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Panel recommends DoP to consider better control over prices of non-scheduled formulations
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Gireesh Babu, New Delhi
November 11 , 2025
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Raising concerns over the high levels of trade margins for non-scheduled formulations owing to the regulatory gap, the Parliamentary Standing Committee on Chemicals and Fertilisers has recommended that the National Pharmaceutical Pricing Authority (NPPA) should consider some appropriate control over the prices of non-scheduled formulations.
The Committee, in its 14th report, a review on the price rise of medicines in the pharmaceutical sector impacting the lives of ordinary citizens adversely, observed that the lack of any control over trade margins, especially in the case of non-scheduled drugs, leaves the door open for widespread profiteering at the cost of patients.
"The Committee desire that the Department undertake a comprehensive review of the extant price regulation framework to plug the existing loopholes in the pricing mechanism effecting the ordinary citizen," it recommended to the Department of Pharmaceuticals.
It said that when the Committee asked about the Departments inaction to curb the trade margins to the tune of 600% to 1,100% in common medications, the Department’s reply appears unsatisfactory as it relied heavily on a general explanation of the Drugs (Prices Control) Order, 2013 (DPCO, 2013).
"The Committee note that the existing Drugs (Prices Control) Order 2013(DPCO) is structurally inadequate to curb pricing malpractices in India’s pharmaceutical sector," it added.
While the DPCO empowers the NPPA to fix ceiling prices for drugs listed under the National List of Essential Medicines (NLEM), it fails to extend this regulatory authority to the non-scheduled drugs.
As such the NPPA is not empowered to regulate trade margins for non NLEM drugs in cases where excessive markups are evident on widely used and lifesaving medicines.
"This regulatory gap allows manufacturers to launch non-scheduled formulations, both branded and generic, at arbitrary points," it opined.
Although the manufacturers are technically restricted from increasing the MRP by more than 10 percent annually, the absence of initial price fixation renders this control largely meaningless. This loophole requires to be corrected, it added.
The Price to Stockist (PTS) data also remains undisclosed to the public, as platforms like Pharma Sahi Daam and Sugam App shows only MRPs and failed to reveal the true extent of profiteering. Fixed dose combination (FDC) drugs, which account for a substantial share of prescriptions in India, also remain outside the ambit of price regulation despite their widespread use and potential for irrational combinations.
"The Committee therefore, recommend that the Department should look into the matter and initiate ameliorative steps in this regard. The Committee would like to be apprised by the steps taken by the department," said the Committee.
"The Committee note that the PTS of ciprofloxin 500 mg and tinidazole 600 mg which came to notice of the Committee, is Rs. 450/- but its MRP is Rs. 3,500/- hence a whopping difference of Rs. 3,050. Similarly PTS of Ibrufin and Labocof is Rs. 831/- and Rs. 316/- but their MRP is Rs. 4,560/- and Rs. 2,850/- respectively hence again a big difference of Rs. 3,729/- and Rs. 2,534/-," it averred.
It added that the Committee fails to understand the distinction made by NPPA regarding scheduled and non-scheduled formulations.
"It seems evident that NPPA needs to put more control on prices of non-scheduled formulation to obviate scope for abuse by manufacturers and marketers," it added, further expressing desire that the NPPA should consider some appropriate control over prices of non-scheduled formulations which are more in use as has been done in the case of scheduled formulations and where prices are under check with more effective control.
The Committee added that it would like to be apprised of the steps taken by the Department as well as NPPA in this regard.
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