Indian Drug Firms Get Big US Orders For Chloroquine
Zydus Cadila and Ipca Laboratories, both top Indian drug makers, have received orders to produce anti-malarial drug chloroquine for the American market amid the outbreak of the COVID-19 pandemic.
US President Trump has called chloroquine a potential “game-changer” for treating the disease caused by the novel coronavirus SARS-COV-2. Also, the US Food and Drug Administration (FDA) has partially lifted a 3-year-old ‘import alert’ on Ipca’s two plants to import the medicine. Zydus Cadila has also received a huge order from the US for the decades-old drug.
Dr. Stephen Hahn, FDA commissioner said the regulator is preparing to test chloroquine in a clinical trial with coronavirus patients.
Trump had, during a White House press briefing on the coronavirus situation, directed the FDA to “eliminate outdated rules and bureaucracy” to help speed up the pace of testing drugs that could help treat the symptoms of COVID-19.
Chloroquine is widely available in India and is manufactured by several local companies including Ipca, Zydus Cadila and Alembic Pharmaceuticals.
Chloroquine works by increasing the levels of haem or heme — a substance toxic to the malarial parasite — in the blood. This kills the parasite and stops the infection from spreading.
Biotech investor and doctor Mike Pellini were the first to use chloroquine as a possible cure for COVID-19, while tech entrepreneur Elon Musk also tweeted that chloroquine was “maybe worth considering” as a potential treatment.
According to some earlier studies, chloroquine has strong antiviral effects on the coronavirus infection of primate cells.
Mumbai-based Ipca informed the Bombay Stock Exchange and the National Stock Exchange that the FDA has allowed the import of hydroxychloroquine sulphate and chloroquine phosphate.
The 2 firms have also started receiving queries from buyers around the globe for chloroquine and the compounds used to manufacture it, known as APIs (active pharmaceutical ingredients).
We are noticing an increase in the emergency demand and inquiries for the chloroquine phosphate and hydroxychloroquine sulphate APIs and its formulations from several countries world over,” Ipca said in its filing to the stock exchanges.
Due to an increase in demand, Ipca is also gearing up to manufacture and supply these products “meeting the stringent CGMP (FDA’s current good manufacturing practice regulations), quality and regulatory requirements, and thus help mankind in the best possible way in these tough times”.
However, the FDA has also informed that the exception will be re-considered if the shortage implications change.
Meanwhile, an official spokesperson for Zydus Cadila said, “Yes, we have received inquiries for the supply of hydroxychloroquine. Our priority at this moment is to ensure consistent supplies, if the need arises, and are ramping up our production.”
The spokesperson added, "The companies can even quadruple our capacities if need be as we are fully integrated to produce both API and finished dose formulation. We believe that we will be able to cater to the requirements as we are among the few companies in the world who have capabilities to manufacture the drug in large quantities."