The National Pharmaceutical Pricing Authority (NPPA) has directed all manufacturers to ensure production and stock of 138,710 vials of methyl prednisolone, 30,15,442 vials (40 mg) of heparin (enoxaparin) and 14,07,206 vials (60 mg) up to July 31, 2020 and also 33 lakh tablet (6mg) of dexamethasone uptil August 15, 2020 for COVID-19 disease management. It has also directed state drug controllers (SDCs) to issue instructions to all the concerned manufacturers to ensure availability and production of these medicines.
This directive is with reference to Union health ministry’s letters dated, March 18, 2020, June 24, 2020, June 27, 2020 and June 29, 2020 regarding requirement and availability of drugs across the country as part of the clinical treatment protocol of COVID-19. Director General of Health Services (DGHS) has also informed requirement for the same to the NPPA.
Methylprednisolone is used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin, kidney, intestinal, lung diseases and immune system disorders. It may also be used with other medications in hormone disorders. Heparin is an anticoagulant (blood thinner) that prevents the formation of blood clots. It is used to treat and prevent blood clots caused by certain medical conditions or medical procedures. It is also used before surgery to reduce the risk of blood clots. Dexamethasone is a corticosteroid used to treat conditions such as arthritis, blood/hormone/immune system disorders, allergic reactions, certain skin and eye conditions among others.
The national drug pricing regulator has also through a letter stated to immediately intimate details regarding production or sale of drugs during the last 2 years, stock lying with the company as on date, production schedule for next six months, details of suppliers from whom sourcing API for the drugs is done and problems if any being faced in such sourcing, details of procurement orders placed by state governments and other additional details.
In order to ensure adequate stocks and ensure supply across the country, NPPA had recently revised the prices of blood thinner drug heparin upwards by 50 per cent until December, 2020 for its consistent availability in view of the increase in API costs from China in COVID-19 scenario.
Price revision was based on union health ministry committee report which states that there has been a 211 per cent increase in the price of heparin’s API as of today when compared to the base year of September 2018.
Upward price revision was also attributed to the fact that heparin is among the essential drugs listed by the Union health ministry that need to be manufactured taking into consideration its commercial viability for its consistent availability in the country. Heparin injection in dosage form and strength of 1,000 IU/ml which used to cost Rs 15.31/ml and heparin injection in dosage form and strength of 5,000 IU/ml which used to cost Rs 37.99/ml will now cost Rs 24.39 per 1 ml in dosage and strength of 1,000 IU/ml and Rs 60.54 in dosage and strength of 5,000 IU/ml 1 ml respectively, as per the NPPA order.
The national drug pricing regulator invoked its extraordinary powers in public interest under para 19 of DPCO 2013 for upward revision of the ceiling prices of heparin injection 1,000 IU/ml and heparin injection 5,000 IU/ml by giving one time increase of 50 per cent from the present ceiling price to be applicable up till December 31, 2020.