The exemption has been granted for SII’s formulation Pneumococcal Polysaccharide Conjugate Vaccine (Absorbed) IP (10 valent) in single dose 0.5 ml vial, five dose 2.5 ml vial and pre-filled syringes 0.5 ml single dose, following the company’s application.
The NPPA noted that SII submitted the documents related to three patents granted by the Patent Office, Government of India, for the product, in 2016, 2017 and 2019 for a term of 20 years from the year 2010. It has also noted that the Central Drugs Standard Control Organisation (CDSCO) has granted a new drug approval to SII to manufacture the new drug in different doses and strengths.
The Authority also considered a report from the Patent Office, on the scope of patent claims with respect to the new drug formulation approval granted by CDSCO in July 14, 2020. The company announced the launch of the pneumococcal vaccine for children under the brand Pneumosil in December, 2020.
An NPPA meeting observed that the company fulfills the conditions of Para 32(ii) of DPCO, 2013, with respect to the formulation. According to the relevant Para, the provisions of the DPCO shall not apply to a new drug produced in the country by a new process developed through indigenous research and development and patented under the Indian Patent Act, 1970 for a period of five years from the date of its commercial production in the country.
Based on this, the Authority decided to grant the exemption for a period of five years from the date of commencement of its commercial production in the country subject to it being co-terminus with the duration of Indian Patent. It has also directed SII to intimate the date of commercial production of the formulation in the country and the launch price of the product.
The vaccine is used for immunization against invasive disease and pneumonia in infants and is administered as an intramuscular dose. SII received the approval from the DCGI after a three-phase trial in India and Gambia.
As per the government’s clinical trial registry, the first phase of the trial was conducted in 2013 in 34 young Indian adults, while the second phase in 114 toddlers of 12-15 months.
The third phase of trials for the pneumococcal conjugate vaccine was conducted on 448 infants between the age of six to eight weeks old, and this was completed in October last year, as per the registry.
The application along with the clinical trial data was reviewed by the Office of Drug Controller General of India with the help of Special Expert Committee (SEC) for vaccines. The Committee recommended grant of permission of market authorization to the vaccine.
Earlier, India’s demand for the pneumococcal conjugate vaccine was substantially met by licensed importers in the country since the manufacturers were all vaccine companies based outside India. Other pneumococcal conjugate vaccines in the global market include Wyeth Pfizer’s Prevenar 13, and GlaxoSmithKline plc’s Synflorix.