A sample of Snake Venom Antiserum (SVA), used for treating snakebite cases, has failed quality testing at the Central Drugs Laboratory (CDL), Kasauli as per the media reports. The antiserum was manufactured by a Maharashtra-based pharmaceutical unit and supplied for use in government hospitals.
According to laboratory findings, the sample did not meet prescribed quality standards during testing at CDL Kasauli. The failure has been confirmed through the official website of the Central Drugs Laboratory.
Moisture Content Exceeds Permissible Limit
During laboratory analysis, the moisture content in the antiserum sample was found to be higher than the permissible limit of three percent. Under revised quality norms introduced in 2022, the acceptable moisture content in antiserum is capped at three percent. Earlier, under the 2018 standards, the limit was one percent. Any sample exceeding the revised threshold is deemed to have failed quality compliance.
Following the test results, the CDL has forwarded the failure report to the Union Health Ministry and the Maharashtra government.
Immediate Halt on Use and Supply
After the sample failed quality checks, authorities have ordered an immediate halt on the use of the affected batch to prevent any incorrect or unsafe usage. The batch will also not be released in the market. Officials stated that the antiserum sample did not meet the updated 2022 standards, leading to its rejection.
Manufactured by Haffkine Bio-Pharma
The Snake Venom Antiserum is manufactured by Haffkine Bio-Pharmaceutical Corporation, a Maharashtra government undertaking, which supplies antiserum to government hospitals across the country. The sample was sent to CDL Kasauli as part of routine quality evaluation.
CDL Kasauli is responsible for testing all vaccines and antiserum manufactured or imported in India. No vaccine or antiserum can be administered to humans without clearance from the laboratory. Any product failing to meet quality standards is barred from market distribution.
During the COVID-19 pandemic, CDL Kasauli played a crucial role by conducting round-the-clock testing of vaccines, including Covishield and Covaxin, enabling their timely rollout. Only after clearance from CDL were these vaccines approved for public use.
The permissible moisture content standards for antiserum were revised in 2022, increasing the threshold from one percent to three percent. Samples exceeding this revised limit are automatically classified as failed during quality testing.