In a decision that will bring relief to Zydus Healthcare, the Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to re-examine the ceiling price for omeprazole 20mg tablets subsequent to obtaining the opinion of a specialists committee.
The department also asked the drug price regulator to counsel an expert panel with respect to a review petition by Sun Pharmaceutical Industries against the price ceiling of its sodium valproate tablet 200mg tablets.
When asked about the development, a spokesperson for Sun Pharmaceuticals stated in an email that the organization had no remarks on the issue. Zydus, in its review petition, contended that the brands considered by the regulator while computing the ceiling price of omeprazole 20mg tablets were not omeprazole but rather omeprazole magnesium.
The petition stated, “The market information of IMS also gives details of omeprazole and omeprazole magnesium separately. Omeprazole magnesium is not quite the same as omeprazole in its structure. The atomic weight of omeprazole magnesium is 713.12 though omeprazole has the sub-atomic weight of 345.42. Omeprazole magnesium tablet is a formulation of separately coated micropellets designed to optimise delivery of drug to the site of its absorption in the small intestine”.
The company argued, “The explanation note clearly features that while omeprazole 20mg tablet qualifies as scheduled drug, omeprazole magnesium which is a different moiety does not qualify as scheduled drug”.
While asking the regulator to re-examine the case, the DoP said the expert panel would check “if the formulations considered contain omeprazole magnesium or not and whether omeprazole magnesium is not quite the same as omeprazole in its structure or not”.
Omeprazole is utilized to treat certain stomach and throat problems, for example, heartburn and ulcers. Tablet breaks down quickly in the stomach and the coated pellets are emptied into the duodenum for faster absorption.
Sun Pharmaceuticals, in its review petition, contended that its product Encorate Chrono 200 is a combination of sodium valproate and valproic acid. National List of Essential Medicines 2015 covers just sodium velproate tablet 200mg and not the combination with valproic corrosive.
But, in its notice NPPA included a commentary stating that “the formulation of sodium valproate includes the combination of sodium valproate and valproic corrosive together comparing to sodium valproate of the stated strength.”
The company pointed out, “With the consideration of this reference, the notified ceiling price became applicable for products containing the combination of Sodium Valproate and Valproic Acid”.
NPPA, in its submission, stressed on that DPCO does not differentiate the active pharmaceutical ingredient (API) utilized as a part of manufacturing.
Manufacturing may utilize API sodium valporate 200mg or sodium valporate 133mg and API valproic acid 58mg to produce sodium valporate tablet 200mg.
The reference is for clarification as it were. Regardless of whether the commentary isn’t in the notice, the ceiling price is applicable,” the controller said.