Exemption to SII pneumococcal vaccine from price control for 5 years: NPPA

New Delhi:  In a major relief to Serum Institute of India, the drug price regulator, the National Pharmaceutical Pricing Authority (NPPA), has decided to grant exemption to Serum Institute of India's (SII) indigenously developed pneumococcal polysaccharide conjugate vaccine against pneumonia from price fixation 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 the Indian Patent.

Following the company's submission, the exemption was granted for SII's formulation of Pneumococcal Polysaccharide Conjugate Vaccine (Absorbed) IP (10 valent) in single dose 0.5 ml vial, multi dosage 2.5 ml vial, and pre-filled syringes 0.5 ml single dose.

This came in line with the application filed by vaccine major Serum Institute of India for exemption under Para 32 (ii) of DPCO 2013 for the formulation of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) IP (10 -Valent) .

The application of Serum Institute of India for exemption under Para 32(ii) of the DPCO 2013 for the formulation of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) IP (10-Valent) was discussed at the recent 96th Meeting of Authority under the DPCO, 2013 held on March 24, 2022.

The Authority noted the application filed by the Serum Institute of India for exemption under Para 32 (ii) of DPCO 2013 for the formulation of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) IP (10-Valent) in (i) 0.5 ml-1 dose (Vial), (ii) 2.5 ml-5 doses (Vial) and (iii) 0.5 ml-1 dose (pre-filled syringes).

The Authority further noted that the Serum Institute of India submitted the following documents:

a. Patent No. 318780 granted on 22.08.2019 to M/s Serum Institute of India Pvt. Ltd for invention entitled "PURIFICATION OF CAPSULAR POLYSACCHARIDES" for the term of 20 years from 15.05.2010, issued by the Patent Office, Government of India.

b. Patent No. 284211 granted on 14.06.2017 to M/ s Serum Ins titute of India Pvt. Ltd for invention entitled "METHOD FOR PREPARING BACTER IAL VACCINES" for the term of 20 years from 26.04.2010, issued by the Patent Office, Government of India.

c. Patent No. 276304 granted on 13.10.2016 to M/ s Serum In stitute of India Pvt. Ltd for invention entitled "METHOD FOR EVALUATION OF MULTIPLE ANTIGENS" for the term of 20 years from 26.03.2010, issued by the Patent Office, Government of In dia.

d. New Drug approval granted to M/s Serum Institute of India Pvt. Ltd from Central Drugs Standard Control Organisation (COSCO) , in form CT-23 to manufacture the new drug "Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) IP (10-Valent) (PCV lOV)" in (i) s ingle dose (0.5 ml) vial, (ii) multi-dose (2.5 ml) vial) and (iii) single dose (0.5ml) pre-filled syringes.

In view of the above documents, the authority noted the Patent Office India Report titled "Report on scope of patent claims with respect to a new drug formulation approval granted by COSCO vide FORM CT23 dated 14th July, 2020 to M/s Serum Institute of India Pvt. Ltd, Pune" sent vide e­mail dated 19.01.2022. The report stated as follows:

".....//. Granted claims 1 to 9 of Patent No. 318780 are related to a process for purification of antigenic polysaccharides by removing protein contaminants and the said process of purification of polysaccharide antigens covers within its scope, the purification of Streptococcus pneumonia serotypes 1,5, 9V,14,19A,19F,23F,7F,6A and 68 included in the formulation approved by CDSCO in the permission dated 17.07.2020.

lll. Granted claims 1 to 10 of Patent No. 2842 11 are related t a method for preparing a size reduced polysaccharide or oligosaccharide by subjecting the polysaccharides or oligosaccharides to a high pressure cell disruption treatment and the said method for preparing polysaccharide or oligosaccharide covers within its scope, the preparation of Streptococcus pneumonia serotypes 1, 5, 9V, 14,19A,19F,23F,7F,6A and 68 included in the formulation approved by CDSCO in the permission dated 1 7.07 .2020.

IV. Granted claims 1-3 of Patent No. 276304 are related to a method for simultaneously detecting the presence of multiple Streptococcus pneumonia polysaccharide antigens in a single vaccine in -process and the said method for detecting the presence of polysaccharides covers within its scope, the detection of Streptococcus pneumonia serotypes 1, 5, 911, 14, 1 9A, 19F, 23F, 7F, 6A and 68 included in the formulation approved by CDSCO in the permission dated 17.07.2020 "

The Authority deliberated upon the matter in detail and observed that Serum Institute of India Pvt. Ltd fulfills the conditions of para 32(ii) of DPCO 2013 with respect to the formulation "Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) IP (10- Valent) (PCV l0V)" in (i) single dose (0.5 ml) vial, (ii) mul ti-dose (2.5 ml) vial), and (iii) single dose (0.5ml) pre-filled syringes.

The condition of para 32(ii) of DPCO 2013 states, " The provisions of this order (Drugs Prices Control Order) shall not apply to a manufacturer producing a new drug in the country by a new process developed through indigenous Research and Development and patented under the Indian Patent Act, 1970 (39 of 1970) (process patent) for a period of five years from the date of the commencement of its commercial production in the country." 

 Accordingly, the Authority decided,

"Exemption be granted to M/s Serum Institute of India Pvt. Ltd under Para 32(ii) of DPCO 2013 for their formulation "Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) IP (10-Valent) (PCV l0V)" in (i) single dose (0.5 ml) vial, (ii) multi-dose (2.5 ml) vial) , and (iii) single dose (0.5ml) pre-filled syringes for a period of five years from the date of commencement of its commercial production in the countr y subject to it being co-terminus with the duration of Indian Patent."

Further, the Authority directed that the Serum Institute of India be requested to intimate the date of commercial production of the formulation "Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) IP (10-Valent) (PCV l0V)" in (i) single dose (0.5 ml) vial, (ii) multi-dose (2.5 ml) vial, and (iii) single dose (0.5 ml) pre-filled syringes in the country and the launch price of the product.

Finally, recalling the decision taken in its 84th meeting dated 10.03.2021, the Authority directed Serum Institute of India to seek retail price approval, if applicable, three months before the expiry of the exemption granted under Para 32 (ii) of DPCO 2013.