The directions, first issued on 22 January 2020, were aimed at ensuring the continued availability of the TT vaccine and had been extended periodically over the past five years. However, a recent review by the Authority found that the original rationale for regulatory intervention no longer holds.
This came after the authorities deliberated on the directions issued to Serum Institute of India under Para 3 of DPCO, 2013, with respect to Tetanus Toxoide Vaccine (5 ml and 0.5 ml), at the 141st meeting under the DPCO, 2013, which was held on 23rd December, 2025.
The tetanus toxoid is a vaccine used to prevent tetanus (lockjaw), a serious and potentially fatal bacterial disease caused by the neurotoxin of Clostridium tetani. The toxoid is an inactivated, non-toxic form of the bacterial toxin that still stimulates the human immune system to produce protective antibodies.
At the recent meeting, the Authority noted that direction under Para 3 of DPC0, 2013, was issued to Serum Institute of India on 22.01.2020 for continued production/sale in respect of Tetanus Toxoid Injection in two pack sizes, i.e., (i) 0.5 ml pack and (ii) 5 ml pack. The said directions were extended from time to time and are effective till 31.12.2025.
The Authority was briefed that the Immunization Division, MoH&FW, vide email dated 18.12.2025, has confirmed that the Tetanus Toxoid vaccine was not procured by the Central Medical Service Society (CMSS) during the last five years.
Further, the Authority noted,
"Analysis of market data shows that there are other market players of the said subject formulations, and the total MAT values over the last 5 years are in the same range. Further, the market share of the Serum Institute of India is 0.00% & 0.41% for Tetanus Toxoid 5ml pack and 0.5 ml packs, respectively, based on Nov 2025 market data."
Taking these factors into account, the Authority concluded that continued use of Para 3 of DPCO, 2013, an extraordinary provision meant to safeguard the availability of essential medicines, is no longer justified in this case. Consequently, it decided to allow the special directions to lapse after their current validity ends on 31 December 2025.
In view of the above, the Authority held,
"The Authority decided not to further extend the period of said directions in respect of Tetanus Toxoid Injection in two pack sizes, i.e., (i) 0.5ml pack and (ii) 5 ml pack manufactured by Serum Institute of India."
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