As global demand for HCQ rises, Indian pharma firms to keep huge buffer stock

India’s pharmaceutical industry has assured the government it will be able to comfortably meet the domestic needs for hydroxychloroquine after exporting to the US and other overseas buyers, industry executives said.

The malaria drug is touted by some—most famously US President Donald Trump—as a potential cure for covid-19, although there is only anecdotal evidence for it.

Putting at rest fears that India could run short of the drug, pharmaceutical firms have promised that they will keep a minimum buffer stock of 100 million tablets of chloroquine and its safer derivative hydroxychloroquine before exporting any.

“Production is going on in full swing. We have a capacity to make 20 crore (200 million) tablets in a month,” Indian Drug Manufacturers’ Association secretary general Daara B. Patel said in an interview, adding that India is self-sufficient in both final products and raw materials for the drug.

Ipca Laboratories Ltd, Alembic Ltd, Torrent Pharmaceuticals Ltd, Wallace Pharmaceuticals Ltd and Zydus Cadila are among the major suppliers of hydroxychloroquine in India. Ipca Laboratories is also a major supplier of the active pharmaceutical ingredients of the product.

A Zydus Cadila spokesperson told Mint that the company has ramped up production of hydroxychloroquine to 30 tonnes a month from 3 tonnes earlier and will increase capacity to 40-50 tonnes if the need arises.

During March, 2.75 million strips of the drug worth ₹21 crore were sold. In comparison, 1.7 million strips worth ₹12 crore were sold every month from March 2019 till February, shows data from market researcher AIOCD-Awacs.

While most drug regulators, including in the US, have taken a cautious stand while allowing for the emergency use of the drug in treatment of covid-19, India has allowed for its use on healthcare workers, who have not tested positive, and contacts of patients as a preventive measure.

“India is possibly among the very few countries that have gone ahead of others and approved the use of chloroquine or hydroxychloroquine for healthcare workers and for contacts of patients,” Shahid Jameel, chief executive officer of Wellcome Trust and Department of Biotechnology India Alliance, said, adding that it makes sense in the context of India, where there is a shortage of protective gear for healthcare workers.

While the therapeutic uses of hydroxychloroquine for covid-19 are yet to be verified, various doctors have raised concerns about its safety, especially for cardiac patients.

Most of the optimism globally around this drug is based on research led by Didier Raoult of the University of Marseille and published in the International Journal of Antimicrobial Agents.

The journal is run by the International Society of Antimicrobial Chemotherapy, which itself criticized the research in a statement on Friday, citing lack of randomization of patients and the process followed to ensure their safety.

“Every pandemic creates a situation of desperation, and medical societies also get into this trap of desperate remedies during desperate times,” pulmonologist Satyanarayana Mysore said.

To be sure, there are other research papers talking about the drug’s efficacy in treating covid-19,but none have established its safety and efficacy in randomized clinical trials involving many patients.

Two major trials are underway to test if existing drugs can be used to prevent infections. One is the “Solidarity Trial” by the World Health Organization in collaboration with a number of countries, including India; and the other is supported by Wellcome Trust, Bill & Melinda Gates Foundation and Mastercard.

“In about a month, the result of those will come out, and those will be large, random control trials. Then we will know whether this is efficacious or not,” Jameel said.