NPPA Compliance for Surgical Dressing Company

PROBLEM STATEMENT

A surgical dressing company faced non-compliance issues with the National Pharmaceutical Pricing Authority (NPPA) regulations due to an MRP increase exceeding the permissible 10% annual cap. Non-compliance with NPPA’s price control regulations threatened penalties and disrupted market operations.

Our Approach

Compliance Review: Conducted a detailed review of the client’s pricing strategy and compared it with NPPA guidelines for medical devices under price control.
Justification and Documentation:
- Prepared a thorough cost analysis and justification explaining the reasons for the MRP increase, including rising input costs and operational expenses.
- Compiled supporting documentation, such as production cost breakdowns and market data, to substantiate the price revision.
Liaison with NPPA: D2R coordinated with NPPA officials, presenting the justification and negotiating a resolution. We ensured the client addressed all regulatory requirements and submitted any additional information requested by NPPA.
Long-term Compliance Strategy: Provided the client with a compliance framework to monitor future price adjustments within NPPA’s limits and avoid similar issues.

Outcome

The case was resolved amicably with NPPA accepting the justification for the price increase. The client avoided penalties and continued operations without disruptions. The compliance strategy implemented ensured adherence to NPPA regulations moving forward, safeguarding the client’s market position.

Case Studies

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NPPA Compliance for Surgical Dressing Company

PROBLEM STATEMENT

Our Approach

Outcome

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