The National Pharmaceutical Pricing Authority (NPPA) has further extended the revised ceiling price of two strengths of heparin injection vide notification No. S.O. 4589(E) dt 29-09-2022, and the price fixed for liquid medical oxygen (LMO) and oxygen inhalation for three months, till December 31, 2022, vide notification No. S.O. 4590(E) dt 29-09-2022.

Download notification NO. S.O. 4589(E) dt 29-09-2022

Download notification NO. S.O. 4590(E) dt 29-09-2022

The price regulations were introduced during the C-19 pandemic in order to ensure the continuous availability of these products.

The revised ceiling prices of heparin injections at 5000 IU/ml and 1000 IU/ml were earlier extended for the fourth time, for a period of six months till September 30, 2022.

The Authority said that since the matter regarding the nomination of the new chairman of the Committee to monitor export/import trends of active pharmaceutical ingredients (APIs) is under consideration, the import data of heparin API from the port offices of the Central Drugs Standard Control Organisation (CDSCO) during the period from March 2022 to August 2022 was obtained from CDSCO and examined by NPPA.

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It also observed that the import prices of heparin API during the period from March to August 2022 were in a similar range to that of the earlier period, based on which the revised ceiling price was earlier extended.

Observing that the availability of heparin injection, a scheduled formulation, is essential for the C-19 pandemic since the pandemic is not fully subdued.

The extension of the revised ceiling price of the drug is up to December 31, 2022, or until further orders, whichever is earlier.

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It was first revised upwards by the Authority through an order on June 30, 2020, based on applications from several companies having a major market share.

The companies requested an upward revision of the ceiling prices of the drug, citing reasons that the cost of active pharmaceutical ingredients, which constitute a major portion of the input cost and are mainly imported from China, has risen to a considerable extent, making the companies entirely unviable to continue manufacture and formulation.

The companies also contended that over the years the regulated prices have decreased, whereas there has been a consistent increase in the 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 5000 IU/mL as an essential medicine for the treatment of C-19 patients.

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There were reports of a shortage of injections during the time of the pandemic.

In an earlier report, the Committee noted that there has been a considerable increase in the price of API heparin when compared to the base year of September 2018.

The committee recommended a short-term upward price revision for 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 percent 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 a heparin injection of 1000 IU/ml for a unit of 1 ml and Rs 60.54 for a heparin injection of 5000 IU/ml for 1 ml.

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The Authority has also extended the period for the price cap on liquid medical oxygen (LMO) and oxygen inhalation (medicinal gas) from June 30 to September 30, 2022.

NPPA has sought comments and inputs from the Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, for further extension of prices of LMO and oxygen inhalation in cylinders beyond September 30, 2022, and in a meeting held on September 27, it has been decided to extend the prices for three months till December 31, 2022.

The Authority deliberated upon the matter in detail during the meeting and, considering the continuing C-19 pandemic, decided that the revised price of LMO and oxygen inhalation in cylinders be fixed at first in September 2020, to be extended for three more months till the end of December or until further orders, whichever is earlier, in the public interest.

The Authority, in 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 the C-19 pandemic.

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During the pandemic, around 50 percent of the total liquid oxygen production is being used for medical purposes, in comparison to around 15 percent of the usage during the pre-C-19 period.

Medicinal Gas is a scheduled formulation under the amended Schedule I of Drugs (Prices Control) Order , 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 the 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.

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