Industry
NPPA (IPDMS) Registration
Get professional support for obtaining National Pharmaceutical Pricing Authority (NPPA) registration on the IPDMS portal for medical device and IVD manufacturers, marketers, importers and distributors under the Drug Price Control Order, 2013.
Overview
NPPA (IPDMS) registration refers to the registration of a company, its products and its manufacturing site on the Integrated Pharmaceutical Database Management System (IPDMS) portal. This registration is a pre-requisite for medical device and IVD manufacturers, marketers, importers and distributors to make various mandatory submissions under Drugs (Prices Control) Order, 2013.
Services
We provide end-to-end services for obtaining NPPA (IPDMS) registration under Drugs (Price Control) Order, 2013 which includes:
- IPDMS portal account creation
- Registered data amendment
- Login credentials change support
- Contact person change support
- Foreign manufacturing plant addition
- Domestic manufacturing plant addition
- Product addition
- NPPA Notice reply support
- Representation before NPPA
- NPPA Compliance support
Process
There are generally six steps to obtaining an NPPA registration under Drug Price Control Order, 2013
- 1
Submission
Submission of documents
- 2
Generation of login credentials
Generation of login ID and password
- 3
OTP Validation
Validation of OTPs on the IPDMS portal
- 4
Registration
Account creation / registration on the NPPA IPDMS portal
- 5
Site registration
Registration of manufacturing site where the medical devices and IVDs are manufactured. In the case of imports, the foreign manufacturing site is required to be registered.
- 6
Product Registration
Registration of the medical devices and IVDs manufactured at the manufacturing site.
Timeline
NPPA (IPDMS) registration is generally granted immediately after the submission of the application. However, in certain cases, the receipt of email along with the login credentials might take around two – five working days.
Validity
The NPPA (IPDMS) registration is valid in perpetuity.
Key documents required
- GST Certificate and PAN Card of the company
- Certificate of incorporation
- Import Export Code (in case of importer)
- ID proof of authorized person (PAN card, Adhar card)
- Manufacturing license / import license
Fees
No govt fee is applicable