NPPA refuses to exempt these drugs from DPCO 2013

The NPPA, in a recent meeting considered the report and opined that the FDC is not qualified for exemption under Para 32 of the DPCO 2013.

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NPPA Price of drugs

Last Updated on May 14, 2022 by The Health Master

Neon Lab’s local anaesthetic drug

The National Pharmaceutical Pricing Authority (NPPA) has refused Neon Laboratories’ application to exempt its local anaesthetic product from price control based on the Patent Office’s report that it is not within the scope of the granted claims.

Neon Laboratories has applied for exemption of its fixed dose combination ropivacaine hydrochloride IP equivalent to anhydrous ropivacaine hydrochloride 7.5 mg and dextrose (monohydrate) IP 80 mg per ml injection, which received approval from the Central Drugs Standard Control Organisation (CDSCO) on October 1, 2018.

The company submitted the copy of the CDSCO’s new drug approval and also the patent certificate issued by the Patent Office, Government of India for hyperbaric injection solution of ropivacaine hydrochloride and process for preparation, granted on December 11, 2018 with the period of grant panning out 20 years from July 13, 2015.

It has submitted application to the price regulator under Para 32 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.

Ropivacaine hydrochloride is a new long acting amino-amide local anaesthetic agent with pharmacodynamics, pharmacokinetic properties with chemical structure resembling bupivacaine hydrochloride, according to the patent documents with the patent regulators.

The Patent Office, in its report on scope of patent claims with respect to new drug formulations approval granted by CDSCO, said that the amount of drug ropivacaine hydrochloride is different in both the formulations -the one that is approved by the CDCSO and the other that is allowed in the granted patent.

“What has been approved by CDSCO as a formulation (of 1ml) containing 7.5 mg of ropivacaine hydrochloride is not within the scope of claims of granted patent in terms of amount of drug ropivacaine hydrochloride, whereas the formulation also contain 80 mg of dextrose, which is within the scope of granted patent,” said the report from the Patent Office.

Further, it added, the formulation approved by CDSCO also differs in respect of base/acid included to adjust the pH between 3.5 to 6.0 as per claim 1 of granted patent, which is not mentioned in the approved formulation of the drug regulator.

The NPPA, in a recent meeting considered the report and opined that the FDC is not qualified for exemption under Para 32 of the DPCO 2013.

It may be noted that the Authority, in the same meeting, refused to grant exemption from DPCO 2013 to Bharat Serums & Vaccines Ltd for three immunoglobulin products – recombinant anti Rho-D immunoglobulin injection 300 mcg (liquid injection) in 2 ml vial and 1ml graduated pre-filled syringe and anti Rho-D immunoglobulin (r-DNA origin) 150 mcg liquid injection in 2 ml vial, which were approved as new drug by the Central Drugs Standard Control Organisation.

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Bharat Serums & Vaccines’ immunoglobulin products

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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