India has turned down requests from smaller drug companies to push back the deadline for upgrading their factories to meet World Health Organization (WHO) standards. This is a very important decision that was made because people were angry and at least 24 children died recently because of toxic cough syrup made in India.
The government’s order, which was first given in late 2023, says that all pharmaceutical businesses must spend money on processes to bring their factories up to international standards. These protocols must include ways to stop cross-contamination and make batch-testing necessary. This push started after cough syrups made in India were linked to the deaths of more than 140 children in Africa and Central Asia. This hurt India’s reputation as the “pharmacy of the world.”
Sresan’s refusal to comply was the reason for enforcement.
Major drug companies reached their original target of June 2024, but smaller companies had until December 2024 to do so. Some members of India’s pharmaceutical lobby, on the other hand, asked for additional time, saying that the necessary changes would put enterprises out of business.
Sources said that the main reason the government chose to disregard these petitions was that they found out that Sresan Pharmaceutical Manufacturer, the company that made the exceedingly hazardous Coldrif syrup related to the most recent deaths, had not made any improvements to its facilities.
In October, studies showed that several Coldrif syrups were quite dangerous, therefore the final decision to keep the deadline at the end of the year was made. On Thursday, drug companies were told about the decision at a meeting.
Udaya Bhaskar of the All India Drugs Control Officers’ Confederation said that the most recent deaths may have been avoided if the original deadline had been met. There were a lot of deaths recently that were linked to a batch of Coldrif syrup made in May.
Details about highly toxic contamination
Government tests showed that the Coldrif syrup made by Sresan had a shocking 48.6% diethylene glycol (DEG), which is almost 500 times more than what India and the WHO say is safe.
Sometimes, “fraudulently or unintentionally,” DEG and its similar chemical, ethylene glycol, are used instead of more expensive pharmaceutical-grade solvents like glycerine and propylene glycol. The Indian Pharmacopoeia Commission (IPC), which sets national drug standards, now requires all manufacturers to test all oral liquids for DEG and ethylene glycol before they can be sold.
Since then, the government has taken away Sresan’s manufacturing license, banned its goods, and detained its founder, S. Ranganathan, on suspicion of killing someone. The examination found “numerous critical violations of even existing standards” at the site, which was described as a “ramshackle shed-like structure.”
Changes in regulations and their effects
The sad events have sparked a new public debate in India about how safety standards are enforced. This is because the strict criteria for testing drugs for export did not apply to drugs meant for use in India.
India aims to get rid of a controversial law from 2023 that says cough syrups must be tested at government-approved labs before they can be exported. This is because the WHO criteria have to be followed. Bhaskar backed this decision and said that the manufacturer, not the government, should be in charge of testing.
Regulator Resolve vs. Industry Concerns
There are around 3,000 enterprises in India’s $50 billion pharmaceutical industry, and they run more than 10,000 plants. Most of the production comes from big companies, but a lot of it comes from small and medium-sized businesses (SMEs).
Jagdeep Singh, secretary of the SME Pharma Industries Confederation, said that if the deadline isn’t pushed back, almost half of the production units in pharmaceutical centers like Himachal Pradesh could have to close. He said this is because they are worried about product shortages and mass unemployment.
But it looks like regulators are set on their course. One source said, “The deadline can’t be pushed back again and again—people are dying.” They also said that significant drug companies that have previously complied might make up for any market gap.
The Cost to People
The strict action is too late for families like Mayank Suryavanshi’s. He was only 3.5 years old and died of acute kidney failure on October 9 after being given Coldrif. Nilesh Suryavanshi, his father, asked the government to make sure that no other parent had to go through the same thing.
As part of the manslaughter inquiry, local doctor Praveen Soni has been detained. He gave Coldrif to numerous of the dead youngsters. Sushant Kumar Thakre, a school teacher whose two-year-old daughter Yojitha died after ingesting the syrup, said, “The medicine turned into poison and killed my daughter.” This showed how much the community had lost faith in the medicine.