Effective NPPA and DPCO compliance requires accurate pricing data, timely regulatory submissions and continuous monitoring of applicable price-control requirements. We help pharmaceutical companies manage these obligations and maintain appropriate pricing documentation and compliance records.
What We Deliver
- NPPA Price Notifications & Compliance — Support for understanding and implementing NPPA price notifications, including applicable ceiling-price and retail-price requirements.
- IPDMS Registration & Compliance — Assistance with IPDMS registration, profile management, product-related information and applicable submissions.
- Form II & Form V Submissions — Preparation and filing support for applicable Form II and Form V submissions relating to price revision and related DPCO requirements.
- Price Revision & WPI Compliance — Support for annual permissible price revision, applicable WPI-linked requirements and associated submissions.
- DPCO Compliance — Advisory support for compliance with applicable provisions of the Drugs (Prices Control) Order, including pricing, MRP and related obligations.
- NPPA Notices & Regulatory Responses — Technical review and preparation of responses to NPPA communications, notices, observations and pricing-related queries.
- Ceiling Price & Retail Price Assessment — Review of applicable pricing requirements and assessment of product pricing against notified requirements.
- Pricing Data & Documentation Review — Review of PTR, MRP, product information and supporting documentation relevant to NPPA/DPCO compliance.
- Overcharging & Pricing Compliance Matters — Support in assessing pricing-related discrepancies, potential overcharging issues and associated regulatory requirements.
- Ongoing NPPA Compliance Support — Retainer-based monitoring of NPPA notifications, pricing changes, submissions and applicable compliance requirements.
Our Approach
Assess
We review your product portfolio, pricing information, applicable DPCO provisions and existing NPPA/IPDMS compliance status.
Calculate & Prepare
We assess applicable pricing requirements and prepare the required data, forms and supporting documentation.
Submit & Respond
We support applicable IPDMS submissions and assist with regulatory communications, queries and NPPA responses.
Monitor & Maintain
We monitor applicable price notifications, revisions and compliance requirements to help maintain ongoing pricing compliance.
Who this is for
Why NPPA & DPCO Compliance Matters
Pricing compliance extends beyond applying a notified price. Companies must maintain accurate pricing information, implement applicable revisions, complete required submissions and maintain supporting documentation. A structured compliance system helps reduce the risk of pricing discrepancies, regulatory queries and potential overcharging-related issues.
IPDMS Compliance Support
We assist pharmaceutical companies with IPDMS-related registration, data submission and ongoing compliance requirements, including applicable Form II and Form V submissions and updates relating to price revisions.
IPDMS Registration
Registration and profile-related assistance.
Form II / Form V
Preparation and submission support for applicable pricing information.
Data & Compliance Updates
Review and updating of relevant product and pricing information.