Ceiling Price for Acyclovir 800 mg Tablets upheld

Last Updated on December 1, 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.

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.

For informative videos by The Health Master, click on the below YouTube icon:

• NPPA’s ceiling price for Methylprednisolone Upheld
  December 1, 2024
• Hospital caught overcharging for Medicines: Hyderabad
  December 1, 2024
• Standards for 214 Critical Medical Devices to be developed
  December 1, 2024
• FDA Maharashtra cracks down on 15 Medical Stores
  December 1, 2024
• Ceiling Price for Acyclovir 800 mg Tablets upheld
  November 30, 2024
• Strengthening drug security through Pharmaceutical Supply Chain
  November 30, 2024

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

For informative videos on consumer awareness, click on the below YouTube icon: