The Directorate General of Foreign Trade (DGFT), an arm of the Ministry of Commerce and Industry has amended the export policy of hydroxychloroquine and its formulations, banning exports from special economic zone (SEZ) and Export Oriented Units (EOUs) as well.
Recently, the Indian Council of Medical Research (ICMR) had recommended the use of hydroxychloroquine for prophylaxis to asymptomatic healthcare workers involved in the care of suspected or confirmed cases of Covid-19. These staff can take 400 mg twice a day on day one, followed by 400 mg once weekly for next seven weeks. And it is also recommended for persons who are taking care of household confirmed cases of Covid-19, for whom the dose will be 400 mg twice a day on day one, followed by 400 mg once weekly for next three days.
To fulfill the rising demand of hydroxychloroquine and its formulations in the domestic market, the government has identified manufacturers and placed an order for 10 crore tablets of hydroxychloroquine. Ipca Laboratories, Zydus Cadila and Wallace Pharmaceuticals are the leading players in this segment.
Vinay Pinto, Executive Director, Wallace Pharma said, “Wallace has the capacity to manufacture 4-5 crore tablets a month. However, we are facing a dual challenge of an acute shortage of hydroxycloroquine sulphate API, and an escalation in bulk drug prices.”
He also informed that they have many open orders in hand from several state governments to the tune of several crore tablets but they cannot supply due to non-availability and high price of API.
Pointing out the problem, Pinto also suggested, “The shortage of hydroxychloroquine sulphate API is partly due to the shortage of HNDA, a KSM. Indian government who has been extremely responsive and helpful should assist industry in the procurement direct from China.”
In a notification dated April 4, number 01/2015-2020 states that the export of hydroxychloroquine and its formulations falling under any ITCHS code, including the ITCHS Code mentioned in the notification no 54 dated, March 25, 2020 is no longer allowed from SEZs and EOUs or against advance authorisation or under the para 1.05(b) of Foreign Trade Policy 2015-2020 or against fill advance payment as special in the para 2 in the notification.
Earlier the government had banned the export of hydroxychloroquine and formulations exempting units from SEZ and EOUs. However, in the notification dated March 25, number 54/ 2015-2020 also mentioned that the Government of India can export these APIs and formulations to other countries on humanitarian grounds on case to case basis on the recommendations of the Ministry of External Affairs. However, the latest notification clearly mentions that, this remains completely prohibited without any exception.
Commenting on the recent notification banning complete export of hydroxychloroquine and its formulations, Rajesh Gupta, All India Head-Pharma, Laghu Udyog Bharti said, “We welcome the move initiated by the government and understands their core intention behind the bold step, nation comes first.”
Although the industry was expecting that the government would lift export restriction on 26 APIs and formulations, it was also anticipating this step.
Ipca Laboratories and Zydus Cadila did not respond to queries.