Serum institute of India, SII, gets exemption for Pneumococcal Polysaccharide Conjugate Vaccine from price control by National Pharmaceutical Pricing Authority for five years.
Serum Institute of India sent application for exemption from the provisions of DPCO, 2013 under Para 32 in respect of the formulation Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) IP (10-Valent) (PCV 10V) in single dose (0.5 ml) vial, multi-dose (5 dose-2.5 ml) vial, and single dose (0.5ml) pre-filled syringes which was duly approved by the Office of Central Drugs Standard Control Organisation (India) as new drug under the Drugs and Cosmetics Act, 1940 and Rules thereunder on 14.07.2020.
Para 32 of DPCO states that a manufacturer producing a new drug patented under the Indian Patent Act, 1970, for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country.
The Patent Office, Government of India has granted Patent to SII for an invention entitled PURIFICATION OF CAPSULAR POLYSACCHARIDES, A METHOD FOR PREPARING BACTERIAL VACCINES and METHOD FOR EVALUATION OF MULTIPLE ANTIGENS for the term of 20 years from 2010 in accordance with the provisions of the Patents Act, 1970.
NPPA at its 96th meeting dated 24.03.2022 observed that SII meets the requirement and decided that exemption may be granted to SII for a period of five years from the date of commencement of its commercial production in the country. Further, the period of five years is co-terminus with the duration of Indian Patent.
PNEUMOSIL [Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)] (10- valent) is a sterile suspension of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F individually conjugated by using 1 cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry (CDAP) to non-toxic diphtheria CRM197 protein. The polysaccharides are chemically activated and then covalently linked to the protein carrier CRM197 to form the glycoconjugate. Individual conjugates are compounded and then polysorbate 20 and aluminium phosphate are added to formulate the vaccine. The potency of the vaccine is determined by the quantity of the saccharide antigens and the saccharide-to-protein ratios in the individual glycoconjugates. The vaccine meets the requirements of WHO, IP and BP when tested by the methods outlined in WHO TRS 977, IP and BP.
By this vaccine, active immunization against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F in infants and toddlers from 6 weeks up to 2 years of age. The use of vaccine should be determined on the basis of relevant recommendations and take into consideration the disease impact by age and regional epidemiology.
