The Indian pharma major Wockhardt Ltd has received favourable ruling from the reviewing authority Department of Pharmaceuticals (DoP) on its review petition against the fixing of ceiling price of dicyclomine injection as the DoP has directed the NPPA to re-fix the ceiling price of dicyclomine injection (Spasmoproxyvon).
The National Pharmaceutical Pricing Authority (NPPA) had earlier fixed the ceiling price of dicyclomine injection (Spasmoproxyvon) vide its order No. S.O. 3431(E), dated 10.11.2016. Aggrieved by the order, Wockhardt filed a review petition against the NPPA order.
In the review application, the petitioner contended that the ceiling price of the formulation has been worked out considering average price of 1 ml, 2 ml, 10 ml and 30 ml packs taken together. This is in contravention with above notification no S.O. 1192 (E) which clearly states that in case of injections separate ceiling price should be fixed for each pack size.
During examination, the DoP noted that the grievance of the company that NPPA has clubbed the PTR of 1ml, 2ml, 10ml and 30 ml packs while calculating the ceiling price of this formulation, in the absence of mention of any particular pack size in NLEM, 2015, the clubbing of PTR by NPPA is justified. However, the company submitted its representation under para 11(3&4), which states that “Government may fix and notify separate ceiling price or retail price for such formulations with specified therapeutic rationale, considering the type of packaging or pack size or dosage compliance or content in the pack namely liquid, gaseous or any other form, in the unit dosage as the case may be, conforming to Indian Pharmacopeia or other standards as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder for the same formulation.”
The DoP further noted that the NPPA confirmed that the representation submitted by Wockhardt under para 11(3&4) is under examination. The company also stated that NPPA has considered the PTR of their 30ml pack, which was discontinued manufacturing in the year 2005. The Hearing Authority is of the opinion that NPPA may be directed to examine the representation submitted by Wockhardt under para 11(3&4) and relevant document/information submitted by the petitioner company about discontinuation of their 30ml pack, and to re-fix the ceiling price of dicyclomine injection on merit.
After hearing both the parties, the DoP ordered, “NPPA is hereby directed to examine the representation submitted by Wockhardt Ltd. under para 11(3&4) and relevant document/information submitted by the petitioner company about discontinuation of their 30ml pack, and to re-fix the ceiling price of dicyclomine injection on merit, within 30 days of this Order and to send the compliance report to the Department”.