Indian pharmaceutical companies are raising monthly production of anti-malarial drug Hydroxychloroquine (HCQ) four times to 40 metric tonnes (MT) by the end of this month and five to six times to over 70 metric tonnes (MT) by next month. The plan to step up production came after the Government of India indicated it will help countries in dire need of the drug to fight novel coronavirus.
Peak capacity would produce 35 crore (350 million) tablets of 200 mg dosage every month. India's own requirement is unlikely to exceed 10 crore tablets for which the government has already placed an order with leading domestic manufacturers Zydus Cadila and Ipca Laboratories. Industry experts say 10 crore tablets are good enough to treat seven crore people, if required. In India, HCQ costs less than Rs 3 per tablet.
The remaining production will be exported to neighbouring countries as well as countries such as the US which need them. According to some studies, HCQ has shown strong antiviral effects on the coronavirus infection, which prompted US President Donald Trump to seek India's help in procuring the drug.
Other leading manufacturers of HCQ include Intas Pharmaceuticals, McW Healthcare of Indore, Macleods Pharmaceuticals, Cipla and Lupin. API suppliers for the drug include Abbott India, Rusan Pharma, Mangalam Drugs, Unichem Remedies, Laurus Labs, Vijayasri Organics, etc.
"Together, we estimate active pharmaceutical ingredient (API) production can be augmented to 40 metric tonnes (MT) this month and to 70 MT per month in two months," said a top executive with a leading HCQ drug manufacturer.
Sources said the manufacturers are cautious, as studies done so far to judge the efficacy of HCQ in treating coronavirus included smaller populations only. Large trials start only this week. Reports said one study had also failed to prove its efficacy, though it is a safe and proven molecule.
Ironically, HCQ is no more a primary anti-malarial drug. It is mostly used globally to treat some immunological diseases like Lupus and Rheumatoid Arthritis. Indian drug formulators export 80-85 per cent of the production to almost all parts of the world, as global pharma majors more or less stopped large scale production of this low cost molecule due to lack of demand.
Two major Indian manufacturers - Zydus Cadila and Ipca Laboratories - have backward integrated production capacity - from key raw materials that can be converted to intermediates and then to APIs and to final formulations, in the 12-15 step process to make the medicine.
Most of the other Hydroxychloroquine API manufacturers import some key raw materials and intermediates from China or source them from countries like South Korea, Italy or Finland.
API manufacturers keep an inventory of raw materials for six months. With most of China returning to normalcy, sourcing raw material will not be an issue, industry sources said. An Indian Drug Manufacturers Association (IDMA) spokesperson even told India Today that shipments of intermediate chemicals for making HCQ have commenced from China.
"We have ramped up production to 20 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 the need arises. As we are fully integrated, this should not pose a challenge. The priority is to ensure that all patients who need the drug get it," Zydus Cadila Managing Director Dr Sharvil P Patel said in a statement.
The current increase in production, is also apparently a 10-fold increase already from about 4 MT. This current enhanced capacity alone is apparently good enough to make about 150-200 million tablets. The US Food and Drug Administration (FDA) has temporarily cleared the over three-year ban on Ipca's API manufacturing unit at Ratlam in Madhya Pradesh and two formulation facilities in Pithampur in Madhya Pradesh and Silvassa. Ipca, which earned 18 per cent of its revenues in 2018-19 from sale of anti-malarials, had sales of API and intermediates worth Rs 885 crore. About 77 per cent of this was exports, except to the US due to the ban.
Chloroquine was discovered in 1934 by Hans Andersag and his team at Bayer's laboratories, but was not used for over a decade as researchers feared that it was too toxic for human use. In 2017, the World Health Organization (WHO) estimated that there were 219 million cases of malaria worldwide, causing 435 thousand deaths, or 1,190 per day, mostly young children.
Sources said India's exports of HCQ in 2018-19 was only $51 million and the whole current size of the US market is only $220 million, generating about 5.5 million annual prescriptions. Zydus Cadila is the largest player in the US market with 32 per cent market share by volume and the top ten players include Dr Reddy's Lab (10 per cent) and Sun Pharma (7 per cent).
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