The Department of Pharmaceuticals (DoP) has rejected the review petitions filed by several companies including Sun Pharmaceutical, Unichem Laboratories, Panacea Biotec, Win-Medicare, etc. against the ceiling of prices on their products. However, the department has asked the NPPA to revalidate data bases on which it had fixed the prices of these drugs.

Sun Pharmaceutical Industries had filed the review applications against the NPPA notifications S.O. Nos.1625 (E), 1653 (E) dated 14.06.2013, 1803 (E), 1811 (E), 1817 (E) dated 21.06.2013 fixing price of scheduled medicines under DPCO, 2013. The drugs included isosorbide 5 mononitrate tablet (10mg), pantoprazole injection (40 mg), ondansetron injection (2mg/ml) atorvastatin tablets (10mg) and alprazolam tablets (0.25mg).

The Department held personal hearing on September 23 on the case, before disposing of the petition. “The Review applications filed by the Petitioners are disposed of requesting NPPA to revalidate the data by conducting a broad based survey by placing the information on their website and other public modes,” the DoP in its order said.

Likewise, Unichem Laboratories had challenged the prices fixed by the NPPA on the drugs warfarin sodium tablets (5 mg), olanzapine tablet (10 mg), albendazole tablets (400 mg), albendazole suspension (200 mg/5 ml), atorvastatin tablets (10 mg), alprazolam (0.25mg), tramadol capsule (50 mg), cetrizine tablets (10 mg) and alprazolam (0.5mg).

After personal hearing on 11.9.2013, the DoP directed the NPPA to revalidate the data under para 9 of the DPCO, 2013 through a broad based survey i.e. IMS Health data to be placed on website of NPPA. NPPA should seek further information from all sources through the website within a specified time frame i.e. 15 days and do the revalidation exercise. Till such time a decision on inclusion/ exclusion of modified releases is taken by the Government, the Petitioners have to maintain the ceiling prices notified by NPPA.

Panacea Biotec challenged the NPPA notification dated 21.8.2013 for fixing ceiling price of scheduled medicine Oral Poliomyelitis Vaccine (LA) Soution.  In this case too, the DoP in its order dated December 20 asked the national drug regulator to “revalidate and evaluate the data by conducting a broad based survey by placing the information on their website and other public modes”.

Likewise, Win-Medicare and Modi-Mundipharma challenged the prices of scheduled medicine povidone iodine oinment 5%. In both the cases, the DoP disposed of the case on the grounds that price fixation by NPPA is as per the provisions of DPCO, 2013.  However, NPPA was directed to revalidate data as empowered under Para 9(1) of DPCO, 2013.