In a bid to ensure adequate availability of drugs used in the fight against Covid-19, India’s drug pricing regulator has asked pharmaceutical companies to share information such as the stock position, the countries from where the key starting material is being imported and details of procurement orders.
The National Pharmaceutical Pricing Authority (NPPA) has written to the chief executives and managing directors of drug makers, asking them to share details regarding the two corticosteroids dexamethasone and methylprednisolone, along with the anticoagulant Heparin (enoxaparin), said people aware of the matter. It has also asked the companies to ensure that there is enough inventory, they said.
Since these drugs are part of clinical treatment protocol of Covid-19, the Directorate General of Health Services (DGHS) has estimated a requirement of 138,710 vials of methylprednisolone, 3,015,442 vials of 40 mg and 1,407,206 vials of heparin by July 31. The DGHS has also said that around 3.3 million tablets of dexamethasone will be required by August 15.
The NPPA has asked companies to maintain adequate stock and ensure supply across the country whenever and wherever short supply is reported.
It has sought details such as production and sale of these drugs in the past two years, stock lying with the company as on date, production schedule for the next six months , details of suppliers from whom the active pharmaceutical ingredient (API) is sourced and whether they are facing any trouble procuring it. Companies have also been asked to share procurement orders placed by the state governments.
With a market share of 43.41 %, Pfizer is the major manufacturer of methylprednisolone, followed by Sun Pharmaceutical Industries, Neon Laboratories , Intas Pharmaceuticals and Zydus Cadila.
Major manufacturers of heparin are Bharat Serums and Vaccines, followed by Sanofi India, Emcure Pharmaceuticals, Cipla and Abbott Healthcare.
Zydus Cadila is the major manufacturer of dexamethasone, with a market share of 80.20%, followed by Wockhardt and Cadila Pharmaceuticals.
The NPPA also sent the letter to the state drug controllers, said the people cited earlier.
India, in its revised clinical management protocol for Covid-19, allowed the use of steroid dexamethasone, the first drug to show improved survival in severe patients of SARS Cov2 virus in recent trials by the University of Oxford. The revised protocol allows dexamethasone use as an alternative to methylprednisolone. Both these drugs are steroids, decrease inflammation and reduce the activity of the immune system.