India has rejected drugmakers’ requests for a year-end extension to upgrade their manufacturing facilities to international standards, four sources said, amid public anger over the recent deaths of at least 24 children who consumed locally made cough syrup.
By the end of 2023, New Delhi has ordered drug companies to ensure their plants meet standards recommended by the World Health Organization, which would require them to invest in protocols to prevent cross-contamination and allow for batch testing of samples, among other measures. The mandate was established after Indian cough syrups were linked to the deaths of more than 140 children in Africa and Central Asia, severely tarnishing India’s image as the “pharmacy of the world”.
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While big pharma met the June 2024 deadline, smaller firms were given a 12-month reprieve for their separate target of December 2024. But some in India’s pharma lobby are pushing for more time, warning that costs will force businesses out of business.
But news that pharmaceutical maker Sresan — which made Coldrif syrup, which has been linked to the latest deaths — had not upgraded its facilities was a key factor in persuading government officials to ignore the calls, said three people, who spoke on condition of anonymity to discuss the private proceedings.
The decision was made in October after tests confirmed high levels of toxicity in some Coldrif syrups, according to two of the people. Drugmakers were informed of the decision at a conference on Thursday, one of them said.
Once the upgrades are complete, India plans to phase out a controversial rule introduced in 2023 that mandates additional testing of cough syrups at government-designated laboratories before export, one of the people said.
This requirement does not apply to medicines intended for home use. The recent deaths have reignited public debate in India about the selective enforcement of safety standards.
Read also | WHO issues warning against Coldrif and other cough syrups after children die in MP
The health ministry and the Central Drugs Standard Control Organization (CDSCO), the federal pharmaceutical regulator, did not return requests for comment. Representatives of Sresan did not respond to repeated phone calls.
Had India kept its original deadline, the latest deaths could have been avoided, said Udaya Bhaskar of the All India Drugs Control Officers’ Confederation, which represents pharmaceutical regulators. All of the recent deaths have been linked to a dose of Coldrif syrup produced in May.
Bhaskar said he supports scrapping additional tests for exports once all labs are certified to WHO standards: “It’s not the government’s job to test every batch. That responsibility lies with the manufacturer. It’s the government’s duty to ensure compliance.”
Highly toxic
Government tests found that the syrup produced by Sresan contains 48.6% diethylene glycol (DEG), which is almost 500 times the limit set by India and the WHO.
DEG is sometimes “fraudulently or inadvertently” used in place of more expensive pharmaceutical-grade solvents such as glycerin and propylene glycol, according to an October 13 presentation on medical contamination by the Indian Pharmacopoeia Commission (IPC), which sets national drug standards.
In October, the commission began requiring manufacturers to test oral liquids for the presence of DEG and another comparable substance, ethylene glycol, before sale.
Read also | TN Govt Cancels Coldrif Cough Syrup Manufacturing License
A Reuters investigation in 2023 uncovered regulatory and legal loopholes that allowed unscrupulous manufacturers to substitute DEG for pharmaceutical-grade propylene glycol. Despite earlier deaths abroad, there is no record of anyone being jailed in India.
“Contamination can occur through deliberate falsification to reduce costs or accidental mix-up and mislabeling, particularly in shared processing facilities,” according to an October presentation seen by Reuters.
While the IPC did not name specific companies, CDSCO said in October that recent inspections revealed that some firms had failed to test every batch of medicinal ingredients as required by law.
Authorities have since revoked Sresan’s manufacturing license, banned its products and arrested its founder S. Ranganathan on suspicion of murder.
Sresan’s corporate office in a residential building in the southern city of Chennai and its manufacturing plant – which is housed in a dilapidated shed-like structure – were closed when Reuters visited.
“There have been numerous critical violations of even existing standards. The unit is not fit for production,” said one of the people briefed on the preliminary investigation.
However, the closure of Sresan’s facilities comes too late for Mayank Suryavanshi.
A 3½-year-old boy from the Parasia area of Madhya Pradesh developed a fever on September 22, for which a local doctor prescribed Coldrif.
Mayank was taking doses made by Sresan but his condition worsened. He died of acute kidney failure in the early hours of October 9.
“We never imagined that a simple medicine could become life-threatening,” said his father Nilesh Suryavanshi, who works as a daily wage labourer.
“My child should be the last,” he said. “The government must ensure that no other parent suffers like this.”
“People Are Dying”
India’s $50 billion pharmaceutical industry consists of around 3,000 companies that operate more than 10,000 factories.
According to government data, about two dozen companies are responsible for most of the drugs produced in the country. Much of the remaining 40% is produced by small and medium-sized enterprises, many of which fear that the cost of upgrading their equipment will make it economically unviable.
Jagdeep Singh, secretary of the SME Pharma Industries Confederation, warned that almost half of the manufacturing units in the pharma hub of Himachal Pradesh state would be shut down if there was no extension.
“I can guarantee there will be shortages, unemployment and massive national losses,” he said, adding that some firms have already stopped producing products because customers refuse to bear the cost of upgrading.
Read also | ED raided seven Chennai locations linked to Sresan Pharma in Coldrif cough syrup
But regulators appear no longer convinced by that argument, one of the sources told Reuters.
The deadline “can’t be extended over and over again — people are dying,” the person said, adding that major drugmakers, which have already upgraded their facilities, could meet any shortfall.
In rural Parasia, the local community continues to count the cost of drug safety violations.
Read also | Cough syrup deaths in MP, Rajasthan: Center finds toxic chemical in Coldrif
County drug inspectors visit pharmacies to randomly collect cough syrup samples for testing. At least four pharmacies that sold Coldrif have been temporarily closed for failing to provide documentation related to the sale of the syrup, according to six local pharmacists.
Community health workers were also deployed on door-to-door visits to encourage residents to hand in remaining Coldrif bottles.
A local doctor, Praveen Soni, who prescribed Coldrif to several children who died, has been arrested as part of the homicide investigation. He could not be reached for comment, but previously told local media that it was “difficult to link the death to Coldrif because it had been prescribed for ten years”.
“We blindly trusted him,” said teacher Sushant Kumar Thakre, whose two-year-old daughter Yojitha died after taking the syrup prescribed by Soni.
“The medicine turned to poison and killed my daughter.
