The Gujarat Food and Drug Control Administration (FDCA) has given its approval to 14 pharmaceutical companies to manufacture hydroxychloroquine (HCQ) of varied dosages. According to officials, the new approvals will augment the capacity of the state that currently accounts for almost 50 percent of this antimalarial drug being produced in the country.
“We have given approvals to 14 companies for manufacturing HCQ after the lockdown was announced. There are many players in the state,” said HG Koshia, Commissioner, FDCA while talking to The Indian Express. The official, however, did not reveal the total capacity of HCQ that the new players will add in the state. “We usually do not have the figures of capacities. The companies produce as per the market demand,” he said.
On Monday, Lincoln Pharmaceuticals said that it received an approval from the Gujarat FDCA to manufacture HCQ and other critical drugs to fight COVID-19. Pointing out that “HCQ is a prescription-based drug commonly recommended to coronavirus patients under treatment for the disease,” the company said it will be manufacturing varied dosages of HCQ tablets and HCQ sulphate tablets at its plant in Khatraj near Ahmedabad. The company also plans to export the same after receiving necessary approvals from the Directorate General of Foreign Trade (DGFT).
The FDCA Gujarat said that there are 28 pharmaceutical companies in the state that are currently manufacturing the drug which has been hailed as a “game changer” by US President Donald Trump. “There are two types of manufacturers of HCQ. One that makes formulations and the other that makes API. Zydus Cadila is the biggest in both the categories. The others are Mangalam Drugs and Vital Pharma,” Koshia added.
According to Viranchi Shah, chairman of the Gujarat State Board of the Indian Drug Manufactures’ Association, Gujarat accounts for 50 percent of the 40 crore HCQ tablets produced in the country every month.
“There are about 28 manufactures of HCQ formulations in Gujarat and three for API. They have 35 licences for exports and another 32 permissions for domestic (supply). The current manufacturing capacity in Gujarat is in excess of 20 crore tablets a month,” Shah said. “Globally, India’s share for this drug is almost 70 percent,” he added. The Indian Express had reported that the Special Economic Zones (SEZs) in the state have a capacity to produce 5.4 crore tablets a month.
Shah further said that India has already made a pool of almost 10 crore HCQ tablets, so that the same is sufficient to treat 20 lakh patients in case of a spike in COVID-19 cases.
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