NPPA Retail Price Fixation for Relugolix Combination Tablet

Apr 08, 2026 | by TeamLease RegTech Legal Research Team

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Industry Specific ComplianceThe National Pharmaceutical Pricing Authority (NPPA), on April 2026, under the Drugs (Prices Control) Order, 2013, has computed the retail price of a fixed-dose combination (FDC) comprising:

Relugolix 40 mg + Estradiol 1 mg + Norethindrone Acetate 0.5 mg.

The formulation is manufactured by Macmillon Pharmaceuticals Pvt Ltd and marketed by Aristo Pharmaceuticals Pvt Ltd.

Price Computation Summary:

Relugolix 40 mg (Derived): ₹93.73

Estradiol 1 mg: ₹12.27

Norethindrone 0.5 mg (Derived): ₹1.53

Total (A+B+C): ₹107.53

Less Adjustment (20% deduction): ₹0.31

Worked-out Price: ₹107.22

Claimed Price by Company: ₹137.45

Final Proposed Retail Price: ₹107.22 per tablet (excluding GST)

Basis of Calculation:

Derived prices are computed using the Pronab Sen Committee formula for different strengths.

The final price is the lower of worked-out price and claimed price, as per DPCO norms.

Impact:

The notified price ensures price rationalization and affordability, preventing overpricing of combination drugs while maintaining regulatory compliance.

[Notification No. 19(5080)/2026/DP/NPPA/Div.II]


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