Drugs (Prices Control) Amendment Order, 2026: Key Changes in Drug Pricing, Price Revision, New Drug Launch and Compliance

On 30 June 2026, the Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals) notified the Drugs (Prices Control) Amendment Order, 2026 under Section 3 of the Essential Commodities Act, 1955. The Amendment modifies the Drugs (Prices Control) Order, 2013 (DPCO, 2013) and the changes mainly relate to drug pricing, launch of new drugs, recovery of overcharged amounts, dissemination of revised prices and maintenance of digital records

The Order came into force on 30 June 2026.

Key Highlights:

1. The Amendment substitutes Paragraph 11(3) of DPCO, 2013 to enable the Central Government to notify separate ceiling or retail prices for the same drug where separate pricing is justified based on therapeutic rationale. While determining separate prices, the Government can consider:

   • packaging type;

   • pack size;

   • dosage compliance;

   • dosage form; and

   • conformity with standards prescribed under the Drugs and Cosmetics Act, 1940.

2. A proviso has been inserted in Paragraph 14(2) to restrict the manufacturer’s liability for overcharging only to the quantity of stock actually sold through the distributor or retailer found to have overcharged, provided the manufacturer has complied with Paragraph 24 and other applicable Government guidelines.

3. Existing manufacturers launching the same new drug within 12 months of the Government fixing its retail price are no longer required to submit a fresh application for retail price approval. Instead, they are required to intimate the launch through the newly introduced Form IA within one month.

4. The Amendment strengthens the provisions relating to pricing violations. Manufacturers launching scheduled formulations in contravention of the notified retail price are liable to:

   • deposit the overcharged amount;

   • pay applicable interest; and

   • remain liable for applicable penalty.

The Amendment further prohibits existing manufacturers from launching the same new drug at a price higher than the latest Government-notified retail price during the prescribed twelve-month period.

5. Paragraph 24 has been amended to strengthen compliance obligations relating to dissemination of revised prices. Manufacturers are now required to:

   • circulate revised Market Retail Price (MRP) lists to dealers and retailers within two weeks;

   • publish price reduction notices in at least two national newspapers;

   • issue revised or supplementary price lists in the prescribed forms;

   • display revised price notifications on the company’s website; and

   • furnish batch-wise production and stock details at the time of price revision.

6. The Amendment also revises Paragraph 24(3), requiring manufacturers to issue price lists and supplementary price lists in Form V or Form VI to:

   • The Central Government; and

   • State Drugs Controllers.

Such submissions clearly indicate the relevant Government order or Gazette notification forming the basis of the price fixation or revision.

7. A new Paragraph 29 requires manufacturers to maintain records relating to active pharmaceutical ingredients, bulk drugs, formulations, production and sales for at least seven financial years immediately preceding the current financial year. Where proceedings under the Order are pending, the records must be preserved until their final disposal and produced for inspection whenever required.

8. The Amendment Inserts Form IA under Schedule II for intimation of the launch of new drugs. The Form requires manufacturers or importers to furnish details relating to:

   • Name of the formulation;

   • Name and address of manufacturer or importer;

   • Name and address of marketing company;

   • composition approved by the Drug Control Authorities;

   • launch date;

   • formulation type;

   • pack size;

   • therapeutic category;

   • launch price; and

   • the latest Government-notified retail price.

The Drugs (Prices Control) Amendment Order, 2026 introduces procedural changes relating to price fixation, overcharging, launch of new drugs, price revision and record maintenance. The Amendment seeks to improve regulatory compliance and transparency while retaining the overall framework governing price control of scheduled drugs.

Also Read: Revision of Ceiling Prices to be carried out every five years vide Drugs (Prices Control) Third Amendment Order, 2021