NPPA Panel Rejects Dr Reddy's Omez ODT Plea For Seperate Price, Finds No Therapeutic Edge
New Delhi: In a decisive move against what it viewed as an unjustified price escalation, the Multi-Disciplinary Committee (MDC) under India's drug pricing regulator, the National Pharmaceutical Pricing Authority (NPPA), has rejected Dr Reddy's Laboratories' application for a special price of Rs 17.90 per tablet (excluding GST) for its Omeprazole orally disintegrating tablet (ODT) 20 mg, branded as Omez ODT.
The Committee found no sufficient therapeutic justification to support the request, calling the formulation “a tablet dosage form already covered under the Schedule-I of DPCO, 2013.”
According to minutes from the 66th MDC meeting held on March 3, 2025, the company initially approached the National Pharmaceutical Pricing Authority (NPPA) on November 6, 2024, seeking a separate/special price under Para 11(3) of DPCO, 2013. However, the panel pointed out that the existing ceiling price for Omeprazole 20 mg tablet is Rs 4.42 per tablet (S.O. No. 1489(E) dated 27.03.2025), significantly lower than the price sought.
Earlier in the 64th meeting on December 6, 2024, the Committee examined Dr. Reddy’s technical arguments but found them lacking. It clearly noted:
“There is no incremental specified therapeutic rationale of Omeprazole Orally Disintegrating tablet over the Omeprazole Enteric Coated Tablets.”
On that basis, the Committee had recommended rejecting the application. Following this, Dr. Reddy’s submitted a representation on December 24, 2024, requesting a personal hearing and was allowed to present its case during the 65th MDC meeting on January 23, 2025.
After further deliberations and submission of additional documents via email dated January 24, 2025, the Committee met again in its 66th session to re-examine the applicability of Para 11(3). The Committee observed that the provision of the Para 11(3) of the DPCO, 2013 read as below:
(3) Notwithstanding anything contained in sub-paragraph (1) and (2), 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 Drugs (Prices Control) Order, 2013, the Government may fix and notify separate ceiling price or retail price for such formulations with specified therapeutic rationale, considering the type of packaging or pack size or dosage compliance or content in the pack namely liquid, gaseous or any other form, in the unit dosage as the case may be, conforming to Indian Pharmacopeia or other standards as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder for the same formulation.
It reiterated the scope of the provision: “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 panel made it unequivocal that Omez ODT doesn’t qualify:
“The applied formulation is in 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).”
The Committee thus reaffirmed its earlier stance and formally recommended to reject the application. It noted;
"The current application does not fall in the purview of Para 11(3). Hence, the committee recommended to reject the application."
