Date: 20-May-2020

Gujarat FDCA Approves 59 Product Licenses To 37 New Cos To Produce Azithromycin For Sustainable Supplies To COVID-19 Patients

The Gujarat Food and Drug Control Administration (FDCA) has given approval to 59 product licenses to 37 manufacturers to produce azithromycin which is given to COVID-19 patients as a standard treatment protocol.


As per the clinical management protocol, hydroxychloroquine (HCQ) in combination with azithromycin is to be considered as an off-label indication only in patients with severe COVID-19 under close medical supervision, according to Union health ministry.


“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,” informed Gujarat FDCA Commissioner Dr HG Koshia. Gujarat was the first state in the country to do a stockpiling of 53 lakh HCQ tablets as a precautionary measure to COVID-19, he further added.


The state had procured another one crore tablets to cater to the COVID-19 patients and healthcare workers.


HCQ which is now a Schedule H1 drug is required for prophylactic use for healthcare workers and for people exposed to COVID-19 positive cases besides its wide therapeutic use. “Today, we have total 345 licensed hand sanitisers manufacturers and 1339 product licenses from the earlier 15 manufacturers before the first lockdown ,” further informed Koshia. The Gujarat government recently has 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 exemption which was notified by the state government was done because the cost of isopropyl alcohol (IPA) which was Rs. 80 per litre earlier before the COVID-19 pandemic outbreak is being sold illegally at arbitrary price of Rs. 300 per litre. Today it has stock of 34 lakh hand sanitisers from the earlier 5 lakh sanitisers dated March 21, 2020. It has a stock of around 41 lakhs of 2 ply 3 ply and N95 masks from the earlier 3.68 lakhs as on March 21, 2020.


The state today 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 two to ten times due to sharp rise in their demand to fight 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. Taking a cue from Indian traders, the Chinese exporters have also increased the prices of azithromycin to US$ 150 a kg from US$ 90 per kg earlier.


On the other hand, the prices of HCQ API have gone up ten times to Rs. 70,000 a kg from Rs. 7,000 per kg earlier.