CORONA CAUSES WORLD TO LOOK AT INDIAN PHARMA FOR RELIEF

Hydroxychloroquine (HCQ), an old pharmaceutical molecule, was invented by German multinational Bayer in the 1940s. Most multinationals stopped its production decades back as malaria is no longer prevalent in most developed nations.

India, however makes 80-85 per cent of finished formulations of HCQ, including combination drugs. Majorities are exported to 70-80 countries. It is not a big market, though. India’s exports of HCQ in FY19 were only $51 million and the whole current size of the US market is only $220 million. Zydus Cadila is the largest player in the US market with 32 per cent market share by volume and the top 10 players include Dr. Reddy’s Lab (10%) and Sun Pharma (7%).

HCQ suddenly gained prominence as some studies found it has strong antiviral effects on the coronavirus infection, which neither has a drug nor a vaccine. This prompted US President Donald Trump to direct the US Food and Drug Administration (FDA) to do away with rigid laws to ensure possible treatments for Covid-19.

Like Zydus, Mumbaibased Ipca Laboratories is a large integrated maker of HCQ and supplies across the world, except to the US. That was because its API unit at Ratlam in

Madhya Pradesh and two formulation facilities were banned for almost five years by the USFDA citing sub-standard quality manufacturing. After Trump’’s directive, the FDA has given temporary clearance for all these units to facilitate export to the US.

Another leading Indian respiratory drug maker Cipla was given fast-track permission this week by the USFDA to sell Albuterol Sulfate Inhalation Aerosol. Cipla’s drug is first-generic of Merck Sharp & Dohme

Corp’s Proventil, used to treat severe chest congestion with asthma symptoms, which has a US market of $2.8 billion. Analysts were expecting approval for Cipla’s product only by FY21 and limited sales during the year. Now they estimate FY22 sales of $50-60 million from the product, an inhaler with the medicine. Another Indian drug maker Lupin also has a filing for Albuterol in the US and is expecting a similar fast-track approval.