New Delhi: Allowing the review petition of Zydus Healthcare Limited regarding price fixation of Tiotropium Inhalation (MDI) 9 mcg/dose, the Department of Pharmaceuticals (DoP) has directed National Pharmaceutical Pricing Authority (NPPA) to refix ceiling price of the said formulation.

The formulation is used to control and prevent symptoms of respiratory diseases such as asthma and chronic obstructive pulmonary disease. Tiotropium is also sold by drugmakers including Cipla, Glenmark Pharma, Lupin and Macleods Pharma

In its decision, DoP ordered NPPA to refix the ceiling prices of Tiotropium Inhalation (MDI) 9mcg/dose by considering the Price to Retailer (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 Metered Dose Inhalation(MDI) manufacturing companies.

Zydus in its plea contended that NPPA has made available the working sheet towards the ceiling price of the said formulation only on 12.3.2019. While going through the working sheet, it was observed that the brand Tiomist HFA 9mcg inhaler manufactured by Cadila Healthcare Limited (CHL), Zydus Cadila Group, does not feature at all. As on August 2015, CHL was manufacturing and marketing the said brand in India.

Cadila had filed a scheme of arrangement for transfer of the India Human Formulation Undertaking to its wholly owned subsidiary Zydus Healthcare 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.

Zydus further stated that Tiomist HFA 9mcg Inhaler was manufactured and marketed by CHL, Zydus Cadila as of August 2015. The product 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%.

However, NPPA in its working sheet made available on 12.3.2019 has not considered the said brand having a market share of 6%. It should have been considered because CHL, Zydus Cadila was manufacturing and marketing the said brand in August 2015. While this is also a fact that the said brand is now being manufactured and marketed by ZHL, Zydus Cadila and features in the latest AWACS data.

The company thus sought to direct NPPA to correct the ceiling price of Tiotropium Inhalation (MDI) 9mcg/dose after considering the correct PTR of brand Tiomist HFA 9mcg Inhaler.

In response to the contentions, NPPA said that NPPA has notified the revised ceiling price considering the data submitted by the concerned companies. Zydus was informed about the same stating that the company did not submit the data with respect to Tiomist 9mcg MDI. Accordingly, NPPA has considered the data submitted by the concerned companies.

Deliberating the matter, DoP observed that NPPA fixed the ceiling price of the formulation 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 has not submitted the data with respect to the said product.

The company started the manufacturing and marketing of Tiomist 9mcg MDI after passing an order in the matter of scheme of arrangement for transfer of the Indian Human Formulation Undertaking to the company by NCLT. Till then, the said product was being manufactured and marketed by Cadila Healthcare Limited (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. Zydus submitted documentary proof in support of its claim.

In view of the above, DoP held that 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 M/s Cadila Healthcare Limited for the month of August 2015, in addition to the data of other MDI manufacturing companies.

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