DoP directs NPPA to refix ceiling price of tiotropium inhalation

Mumbai, June 26, 2019: The Department of Pharmaceuticals (DoP) has directed the NPPA to refix the ceiling price of tiotropium inhalation (MDI) 9mcg/dose by considering the PTR of Tiomist 9mcg MDI being manufactured and marketed by Cadila Healthcare for the month of August, 2015, in addition to the data of other MDI manufacturing companies. 

Zydus Healthcare had earlier filed a review application on 27.03.2019 against notification S.O. No.1028(E), dated 26.02.2019 issued by the NPPA fixing the ceiling price of tiotropium inhalation (MDI) 9 mcg/dose. 

In the review application, Zydus Healthcare contented that the NPPA has made available the working sheet towards the ceiling price of tiotropium inhalation (MDI) 9 mcg/dose only on 12.3.2019. While going through the working sheet, the applicant observed that the brand Tiomist HFA 9mcg inhaler manufactured by Cadila Healthcare Ltd (CHL) does not feature at all. As on August 2015 CHL was manufacturing and marketing the said brand in India. CHL had filed a scheme of arrangement for transfer of the India Human Formulation Undertaking to its wholly owned subsidiary Zydus Healthcare Limited (ZHL) with National Company Law Tribunal (NCLT) Bench at Ahmedabad, on a going concern basis, by way of slump sale. NCLT had passed an order in the matter of scheme of arrangement for transfer of the Indian Human Formulation Undertaking to Zydus Healthcare Limited on 18.5.2017. NPPA was informed about the said NCLT order vide ZHL letter No. NPPA/ZHL/2017/0307 dated 3.7.2017. 

The applicant further stated that Tiomist HFA 9mcg Inhaler was manufactured and marketed by CHL, Zydus Cadila as of August, 2015. Tiomist HFA 9mcg inhaler is manufactured and marketed by ZHL, Zydus Cadila w.e.f. 18.5.17. The AWACS data of August 2015 shows that Tiomist HFA 9mcg Inhaler of Zydus Cadila has MRP of Rs. 400.31, PTR of 311.29, MAT Value of 1.35 as of August 2015 and a Market share of 6%. NPPA in its working sheet made available on 12.3.2019 has not considered the said brand having market share of 6%. It should have been considered because CHL, Zydus Cadila was manufacturing and marketing the said brand in August 2015.

During examination, the DoP noted that the NPPA fixed the ceiling price of tiotropium inhalation (MDI) 9mcg/dose vide price notification SO 1028(E), dated 26.02.2019 by considering the data collected from Metered Dose Inhalation (MDI) manufacturing companies for the month of August, 2015, and considered the data of four companies, viz. Cipla Ltd., Glenmark Pharmaceuticals Ltd., Lupin Ltd. and Macleods Pharmaceuticals Pvt. Ltd. NPPA did not consider the data in respect of product Tiomist 9mcg MDI on the ground that Zydus Cadila has not submitted the data with respect to the said product.

It further noted that ZHL started the manufacturing and marketing of Tiomist 9mcg MDI w.e.f. 18.5.2017, after passing an order in the matter of scheme of arrangement for transfer of the Indian Human Formulation Undertaking to Zydus Healthcare Limited by National Company Law Tribunal. Till then, the said product was being manufactured and marketed by CHL. It means, the data of the said product for the month of August, 2015 was available with CHL and not with ZHL. The market share of CHL was 6% in the month of August, 2015. The applicant submitted documentary proof in support of its claim.

“In view of the above, NPPA needs to refix the ceiling price of tiotropium inhalation (MDI) 9mcg/dose by also considering the PTR of Tiomist 9mcg MDI being manufactured and marketed by Cadila Healthcare Limited for the month of August, 2015, in addition to the data of other MDI manufacturing companies,” the DoP in its order said. PharmaBiz