NEW DELHI: Indian pharmaceutical companies have set in motion the process to increase production of anti-malarial drug hydroxychloroquine (HCQ) in the wake of increasing demand from within the country and outside. HCQ has emerged as a good treatment for Covid-19, which has engulfed the entire world. India is the largest exporter of the medicine and produces approximately 70% of the world’s supply of hydroxychloroquine.

However, even as these Indian companies are gearing up to show their “might’ to the world in the fight against the pandemic, a powerful, Western pharmaceutical lobby is working to block it. That India has the might has been acknowledged by US President Donald Trump when he called up Prime Minister Narendra Modi, requesting him to make HCQ available to treat patients in his country.

India currently has an annual installed capacity of producing around 40 metric tonnes of active pharmaceutical ingredients (APIs) of hydroxychloroquine. With this capacity, India can make around 200 million HCQ tablets of 200 mg per month. According to Indian Drug Manufacturers’ Association (IDMA) estimates, India produces 20 million HCQ tablets per month normally, which is just 10% of the existing capacity (200 million), for three indications—malaria, lupus and rheumatoid arthritis.

Speaking to The Sunday Guardian, IDMA Executive Director Ashok Kumar Madan said: “We just use 10% of our capacity and, therefore, we have a spare available capacity of 90%. Now, we have to see what is going to be the requirement. The companies have already started the process of ramping up their production, which can take care of our domestic as well as global requirements. Indian pharmaceutical companies have the capacity to increase production up to 200-300 million tablets per month in the next 3-4 months.”

Sources said that the Government of India has already placed an order with Zydus Cadila and Ipca Laboratories for procuring 10 crore tablets. Sources said a stock of 10 crore tablets is sufficient for India. These companies are increasing their production after the Government of India indicated that it would help countries which are facing the heat of Covid-19.

Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance, told The Sunday Guardian: “India produces approximately 70% of the world’s supply of hydroxychloroquine. The US imported nearly half of the supply of hydroxychloroquine, from India in 2019. Zydus Cadila and Ipca are the major manufacturers of hydroxychloroquine in the country. The companies are ramping up production to ensure an uninterrupted supply for domestic and export markets.” There are many companies which are into manufacturing HCQ tablets like Zydus Cadila, Ipca Labs, Intas Pharmaceuticals, McW Healthcare of Indore, Mcleods Pharmaceuticals, Cipla and Lupin. API suppliers for the drug include Abbott India, Rusan Pharma, Mangalam Drugs, Unichem Remedies, Laurus Labs, Vijayasri Organics etc. Two manufacturers—Zydus Cadila and Ipca Laboratories—have backward integrated production capacity, which means they source the raw materials which are then converted to intermediates and then to APIs and to final formulations, order to make the medicine.

Most of the other HCQ API manufacturers import some key raw materials and intermediates from countries like China, South Korea, Italy or Finland. API manufacturers keep an inventory of raw materials for six months. With most of China returning to normalcy, sourcing of raw material will not be an issue, industry sources said. Sources said that shipments of intermediate chemicals for making HCQ have commenced from China.

The Government of India had put restrictions in order to minimise speculative buying and stockpiling. To meet both domestic and export demand, the government has been working on various scenarios and has now placed paracetamol and hydroxychloroquine under licensed category. The move will ensure adequate availability for supply and distribution to patients and healthcare professionals on priority.

Sources, however, said though pharmaceutical companies are enhancing their HCQ production capacity in view of the sudden surge in demand, they are also cautious as it has still not been proved as the fool-proof treatment of COVID-19. Studies are, in fact, going on all over the world and no concrete outcome has emerged so far.

India is one of the largest manufacturers of HCQ in the world. The country manufactures 70% of HCQ. India exported hydroxycholoroquine API worth $1.22 billion in April-January 2019-20. During the same period, exports of formulations made from hydroxycholoroquine were at $5.50 billion.

On the issue of export of HCQ, a senior Ministry of External Affairs (MEA) official said that domestic requirement will be the priority of the government. He said that the Group of Ministers decided to release some surplus stock for export, after considering the availability of domestic stock and the country’s requirement. “Certain medicines were in restricted list and others in prohibited list. Based on review by Committee of Secretaries and later by Group of Ministers, restrictions were lifted on many medicines, given domestic priorities. HCQ is in high demand globally and many countries have requested for it. While exports to the first list of countries have been approved, the government is working on second and third lists now,” he said. On the other hand, a Health Ministry official said: “Based on the country’s projected requirement, we need one crore tablets of hydroxychloroquine for the coming one week, while the country has 3.28 crore tablets today. The current supply is hence three times more than the domestic requirement for the coming week and is way more than the demand for the coming month as well. Additional supply of 2-3 crore tablets has also been tied up.”