Last Updated on December 31, 2023 by The Health Master
Download the notifications, links given below: The National Pharmaceutical Pricing Authority (NPPA) has further extended the revised ceiling price of two strengths of heparin injection, liquid medical oxygen (LMO) and oxygen inhalation for another six months in order to ensure continuous availability of the drug during C-19 pandemic.
The revised ceiling prices of heparin injection 5000IU/ml and 1000 IU/ml extended for the fourth time, for a period of six months till September 30, 2022.
The committee constituted to monitor export/import trends of APIs, formulations and medical devices needed for C-19 in a letter on March 15, 2022 recommended that the authority may continue with the increased ceiling price for the injection for another six months to ensure continuous availability of this essential drug in the current pandemic situation.
It was first revised upwards by the Authority through an order on June 30, 2020, based on applications from several companies having major market share.
The companies requested for an upward revision of ceiling prices of the drug citing reasons that the cost of active pharmaceutical ingredients (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 manufacture and formulations.
The companies also contended that over the years the regulated price have decreased whereas there is consistent increase in the imported price of APIs thereby making it commercially unviable for the drug manufacturers to manufacture heparin injections.
The ministry of health and family welfare (MoH&FW) has included heparin 5000IU/ml as an essential medicine for treatment of C-19 patients. There were reports of shortage of the injection during the time of pandemic.
In an earlier report, the Committee has informed that there has been considerable increase in price of API heparin when compared to the base year of September, 2018. The committee recommended short term upward price revision of heparin injection.
The NPPA, based on these recommendations, on June 30, 2020, revised the ceiling prices upwards by giving a one time increase of 50 per cent from the existing ceiling price to be applicable up to December 31, 2020.
The ceiling price excluding GST was thus fixed as Rs. 24.39 for heparin injection 1000 IU/ml for a unit of 1 ml and Rs 60.54 for heparin injection 5000 IU/ml for 1 ml.
The Authority has also extended the period for price cap on liquid medical oxygen (LMO) and oxygen inhalation (medicinal gas) from March 31, 2022 to three more months till June 30, 2022, in public interest.
This is for the fourth time the drug price watchdog has extended the revised price of these products in the backdrop of C-19 pandemic and increased demand.
The Department for Promotion of Industry and Internal Trade (DPIIT), ministry of commerce and industry, through an Office Memorandum on March 24, 2022, recommended that the prices of the LMO and medicinal gas may further be extended to another three months beyond March 31, after which the issue may be reviewed by the Department again.
NPPA, in view of continuing extraordinary circumstances due to the C-19 pandemic, decided that the revised price of LMO and medicinal gas fixed for the first time through the order on September 25, 2020, be further extended up to June 30, 2022, or until further order, whichever is earlier, in public interest.
The Authority, on September, 2020, observed that the demand for medical oxygen has gone up almost four times, from 750 MT per day to around 2,800 MT per day, due to C-19 pandemic.
During the pandemic, around 50 percent of the total liquid oxygen production is being used for medical purposes in comparison to around 15 per cent usage during the pre-C-19 period.
Medicinal gas is a scheduled formulation under the amended Schedule I of Drugs (Prices Control) Order [DPCO], 2013, and NPPA had notified its ceiling price as Rs. 17.49 per cubic meter excluding goods and service tax (GST) from March 25, 2020.
The union ministry of health and family welfare has delegated powers to NPPA to take steps to immediately regulate the availability and pricing of LMO and medical oxygen cylinders.
The Authority, through the order, during the time fixed the ex-factory maximum price of LMO at Rs. 15.22 per cubic meter, excluding GST and Rs. 25.71 for medicinal gas per cubic meter in cylinder, inclusive of inward transportation cost incurred for LMO up to filler.
The manufacturers not complying with the price cap, shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955, said the order.
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