NPPA hikes price of critical blood-thinning Heparin injection; Details

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has permitted companies to raise the price of Heparin Injection, a critical blood-thinning drug, until December end. NPPA has now set the ceiling price of 1,000 International Units Per Millilitre (IU/ml) of heparin injection at Rs 24.39 per ml and 5,000 IU/ml of injection at Rs 60.54 per ml.

This came following a number of applications moved by various companies having major market share for upward revision of ceiling prices of Heparin Injection 1000IU/ ml and Heparin Injection 5000IU/ ml under para 19 of DPCO 2013, citing reasons that the cost of APIs which constitute a major portion of the input cost and mainly imported from China, has risen to a considerable extent making the companies entirely unviable to continue to manufacture the formulations.

The companies also contended that over the years the regulated price has decreased whereas there is a consistent increase in the price of imported price of APIs thereby making commercially unviable for the drug manufacturers to manufacture the said product. Some of the brands of heparin are Hep and Hep-Lock by Gland Pharma, Lofh by Abbott, and Celparin by Celon Laboratories Ltd.

The Authority observed that the Ministry of Health and Family Welfare (MoHFW) has included Heparin injection 5000IU/ml as an essential medicine for the treatment of COVID-19 patients. Further, reports of shortage have also been received for Heparin Injection.  

A Committee was constituted to monitor export/import trends of APIs, formulations, and medical devices needed for COVID-19. In its report, the committee informed that there has been a considerable increase in the price of API Heparin when compared to the base year of September 2018. Accordingly, the Committee recommended a short term upward price revision of Heparin Injection. 

NPPA considered the aspect of availability of Heparin Injection 1000IU/ ml and Heparin Injection 5000IU/ ml, a scheduled formulation, especially during the pandemic situation of COVID-19 and opined that any situation of shortage due to price control needs to be seen from a public interest perspective.

Accordingly, NPPA invoked extraordinary powers in the public interest under para 19 of DPCO 2013 for upward revision of the ceiling prices of Heparin Injection 1000IU/ ml and Heparin Injection 5000IU/ ml by giving one time increase of 50% from the present ceiling price to be applicable up to 31st December 2020.

Therefore, in exercise of extraordinary powers in the public interest, conferred by paragraph 19 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May 2013 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) S.O. Number and date specified in column no. 6(a) & 6(b) mentioned in the table below, the National Pharmaceutical Pricing Authority, hereby fixes the prices as specified in column (5) of the Table below as ceiling prices exclusive of goods and services tax applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the dosage form & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof: 

The notification further added;

(a) The ceiling price as specified in column (5) in respect of the formulations with dosage & strength mentioned in column (2) and (3) respectively would be applicable up to 31st December 2020.

(b) All manufacturers of scheduled formulation, 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.

(c) The provisions of para 13(2) of DPCO 2013 would not be applicable on the ceiling price specified in column (5) in respect of the formulations with dosage & strength mentioned in column (2) and (3) respectively.

(d) 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.

(e) 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.

(f) 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.

(g) 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.

(h) The manufacturers of the 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 the 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 ScheduleII of the DPCO, 2013 at least six months prior to the intended date of discontinuation.

(i) 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.

(j) 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.

(k) The price of Heparin Sodium API would be monitored on a monthly basis up to 31st December 2020.  

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