NPPA Clears Serum Institute to Stop Two Tetanus Toxoid Pack Sizes

The National Pharmaceutical Pricing Authority (NPPA) has permitted Pune-based Serum Institute of India (SII) to discontinue the manufacture and sale of two pack sizes of its tetanus toxoid injection—0.5 ml and 5 ml—after concluding that the products have negligible market presence and adequate alternatives are available.

SII had earlier sought approval to withdraw these formulations, but the regulator had repeatedly directed the company to continue production under Para 3 of the Drugs (Prices Control) Order, 2013, citing public interest. This mandate was last extended until December 31, 2025.

Reconsidering the issue, NPPA noted confirmation from the Union health ministry that the vaccine had not been procured by the Central Medical Service Society in the past five years. Market data further showed SII’s share at just 0.00% for the 5 ml pack and 0.41% for the 0.5 ml pack as of November 2025.

In view of sustained low demand and the presence of other suppliers, the Authority decided not to extend the production directive further.

29-12-2025