The Department of Pharmaceuticals (DoP) has rejected three review petitions filed by Mumbai-based pharmaceutical company Wockhardt against NPPA for fixing ceiling price of povidone iodine solution 5%, povidone iodine ointment 5% and human insulin injections.
Wockhardt had filed the review applications against the NPPA notifications S.O. No. 1651(E) dated June 14, 2013 for fixing ceiling price of povidone iodine solution 5% and S.O. NO. 1905(E) dated June 28, 2013 for fixing ceiling price of povidone iodine ointment 5% under Drugs (Prices) Control) Order, 2013 (DPCO, 2013).
The company had filed another review petition with the DoP under para 22 of DPCO-1995 against NPPA price fixation notification No. S.O.2734 (E) dated November 16, 2012 fixing prices of human insulin injections produced domestically.
The Department held personal hearing on 4.9.2013 on the first two cases, before disposing of the petition. “The DPCO, 2013 does not distinguish between sales through retailer shop or through hospital outlets. It is only the “Price to retailer”, which is captured by IMS, that is taken into account for calculation of ceiling price. Therefore, any such further classification or exclusion of hospital sales may not be in line with provisions of DPCO, 2013. Once the brands/generic versions of a particular medicine, having MAT of more than 1%, have been identified, it is only simple averaging of prices of all such versions, which determines ceiling price for that medicine. Para 4 of DPCO, 2013 also mentions the same. Therefore, the procedure followed by NPPA is in line with provisions of DPCO, 2013,” the DoP in its order on the first two petitions said.
On the human insulin injections issue, the DoP order said that while the ceiling price issued by the NPPA on 16.11.2012 may be maintained, which is in the public interest and also as per the spirit of DPCO, NPPA is required to follow the procedure provided under DPCO 1995. The Petitioners may be asked to provide the information in form III or form IV as the case may be within 15 days from the date of issue of the review order and NPPA may be directed to revise the ceiling price by considering the information as provided in this review order or the latest information available to them as per the provisions of DPCO, 1995 and fix the revised ceiling price within a period of two months as specified in the DPCO 95 for price fixation of formulations. While fixing the revised ceiling price NPPA should keep in mind that the allowed price is not evasive and should not have the potential of forcing the major manufacturers out of business thereby creating a shortage of the product in the market. In the meanwhile the Petitioners should be directed to maintain the ceiling price.
NPPA needs to examine the claim of the Petitioners whether glass ball charges as were provided earlier should be allowed in this case also as NPPA in many cases allowed additional requirement on packaging or administering the formulation in earlier cases. They should follow a uniform policy in such cases, the DoP further said.
“However, based on the review order passed earlier in similar other cases of review against the said impugned order, an opportunity was given by NPPA to all the manufacturers/importers of the drug to give presentation on insulin formulations manufactured/imported by them and considering the data/information received from them NPPA has already revised the prices of relevant insulin formulations vide notification No. S.O.1540(E) dated 14.6.2013 in supersession of the impugned notification S.O. No.1734(E) dated 16.11.2012. The above mentioned review application of the Petitioners against S.O. No.1734(E) dated 16.11.2012 is accordingly treated as disposed off,” the DoP in its order said.