India considering the surplus production has lifted its ban on the export of anti-malarial drug Hydroxychloroquine (HCQ) active pharmaceutical ingredients (API) and formulations, in spite the fact that the US drug regulator and the World Health Organisation (WHO) have now ruled against using the drug in treating COVID-19.
To meet the increased demand of the drug during the pandemic India had increased the number of manufacturing units of HCQ from 2 to 12 resulting in an increase of production by three times.
Amid an inter-ministerial High-Level Empowered Committee assessment it was discovered that the production of the drug went from 10 crore tablets per month to 30 crore tablets per month.
Earlier this week, the US Food and Drug Administration (FDA) due to the lack of evidence to prove its effectiveness and potential side effect had revoked the emergency use authorisation (EUA) given to chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 patients,
The WHO also decided to stop a multi-nation solidarity clinical trial involving HCQ.
However, India still uses the drug in the treatment and an Indian Council of Medical Research (ICMR) case-control study recommended using it among the healthcare workers as a prophylaxis (preventive drug).
The country has a surplus of the tablet above its domestic requirements. As per findings by HLL Lifecare Limited (HLL), a central public sector undertaking entrusted with procuring essential drugs and medical devices for dealing with the pandemic 12.22 crore tablets of HCQ 200 mg tablets are required to meet the domestic demand while the country has surplus capacity of 30.66 crore tablets of HCQ 200 mg.
The Central Health Ministry is maintaining enough buffer stock of HCQ to cater to domestic demand.
According to reports, 7.58 crore tablets of HCQ 200 mg have been supplied to state governments, other institutions and Jan Aushadhi Kendras.
Furthermore, 10.86 Crore tablets of HCQ 200 mg has been supplied in local pharmacies. In addition, leading manufacturers are planning to provide at least 5 crore tablets in the domestic market in the month of June.
According to a government statement, In a sample survey conducted by the Drug Controller General of India (DCGI) on May 25-26 it was indicated that there is 93.10 per cent availability of HCQ in pharmacies near to COVID-19 designated hospitals.
India a global market leader in pharmaceuticals supplies over 70 percent of the global demand for this drug. However, as demand increased, the Directorate General of Foreign Trade (DGFT) had prohibited the export of the Hydroxychloroquine on March 25 in order to cater to the domestic requirements of the Nation.
Source: Business Today