The National Pharmaceutical Pricing Authority (NPPA), on July 16, 2026, issued clarifications regarding the filing of Form-IA for new drugs under the Drugs (Prices Control) Amendment Order, 2026. The amended provisions of Paragraph 15 apply only to retail prices notified on or after July 1, 2026, while retail prices notified prior to this date will continue to be governed by the earlier provisions.
Existing manufacturers introducing a new drug with dosage and strength specified in the National List of Essential Medicines (NLEM) must obtain prior retail price approval by filing Form-I. Other existing manufacturers may launch the same formulation at a price not exceeding the NPPA-notified retail price within 12 months of such price fixation and must submit Form-IA through the IPDMS 2.0 portal within one month of launch, along with the prescribed supporting documents.
The NPPA has directed all pharmaceutical companies to strictly comply with the revised filing requirements and ensure that information submitted in Form-IA is accurate and in accordance with the Drugs (Prices Control) Order, 2013, failing which appropriate penal action may be initiated. The IPDMS 2.0 portal has been updated to facilitate online filing, and applicants facing technical issues may report them through the designated NPPA email addresses.
[Office Memorandum F.No. 12(10)/2021/DP/NPPA/Div.II-Partfile(1)]
