NPPA fixes ceiling price of Zydus Cadila Tiotropium post DoP orders

New Delhi: In an implementation of directions given in line with review orders issued by the Department of Pharmaceuticals (DOP), the apex drug price regulator, National Pharmaceutical Pricing Authority (NPPA) has recently fixed the ceiling price of Tiotropium, Inhalation (MDI) 9 mcg/dose.

This came after DOP allowed the review petition of Zydus Healthcare Limited regarding price fixation of the said formulation and directed NPPA to refix its ceiling price.

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.

Zydus in its plea had 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.

Deliberating the matter DOP had held that NPPA needed to refix the ceiling price of Tiotropium by also 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.

Also Read: Refix ceiling price of Zydus Healthcare Tiotropium Inhalation: DoP directs NPPA

Following the directions by DOP, NPPA has now fixed/revised the ceiling price of the said formulation exclusive of goods and services tax applicable.

The details read;

Sl. No.	Name of the Scheduled Formulation	Dosage form & Strength	Unit	Ceiling Price (Rs.)	Review Order number and date	Existing SO number and date
(1)	(2)	(3)	(4)	(5)	(6)	(7)
1.	Tiotropium	Inhalation (MDI) 9	Per Metered Dose	2.36	31015/07/2019- Pricing dated	1485(E) dated 29.03.2019
		mcg/dose			21.06.2019	(at Sl. No. 805)

The NPPA order further added;

• All manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled formulations at a price higher than the ceiling price (plus goods and services tax as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified in column (5) in the above table plus goods and services tax as applicable, if any.


• All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus goods and services tax as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.


• The manufacturers may add goods and services tax only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (5) of the above-said table.


• The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (5) of the above table as per provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 2013. The manufacturer shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers.


• As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.


• Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table launches a new drug as per paragraph 2 (u) of the DPCO, 2013 such existing manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013.


• The manufacturers of above said scheduled formulations shall furnish a quarterly return to the NPPA, in respect of production/import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of production and/or import of scheduled formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation.


• The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955.


• Consequent to the issue of ceiling prices of such formulations as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded.