Ensuring Affordable
Healthcare
for All
National Pharmaceutical Pricing Authority (NPPA) was constituted vide Government of India Resolution dated 29th August, 1997 as an attached office of the Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers as an independent Regulator for pricing of drugs and to ensure availability and accessibility of medicines at affordable prices.
Citizens Corner
Use this short walkthrough to register your company on the IPDMS 2.0 portal. Once your account is created, you will receive your login credentials by email and SMS, and you can proceed to add a plant.
Open your browser and visit https://nppaipdms.gov.in.
Click Login in the top bar (or any tile that asks you to log in), then on the login dialog click “New Company? Register here” to start a fresh registration.
Complete all five sections of the form:
Click Save to complete registration. Login credentials will be sent to the email ID and registered mobile number.
After registration, log in and follow the "Add a plant" process to set up your manufacturing / import unit.
Companies can raise change requests against their already-registered formulations and medical devices on IPDMS 2.0. Each request goes through an internal review workflow; this short walkthrough explains the request types and where to track their status.
Use your registered company credentials to log in to the IPDMS 2.0 portal.
From the post-login menu, go to Company Details and select your company row.
Click the Action menu on the company row, then choose Request History to view the workflow status of every request you have raised.
Request History shows the current stage of each request (Submitted → Under Review → Approved / Reverted) along with remarks from the reviewing officer.
Each manufacturing unit, sub-contracting unit, outsourcing unit and loan-licence unit must be added as a separate plant. Importers must add a plant for each country of import.
Use your registered credentials to log in to the IPDMS Ver 2.0 portal.
Click the Company Detail tab, then click Add Plant.
Select one of the four plant types based on your operation:
Complete every required field on the plant form and click Save to create the new plant.
Repeat this process for every additional plant. After saving, the plant becomes available in the Action column for product and form submissions.
Schedule II
Proforma for application for price fixation / revision of a new drug formulation related to NLEM formulation
(See paragraphs 2(u), 5, 7, 8, 9, 15)
Reference rendering of Form I — use it to gather the required information before opening the actual form in IPDMS.
Schedule II
Proforma for submission of details in respect of discontinuation of the production and / or import of a scheduled formulation
(See paragraph 21(2))
| Sl. No. | Particulars | Description |
|---|---|---|
| 1 | Name of the formulation | |
| 2 | Name and address of the manufacturer / importer | |
| 3 | Name of the Marketing Company, if any | |
| 4 | Composition as per label claimed and approved by Drug Control Authorities | |
| 5 | Drugs Control Authority Permission Number and Date (copy to be enclosed) | |
| 6 | Ceiling Price (in Rs. per unit, excluding taxes) and date of notification | |
| 7 | Applicable GST rate (in %) | |
| 8 | Pack size | |
| 9 | Existing maximum retail price (MRP) of pack including all taxes and its effective date | |
| 10 | Therapeutic category as per NLEM | |
| 11 | Date of commencement of production / import | |
| 12 | Intended date of discontinuation | |
| 13 | Reasons for discontinuation of production / import | |
| 14 | Year-wise Production / Import during the last 5 years including current year (in quantity of packs) | |
| 15 | Year-wise sale during the last 5 years including current year (in quantity of packs) | |
| 16 | Whether any new drug, as defined under DPCO 2013, has been launched or intended to be launched. If so, the details thereof | |
| 17 | Any other information relevant to discontinuation of scheduled formulation |
The information furnished above is correct and true to the best of my knowledge and belief.
