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MDC seeks clarity on application for exemption of nafithromycin from DPCO
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Gireesh Babu, New Delhi
September 30 , 2025
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The Multidisciplinary Committee of Experts (MDC), which advices the National Pharmaceutical Pricing Authority (NPPA) on pricing related matters, has sought further clarity on Wockhardt Ltd's application for exemption of its non-scheduled formulation nafithromycin tablets, the country's first indigenous antibiotic, from the norms under Drugs Prices Control Order (DPCO), 2013.
The Committee noted that while the approval from the Central Drugs Standard Control Organisation (CDSCO) pertains specifically to nafithromycin immediate release film-coated tablets, each tablet containing nafithromycin 400 mg, the patent documents submitted by the company does not mention the name.
"The Committee directed that inputs be obtained from CDSCO and the Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) to verify whether the formulation approved by CDSCO corresponds to the one for which the patent was granted," said the MDC in its latest meeting.
The committee further directed that the application along with the necessary clarifications may be placed before the Committee for further consideration.
Wockhardt submitted an application on July 14, 2025, seeking exemption for the formulation under Para 32 (i) of the DPCO, 2013. The company had submitted the permission of the formulation granted by the CDSCO and the Patent Certificate (Patent No. 415319, granted on December 23, 2022) under the Patent Act, 1970.
Under DPCO, the government shall monitor the maximum retail price (MRP) of all the drugs, including non scheduled formulations and ensure that no manufacturer increases the maximum retail price of a drug more than 10% of MRP during preceding 12 months.
However, Para 32(i) states that the DPCO pricing norms will shall not apply to a manufacturer producing a new drug patented under the Indian Patent Act, 197, for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country.
When the application of Wockhardt was taken up for consideration, the Committee observed that neither the patent certificate, nor the claims filed with the patent office explicitly mention the name nafithromycin. The Committee, in August 7, 2025, sought complete set of claims as submitted to the patent office and in response, the company submitted the details including summary of inventions and claims and the scientific publication from the peer reviewed journal Chromatographia.
Nafithromycin, developed by Wockhardt with support of the Biotechnology Industry Research Assistance Council (BIRAC), under the Department of Biotechnology, was officially launched by the on November 20, 2024. BIRAC provided Rs. 8 crore funding under Biotech Industry Programme for phase 3 clinical trials, for development of the drug.
The Central government, during the launch, said that the drug, marketed as "Miqnaf," targets Community-Acquired Bacterial Pneumonia (CABP) caused by drug-resistant bacteria, which disproportionately affects vulnerable populations such as children, the elderly, and those with compromised immune systems.
"This groundbreaking antibiotic is ten times more effective than current treatments like azithromycin and offers a three-day treatment regimen, significantly shortening the recovery time while improving patient outcomes," said the ministry of chemicals and fertilisers during the time.
Nafithromycin is designed to treat both typical and atypical drug-resistant bacteria, making it a crucial tool in addressing the global health crisis of AMR (anti-microbial resistance). It boasts superior safety, minimal side effects, and no significant drug interactions."
"Nafithromycin’s development marks a historic milestone as the first new antibiotic in its class to be introduced globally in over 30 years. The drug, which has undergone extensive clinical trials across the US, Europe, and India, has been developed with an investment of Rs. 500 crore." said the Ministry. Following announcement of the launch, the drug received final approval from the CDSCO.
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