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New Delhi has ordered pharmaceutical companies to ensure their plants meet World Health Organization-recommended standards by the end of 2023, which will require them to invest in protocols to prevent cross-contamination and enable batch-testing of samples, among other measures. The order was established after Indian-made cough syrup was linked to the deaths of more than 140 children in Africa and Central Asia, causing serious damage to India’s image as the “pharmacy of the world”.
While major pharmaceutical companies met the June 2024 deadline, smaller companies were given a reprieve of 12 months to hit their separate December 2024 target. However, some in India’s pharmaceutical lobby are pushing for more time and warning that the cost would force businesses to go bankrupt.
But news that the Srison pharmaceutical manufacturer — which made the Coldriff syrup linked to the latest deaths — had not upgraded its facilities was a key factor in convincing government officials to ignore those appeals, said three of the people, who spoke on condition of anonymity to discuss the non-public discussions.
The decision was taken in October after tests confirmed high levels of toxicity in some Coldrif syrups, according to the two people. Drug makers were informed of the decision at a conference on Thursday, one of them said.
Once the upgrade is 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 a public debate about selective enforcement of safety standards in India.
The health ministry and the Central Drugs Standard Control Organization (CDSCO), the federal pharmaceuticals regulator, did not respond to requests for comment. Representatives of Srisan did not respond to repeated phone calls.
Uday Bhaskar of the All India Drugs Control Officers Confederation, which represents pharmaceutical regulators, said the latest deaths could have been avoided if India had followed its original deadline. All of the recent deaths were linked to a batch of Coldrif syrup made in May.
Bhaskar said he supports eliminating additional testing for exports after all laboratories are certified as conforming to WHO standards: “It is not the government’s job to test every batch. That is the responsibility of the manufacturer. The government’s duty is to ensure compliance.”
highly toxic
Government tests found that the syrup manufactured by Srisan contained 48.6% diethylene glycol (DEG) or almost 500 times the limits set by India and WHO.
According to an October 13 presentation on medical contamination by the Indian Pharmacopoeia Commission (IPC), which sets national drug standards, DEG is sometimes used “fraudulently or unknowingly” in place of expensive pharmaceutical-grade solvents like glycerin and propylene glycol.
In October the Commission began requiring manufacturers to test oral liquids for the presence of DEG and another comparable substance, ethylene glycol, before sale.
A Reuters investigation in 2023 exposed 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 going to jail in India.
“Contamination may occur through deliberate adulteration to cut costs or accidental mixing and mislabeling, particularly in shared processing facilities,” according to the presentation seen by Reuters in October.
While the IPC did not name specific companies, CDSCO said in October that recent inspections showed that some companies failed to test every batch of medicinal ingredients as required by law.
Authorities have since canceled Srisan’s manufacturing license, banned its products, and arrested its founder S. Ranganathan has been arrested on suspicion of murder.
Sreesan’s corporate office in a residential building in the southern city of Chennai and its manufacturing site – housed in a dilapidated shed-like structure – were both closed during Reuters’ visit.
“There were also several serious violations of existing standards. The facility is unfit for manufacturing,” said one of the people briefed on the preliminary investigation.
However, closing down Srisan’s facilities comes too late for Mayank Suryavanshi.
A three-and-a-half-year-old child from Parasia region of Madhya Pradesh state developed fever on September 22, for which a local doctor prescribed Coldrif.
Mayank took the supplements manufactured by Sreesan, but his condition worsened. He died of acute kidney failure in the early hours of 9 October.
“We never thought that a simple medicine could become life-threatening,” said his father Nilesh Suryavanshi, who works as a daily wage labourer.
He said, “My child should be the last.” “The government must ensure that no other parent has to suffer like this.”
‘People are dying’
India’s $50 billion pharmaceutical industry is made up of about 3,000 companies that operate more than 10,000 factories.
Government data shows that about two dozen companies are responsible for most of the drugs manufactured in the country. Most of the remaining 40% is produced by small and medium-sized enterprises, many of which fear that the cost of upgrading their facilities will make them economically unviable.
SME Pharma Industries Confederation secretary Jagdeep Singh has warned that almost half the manufacturing units in pharmaceutical hub state Himachal Pradesh will be closed if the deadline is not extended.
“I can guarantee there will be shortages, unemployment and massive national losses,” he said. He said some companies have already discontinued products because customers refuse to bear the upgrade costs.
But a source told Reuters that regulators no longer appear convinced by that argument.
“The deadline cannot be extended again and again – people are dying,” the person said, adding that major drugmakers that have already upgraded their facilities can make up for any shortfall.
In rural Parasia, local communities continue to count the costs of drug-safety lapses.
Regional drug inspectors are visiting pharmacies to collect random samples of cough syrup for testing. According to six local pharmacists, at least four pharmacies selling Coldrif were temporarily closed for failing to submit documents related to the sale of the syrup.
Community health workers have also been deployed to go door-to-door to urge residents to surrender remaining Coldrif bottles.
Local doctor Praveen Soni, who had given Coldriff to several children who died, has been arrested as part of a murder investigation. He could not be reached for comment, but previously told local media that “it is difficult to link the deaths to Coldriff because it had been determined for a decade.”
“We trusted him blindly,” said school teacher Sushant Kumar Thackeray, whose two-year-old daughter Yojita died after taking the syrup prescribed by Soni.
“The medicine turned into poison and my daughter died.”