NPPA Refuses To Exempt Bharat Serums & Vaccines’ Immunoglobulin Products From DPCO

New Delhi : The National Pharmaceutical Pricing Authority (NPPA) has refused Bharat Serums & Vaccines Ltd’s (BSVL) application to exempt its three immunoglobulin products from price control based on the Patent Office’s report that they are not covered within the scope of the granted claims.

BSVL has applied for exemption of its recombinant anti Rho-D immunoglobulin injection 300 mcg (liquid injection) in 2 ml vial and 1ml graduated pre-filled syringe, which were approved as new drug by the Central Drugs Standard Control Organisation (CDSCO) in December 24, 2020. Another product – anti Rho-D immunoglobulin (r-DNA origin) 150 mcg liquid injection in 2 ml vial was approved by the drug regulator on August 24, 2021.

The company also submitted the patent certificate issued by the Patent Office, Government of India for invention titled anti-RHD monoclonal antibody, granted on November 2, 2012 with the period of grant panning out 20 years from December 31, 2008.

It has submitted application to the price regulator under Para 32 (i) of the Drugs (Prices Control) Order, 2013, which exempts manufacturers who produce a new drug patented under the Indian Patent Act, 1970 and not produced elsewhere, if developed through indigenous research and development, from the provisions of the DPCO for a period of five years from the date of commencement of its commercial production in the country. The product is developed for prevention of haemolytic disease of newborn and has been claimed as useful in safe delivery and good health to Rh-negative mothers and their newborns in the country.

However, the Patent Office, in its report on scope of patent claims with respect to new drug formulations approval granted by CDSCO, said that the three products applied for DPCO exemption are not covered within the scope of granted claims in Patent No. 254428. The applied products were compared with the granted claims one to 16 as well as description and examples, it said.

“As a result, it is found that said products as such are not covered within the scope of the granted claims and also, there is no full and particular disclosure in the patent specification with respect to the said products,” said the report.

The NPPA, in a recent meeting considered the report and opined that the formulations recombinant anti Rho-D immunoglobulin injection 300 mcg (liquid injection) in 2 ml vial and the same product in 1 ml graduated pre-filled syringe are not qualified for exemption under Para 32(i) of the DPCO 2013.

Considering an application from the company on the third product, anti Rho-D immunoglobulin (r-DNA origin) 150 mcg liquid injection in 2 ml vial, it has observed that the Patent Office report has given the same response. Accordingly the Authority decided that no exemption be granted to BSVL under Para 32(i) of DPCO 2013 for the formulation, and the application be treated as closed.

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