Introduction.
India’s regulatory landscape for medical devices has seen a significant shift. Effective 1st April 2020, the Government of India brought all medical devices under the scope of “drugs” as defined in the Drugs and Cosmetics Act, 1940, making them subject to quality regulation and price control under the Drugs (Prices Control) Order, 2013 (DPCO 2013).
This development has direct implications for medical device manufacturers, importers, and marketers looking to enter or expand in the Indian market.
Regulatory Background: Devices as Drugs
The change stems from the 11th February 2020 notification (SO 648(E)), issued by the Ministry of Health & Family Welfare. This notification mandates that all medical devices be treated as “drugs” from 1st April 2020, thereby bringing them under:
- The Drugs and Cosmetics Act, 1940, and
- The Drugs (Prices Control) Order, 2013 (DPCO 2013) for pricing oversight.
Which Medical Devices Are Regulated?
Currently, the government regulates 24 categories of medical devices. Among these:
4 Devices are Under Direct Price Control (Scheduled Medical Devices):
Medical Device Type | Regulation |
Cardiac Stents | Ceiling price notified by NPPA |
Drug-Eluting Stents | Ceiling price notified by NPPA |
Condoms | Capped under Schedule I |
Intra-Uterine Device (Cu-T) | Price-controlled device |
These devices are listed under Schedule I of DPCO 2013, and their prices are regulated through fixed ceiling prices published by the National Pharmaceutical Pricing Authority (NPPA).
Non-Scheduled Medical Devices (Monitored, Not Fixed)
All other medical devices including syringes, orthopedic implants, BP monitors, thermometers, etc. though notified as drugs, fall under Para 20 of DPCO 2013:
- Para 20(1): Limits price increase of such devices to 10% annually.
- Para 20(2): If the price hike exceeds 10%, the manufacturer must:
- Roll back the price to within the limit
- Deposit the overcharged amount with interest
- Risk additional penalties under the Essential Commodities Act, 1955
How Ceiling Prices Are Calculated (Scheduled Devices)
As per Paragraph 4 of DPCO 2013:
Ceiling Price = Average Retail Price of brands with ≥1% market share + 16% retailer margin
The NPPA determines and notifies these prices via official gazette orders.
Labeling, Reporting & Compliance Requirements
MRP and Packaging
- Maximum Retail Price (MRP) must be printed inclusive of all taxes
- Any MRP change must comply with Para 20 pricing caps
Mandatory Forms under DPCO 2013:
Form | Purpose |
Form V | Declare or revise price to dealers and NPPA |
Form II | Submit revised MRP based on WPI changes (Scheduled devices) |
Form III | Report production/import, stock, and sales data quarterly |
Market Access Strategy for Manufacturers
This regulatory framework affects how medical device companies:
- Set pricing for Indian market access
- Plan product launch timelines
- Build labeling and distribution strategies
- Manage compliance with NPPA and state drug controllers
How Titans Medical Consulting Supports You
At Titans Medical Consulting, we help:
- Identify whether your device is under Schedule I or Para 20
- Calculate valid ceiling or monitored MRP
- Prepare and submit all DPCO compliance forms
- Assist in labeling review and price revision strategy
- Support response during NPPA price audits or overcharge notices
Ready to Enter or Expand in India?
With India’s medical device market under price control surveillance, having a sound pricing and compliance strategy is no longer optional. Titans Medical Consulting offers regulatory clarity, compliance confidence, and strategic market access support.