New Delhi had in late 2023 ordered pharmaceutical companies to ensure their plants meet World Health Organization-recommended standards, which would require them to invest in protocols to prevent cross-contamination and enable batch-testing of samples, among other measures.
The mandate was established after India-made cough syrups were linked to the deaths of over 140 children in Africa and Central Asia, severely denting India’s image as a “pharmacy of the world.”
While major pharmaceutical companies met a June 2024 deadline, smaller firms were granted a 12-month reprieve on their separate December 2024 target. Some in India’s pharmaceutical lobby have, however, been pushing for more time, warning that businesses would be forced into bankruptcy by the costs.
But news that Sresan Pharmaceutical Manufacturer – which made the Coldrif syrup that was 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 non-public deliberations.
The decision was made in October after tests confirmed a high level 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 completed, 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.
If India had adhered to 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 the recent deaths were linked to a batch of Coldrif syrup made in May.
Bhaskar said he supported scrapping additional testing for exports once all labs were certified to WHO standards: “It’s not the government’s job to test every batch. That responsibility lies with the manufacturer. The government’s duty is to ensure compliance.”
HIGHLY TOXIC
Government tests found the syrup manufactured by Sresan contained 48.6% diethylene glycol (DEG), or nearly 500 times the limit set by India and the WHO.
A Reuters investigation in 2023 had exposed regulatory and legal gaps that allowed unscrupulous manufacturers to substitute DEG for pharmaceutical-grade propylene glycol. Despite the earlier deaths abroad, there is no record of anyone getting jailed in India.
“Contamination may occur through deliberate adulteration to cut costs or accidental mix-ups and mislabelling, especially in shared processing facilities,” according to the October presentation seen by Reuters.
Authorities have since revoked Sresan’s manufacturing license, banned its products, and arrested its founder S. Ranganathan on suspicion of manslaughter.
Sresan’s corporate office in a residential building in the southern city of Chennai and its manufacturing site – which is based in a ramshackle shed-like structure – were both closed during Reuters’ visits.
India’s US$50 billion pharmaceutical industry is composed of some 3,000 companies that operate over 10,000 factories.
About two dozen firms are responsible for the majority of drugs manufactured in the country, government data show. Much of the remaining 40% is produced by small- and medium-size enterprises, many of which fear the costs of upgrading their facilities will render them economically unviable.
Jagdeep Singh, secretary of the SME Pharma Industries Confederation, has warned that nearly half of the manufacturing units in the pharmaceutical hub state of Himachal Pradesh would shut if an extension was not forthcoming.
But regulators no longer seem convinced by that argument, one of the sources told Reuters.
The deadline “cannot be extended again and again – people are dying,” the person said, adding that major drugmakers which have already upgraded their facilities could meet any shortfall.