New Delhi: When the US drug regulator placed Indian generic pharma firm Ipca Laboratories under an import ban on 15 June 2017 after its facility failed USFDA’s routine inspection, not a lot of questions were raised. The US Food and Drug Administration (USFDA) routinely goes after Indian drugmakers, and Ipca, with an annual income of Rs 3,700 crore, isn’t a big fish.
But questions were raised on 20 March, when the USFDA peremptorily and somewhat inexplicably lifted the ban, and Ipca Labs happily notified this to the stock exchanges.
What brought about this sudden change of heart in the USFDA? The mystery wasn’t as deep as it appeared.
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How IPCA gained because of Trump
During his 19 March White House coronavirus briefing, US President Donald Trump declared hydroxychloroquine (HCQ), a seven decade-old anti-malarial drug, as a Covid-19 “game-changer” the world had been waiting for.
Indian companies produce approximately 70 per cent of the global output of this cheap old drug. Until 2014, Ipca Labs held a 60-per cent market share in HCQ supplies to the US. However, after the ban, Zydus Cadila became the largest player with a 32-per cent market share.
After Trump’s announcement and the subsequent lifting of ban, on cue arrived a large US order to Ipca and Zydus Cadila.
Following this, and some early Chinese and French clinical pointers, the Indian Council of Medical Research recommended HCQ as a preventive treatment for health personnel and family members handling Covid-19 patients on 22 March.
The resultant run on the drug — which is used to treat auto-immune conditions like Lupus and rheumatoid arthritis, and in some cases diabetes — in Indian retail markets led the Narendra Modi government to ban its export on 25 March.
“In many countries, including India, it (HCQ) is also approved for prescription for diabetics for lowering blood sugar levels. It is, however, prescribed rarely for that purpose now as better anti-diabetic treatments have emerged,” said Anoop Misra, chairman, Fortis Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology.
The high drama that followed the ban — the Trump-Modi phone call, the US President’s ‘retaliation’ threat, the Modi government’s relaxation for exports to friendly countries, and then the exchange of ‘thank you’ tweets — made headlines this entire week.
But what is mostly not known yet is that the US orders for these two companies were meant to be serviced by their Export Oriented Units (EOUs), which were exempted by the initial Indian ban.
In any case, the orders were placed before the bans. The Modi government allowed the EOUs to service these earlier orders.
As of 10 April, not a single pill has been dispatched by IPCA for the US and the order isn’t ready yet either, IPCA joint managing director Ajit Kumar Jain told ThePrint. However, it will be done soon.
“Four crore pills, out of the 10 crore pills ordered by the Government of India, have already been dispatched. We are still working on the American order which will take some time,” Jain said, without disclosing the size of the US order and tentative date of delivery.
Jain was referring to the Indian government’s order of 10 crore HCQ tablets order to Ipca and Zydus earlier this month.
While both companies remained tight-lipped about the quantity of prepaid orders from the US, government sources pegged it at around 2 crore pills.
“The order is around 2 crore pills. Fifty lakh has been dispatched this week but it includes the donation of HCQ from Amneal Pharmaceuticals,” said a senior official from the Department of Pharmaceuticals.
HCQ — a global asset now
HCQ, a drug nobody much cared for decades, is so cheap it was sold like any regular commodity. But after Donald Trump’s 19 March announcement, the Rs 3-tablet suddenly turned into a global strategic asset, essentially for India.
At least 30 major countries, at the highest levels, asked India for HCQ after Trump’s declaration. Brazil’s President Jair Bolsonaro famously invoked the legend of Lord Hanuman and Sanjivani Booti.
India is now shipping the drug to all these countries, including Germany, Spain, Australia and Indonesia. Additionally, India is offering it free or preferentially to its neighbours.
All this has come despite the fact that HCQ is an unlikely missile in the global war against Covid-19. There is little evidence of it working on the novel coronavirus. But preliminary reports from early clinical data and a larger trial in New York indicate there is some vigour in it.
India’s HCQ manufacturing numbers
India currently makes around 20 crore pills of HCQ on a monthly basis even as it consumes only 20-25 lakh pills. The rest is exported.
According to data from pharmacists’ lobby All India Organisation of Chemists and Druggists, IPCA sold 21.74 lakh HCQ tablets out of India’s total sale of 27.54 lakh tablets in March. Wallace sold 1.70 lakh pills followed by Torrent Pharmaceuticals (1.26 lakh pills) and Zydus Cadila (98,000).
The IPCA joint MD told ThePrint his company has the capacity to manufacture 20 metric tonnes, or 10 crore tablets, but “we have used only around 20 per cent of our capacity for the Indian market”.
“Rest 80 per cent had been exported across the world including Commonwealth of Independent States, Europe, Africa and Latin America. We can expand our capacity much more,” said Jain.
Zydus Cadila has ramped up its HCQ production from 3 metric tonnes per month to 30 metric tonnes to meet the requirements, and will be scaling it up further to about 40 to 50 metric tonnes in the coming months if need arises, said a company spokesperson.
“As we are fully integrated, the production of HCQ does not pose a challenge,” said the spokesperson.
Unlike other Indian drugs, even the raw materials, or APIs, for HCQ are made in India by IPCA Labs, Zydus Cadila and Mangalam Drugs and Organics, among others.
HCQ, once a lowly commodity is now in desperate global demand, much like India’s guar gum may have been when the US and Canada needed it for their shale gas fracking operations. Substitutes were found in the course of time and guar gum returned to its humdrum reality. For HCQ, this is its unlikely moment of global fame.