In recent weeks, more and more companies continue to bolster their capacities to produce hydroxychloroquine (HCQ) as the list of countries turning to India seeking the “wonder drug” expands by the day.

Following President Trump’s call and the subsequent relaxation of export curbs on HCQ, Indian manufacturers have rallied around the cause and went into an expansion spree.

Chloroquine is a hugely popular medicine widely used to treat infections caused by malarial parasites for decades. The anti-inflammatory activity of the medicine makes it an option for a few auto immune disorders as well, including rheumatoid arthritis and systemic lupus erythematosus.

HCQ has demonstrated limited anti-viral activity too. Studies conducted on a small number of patients infected with SARS-CoV-2 recently in China and France found that HCQ may be helpful in faster clearance of the virus from the system in mild cases. The drug in combination with the antibiotic azithromycin has also been shown to stall the progression of COVID-19 in a handful of cases. 

Despite the low evidence, the drug is being used as a prophylactic in many places due to the lack of proven agents for the frontline healthcare professionals to use to prevent the risk of infection from the novel coronavirus. HCQ’s efficacy on severe COVID-19 cases, however, is still being evaluated. The FDA has granted an Emergency Use Authorization (EUA) to HCQ, recently.

The U.S. President personally asked the Indian prime minister to expedite the export of HCQ tablets after easing the ban the latter imposed on the overseas trade of more than a dozen APIs and their formulations including the anti-malarial drug in the wake of the emergent coronavirus pandemic.

As soon as India decided to ship HCQ to select nations including the U.S., a large section of manufacturers having the knowhow to make HCQ pills embarked on activities to scale up production.

Several COVID-19-stricken nations desperately looking for a remedy soon started sourcing HCQ to India, a well-known destination for low-cost chloroquines.

Estimates show that India accounts for about 70-80 percent of the world’s HCQ production. And the country exports nearly 90 percent of the total output to more than 40 destinations.

HCQ exports registered a 46% jump from $35.31 million during 2017-18 to $51.67 million during 2018-19.

Indian manufacturers have produced 200 million tablets of HCQ in the month of April alone, according to Pankaj Patel, chief executive officer of Zydus Cadila. The Ahmedabad-based firm is one of the top manufacturers of HCQs in the country.

Zydus Cadila can ramp up production by about 10 times to make 30 tons of API equivalent to 150 million 200 mg tablets in May, he added.

IPCA Labs is another leading producer of HCQ which has fully back-integrated key starting materials and APIs for its own chloroquine formulations.

The Mumbai-based firm was facing an export ban by the U.S. FDA. Anticipating a possible shortage of the drug, the agency had recently made an exemption on an import alert on IPCA’s API factories at Ratlam and two formulation facilities in Indore and Pipariya in Madhya Pradesh making chloroquine pills.

Intas, Laurus Labs, Mangalam Drugs and Organics and Watson are the other major players manufacturing HCQ formulations and APIs.

Quite a few midsize and small contract development and manufacturing organizations (CDMOs) have also started procuring the raw materials as part of scaling up production.

The surging domestic as well overseas demand made as many as 50 drug manufacturers in Himachal Pradesh who are holding product licenses to manufacture HCQ tablets ready to cater.

Further, as the humble chloroquine moved center-stage with immense fanfare, it gave a new lease on life to several manufacturers who were either ailing due to low demand or on the point of exit.

Bengal Chemicals & Pharmaceuticals Ltd. (BPCL) is a good example. The public firm, which has been in the red for some time, is back in news with the announcement that it has the know-how and capacity to make HCQs. The oldest pharmaceutical company in India, BPCL is a pioneer in chloroquine making.

After receiving the license from the concerned authorities, the company is now sourcing the necessary raw materials to commence production. BPCL’s factory in Kolkata has the capacity to make as many as one million tablets a day, according to company officials.

Reports indicate that India is fast-tracking the supply of HCQ to certain friendly nations. Even as the demand grows and more companies join the fray, the procurement of raw materials could well pose a challenge.