Even as the Donald Trump government in the US revoked emergency-use authorisation of hydroxychloroquine (HCQ) for treating Covid-19, smaller players in India do not see much impact on exports of the drug.
This is because while the emergency use authorisation for treating Covid-19 was a recent move, the drug has been used since years for rheumatoid arthritis (RA) and autoimmune disease lupus.
"Revocation of the emergency use approval means that the drug can be reused in future when approved after clinical study results. However, the decades old drug is used in RA and lupus which still continues. Use of HCQ for treating Covid has been a recent phenomena, although it did create a huge buzz around the drug. However, the impact on exports will be minimal for the industry, especially in Gujarat," said Viranchi Shah, Senior National Vice President at Indian Drug Manufacturers' Association (IDMA).
A senior government official said that the share of HCQ in India's overall pharma exports is miniscule, so it does not impact the exports as such. "Smaller firms had seen an opportunity and started exports to several countries across the globe. They did not need to alter their product line for making HCQ which is a simple to make drug. Therefore, unless they have piled up lot of inventory of HCQ active pharmaceutical ingredients (API), there should not be a problem," he said.
India exported about $15 million of HCQ in May, almost 50 per cent up from $10 million in April. Since HCQ is a low value item (Rs 2 or so per tablet), this means the export volumes have been high - over 400-600 million tablets per month.
Gujarat in recent times has been one of the largest makers and exporters of HCQ in the country, with the state food and drug control administration granting license to scores of players in recent times. It is estimated that there are nearly 70 pharma units with license of HCQ formulations while there are three active pharmaceutical ingredients (API) manufacturers for the drug in the state with Cadila Healthcare Ltd. (Zydus Cadila) being the largest.
"HCQ is a decades old drug used in rheumatoid arthritis and lupus among others. Hence, demand for the drug is still strong. Gujarat supplies 60-70 per cent of US's HCQ for RA and lupus alone. Recently, the US had repurposed use of HCQ for Covid which it has now revoked. However, HCQ exports may still continue for treating the primary disorders it is meant for," said H G Koshia, Commissioner, Food and Drug Control Administration (FDCA), Gujarat.
In the domestic market, the government has picked up stock for 100 million tablets by April. Each patient requires either five to nine tablets. Going by that, the stock would last for months as it can cater to about 10 million people.
However, the government source added that with the Covid-19 cases witnessing a spike, there can be fresh demand for HCQ tablets.
Meanwhile, the industry involved in HCQ manufacturing in India is awaiting certain study results around the drug's efficacy in treating Covid-19 being conducted in the UK. According to industry sources, depending on the study results, positive or negative impact on HCQ exports from India can be gauged in the short run.