contained “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”. 

In December, the Uzbekistan health ministry reported that 18 children in the country had also died from side effects of cough syrup produced by an Indian pharmaceutical firm, Marion Biotech based in Uttar Pradesh . The WHO issued a warning against two of the company’s cough syrups after the deaths, finding that they were contaminated.

Out-of-date drug laws

India is the world’s largest exporter of generic drugs — its sales exceeded $22 billion last year. Around 20% of India’s pharma exports go to Africa. During the COVID-19 pandemic, India supplied more than 200 million doses of vaccines to nearly 100 countries, most of them in the Global South.

But these drugs are regulated under the  Drugs and Cosmetics Act of 1940, a decades-old law which has had no amendments or changes over the years. 

Prashant Reddy, a lawyer specialising in drug regulation and intellectual property, who recently co-authored the book, The Truth Pill: The Myth of Drug Regulation in India, said: “Apart from these recent scandals where children have actually died, there have been plenty of complaints from countries including Vietnam, Ghana, Sri Lanka, and Nigeria. The government of India is aware of those complaints. They just don’t know what steps to take to counter the situation.” 

While there is a national regulatory authority, the Drugs Controller General of India (DCGI), every state has its own drug regulator that is able to authorise drugs. Currently, India has 38 such regulators, which is one of the major hurdles in the regulatory system.

“In 2013, the government introduced the Drugs and Cosmetics Amendment Bill, which would have helped and given the Central Drugs Standard Control Organisation (CDSCO) more powers over regulating exports. But that Bill never went through parliament and was withdrawn by the next government when came into power,” said Reddy. 

“After that, there has been complete paralysis when it comes to policy on drug regulation. In July 2022, a new law was framed and advertised for comments from experts and the public but this new law is a copy of the old law with a few minor changes. Basically, the government is not giving it serious enough thought on how to tackle the issue,” she added.

Pharmacy of the world

India is often referred to as the pharmacy of the world. The country supplies vaccines and generic medicines to high and low-and-middle-income countries (LMICs) alike.

However, high-income countries like the US Food and Drug Administration (FDA) can, and do, conduct their own inspections of Indian facilities (India has the largest number of FDA-approved plants outside the US).

But most LMICs don’t have the capacity to do so and, either rely on global regulatory mechanisms such as the WHO prequalification system or the national regulatory authority of the exporting country, in this case, India.  

Dr Javier Guzman, Director of Global Health Policy and Senior Fellow at the Center for Global Development, said that quality-related scandals such as those in Gambia or Uzbekistan, erode the trust of LMICs. It is clear that the regulatory system in India has to be strengthened if the country still wants to be the pharmacy of the world.

“The Indian government must align regulatory standards across the country, making sure state-level agencies have the same stringency as the national regulatory authority, the Drugs Controller General of India (DCGI),” Guzman told Health Policy Watch.

“The government of India must recognize that the presence of multiple regulatory authorities under different state governments fractures accountability, and vested interests of small, often lower-quality manufacturers inhibit stricter enforcement.  That’s why DCGI should be responsible for guaranteeing that all regulatory functions, including those implemented by state agencies, are performed adequately,” added Guzman.

International humiliation

Malini Aisola, co-convener of All India Drug Action Network (AIDAN), highlighted that the lack of transparency of the Indian government has created a serious dent in its reputation globally. 

After these international incidents, the regulators should have retracted the batches of these syrups from the market and conducted a thorough investigation but nothing of that sort happened, said Aisola.

“Even when the Gambian government and WHO had proof about the substances in the medicine, they denied those reports too. Instead of investigating the matter and coming up with transparent reports, the government maintained a narrative that WHO is causing a dent to their reputation,” she added. 

While the Indian government conducted an investigation into Maiden Pharmaceuticals, the expert panel it set up claimed that the clinical information shared by the WHO was “inadequate” to determine the cause of the children’s deaths. 

The WHO has disputed this claim, saying that it had supplied India will all the relevant information, and there were very high levels of contamination in the cough syrups made by Maiden.

Since this incident, the WHO intends to conduct independent reviews of its member states’ mechanisms to reduce these incidents. 

But Aisola questions the WHO’s power to intervene: “WHO is not a regulatory body and they can’t have mechanisms to enforce quality or to carry out surveillance within countries. That remains the function of the national governments. Should they have wide powers? That might be helpful but that would take a massive investment and place WHO in possible conflict with the government.”

Image Credits: WHO, Safina Nabi.

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