The Department of Pharmaceuticals has notified the Drugs (Prices Control) Amendment Order, 2026, introducing amendments to the Drugs (Prices Control) Order, 2013. The changes include provisions related to separate pricing for specific drug packs, new drug launch requirements, overcharging liability, price communication, record maintenance, and the introduction of Form IA. The amendments came into force on 30 June 2026 upon publication in the Official Gazette.
The Department of Pharmaceuticals has issued the Drugs (Prices Control) Amendment Order, 2026, amending various provisions of the Drugs (Prices Control) Order, 2013. The notification introduces procedural changes related to ceiling prices, retail prices, manufacturer obligations, record maintenance, and reporting requirements. The amendments took effect on 30 June 2026 following publication in the Official Gazette.
Key amendments include:
- Government may notify separate ceiling or retail prices for the same drug based on therapeutic rationale, packaging, pack size, dosage compliance, or content.
- Existing manufacturers launching the same new drug within 12 months of retail price fixation are exempt from applying for approval but must submit Form IA within one month of launch.
- Manufacturers must maintain specified sales and related records for at least seven financial years.
- Revised requirements have been introduced for price list communication and calculation of overcharging liability in specified situations.
The amendments aim to improve implementation and regulatory compliance under the Drugs (Prices Control) Order, 2013.