The National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling price of two anticoagulant formulations and the retail price of 51 new drugs after considering representations on the price fixation by the stakeholders.

The Authority has considered the representations received from the companies on two formulations – dabigatran capsule 110 mg and dabigatran capsule 150 mg, which were newly added to the revised Schedule I of the Drugs (Prices Control) Order, 2013, after inclusion of the National List of Essential Medicines (NLEM), 2022 into the Schedule.

Dabigatran is a drug used for the treatment of blood clotting in various body parts, such as the deep vein thrombosis and pulmonary embolism, among others. The Authority fixed the ceiling price of dabigatran 110 mg at Rs. 31.81 per capsule and dabigatran 150 mg at Rs. 35.59 per capsule.

The representations were related to the price to retailer (PTR) revision based on wholesale price index (WPI) increase availed by the companies in April, 2022, not being reflected in the July, 2022 Pharmatrac database.

“The Authority noted that the revision in PTR has been made based on verification done with the Form V submitted by the companies till July 31, 2022, that is the month and the database used for fixation of ceiling prices since these are newly added schedule formulations and Form II is not applicable in these cases,” observed the Authority while fixing the ceiling prices.

The Authority has so far notified 689 formulations under the revised Schedule I based on the methodology deliberated in the previous meetings held on November 23, 2022, March 29, 2023 and May 1, 2023 for fixation of ceiling price of scheduled formulations.

The Authority also fixed the retail price of 51 new drug formulations, of which 24 antidiabetic formulations were lead with dapagliflozin and another 14 with vildagliptin and two with sitagliptin molecules, which went off-patent in the recent years.

The prices on these formulations, recommended by the Multidisciplinary Committee of Experts (MDC) were fixed in line with the DPCO amendment on May 11, 2023 related to the fixation of prices of new drugs that contain molecules or components or ingredients that have become off-patent or about to become off patent.

The Authority also deliberated on the representations from Zydus Healthcare Ltd and Emcure Pharmaceuticals Ltd, filed in the month of June, against methodology adopted by the MDC while recommending the prices of such formulations in its meeting. The representations were filed within 10 working days of uploading the minutes of the MDC meeting.

However, the Authority said that the methodology followed by the MDC is in line with the DPCO amendment and hence, decided to reject the representations and approved the retail prices recommended by the MDC.

While the Authority took up 52 cases of retail price fixation, one application related to ceftazidime and avibactam powder for concentrate for solution for infusion, manufactured by Protech Telelinks and marketed by Samarth Life Sciences Pvt Ltd was deferred in view of certain points raised during the discussion and directed that the matter may be re-examined.

The DoP has amended the Drugs (Prices Control) Order, 2013 to include provisions by which the retail price of new drugs with ingredients that have become off-patent or about to become off-patent will be arrived at by reducing fifty percent of the price calculated as per the provisions of the price control order. Similar provision has also been notified by the DoP for the revision of ceiling price of scheduled formulation after expiry of patent issued under the Patents Act, 1970.

According to the notification, which announced the Drugs (Prices Control) Amendment Order, 2023 that came into force on the date of publication of the Order in the Gazette on May 11, 2023, the DoP has added a sub-paragraph, which states, “the retail price of the new drug shall be arrived by reducing fifty per cent of the price calculated under sub-paragraph (1) of paragraph 4, and if the new drug is not available in the domestic market, the retail price of the new drug shall be fixed as per the provisions of the sub-paragraph (2) of this paragraph.”

It further adds that after one year from the date on which the retail price was fixed as per the Order or the date on which price to retailer of at least one company fixed under the regulation is captured in the pharmaceutical market database, whichever is later, the retail price for the subsequent manufacturers shall be fixed as per sub-paragraph (1) of Paragraph 4.

This is provided that while fixing the retail prices under this, the prices of the brand of the manufacturer having the patent and the manufacturer holding the permission granted by the patentee shall be excluded.

Further, the amendment added one more paragraph, 18A after the existing paragraph 18, to add that the revision of ceiling price of scheduled formulation after expiry of patent issued under the Patents Act, 1970 (39 of 1970), into the price control order.

“In the case of scheduled formulation or its molecules or components or ingredients, which are patented under the Patents Act 1970 (39 of 1970), the ceiling price, on expiry of the patent, shall be revised by reducing the present ceiling price by fifty per cent, and after one year, the ceiling price shall be revised again as per the provisions of sub-paragraph (1) of paragraph 4, based on the market data of the preceding month,” said the new paragraph.