Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
Last Updated on July 2, 2026 by The Health Master
DPCO 2026
The Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals) has released the Drugs (Prices Control) Amendment Order, 2026 (DPCO 2026).
This order was issued under the Essential Commodities Act, 1955 and introduces several changes that will alter the way in which the Department of Pharmaceuticals regulates the manufacturing and pricing of drugs within India.
Download: S.O. 3516(E) dt 30-06-2026 Drugs (Price Control) Amendment Order 2026
The new regulations will impact all individuals associated with the pharma industry, including executives, compliance officers, and specialists who interact with the DPCO.
Separate Pricing for Custom Formulations
One of the primary changes to the DPCO 2026 order is a revised Paragraph 11 (3) that provides the Central Government with the power to fix and notify separate ceiling or retail prices for specific drugs.
Even where a price has been established for a drug under the existing regulations, separate prices can be established for specific drugs according to different criteria.
Those separate prices will take into consideration factors including but not limited to the following factors:
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The indications for which the drugs are used
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The types of packaging or sizes of the packages of the drugs
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Requirements for the dosages of the drugs
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The form in which the drugs are contained in their packages
The requirements for such customized drugs will have to meet the specifications of the Indian Pharmacopeia (IP) for approval.
No Liability for Preexisting Stock
Another of the changes to the DPCO 2026 order is the introduction of Paragraph 14(2), which establishes that if a manufacturer of a drug can prove that it distributed a notice of the new ceiling price for that drug to all other stakeholders in the supply chain of the drug, then the manufacturer will not be held financially liable for overcharging that resulted from that drug’s pre-existing stock.
Furthermore, to receive such a protection under Paragraph 24(1) of the order, manufacturers will have to provide documentation of their distribution of a price list to retailers within two weeks of the announcement of the ceiling price by the DPCO.
Such documentation will have to include the dissemination of the following:
Requirements for Proof of Dissemination of Ceiling Price
|
Requirement |
Mandatory Dissemination Action Required |
|
Retailer Outreach |
Direct circulation of the revised MRP list to all dealers and retailers for consumer display. |
|
Public Media |
Publication of advertisements detailing price cuts in at least two national newspapers. |
|
Official Filing |
Issuance of updated supplementary price lists to State Drugs Controllers using Form V or Form VI. |
|
Digital Transparency |
Creation of a dedicated “DPCO Matters” section on the homepage of the company website, featuring active price updates. |
|
Inventory Audit |
Submission of batch-wise production details and distributor stock status recorded at the exact time of revision. |
Launching New Drugs with Ease
The DPCO 2026 order also includes changes to Paragraph 15 relating to the launch of what are referred to in the order as “new drugs” by existing manufacturers.
Specifically, the revised order states that if a manufacturer manufactures a new drug that is identical to the existing drug, and they intend to launch it within 12 months of the price being established for the initial launch of that drug, they are not required to apply for a ceiling price for that drug.
Instead, after the launch, they will be required to submit an intimation of the launch of that new drug via Form-IA within one month after its launch.
Furthermore, manufacturers will be prohibited from launching a “new drug” at a price that is higher than the established retail prices for that drug within the past 12 months.
Any launches of drugs at a higher price or failure to file Form-IA will result in the manufacturer being required to deposit into the government the total amount of overcharged money and the interest earned by the manufacturer on that amount.
Extended Time Requirement to Maintain Manufacturing Records
Another change to the DPCO 2026 order is changes to Paragraph 29 that extend the required length of time that manufacturers are required to maintain their manufacturing and quality control records.
Specifically, manufacturers will now be required to maintain their records for a minimum of seven (7) years prior to the current financial year.
In addition, if the drugs of any manufacturer are under a legal proceeding with the Department of Pharmaceuticals, the records related to those drugs will have to be maintained indefinitely.
Introducing New Form-IA
In order to comply with the requirements to announce the launch of new drugs, manufacturers will be required to prepare and verify the information within Form-IA, which is a proforma that will include information about the drug’s:
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Brand and the name of the formulation
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Addresses of the manufacturer, importer, and marketing company
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Composition of the drug as approved by Drug Control Authorities
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Date of launch of the drug
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Sizes and types of packages of the drug
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Price of the drug and its comparison to established prices
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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