Government lifts ban on export of Hydroxychloroquine API and formulation drug

An Inter-ministerial High-Level Empowered Committee meets regularly on a fortnightly basis for assessing the availability of drugs in the country and will continue to meet to monitor the situation.

Government has lifted the ban on the export of anti-malarial drug Hydroxychloroquine (HCQ) API and formulation.with immediate effect. 

Based on inter-ministerial consultation held on 03.06.2020 by a High-Level Empowered Committee having representations from  Ministry of Health and Family Welfare, Department of Pharmaceuticals, Ministry of External Affairs, Ministry of Commerce and Industry, Department of Revenue and others, Department of Pharmaceuticals has recommended that ban on the export of Hydroxychloroquine (API as well as formulations) may be lifted.  Directorate General of Foreign Trade -DGFT has issued a  formal notification in this regards yesterday.

An Inter-ministerial High-Level Empowered Committee meets regularly on a fortnightly basis for assessing the availability of drugs in the country and will continue to meet to monitor the situation.

In the meeting, it was noted that during March-May, 2020 period (COVID-19 period) numbers of manufacturing units of Hydroxychloroquine have increased from 2 to 12 and the country’s production capacity of Hydroxychloroquine have increased three times i.e. from 10 Crore (Approx) tablets per month to 30 Crore (Approx) tablets per month. Currently, India is having a surplus of Hydroxychloroquine tablets over and above its domestic requirements. 

It was also noted that the requirement of Ministry of Health and Family Welfare for Hydroxychloroquine has been fulfilled completely as12.22 Crore tablets of HCQ 200 mg Tablets has been given to HLL Lifecare Limited (HLL), a central public sector undertaking, for dealing with COVID-19. Presently, MoHFW is maintaining enough buffer stock of HCQ to cater to domestic demand.

In addition, 7.58 Crore Tablets of HCQ 200 mg has been supplied to State Government, other Institutions and BPPI/Jan Aushadhi Kendras for the fulfilment of their requirement. Further, around 10.86 Crore tablets of HCQ 200 mg has been supplied in local pharmacies for catering to the domestic demand.

Thus, a total of 30.66 Crore tablets of HCQ 200 mg has been made available to the domestic market to cater to the demand of the country. There is no unfulfilled domestic demand for Hydroxychloroquine. Further, Major manufacturers of Hydroxychloroquine will supply at least 5 Crore tablets in the domestic market for the month of June 2020.

Drug Controller General of India (DCGI) conducts a survey regarding the availability of Hydroxychloroquine and other drugs in the domestic market from time to time. It was noted that in a sample survey conducted on 25th and 26th May 2020, the availability of Hydroxychloroquine was indicated at 93.10% in Pharmacies near to COVID-19 designated hospitals.

Accordingly, it has been decided to lift the ban on the export of Hydroxychloroquine (API as well as formulations). However, at the same time, Domestic producers of HCQ other than EOUs, SEZs and Units will continue to supply at least 20% tablets of total manufacturing for local pharmacies or trade, whichever is higher for the month of June 2020. The supply made to State Governments, HLL and other public and private institutes will be over and above the quantity mentioned this quantity. Further, all manufacturers of shall fulfil any order placed by HLL, State Government(s) or any other Government Institute on a priority basis. Drug Controller General of India (DCGI) has been directed to ensure compliance of these conditions.

(With Inputs from PIB)