Archive · 25 Jan 2026
India Rejects Chinese Polio Strain in 6-in-1 Vaccine
India's drug regulator, CDSCO, has said no to testing a new 6-in-1 vaccine for babies.
This vaccine was made by Indian Immunologicals Ltd and included a polio strain from China.
The regulator is worried that this strain could accidentally escape and bring back polio, a disease India has been free of for 14 years.
They also said the vaccine maker didn't provide enough safety data from other countries where it was used.
The vaccine company says the Chinese strain is safe and used in other countries, but the regulator wants more proof.
Health experts agree that keeping polio away is very important, and they don't want to take any risks.
Right now, India uses a 5-in-1 vaccine and separate polio drops, and the regulator wants to keep it that way until they are sure the new vaccine is safe.
CDSCO rejected IIL's request for human trials of a 6-in-1 vaccine containing a Chinese polio strain.
The regulator cited safety and containment concerns, including the lack of post-marketing surveillance data.
Sinovac's polio strain lacks WHO's Poliovirus Containment Certification, raising biosafety worries.
India has been polio-free since 2014, and the regulator wants to prevent any risk of reintroduction.
IIL argues that the Chinese strain is safe and used in other countries, but the regulator seeks more evidence.
- Who
- Indian Immunologicals Ltd (IIL) and the Central Drugs Standard Control Organisation (CDSCO)
- What
- Rejection of human trials for a 6-in-1 vaccine containing a Chinese polio strain
- When
- The decision was made after a meeting on 22 December 2023
- Where
- India
- Why
- Concerns over potential safety and containment issues, and the risk of reintroducing polio
- Vaccine Developer
- Indian Immunologicals Ltd (IIL)
- Polio Strain Origin
- China (Sinovac)
- Regulator
- Central Drugs Standard Control Organisation (CDSCO)
- Reason for Rejection
- Safety and containment concerns
- Polio-Free Status
- India since 2014
- Vaccine Type
- Hexavalent (6-in-1)
- Current Polio Vaccine
- Pentavalent (5-in-1) + oral polio drops
- WHO Certification
- Sinovac lacks WHO Poliovirus Containment Certification