DoP amends DPCO 2013 to ease compliance, clarify overcharging liability

The Department of Pharmaceuticals (DoP) has notified the Drugs (Prices Control) Amendment Order, 2026, introducing a series of amendments to the Drugs (Prices Control) Order (DPCO), 2013 aimed at improving regulatory clarity, easing compliance for pharmaceutical manufacturers and strengthening monitoring under the price control regime. The amendments came into effect on June 30, 2026.

Among the key changes is a provision allowing the government to notify separate ceiling or retail prices for the same scheduled drug based on pack size, packaging type, dosage compliance or formulation characteristics.

The notification also provides significant relief to manufacturers in cases involving overcharging. Under the amended Paragraph 14, a manufacturer’s liability will now be restricted to the stock traded through the specific distributor or retailer found to have overcharged, provided the manufacturer demonstrates compliance with the requirements under Paragraph 24 and other government guidelines.

In another important amendment, the DoP has simplified the pricing requirements for follow-on manufacturers launching an already approved new drug. Existing manufacturers introducing the same new drug within 12 months of the retail price fixation will no longer be required to seek fresh retail price approval. Instead, they must intimate the launch to the government in the newly introduced Form IA within one month of commercialisation. However, manufacturers launching products above the notified retail price will continue to be liable to deposit the overcharged amount along with applicable interest and penalties.

The amendments also introduce additional safeguards relating to price revisions. Manufacturers seeking protection from wider overcharging liability will be required to demonstrate that revised prices have been effectively communicated to dealers, retailers and consumers through multiple channels. These include circulating revised price lists within two weeks of notification, publishing advertisements in at least two national newspapers, issuing revised Forms V or VI, displaying updated prices on the company’s website and submitting batch-wise production and stock details at the time of price revision. In such cases, overcharging liability will be calculated only on the stock handled by the retailer, distributor or stockist found selling above the notified price.

Another notable amendment relates to record retention. Manufacturers will now be required to maintain records relating to active pharmaceutical ingredients, bulk drugs, formulations and sales for a minimum of seven financial years immediately preceding the current financial year. The records must also be preserved until the conclusion of any proceedings initiated under the DPCO, if applicable. The government will retain the authority to inspect these records whenever required.

The amendment further mandates manufacturers to furnish price lists and supplementary price lists to State Drug Controllers and the government with references to the relevant price fixation or revision notifications issued under the DPCO. It also formally introduces Form IA to facilitate mandatory reporting of new drug launches, including information on formulation details, launch price, pack size and the latest government-notified retail price.

The latest amendments are expected to improve operational clarity for manufacturers while reinforcing transparency and compliance within the country’s drug pricing framework.

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