Schedule II
Proforma for submission of revised-prices for scheduled formulations
(See paragraph 16)
| Sl. No. | Name of the Product (Formulation and its dosage forms) | Composition, as approved by Drug Control Authorities | Pack Size | GST rate (in %) | WPI rate change w.r.t. preceding year (in %) | Price to retailer per pack (excluding taxes) (Rs.) | Maximum Retail Price (incl. of all taxes) (Rs.) | Notified Ceiling Price (in Rs., excluding taxes) | Batch no. and date from which price revision is effective | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre revised | Revised | Pre revised | Revised | ||||||||
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) | (11) | (12) |
| Scheduled formulations | |||||||||||
| Own Manufactured Formulations | |||||||||||
| Purchased Formulations | |||||||||||
| Imported Formulations | |||||||||||
Schedule II
Proforma for quarterly return in respect of production / import and sale of NLEM drugs
(See paragraph 21(1))
Table A — Scheduled Formulations
| Name of the Scheduled Formulation | Composition / Strength | Dosage Form | Unit (No / kg / Ltr) | Production / Import Level | Domestic Sale | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Previous Year | 1st Quarter | 2nd Quarter | 3rd Quarter | 4th Quarter | Previous Year | 1st Quarter | 2nd Quarter | 3rd Quarter | 4th Quarter | ||||
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) | (11) | (12) | (13) | (14) |
Table B — Bulk Drugs / APIs used in Scheduled Formulation
| Name of the Bulk Drugs / APIs used in Scheduled Formulation | Unit (kg / Ltr) | Installed Capacity | Production / Import Level | Domestic Sale | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Previous Year | 1st Quarter | 2nd Quarter | 3rd Quarter | 4th Quarter | Previous Year | 1st Quarter | 2nd Quarter | 3rd Quarter | 4th Quarter | |||
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) | (11) | (12) | (13) |
Constraints, if any:
Note: Production outsourced / carried out on job-work basis should also be included.
Schedule II
Proforma for Price List
(See paragraphs 2(s), 24, 25, 26)
Table A — Scheduled Formulations
| Sl. No. | Name of the Product (Formulation and its dosage forms) | Composition, as approved by Drug Control Authorities | Pack Size | GST rate (in %) | Price to Distributor (excluding taxes) (Rs.) | Price to retailer (excluding taxes) (Rs.) | Prerevised Maximum Retail Price, if any (incl. of all taxes) (Rs.) | Maximum Retail Price (incl. of all taxes) (Rs.) | Batch no. and date from which price revision is effective | Production capacity |
|---|---|---|---|---|---|---|---|---|---|---|
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) | (11) |
| Scheduled formulations | ||||||||||
| Own Manufactured Formulations | ||||||||||
| Purchased Formulations | ||||||||||
| Imported Formulations | ||||||||||
Table B — Non-Scheduled Formulations
| Sl. No. | Name of the Product (Formulation and its dosage forms) | Composition, as approved by Drug Control Authorities | Pack Size | GST rate (in %) | Price to Distributor (excluding taxes) (Rs.) | Price to retailer (excluding taxes) (Rs.) | Prerevised Maximum Retail Price, if any (incl. of all taxes) (Rs.) | Maximum Retail Price (incl. of all taxes) (Rs.) | Batch no. and date from which price revision is effective | Production capacity |
|---|---|---|---|---|---|---|---|---|---|---|
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) | (11) |
| Non-Scheduled formulations | ||||||||||
| Own Manufactured Formulations | ||||||||||
| Purchased Formulations | ||||||||||
| Imported Formulations | ||||||||||
Note: In case of purchased / imported formulation, the name of the manufacturer shall be indicated.
The information furnished above is correct and true to the best of my knowledge and belief.
Schedule II
Proforma for Price List for Medical Devices
[See paragraphs 24(3) & 25(2)]
Price List (Amount in Rupees)
| Sl. No. | Medical Device Registration No. issued by CDSCO | Medical Device Category as per DCGI approval / Generic Name | Product Name / Specification as per DCGI approval / Generic Name | Product Code (if any) | Brand Name | Minimal Unit Sale / Retail Pack Size | Price to Distributor / Stockist Hospital (excluding applicable taxes) | Price to Retailers (excluding applicable taxes) | Applicable GST % | Revised Maximum Retail Prices | Effective Batch No. and Date | Previous Maximum Retail Prices | Remarks |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) | (11) | (12) | (13) | (14) |