No shortage of dexamethasone in India, Chinese raw materials remain key

Dexamethasone, the low cost and widely available medication used to treat allergies and pain, has emerged as a dark horse in the race to find therapies to save people from the novel coronavirus, or COVID-19, pandemic. The drug is now being touted as the first life-saver against COVID-19.

The initial clinical trial results from the United Kingdom show dexamethasone, a corticosteroid, can be lifesaving for patients who are critically ill with COVID-19. For patients on ventilators, the treatment was shown to reduce death by about one-third, and for patients requiring only oxygen, death was cut by about one-fifth, according to preliminary findings. The full data of the trial is not yet out and it expected shortly.

The preliminary data has set the ball rolling for the drug that has been used since the 1960s. Dexamethasone has been listed on the World Health Organisation's (WHO) Model List of Essential Medicines since 1977 in multiple formulations, and is currently off-patent and affordable in most countries. In India too, it is covered under drug price control.

"This is the first treatment to be shown to reduce mortality in patients with COVID-19 requiring oxygen or ventilator support,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

In India, Zydus Cadila is the leading producer of dexamethasone.

Sources within Zydus Cadila told Moneycontrol that the company has enough capacity to meet domestic need. "We are happy that this drug has some effectiveness on COVID-19," a company executive said.

According to Sudarshan Jain, Secretary General of Indian Pharmaceutical Alliance, Zydus Cadila has 83 percent market share for the drug.

Jain said he doesn't have information on volume capacity of the drug at the moment, but he expressed confidence about Zydus being able to rise up to the potential demand for the drug.

"Already it (dexamethasone) has been part of the protocol in many hospitals in Maharashtra. Now, it is being documented by a UK study. Zydus has been supplying the drug to these hospitals," Jain said.

Zydus sells dexamethasone in both injection and tablet formulations. The injection called Dexona sells at Rs 10 per 2 ml dose. The 30 tablet strip retails for about Rs 6.38, as per listed prices on online pharmacy Netmeds.

The other brands of Wockhardt, Sun Pharmaceutical Industries, Cipla, Glenmark Pharmaceuticals, Intas Pharmaceuticals, Cadila Pharmaceuticals, Sterkem Pharma and several others retail at almost similar prices.

Hari Natarajan, Founder and Managing Director Pronto Consult, said dexamethason's entire market size in India would be around Rs 100-120 crore. "Along with Zydus, there other players, but these are small. Zydus has an advantage," he added.

Moneycontrol learns that companies that manufacture dexamethasone rely on imports of Chinese active pharmaceutical ingredients (APIs) and intermediates.

"Dexamethasone is a low volume drug, with restriction on pricing, so there isn't much incentive for local drug makers to produce active pharmaceutical ingredients (API) or intermediates of the drug," said an executive of an API company.

In fact, dexamethasone is one among the 53 drugs listed by the Indian government, eligible under the production linked incentive (PLI) scheme that was announced recently. PLI was announced to promote domestic manufacturing of critical Key Starting Materials (KSMs)/drug intermediates and APIs of life-saving drugs. India imports about 63 percent of its API needs, much of that comes from China.

With latest high tension at the India-China border in Ladakh, which resulted in death of 20 Indian soldiers, there are apprehensions about the incident impacting trade as well.

Jain of IPA said he is hopeful things wouldn't get impacted.