Importer & Manufacturer | Source: NPPA
Published On: 16-07-2026
Enforcement Date: 16 July, 2026
NPPA Issues Clarifications on Filing of Form-IA for New Drugs under the Drugs (Prices Control) Amendment Order, 2026
The National Pharmaceutical Pricing Authority (NPPA) has issued clarifications regarding the filing of Form-IA under the Drugs (Prices Control) Amendment Order, 2026. The clarification explains the applicability of the amended Paragraph 15, filing requirements for manufacturers launching new drugs, timelines for Form-IA submission, and compliance obligations through the updated IPDMS 2.0 portal.
The National Pharmaceutical Pricing Authority (NPPA) has issued an Office Memorandum clarifying the filing requirements for Form-IA following the Drugs (Prices Control) Amendment Order, 2026 (13th Amendment to the Drugs (Prices Control) Order, 2013).
Key points include:
- Clarifies applicability of amended Paragraph 15 under the Drugs (Prices Control) Amendment Order, 2026.
- Retail prices notified before 1 July 2026 are not covered by the amended provisions.
- Existing manufacturers introducing a new NLEM drug must apply for prior price approval using Form-I.
- Other manufacturers launching the same approved formulation must file Form-IA within one month of launch through IPDMS 2.0.
- Manufacturers must submit supporting documents and ensure compliance with DPCO, 2013 provisions.
- NPPA has updated the IPDMS 2.0 portal to facilitate online Form-IA submission.
Applicable For: Importer & Manufacturer
Reference Number: F.No. 12(10)/2021/DP/NPPA/Div.II-Partfile(1)
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