Mumbai based pharmaceutical firm, Ipca Laboratories recently announced that the United States Food and Drug Administration (FDA) has made an exception to the import alert for hydroxychloroquine sulphate and chloroquine phosphate Active Pharmaceutical Ingredients (APIs) and hydroxychloroquine sulphate tablets.
Harish Kamath, Corporate Counsel and Company Secretary, Ipca Laboratories said, “Due to the shortage implications and/or medical necessity of the certain drugs and finished products, our import alert on hydroxychloroquine sulphate and chloroquine phosphate APls and bydroxychloroquine sulphate tablets were lifted by the US FDA. Except for the US market, we are the largest producer of both these APIs and branded medicines across the globe. Although, we have the market’s understanding of that (US) market as well.”
Answering to the possible treatment method of Covid-19, Kamath expressed, “The only thing is that presently, there is no scientific evidence, which can confirm the use of hydroxychloroquine for the treatment of Covid-19. Globally, lots of pharma companies have already initiated the research work for the indication of Coronavirus treatment, and if any country’s regulatory body approves it, then we see a better future .”
Commenting on the company’ capabilities fulfilling the huge demand, Kamath said, ” We already have approvals for these APIs and finished formulation. So for us, there is no issue in supplying it. If there is a demand, Ipca Laboratories has the capacity and capabilities to help mankind. Presently, we are supplying these products to all the markets, wherever we have our presence except for the US market.”
Responding to the issue of addressing the US market’s demands, Kamath informed that due to lockdown in the country, there may be some delay as all factors need to be studied and re-examined to meet the country’s requirements. “However, we have the capacities and capabilities for the manufacturing of these APls and its formulations, and our team is gearing up to manufacture and supply these products meeting the stringent cGMP,” he added.
US FDA has also informed that the exception will be re-considered if the shortage implications change.
Ipca Laboratories manufacturers hydroxychloroquine sulphate and chloroquine phosphate APls at its API manufacturing unit situated at Ratlam, Madhya Pradesh and hydroxychloroquine sulphate tablets at formulations manufacturing units at Pithampur SEZ Indore, Madhya Pradesh and Piparia, Silvassa.
Ipca’s announcement comes in the wake of Indian Council of Medical Research (ICMR) declaring that it has constituted the National Task Force for Coronavirus (Covid-19) patient, recommending the use of anti-malaria drug hydroxychloroquine to treat high risk cases of Covid-19 with utmost precautions.
Prof (Dr) Balram Bhargava, Director General ICMR said that the National Task Force for Covid-19 recommends the use of hydroxy-chloroquine for prophylaxis to asymptomatic healthcare workers involved in the care of suspected or confirmed cases of Covid-19 can take 400 mg twice a day on day, followed by 400 mg once weekly for next seven weeks. And it can also be recommended for people who are taking care of household confirmed cases of Covid-19 and the dose will be 400 mg twice a day on day, followed by 400 mg once weekly for next three weeks. However, he also emphasised that the drug can not be given to children to under the age of 15 and it should be prescribed by a registered medical practitioner only. And if anyone becomes symptomatic while taking the drug, they should report immediately about it and get tested as per the national guidelines and follow the standard treatment protocol.
Last week, the US President Donald Trump from White House has also made an announcement that chloroquine, one of the oldest and best-known anti-malarial drugs had been approved by the US Food and Drugs Administration (FDA), and the country going to make the drug available almost immediately.