“Two India-based vaccine manufacturing sites from where Sanofi was supplying its IPV vaccine have been shut,” the documents said.
IPV is manufactured by only two companies – Sanofi Pasteur and Serum Institute of India (SII). Pune-based SII started its supplies of the vaccine only in 2021. Sanofi is believed to cater to over 80% of India’s IPV dose requirements.
“We are fully committed to fulfil our public health mission in India,” a Sanofi India spokesperson said in response to questions from ET.
“Having been a long-standing contributor to India’s journey to become polio-free, we stay dedicated to supporting India’s public health programme for polio eradication in alignment with the authorities.” In September 2023, however, Sanofi had announced in a public notice that due to the discontinuation of the manufacturing and marketing, the product may not be available in the market. IPV is an integral part of India’s Universal Immunization Programme (UIP) that provides free immunisation to children against 12 preventable diseases including measles, diphtheria, hepatitis B, and tuberculosis. IPV was introduced into UIP in 2015 as part of a global polio endgame strategy.
Experts said the impeccable record of a polio-free India rides on uninterrupted vaccine supplies.
“Time is running out to find alternate supply arrangements,” a public health expert told ET on the condition of anonymity. “By now, the government should have floated tenders or placed additional orders to Serum. This shows the callousness as it will affect polio surveillance and polio control measures.”
Another expert said, “This is critical as polio has been eradicated from the country and any procurement delay can impact the country’s polio-free status. The government should explore all options which include ordering additional quantities from Serum.”
Pune-based SII may need to ramp up its capacity to bridge the demand shortage, experts said. The IPV shots are administered to children at six weeks, 14 weeks and nine months. While oral polio drops are administered at birth and then at 6,10,14 months and 1.5 years. India was the first country to introduce fractional doses in 2016 to dissipate a shortage of IPV.
In January 2023, Sanofi had said some of its activities at Medchal and Muppireddypally sites in Telangana were no longer viable. The French drugmaker had failed to win a large contract for supplies of its Shan5, a vaccine to prevent five diseases, rendering much of its facilities redundant. It had then offered VRS to its over 800 staffers at the two facilities. However, Sanofi at that time had maintained that supplies of the polio vaccines will remain unimpacted. But the situation has changed, going by the documents accessed by ET.
Sanofi has made multiple submissions to the union health ministry, cautioning against the impending supply challenges and had sought relaxation of a condition for continuation of such supplies, the documents showed.
