The Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, has clarified that under the Drugs (Prices Control) Amendment Order, 2026, any existing manufacturer launching the same new drug formulation whose retail price has been notified by the National Pharmaceutical Pricing Authority (NPPA) within the preceding 12 months must adopt the same notified retail price and submit Form-1A to NPPA within one month of the product launch. The Ministry further clarified that Form-1A does not require domestic pharmaceutical manufacturers to register their production lines or batches.
The Ministry stated that NPPA is responsible for implementing the Drugs (Prices Control) Order, 2013 (DPCO, 2013) and monitors the prices of both scheduled and non-scheduled medicines. Overcharging cases are identified through inputs received from Price Monitoring and Resource Units (PMRUs), State Drugs Controllers, market sample purchases, market database reports, and public complaints. Where a prima facie case of overcharging is established, NPPA initiates action under the provisions of the DPCO, 2013.
[Release ID: 2292477]
