Cough syrup quality issues persist among 54 Indian pharma firms. According to government data from the Central Drugs Standard Control Organisation (CDSCO), at least 6% of cough syrup samples from these manufacturers failed export quality tests until October this year. The CDSCO report, based on tests conducted across various states, revealed that out of 2,014 samples, 128 (6%) were deemed “not of standard quality” (NSQ).
Government laboratories, including the Indian Pharmacopoeia Commission in Ghaziabad, Central Drugs Laboratory in Kolkata, Central Drug Testing Laboratory in Chennai, Mumbai, and Hyderabad, and Regional Drugs Testing Laboratories in Chandigarh and Guwahati, along with NABL-accredited state drugs testing laboratories, participated in the testing process.
Specifically, in Gujarat, 51 out of 385 samples tested were NSQ, while in Ghaziabad, 29 out of 502 samples failed the quality test. The scrutiny follows a directive from the Union commerce ministry in May, making it mandatory for cough syrup manufacturers to undergo government lab testing before exporting. This decision aimed to address concerns after India-made cough syrups were allegedly linked to child deaths in other countries.
In December of the previous year, Marion Biotech’s cough syrup, based in Noida, was implicated in the deaths of 18 children in Uzbekistan. The World Health Organization issued a medical product alert on October 5, 2022, related to four cough syrups manufactured by Haryana-based Maiden Pharmaceuticals — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup. The UN body linked Maiden’s syrups to the tragic death of 66 children in The Gambia.
These incidents underscore the need for stringent quality control measures in the pharmaceutical industry, prompting regulatory actions to safeguard public health and uphold international standards.