The Central Drugs Standard Control Organization (CDSCO) has released a report detailing various instances of substandard vaccines identified in India over the past six years, i.e. from 2017-2023. This report was issued on September 11, 2024
The report identified substandard vaccines across various categories, including typhoid, tetanus, polio, and COVID-19 vaccines.
Issues included incorrect identity, failing potency tests, improper storage conditions, and even spurious vaccines.
The CDSCO took various actions depending on the severity of the issue. These included:
- Joint investigations at manufacturing sites
- Issuing show-cause notices to manufacturers
- Product suspension or recall
- Legal action against involved parties
Specific Examples
- 2017: A sample of Bio Typh (Typhoid Vaccine) was declared “spurious” and not manufactured by the labeled firm. A legal case is ongoing.
- 2018: Certain batches of polio vaccine from Bio med. failed identity tests for Type-2 poliovirus. Legal action was initiated.
- 2021-2022: Multiple instances of spurious COVID-19 vaccines were identified and confiscated. Police investigations and court cases are underway.
- 2022: A batch of Typhoid Polysaccharide Vaccine (TYPBAR) from Bharat Biotech exceeded acceptable levels of O-acetyl content. The product permission was suspended for 15 days.
Public Health Concerns
Substandard vaccines pose a significant public health risk. They may be ineffective in preventing diseases and could even cause harm. This report highlights the importance of continued vigilance by regulatory bodies and the need for public awareness regarding vaccine safety.
