NPPA fixes retail price of Vitamin D3 strips marketed by Cadila Pharma

New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India, has fixed the retail price of Vitamin D3 (Cholecalciferol) orally disintegrating strips manufactured and marketed by Zim Laboratories and Cadila Pharmaceuticals respectively.

This price revision came after the Indian drug price regulator, NPPA, revised the retail prices of Vitamin D3 (Cholecalciferol) orally disintegrating strips under the Drugs (Prices Control) Order, 2013 based on the decision of the 91st Authority meeting dated 29.07.2021.

The NPPA in its 91st authority meeting under DPCO, 2013 held on 29.07.2021 noted that based on the application of Cadila Pharmaceuticals Ltd, the retail price of Vitamin D3 (Cholecalciferol) 60000 lU orally disintegrating strips was calculated and the draft working sheet was uploaded on the NPPA's website on 07.04.2021, so as to enable the company to make representations, if any, within 10 working days.

However, since the company had made no objections or submitted any documents in support of their claim at the time, the Authority, at its 86th meeting on April 28, 2021, set the Retail Price of Vitamin D3 (Cholecalciferol) 60000 lU orally disintegrating strips at Rs. 20.16 per strip excluding GST and notified it via S.O. 1724(E) dated April 30, 2021.

Thereafter, in line with the NPPA's notification, Cadila Pharmaceuticals filed a review application before the Department of Pharmaceuticals (DoP) stating that erroneous data was used in the calculation of the retail price.

In view of the above, the Department of Pharmaceuticals (DoP), in a letter dated 30.06.2021, requested NPPA to "complete their first hand re-verifications of basic data and calculations based thereupon before making any decision about reviewing the case."

Furthermore, the Authority also noted that based on the corrected data submitted by the AIOCD­ AWACS Pharmatrac, the revised retail price of Vitamin D3 (Cholecalciferol) 60000 IU orally disintegrating strip comes to Rs. 30.39 per strip excluding GST.

After detailed deliberation, the authority decided to re-fix the retail price of Vitamin D3 (Cholecalciferol) 60000 IU orally disintegrating strips for Zim Laboratories (manufacturer)/Cadila Pharmaceutical Ltd (marketer) which was earlier fixed vide SO. 1724(E) dated 30.04.2021 [SI. No. 20) and approved the revised price at Rs. 30.39 per strip excluding GST based on corrected data.

Therefore, in its latest notification, the NPPA stated that in line with the directions given by the Department of Pharmaceuticals (DOP) vide letters specified in column (6) of the table herein below and in exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated May 30, 2013 and S.O. 701 (E) dated March 10, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order(s) of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) specified in the Column (7) of the table, the National Pharmaceutical Pricing Authority (NPPA), fixed, the price as specified in column (5) of the table herein below as the retail price, exclusive of Goods and Services Tax, if any, in relation to the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit and name of manufacturer & marketing company , as specified in the corresponding entries in columns (3), (4) and (8) thereof;

The notification further added;

(a) The manufacturer of above mentioned formulations i.e. "new drug" under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove.

(b) The manufacturer may add Goods and Services Tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (5) of the above said table.

(c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 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.

(d) 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.

(e) The above mentioned retail prices are applicable only to the manufacturer / marketer as mentioned above for generic / any brand of the same composition / strength of the subject formulations, subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies.

(f) In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.