Despite the fact that the US government has abolished the emergency use of hydroxychloroquine (HCQ) for the treatment of coronaviruses (Covid-19), small players in India see no major impact on the export of this drug.
The reason for this is that although emergency approval has only recently been granted for the treatment of Covida, over the years the drug has been used to treat rheumatoid arthritis (RA) and autoimmune lice drops.
Withdrawing the exemption for emergency use means that the medicinal product can be reused in the future if it is approved after the clinical trial. Yet this drug, which has been used for several decades, is still used in Armenia and for lupus, and it is still used to this day. The use of HCQ for the treatment of Covida is a recent phenomenon, although it has made a lot of noise around the drug. However, the impact on exports will be minimal for the industry, especially in Gujarat, said Viranchi Shah, Senior National Vice President of the Indian Drug Association (IDMA).
The senior official stated that HCQ’s share of India’s total pharmaceutical exports was insignificant. It therefore has no effect on exports as such.
Small businesses saw the opportunity and started exporting to various countries around the world. They did not have to change their product line to produce HCQ, which is an easy drug to produce. So if they haven’t accumulated a batch of active pharmaceutical ingredients (APIs) for QCS, there shouldn’t be a problem, he said.
In May, India exported about $15 million. This is an increase of almost 50% compared to the $10 million of the ZEC. As HCQ is a low-grade product (around 2 rupees per tablet), this meant that the volume of exports was high – more than 400-600 million tablets per month.
Gujarat, has recently become one of the largest HCQ producers and exporters in the country, with the State Food and Drug Administration recently licensing the highest scoring players.
It is estimated that around 70 pharmaceutical units are permitted for HCQ products and three active pharmaceutical ingredient (API) manufacturers for this product. The health service of Cadila (Zydus Cadila) is the most important of all.
HCQ is a 10-year-old drug used for rheumatoid arthritis and lupus. As a result, the demand for this drug is still high. Gujarat supplies 60-70% of US headquarters for AR and lupus only. Recently, the United States refused to use HCQ for Covid, which they have now recalled. However, exports of HCQ can still be used to treat the primary diseases for which they are intended, said H.G. Kosha, Commissioner of the Food and Drug Administration (FDCA) in Gujarat.
On the domestic market, the government had collected 100 million pills of shares in April. Each patient needs five to nine tablets. In this scenario, the action will take several months, as it could serve about 10 million people.
Meanwhile, the Indian HCQ industry is awaiting the results of a study on the efficacy of the drug in the treatment of Covid-19, which is being carried out in the UK.
According to industry sources, exports of HCQ from India may have both positive and negative effects depending on the results of the study.