NPPA Revises Ceiling Prices of Scheduled Drugs Following DoP Order

The revised prices affect antiviral, antihypertensive, antiretroviral, and anti-asthma medications.

The National Pharmaceutical Pricing Authority (NPPA) has announced upward revisions to the ceiling prices of four scheduled drugs, following directives from the Department of Pharmaceuticals (DoP). 

The revised prices affect antiviral, antihypertensive, antiretroviral, and anti-asthma medications.

The NPPA has increased the ceiling price of the antiviral drug valganciclovir 450 mg from INR 400.73 to INR 408.27 per tablet. The price of metoprolol 25 mg, a common antihypertensive, has been adjusted from INR 4.20 to INR 4.25 per tablet. 

Additionally, the ceiling price for the antiretroviral drug lamivudine 100 mg has risen from INR 10.40 to INR 11.07 per tablet. The price of the anti-asthma medication montelukast 4 mg has increased from INR 10.03 to INR 10.23 per tablet.

These adjustments were made following review applications by RPG Life Sciences and Cipla, reflecting changes in the Wholesale Price Index (WPI). 

Moreover, the revised prices account for a WPI increase of 12.1218% effective from April 1, 2023, and a 0.00551% increase effective from April 1, 2024.

Review Applications & Stakeholder Feedback

The NPPA released draft calculation sheets with the updated prices on its website and invited stakeholder feedback. No comments were received regarding the revised draft prices for valganciclovir and metoprolol.

For metoprolol 25 mg, Cipla raised concerns that the price of the non-scheduled variant, metoprolol ER 25 mg tablets, had been incorrectly included in the calculation. 

Further, the NPPA noted that in the revised Schedule I of the National List of Essential Medicines (NLEM) 2022, metoprolol is listed only as a 25 mg tablet. Consequently, the ceiling price was calculated based on this classification, following methodologies used under both NLEM 2015 and 2022.

RPG Life Sciences had filed a review application for its valganciclovir 450 mg tablets and metoprolol 25 mg tablets, challenging the ceiling prices set in December 2022 and January 2023, respectively. 

The company contended that the NPPA had erred in price fixation and requested corrections. RPG Life Sciences argued that the NPPA had not adhered to the required procedures for reviewing and updating ceiling prices.

Recalculation Orders

The review authority accepted RPG Life Sciences’ contention and referred the cases to the NPPA for recalculation. The Department of Pharmaceuticals had previously observed that the NPPA did not adequately consider Cipla's Form V submissions for lamivudine and montelukast. 

Cipla had contested the ceiling price fixation orders for these drugs issued in December 2022, alleging that the NPPA did not account for revised Price to Retailer (PTR) data.

During the review process, it was determined that NPPA had inadvertently omitted Cipla’s Form V in the PTR calculations. The review authority agreed that recalculations were necessary based on the corrected PTR data.