Neon Lab’s local anesthetic drug’s exemption from DPCO refused

Based on the Patent Office’s report claiming that India’s National Pharmaceutical Pricing Authority (NPPA) has refused Neon Laboratories’ application to exempt their local anesthetic product from price control under the Drugs (Prices Control) Order, 2013 observing that it is not within the scope of the granted claims.

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

Neon Laboratories had submitted a copy of the Central Drugs Standard Control Organisation (CDSCO) ‘s new drug approval and also the patent certificate which the Patent Office issued, union government of India for the hyperbaric injection solution of ropivacaine hydrochloride and the process for preparation, granted on December 11, 2018, with the period of the grant being out 20 years from July 13, 2015.

It has submitted an application to the National Pharmaceutical Pricing Authority (NPPA) of India under Para 32 of the Drugs (Prices Control) Order (DPCO), 2013, which exempts manufacturers that produce a new drug patented under the Indian Patent Act of 1970 and not made elsewhere, if it was developed through indigenous research and development, from the provisions of the Drugs (Prices Control) Order (DPCO), 2013 for five years beginning from the date of commencement of its commercial production in the country.

Ropivacaine hydrochloride from Neon Laboratories is a new long-acting local-amide anesthetic agent with pharmacodynamics, pharmacokinetic properties, and a chemical structure resembling bupivacaine hydrochloride, according to the various patent documents submitted with the union patent regulators.

The Patent Office stated that the amount of drug ropivacaine hydrochloride is different in both the formulations in its report on the scope of various patent claims concerning new drug formulations approval granted by the Central Drugs Standard Control Organisation (CDSCO)  – the one that is approved by the Central Drugs Standard Control Organisation (CDSCO) 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 the granted patent in terms of the amount of drug ropivacaine hydrochloride, whereas the formulation also contains 80 mg of dextrose, which is within the scope of a granted patent,” asserted the report from the Patent Office.

Further, it claimed that the formulation approved by Central Drugs Standard Control Organisation (CDSCO) also differs in respect of base and acid, including adjusting the pH between 3.5 to 6.0 as per claim 1 of a granted patent, which is not mentioned in the approved formulation of the drug regulator.

The National Pharmaceutical Pricing Authority (NPPA) considered the report in a recent meeting. It opined that the FDC is not qualified for exemption under Para 32 of the Drugs (Prices Control) Order (DPCO), 2013.

The reader may note that the National Pharmaceutical Pricing Authority (NPPA), in the same meeting, has refused to grant exemption from the Drugs (Prices Control) Order (DPCO), 2013 to Bharat Serums & Vaccines Ltd for their 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. These were approved as new drugs by the Central Drugs Standard Control Organisation.

These decisions will help lower the prices of these pharma drugs and thus increase their availability to the general public. While patent protection encourages research, it is essential to ensure that drug prices stay affordable.