Cough Syrup Contamination Issue: What Has Changed In Pharma Quality Checks And Why Labs Are Overloaded

India’s pharmaceutical industry is scaling up product testing practices in response to stringent government mandates. The move follows recent cough syrup contamination incidents that resulted in the deaths of many children and the subsequent suspension of licences for substandard products.

Drug makers are investing heavily in advanced equipment to detect toxic substances amid a surge in joint inspections by state and central regulators. According to industry insiders, joint risk-based assessments have intensified nationwide, prompting pharma companies to adopt stricter vigilance, The Economic Times reported.

With heightened focus on testing, regulators are making efforts to bolster the overall integrity of India’s drug-manufacturing ecosystem. Earlier, the checks were primarily focused on the raw material and testing of the finished cough syrups was compulsory mainly for export batches. However, things have swiftly changed in the last couple of months.

While testing volumes have jumped dramatically, there is also a demand for certain machines with specific capabilities. One such equipment is a gas chromatograph (GC), which detects diethylene glycol and ethylene glycol. These were the toxic contaminants found in recent cough syrup contamination cases, the ET report added. Now, the government has made it mandatory to test for these elements following the cough syrup tragedies.

The demand has particularly increased among mid-sized and smaller pharma companies, which earlier did not possess this machine in-house. The report added that just in the last two to three weeks, nearly 100 GC machines have been procured in manufacturing hubs like Baddi in Himachal Pradesh.

Most GC machines, priced at about Rs 20 lakh each, are imported from Japan, Singapore, the US, or China. The report also added that there is a high demand for skilled technicians to operate this specialised equipment. 

Most large Indian pharma companies maintain their in-house testing facilities. However, many still rely on contract research organisations to handle additional sample testing.

According to the ET report, testing volumes have jumped several-fold in the last two months. Labs that once handled only a few liquid-oral batches now process dozens of samples. At Auriga Research in Delhi, daily liquid-oral testing has soared from five to six batches to nearly 120. Given that each batch contains 10,000–100,000 bottles, the lab is now testing 1.2 million to 12 million bottles per day.

"We see a big surge in liquid oral samples for testing across our labs from large and midsize pharma companies," Auriga Research’s Managing Director Saurabh Arora told the publication.

Even Ayurvedic manufacturers are submitting syrup samples for testing to avoid any risk. The report cited data from PharmaTrac to note that the segment has grown from Rs 16,000 crore in 2021 to nearly Rs 24,000 crore today, prompting heightened quality vigilance.