Written by Prabha Raghavan | New Delhi | Published: June 18, 2020 3:04:44 am
A pharmacist displays a box of Dexamethasone. Dexamethasone is a generic steroid widely used in other diseases to reduce inflammation. (Reuters)
Promising findings from the United Kingdom’s RECOVERY clinical trial have brought India’s anti-inflammatory steroid dexamethasone market under the spotlight. While medical experts here are still studying the findings to understand how beneficial it may be as part of India’s treatment protocol for COVID-19 patients, industry executives expect global demand for the drug to shoot up like in the case of hydroxychloroquine (HCQ) earlier.
The “first drug to be shown to improve survival”, dexamethasone reduces death by up to a third in COVID-19 patients on ventilator support, and by a fifth in patients receiving only oxygen, researchers leading the trial had announced.
Dexamethasone in India seems like a fairly small market by value, but not by volumes, according to Indian Pharmaceutical Alliance secretary general Sudarshan Jain. “It is under price control, which is why the market size is small,” he said.
In the 12 months ended May 31, 2020, the drug had a market size of around Rs 104 crore, with around 239 million units sold in the country, shows data from pharmaceutical market research firm AIOCD Awacs PharmaTrac. Of this, Zydus Cadila catered to the lion’s share of domestic demand (around 82 per cent of the total volume) and accounted for nearly 83 per cent of the market value in the process with its brand, Dexona.
Other major players in this market include Wockhardt, with its brand Decdan, and Cadila Pharmaceuticals, with Dexasone.
“This (the trial’s findings) is a clearly good observation in the ventilator cases,” said Dr Shashank Joshi, member of Maharashtra’s COVID-19 task force. While this is a “welcome” development, the task force is studying the full text of the trial before taking a call on how to incorporate it in their clinical management protocol.
“What we realised as COVID evolved in India was that most patients here do not need ventilators, but oxygen,” he said. Here, several hospitals in India had already been using corticosteroid IV methylprednisolone to manage patients on oxygen support, he said. The Indian Council of Medical Research (ICMR) on June 13 recommended the use of this particular drug in the clinical management of moderate cases on oxygen support.
“We have been using IV methylprednisolone judiciously in appropriately selected cases…to save lives and prevent them from going on the ventilator. Once a patient is ventilated, then the mortality rate is very high, for which dexamethasone now seems to be (a potential treatment option),” he said.
“I have a very strong caution note—I do not want any person at home or with a mild disease to use steroids in their treatment. It’s a contra-indication because it may aggravate their condition and may be dangerous,” he added.
The global market for dexamethasone is around $470 million, with around 5.85 billion units sold, according to IQVIA MIDAS 2020. While the top markets by value are the US, EU and Japan, India, Indonesia and China account for the highest volumes.
Indian pharmaceutical firms have the largest share of the global volume—around 46 per cent—”largely” driven by the country’s own consumption of the drug, according to the advanced analytics firm.
However, following the latest findings in the RECOVERY trial, industry executives expect a growth in demand for exports to other countries as well. Pharmaceutical Export Promotion Council (PHARMEXCIL) chairman Dinesh Dua expects the demand to be “bigger” than what India experienced for hydroxychloroquine.
Exports of dexamethasone between April 2019 and February 2020 were around $17.34 million, with Nigeria, China and Iraq accounting for the top export destinations by volumes, according to the commerce ministry.
“Unfortunately, the API (active pharmaceutical ingredient) for dexamethasone mostly comes from China. There are hardly one or two manufacturers in India, and they too have very small capacity. It’s all dominated by China,” Dua told The Indian Express.
So far, no demand for the drug has been flagged to the export promotion body, but “these are still early days”, he said.
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