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 The National Pharmaceutical Pricing Authority (NPPA) has accepted the recommendation of its Multidisciplinary Committee (MDC) of Experts to reject an application of Dr Reddy's Laboratories seeking special price for omeprazole delayed release orally disintegrating tablet of a certain dosage strength.
The company applied for grant of separate price of Rs. 17.90 per tablet without Goods and Services Tax (GST) for omeprazole delayed release orally disintegrating tablet 20 mg under the brand name Omez ODT, under the provision of Drugs Prices Control Order (DPCO), 2013, from the Rs 4.42 per tablet price fixed on March 27, 2025.
The MDC, which advises the NPPA in drug pricing in the country, in a meeting held on July 3, 2025 rejected the application of Dr Reddy's Laboratories observing that the application does not fall in the purview of Para 11(3) of the DPCO, 2013.
Under Para 11(3) of the DPCO, in the case of injections or inhalation or any other medicine for which dosage form or strength or both are not specified in the Schedule-I of the DPCO, the government may fix and notify separate ceiling price or retail price with specified therapeutic rationale, considering various aspects. The company relied on this Para in its application for a separate price for the drug.
MDC opined that Para 11(3) may be invoked in case of injections or inhalation or any other medicine for which dosage form or strength or both are not specified in the Schedule-I.
"The applied formulation is tin tablet form and the dosage & strength of the same is mentioned in the Schedule-I. Therefore, the current application does not fall in the purview of Para 11(3). Hence, the committee recommended to reject the application," it added.
Deliberating the matter, the Authority in its 135th meeting under DPCO, 2013, held on July 30, accepted the recommendation of the MDC.
It may be noted that the matter was deliberated in an earlier MDC meeting held on December 6, 2024, including the technical justifications provided by the company and opined that there is no incremental specified therapeutic rationale of omeprazole orally disintegrating tablet over the omeprazole enteric coated tablets. The Committee recommended rejecting the application during the meeting.
However, the company on December 24, 2024, represented and requested to grant an opportunity for making a personal representation to NPPA or in person deliberation in front of the upcoming Multi-Disciplinary Committee in the month of January, 2025.
The matter was considered in a meeting held on January 23, 2025, where the company gave a detailed presentation. The Committee then asked the company to submit the study or supporting documents showing the usefulness of the said formulation and other additional documents in support of its claim. The company submitted its response based on this, on the next day itself.
Omez ODT is used to reduce the amount of acid produced in the stomach and is used in treatment of related diseases such as heartburn, acid reflux, peptic ulcer, among others.
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