59 product licenses to 37 new comapines to manufacture azithromycin approved by Gujarat FDCA

The Gujarat Food and Drug Control Administration (FDCA) has approved 59 product licenses to 37 manufacturers for production of azithromycin as a basic treatment for Covid-19 patients.

Hydroxychloroquine (HCQ) in combination with azithromycin is given to the patients as a standard treatment protocol with severe COVID-19 under close medical supervision, according to Union health ministry.

Gujarat FDCA Commissioner Dr HG Koshia said that “The state earlier had 615 companies which are manufacturing azithromycin. Besides this, the state drug regulator today has a total of 141 hydroxychloroquine manufacturers from the earlier 29 HCQ manufacturers before March 21, 2020. Most of these HCQ manufacturers which produce in both 200 and 400 milligram (mg) dosage form are mostly export oriented. Gujarat was the first state in the country to do a stockpiling of 53 lakh HCQ tablets as a precautionary measure to COVID-19.”

“Today, we have total 345 licensed hand sanitisers manufacturers and 1339 product licenses from the earlier 15 manufacturers before the first lockdown ,” Koshia further added. The Gujarat government has also exempted sale and distribution of ethanol for production of hand sanitisers in order to tide over the shortage of hand sanitisers in the state.

The cost of isopropyl alcohol (IPA) which was Rs. 80 per litre earlier before the COVID-19 pandemic and was sold illegally at inflated price of Rs. 300 per litre. The exemption which was notified by the state government because of inflated price.
At present, the state has a total of around 33 lakhs of HCQ tablets with 29.32 lakh tablets of HCQ of 200 mg dosage, 2.17 lakh HCQ tablets of 300 mg dosage and 1.25 lakh tablets of 400mg dosage.

The prices of active pharmaceutical ingredients (APIs) of azithromycin and HCQ have increased from twice to ten times due to increase in demand against COVID-19 pandemic. The prices of azithromycin have jumped to Rs. 16,000 per kg from Rs. 9,000 per kg earlier. The API is imported from China.
Source: Pharmabiz


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