Last Updated on December 8, 2024 by The Health Master
Acyclovir 800 mg
In a recent development, Cipla Ltd., a prominent pharmaceutical company, has encountered a setback in its bid to challenge the ceiling price set by the National Pharmaceutical Pricing Authority (NPPA) for its antiviral drug, Acyclovir 800 mg tablets.
The Department of Pharmaceuticals (DoP) has upheld the NPPA’s decision, rejecting Cipla’s review application.
The Dispute
Cipla had filed a review petition against the NPPA’s January 11, 2023 order, which fixed the ceiling price for Acyclovir 800 mg tablets.
The company argued that its brand, Acivir 800 mg tablet DT 5’s, was included in the revised Schedule I of the Drugs Prices Control Order (DPCO), 2013, and that the NPPA should have considered the revised Price to Retailer (PTR) for calculating the ceiling price.
Cipla’s Argument
Cipla contended that:
- The NPPA should have used the revised PTR of Rs. 175.88 instead of the older PTR of Rs. 159.89.
- The 10% annual increase in Maximum Retail Price (MRP) for non-scheduled formulations should have been factored into the ceiling price calculation.
- The NPPA’s decision to use July 2022 data for price calculation was not justified.
- The NPPA did not follow its own guidelines regarding the review process and the publication of revised draft calculation sheets.
NPPA’s Counter-Argument
The NPPA defended its decision by stating that:
- The decision to use July 2022 data was based on previous decisions and the time lag in reflecting price changes.
- The formulation was non-scheduled before NLEM, 2022, and Form II submission was not applicable.
- The 10-day review period for revised draft calculation sheets only applies to suo moto corrections.
The DoP’s Decision
The DoP, after considering the arguments from both sides, sided with the NPPA.
The review authority upheld the NPPA’s decision to fix the ceiling price and rejected Cipla’s review application.
Implications
This decision has significant implications for the pharmaceutical industry, particularly for companies that challenge price control orders.
It reinforces the NPPA’s authority in setting drug prices and highlights the importance of adhering to regulatory guidelines.
Key Takeaways
- Cipla’s challenge to the ceiling price for Acyclovir 800 mg tablets was unsuccessful.
- The DoP upheld the NPPA’s decision, reinforcing the regulatory authority’s power.
- Pharmaceutical companies should carefully consider the regulatory implications of price challenges.
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What is Acyclovir 800 mg?
Acyclovir is an antiviral medication used to treat herpes simplex virus infections, including cold sores and genital herpes.
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What is the NPPA?
The National Pharmaceutical Pricing Authority is a government agency responsible for regulating the prices of essential medicines in India.
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What is the DPCO?
The Drugs Prices Control Order is a government order that regulates the prices of certain essential medicines.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
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