NPPA Compliance & Price Regulation for Medical Devices

NPPA monitors all medical devices declared as drugs under the Drugs & Cosmetics Act, applying distinct price control mechanisms based on statutory classification.

Scheduled Devices

Non-Scheduled Devices

Importer Disclosures

Medical devices included in the National List of Essential Medicines (NLEM) subject to strict ceiling price limits fixed directly by NPPA.

All other notified medical devices monitored under DPCO Clause 20, capping Maximum Retail Price (MRP) increases at 10% annually.

Statutory requirements for importers to issue Form V price lists to trade channels, state drug controllers, and the pricing authority.

NPPA Compliance Steps for Medical Device Importers

IPDMS Registration

Form V Filings

Annual MRP Cap Monitoring

Price List Distribution

Establish company credentials on the Integrated Pharmaceutical Database Management System for direct digital filings with NPPA.

Submit mandatory Form V declarations detailing landed costs, trade margins, and proposed MRP within 15 days of commercial launch.

Track non-scheduled device price revisions to verify total increases remain strictly within the allowable 10% rolling 12-month limit.

Distribute updated Form V price disclosures to distributors, hospitals, state drug authorities, and publish on public platforms.

NPPA Price Control Parameters

10%

Max Annual Non-Scheduled MRP Increase

15 Days

Form V Submission Deadline

Clause 20

DPCO Price Monitoring Provision

IPDMS

Mandatory Online Reporting Portal

Consult Artexa's regulatory specialists for end-to-end NPPA compliance audits, Form V submission management, and price increase verification in India.