Drugs (Prices Control) Order amended to revise pricing approvals, overcharging liability, launch reporting and record retention requirements

The Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, has notified the Drugs (Prices Control) Amendment Order, 2026, amending the Drugs (Prices Control) Order, 2013. The amendment revises the manner in which prices may be fixed for different presentations of the same drug, introduces exemptions for certain manufacturers launching already price-fixed new drugs, narrows the scope of overcharging liability in specified cases, prescribes additional obligations for communicating price revisions, and formalises record-retention and launch-intimation requirements. The amendment has come into force from the date of its publication in the Official Gazette, i.e., 30th June 2026.

Key Highlights:

1. The amendment permits the Government to notify separate ceiling prices or retail prices for the same drug based on factors such as pack size, packaging type, dosage compliance requirements, pack contents and dosage form, including liquid and gaseous forms, where a specific therapeutic justification exists.
2. For scheduled formulations manufactured or available in the market prior to notification of a ceiling price, a manufacturer’s overcharging liability will be restricted to the stock sold through the distributor or retailer found to have overcharged, provided the manufacturer demonstrates compliance with prescribed price-revision implementation and dissemination requirements.
3. Existing manufacturers launching the same new drug within twelve months of fixation of its retail price are no longer required to seek fresh price approval. However, details of such launch must be furnished to the Government within one month in the newly introduced Form IA.
4. Manufacturers launching such drugs cannot price them above the latest retail price fixed by the Government during the preceding twelve months. Any amount charged in excess of the notified price will be recoverable along with interest, in addition to applicable penalties.
5. To establish compliance with price-revision obligations, manufacturers are now required to undertake specific measures including circulation of revised price lists to dealers and retailers, publication of price-reduction notices in at least two national newspapers, issuance of revised or supplementary price lists, maintenance of a dedicated DPCO section on the company website, and preservation of batch-wise production and stock details.
6. The basis for determining overcharged amounts has been modified. Where a manufacturer demonstrates compliance with the prescribed dissemination requirements, recovery may be restricted to the stock held by the retailer, distributor or stockist found selling the formulation above the notified ceiling price.
7. Price lists and supplementary price lists issued to regulators are now required to specifically reference the relevant Government order or Gazette notification under which the price fixation or revision has been made.
8. Manufacturers are now required to maintain records relating to APIs, bulk drugs, formulations and other prescribed records for at least seven financial years immediately preceding the current financial year. Where any proceeding under the Order has been initiated or remains pending, such records must be preserved until final disposal of the proceeding.
9. A new statutory Form IA has been introduced for reporting launch of new drugs and requires disclosure of details such as formulation particulars, manufacturer/importer information, launch date, pack size, therapeutic category, launch price and the latest Government-notified price.

Source: E Gazette