Last Updated on August 9, 2025 by The Health Master
Non-Scheduled Formulations
The National Pharmaceutical Pricing Authority (NPPA) has issued a direction to all pharmaceutical manufacturers to align the Maximum Retail Prices (MRPs) of non-scheduled formulations for all brands.
This directive, according to the Drugs (Prices Control) Order, 2013 (DPCO, 2013), emphasizes that the annual increase in MRP for these crucial medicines must not exceed 10% from the previous year.
DPCO, 2013 and Its Implications
The recent Office Memorandum from the NPPA that was issued on 22-07-2025 is to be considered as a strict reminder that the DPCO, 2013 is exercising its power as per Section 3 of the venerable Essential Commodities Act, 1955.
At the heart of this directive lies Paragraph 20 of the DPCO, 2013.
This crucial provision specifically empowers the government to meticulously monitor the prices of both non-scheduled formulations and medical devices.
The NPPA’s latest communication unequivocally states, “All manufacturers are hereby directed to align the prices of non-scheduled formulations launched under different brands, as per the provisions of para 20 of the DPCO, 2013, so that the difference in MRP is not more than ten percent.”
The 10% Cap: A Crucial Mechanism for Price Stability
The essence of Paragraph 20 (1) of the DPCO, 2013, is to create a safety net against arbitrary price escalations.
As per the directions, no pharma manufacturer shall increase the MRP of a drug by more than 10% of its MRP during the preceding twelve months.
If it increases more than the 10% threshold, pharma manufacturers are legally bound to reduce the price to comply with this limit for the subsequent twelve months.
Penalties and Overcharging
The NPPA has given the clear message that non-compliance will not be tolerated.
The NPPA has issued a clear warning that any violation of these provisions “shall attract penal action under the provisions of the DPCO, 2013 and Section 7 of the Essential Commodities Act, 1955.”
This means that pharma manufacturers found in breach of the regulations may face legal and financial troubles.
Furthermore, Paragraph 20 also includes an important sub-provision that holds pharma manufacturers liable to deposit any overcharged amount, along with accrued interest, from the date of the unwarranted price increase.
Q: What is a “non-scheduled formulation”?
A: As per Para 2(i)(v) of the DPCO, 2013, a “non-scheduled formulation” refers to any drug formulation that is not included in Schedule-I of the DPCO, 2013.
Q: What is Schedule-I ?
A: Schedule-I is the list of essential medicines whose prices are directly controlled by the government.
Q: What is the main role of the National Pharmaceutical Pricing Authority (NPPA)?
A: The NPPA is a government regulatory body in India responsible for fixing and revising the prices of scheduled drugs and for monitoring the prices of non-scheduled formulations.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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