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 after obtaining the opinion of an experts committee.
The department also asked the national drug price regulator to consult an expert panel regarding a review petition filed by Sun Pharmaceutical Industries against the price ceiling of its sodium valproate tablet 200mg tablets.
When asked about the development, a spokesperson of Sun Pharmaceuticals stated in an email that the company had no comments 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 omeprazole magnesium. “The market data of IMS also provides details of omeprazole and omeprazole magnesium separately. Omeprazole magnesium is different from omeprazole in its structure. The molecular weight of omeprazole magnesium is 713.12 whereas omeprazole has molecular weight of 345.42. Omeprazole magnesium tablet is a formulation of individually coated micropellets designed to optimise delivery of drug to the site of its absorption in the small intestine,” the petition stated.
The abstract of explanation (5) to Schedule 1 of Drug Price Control Order (DPCO) states that “in cases where an active moiety is available as different isomers or analogues or derivatives, they are considered as separate entities, and inclusion of one does not imply inclusion of all isomers or analogues or derivatives”.
“The explanation note clearly highlights that while omeprazole 20mg tablet qualifies as scheduled drug, omeprazole magnesium which is a different moiety does not qualify as scheduled drug,” the company argued.
Defending its stance, the regulator said price fixation has been done strictly in accordance with the provisions of DPCO, 2013.
While asking the regulator to re-examine the case, the DoP said the expert panel would check “whether the formulations considered contain omeprazole magnesium or not and whether omeprazole magnesium is different from omeprazole in its structure or not”.
Omeprazole is used to treat certain stomach and esophagus problems such as acid reflux and ulcers. Omeprazole magnesium tablet is an innovative formulation developed to offer increased convenience, flexibility and predictability of absorption. These tablets are dispersed in water for quicker absorption as each such tablet is made of individually coated micropellets. Tablet disintegrates rapidly 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 only sodium velproate tablet 200mg and not the combination with valproic acid. However, in its notification NPPA included a footnote stating that “the formulation of sodium valproate includes combination of sodium valproate and valproic acid together corresponding to sodium valproate of the stated strength.”
“With the inclusion of this footnote, the notified ceiling price became applicable for products containing combination of Sodium Valproate and Valproic Acid,” the company pointed out.
NPPA, in its submission, stressed that DPCO does not differentiate the active pharmaceutical ingredient (API) used in manufacturing. “Valproic acid, its salts and esters are used in the treatment of various types of epilepsy. Manufacturer may use API sodium valporate 200mg or sodium valporate 133mg and API valproic acid 58mg to manufacture sodium valporate tablet 200mg. The footnote is for clarification only. Even if the footnote is not in notification the ceiling price is applicable,” the regulator said.
However, refusing to endorse the stand of the petitioner or the regulator, the DoP has directed the latter to seek the opinion of experts and re-examine the price accordingly.