NPPA fixes MRP of 3 formulations post expiry of price exemption granted under para 32, DPCO
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 3 formulations after expiry of exemption granted under para 32 of under Drugs (Prices Control) Order. The formulations include Torrent Pharma's Prasugrel Hydrochloride and Aspirin Capsule combination and Wockhardt Pharma's Insulin Human Injection and Isophene Insulin Human Suspension plus Insulin Human Injection.
Cocktail of Prasugrel Hydrochloride and Aspirin Capsule is used by patients with heart disease (recent heart attack, unstable angina) who undergo a certain heart procedure (angioplasty), while injections of insulin can help treat both types of diabetes.
Medical dialogues team had earlier reported that the NPPA had decided to send a show-cause and overcharging notice to drug major Wockhardt Ltd for failing to seek any price approval for formulations including Isophane Insulin Human Suspension and Injection despite the expiry of the exemption granted under para 32(iii) of DPCO 2013.
Now, based on the decision of 84th Authority meeting, 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 the 30th May, 2013 and S. O. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in column (6) 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 (5) thereof;
Name of the Formulation / Brand
Manufacturer & Marketing
Prasugrel Hydrochloride + Aspirin Capsule
Each capsule contains: Prasugrel Hydrochloride 10 mg (as film coated),
Aspirin 75 mg (as enteric coated)
M/s Torrent Pharmaceuticals Pvt. Ltd.
Insulin Human Injection,
Isophene Insulin Human Suspension + Insulin Human Injection
70% Isophene Insulin Human Suspension and 30% Insulin Human Injection, 200IU/ml
M/s Wockhardt Ltd
The NPPA in its notice further added:
(a) The manufacturer of the above-mentioned formulations i.e. "new drug" under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (6) 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 (6) 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 (6) 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 the 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 price is applicable only to the individual manufacturer/marketer as mentioned above i.e. who have applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfilment 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 manufacturer/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.
(g) Consequent to the issue of ceiling price of such formulation 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.