New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has once again extended its mandate to Pune-based Serum Institute of India (SII) to continue manufacturing two of its scheduled formulations against tetanus for another one year, till December 31, 2024. SII had earlier submitted Form IV intimation seeking the drug price regulator’s approval to discontinue these two formulations.
An Authority meeting held on December 15, 2023 noted that an earlier order on December 15, 2022, under the provisions of the Drugs (Prices Control) Order (DPCO), 2013, asking the company to continue production of these two formulations was extended till December 31, 2023.
“The Authority deliberated upon the matter in detail and decided to re-invoke Para 3 of DPCO, 2013 to direct Serum Institute of India Pvt. Ltd to continue the production and sales of two scheduled formulations (1) tetanus toxoid injection in 0.5 ml pack and (ii) tetanus toxoid injection in 5 ml pack up to December 31, 2024,” it concluded.
The Para 3 of DPCO, 2013 comprise directions to manufacturers of active pharmaceutical ingredients (API) or bulk drugs or formulations, under which the government may direct any manufacturer of any API or bulk drug or formulation to increase the production and to sell such ingredients to other manufacturers and to sell the formulations to institutions, hospitals or any other agency.
In May, 2020, considering the company’s application, the Authority observed that the company has a market share of 21.51 per cent and 26.33 per cent on the 0.5 ml and 5 ml injection formulations, respectively. It said that only one other company, Biological E Ltd is present in the market for these drug formulations in the country. Biological E had 79 per cent market share in tetanus toxoid 0.5 ml and 72 per cent market share in tetanus toxoid injections 5 ml units. NPPA has been extending the mandate to SII for manufacturing of these formulations for a few years now, according to the pricing authority documents.
Interestingly, the drug manufacturer and the drug price regulator had earlier locked horns in the Department of Pharmaceuticals in connection with fixing the price for these two formulations.
The NPPA initially fixed the price of ‘each pack’ of tetanus toxoid at Rs. 10.29 and all manufacturers, including Serum Institute, implemented ceiling price for 0.5ml ampoule of the medication. However, the price regulator later issued a corrigendum and modified the meaning of ‘each pack’ referred to in the notification as ‘l ml’. But no manufacturer in India makes or sells a 1ml vial of tetanus toxoid and only 0.5ml ampoules and 5ml vials of the product are available in the market. An ampoule is a single dose pack sold to consumers directly from retail chemists while a 5ml vial is a multi-dose pack sold mostly to large institutions such as hospitals.
With the modified price issued by the NPPA, the pro-rata rate of a 0.5ml ampoule of tetanus toxoid vaccine became Rs. 5.15. The industry, including SII, made a collective representation to the NPPA to no avail. Subsequently, one of the manufacturing companies, Biological E. Limited, filed a writ petition in the Delhi High Court and got a stay order, as reported earlier.
Based on the representation of manufacturers, the NPPA placed the matter before its expert committee and, on its recommendation, fixed separate ceiling prices for consumer packs of 0.5ml and hospital packs of 5ml. However, in the new revision, the regulator restricted the “price per unit considered” to Rs. 4.90.
Serum Institute, in a review petition, contended that the regulator’s decision to restrict the “price per unit considered” to Rs. 4.90, in spite of the stay order issued by the Delhi High Court, is improper and nonfunctional.
The DoP, in June, 2018, directed the NPPA to fix the ceiling prices of tetanus toxoid vaccine injections, de novo, separately for 0.5ml ampoules and 5ml vials by considering market price of May 2012 or September 2013, as the case may be, of those companies having market share of more than 1 per cent of the moving annual turnover.
With this order, the department also disposed of a separate joint review application filed by other manufacturers of the product over the same issue. The order was also applicable to separate petitions filed on the same issue by other manufacturers of the vaccine during the time including Biological E. Limited and Dano Vaccines and Biologicals.
