NEW DELHI – Govind Ram is still waiting to get justice for the death of his daughter in 2019 – who allegedly died from contaminated cough syrup.
In December 2019, Ram’s two-year-old, Surabhi, had a fever and chest congestion. Ram, a labourer in the Udhampur district of India’s Jammu and Kashmir region, took his daughter to a local doctor who prescribed a cough syrup.
But her condition deteriorated further, and she was taken to a sub-district hospital then to a district hospital. Doctors there told her father to take her home as there was no chance of her survival, and she died a short while later.
Ram does not know whether he will ever get justice for the death of his daughter, who authorities believed died from ingesting a contaminated cough syrup.
Earlier this month, the deaths of 66 Gambian children were linked to contaminated cough syrup manufactured by Indian company, Maiden Pharmaceuticals. The Maiden-made cough syrups were contaminated with diethylene glycol (DEG), commonly used in anti-freeze, and ethylene glycol (EG).
The Indian government has stopped production at the company’s facility in Haryana at the request of the World Health Organization (WHO).
Not the first time
This is not the first time that such contamination has been alleged in Indian pharmaceutical products where substandard and contaminated medicines remain a widespread problem.
Between 2019 and 2020, 13 children died after reportedly being administered a cough syrup adulterated with DEG in the northern state of Himachal Pradesh. The deaths of another 12 children in Jammu, including Surabhi, were also alleged to have been tied to their consumption of cough syrup tainted with DEG.
Both of the syrups were reportedly manufactured by Digital Vision, which is based in Himachal Pradesh. Two years later, the Himachal Pradesh’s Drugs Control Administration (DCA) has yet to complete its probe of the cases, which would allow charges to be filed.
“The company’s manufacturing license was suspended, but later restored, first partially and then fully,” said Assistant Drugs Controller Garima Sharma, but did not explain how this had happened when the probe was not complete.
Lax regulatory authorities
These are not isolated cases. The manufacture of sub-standard – and in some cases dangerous – drugs in India is rampant and the lax implementation of regulations enables manufacturers to escape any consequences.
While the sale of inferior quality drugs is a serious offence under Indian law with minimum prison term of a year and fines for the manufacturers, the provisions of the law are rarely enforced against the errant drug manufacturers. In most cases, the regulators simply suspend the drug maker’s license for a few days.
Take Digital Vision, which is supposedly being investigated for Surabhi’s death. It has 19 violations of quality standards since 2009 yet regulators have taken no significant action against it.
The October monthly alert from India’s Central Drugs Standard Control Organization (CDSCO) identifies 59 medicines that failed safety standards, including painkillers and calcium.
“Due to repeated failure of samples of these medicines, action has been taken against them,” said Himachal Pradesh Drug Controller Navneet Marwah, explaining that these medicines had been withdrawn.
“Monitoring is needed from the time the medicine is made till it reaches the patient because it is a matter of life and death,” said Amulya Nidhi, national co-convener of People’s Health Movement of India.
“After giving permission to manufacture a medicine it should be seen if the procedure and the guidelines related to it are being followed or not. These are regulatory failures.
“It is also important to see what action they have taken after the death of so many children. They have done nothing. Issuing notices to drug manufacturers can’t be called an action when innocent lives are lost,” added Nidhi.
According to Nidhi, a 2012 parliamentary report from the Standing Committee on Health and Family Welfare on the functioning of the Central Drug Standard Control Organization (CDSCO), had found some instances of collusion between the manufacturers, doctors and regulatory agency and had made a large number of recommendations for drastic revamping of the CDSCO.
“It is a regulatory failure and the monitoring process is very weak in our country which is responsible for such a condition,” he added.
Expired medicines and fake COVID-19 treatments
Many other cases of the manufacture or sale of substandard drugs have been reported in the recent past. In February, a firm in Agra in the northern state of Uttar Pradesh was found to be buying expired medicine at low cost, repackaging and reselling it.
The Authentication Solution Providers’ Association (ASPA), an organization working against counterfeiting activities, said that fake COVID-19 medicines had been found in most Indian states over the last two years, especially at a time when there was severe shortage of COVID-19 products.
India lacks suitable regulations for the pharma industry and the regulations and legal structures are not well defined, according to ASPA.
Exports of substandard Indian drugs
India is the world’s largest manufacturer of generic drugs, with sales of more than $2.4 billion in March 2022 alone.
But some experts estimate that probably between 12% and 25% of the active pharmaceutical ingredients and finished medical products supplied globally from India are contaminated, substandard or counterfeit.
— Gambiana (@gambiananews) October 24, 2022
In the case of deaths of the contaminated medicines sold in The Gambia, Indian regulators allowed a habitual offender firm to export substandard drugs, public health activists Dinesh Thakur and T Prashant Reddy told India Today. Thakur is the co-author of a book entitled ‘The Truth Pill’, on substandard medicines in India’s pharma industry.
“A Certificate of a Pharmaceutical Product (CoPP) is needed by the importing country when the product in question is intended for registration, with the scope of commercialisation or distribution in that country,” they said.
The CoPPs, effectively export permits, are issued by the CDSCO which operates under the central government’s Ministry of Health, they added.
“Therefore, it was not correct to suggest that Haryana’s state regulator gave the approval to this drug and that the central body had nothing to do with the approvals,” they said, adding that the same cough syrups were also authorized for sale in India – contrary to government statements to the effect that they were only marketed for export.
WHO’s investigation raises the stakes
While problems with poor quality medicines have flown under the radar for years, the recent alarm sounded by WHO on the four types substandard cough syrups made by Maiden Pharmaceutical has raised attention about the issues at play.
India’s Ministry of Health and Family Welfare said that the Central Drugs Standard Control Organisation took up the issue with the regulatory authorities in Haryana, under whose jurisdiction the drug manufacturing unit of Maiden is located. The Indian government and the Haryana government imposed a ban on Maiden Pharmaceuticals.
External Affairs Minister Dr S Jaishankar told his counterpart in Gambia, Dr Mamadou Tangara, that the matter was being seriously investigated by appropriate authorities.
Despite the accumulating claims and evidence, India’s mainstream medical community has been slow to react.
“It is too early to say that the syrup has caused deaths in Gambia. Syrup sells a lot, but it has to be seen that the children had not eaten anything else that could have caused their death,” said Sahajanand Prasad Singh, president of the Indian Medical Association.
Brushing aside the WHO reports that syrups used by the children had been adulterated, he added: “I do not think that consuming syrup alone would have such fatal consequences.”
However, the WHO has said clearly that syrups sold in the Gambia and used by the children had definitely been adulterated by a toxic compound that can lead to death. Although the global health agency has been clear that the exact cause of death has not yet been determined.
Weak or substandard medicines are also a major driver of antimicrobial resistance – which is reaching epidemic proportions in India as well. Experts say India is one of the nations worst hit by antimicrobial resistance. Antibiotic-resistant neonatal infections alone are killing about 60,000 newborns each year. A new government report says things are getting worse, with tests conducted at a hospital revealing that a number of key drugs were barely effective.
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