Government does U-turn on export of Hydroxychloroquine

Published : April 08, 2020 20:36 IST

On April 7, four days after declaring that the drug Hydroxychloroquine (HCQ) will not be exported without any exception, given its use and importance for the highly vulnerable category of health workers, the Union government did a U-turn, allowing a partial export of the drug after the United States President, Donald Trump, spoke of retaliation if India did not accede to his request. Hydroxychloroquine is certified for prophylaxis (prevention) and treatment of high-risk individuals, namely health care providers and laboratory contacts exposed to and infected with the coronavirus.

On April 4 the Directorate General of Foreign Trade (DGFT) prohibited the export of HCQ and its formulations “without any exception” even in cases where full advance payment had been made. On March 25, the DGFT had allowed partial export of the drug to fulfill export obligations which fulfilled the conditions of “advance licence”, issuance of “irrevocable letter of credit”, and where full advance payment had been received against specific shipments.

Replying to a question during his regular media briefing at the White House about India’s ban on the export of HCQ, the U.S. President said he had spoken to the Indian Prime Minister on Sunday (April 5). “If he doesn’t allow it to come out, that would be okay. But, of course, there may be retaliation. Why wouldn’t there be?” Trump said.

Within two days of Trump’s statement, a note issued by the Ministry of External Affairs conveyed that there was no pressure but that the decision was taken on “humanitarian grounds”. Some sections of the media had created an unnecessary controversy, the note said, and added that some “temporary steps were taken to restrict exports of a number of pharmaceutical products”. A comprehensive assessment was made, meanwhile, of “possible requirements under different scenarios…. After having confirmed the availability of medicines for all possible contingencies currently envisaged, these restrictions have been largely lifted,” the MEA note said. The stock position could allow our companies to meet the export commitments that they had contracted, it stated.

“Given the enormity of the COVID-19 pandemic, India has always maintained that the international community must display strong solidarity and cooperation. This approach also guided our evacuation of nationals of other countries. In view of the humanitarian aspects of the pandemic, it has been decided that India would license paracetamol and HCQ in appropriate quantities to all our neighbouring countries who are dependent on our capabilities. We will also be supplying these essential drugs to some nations who have been particularly badly affected by the pandemic. We would therefore discourage any speculation in this regard or any attempts to politicise the matter,” the note said. In fact, it was not a DGFT notification but the MEA note that clarified that both HCQ and paracetamol had been placed in the licensed category of drugs and that their “demand position would be continuously monitored.”

In the absence of a vaccine or a cure for the coronavirus infection, the National Task Force of the Indian Council of Medical Research had recommended the use of HCQ under certain conditions for high-risk persons like health care providers. The drug, according to the ICMR, has been found effective against COVID-19 in laboratory and in-vivo (processes taking place inside a living organism) studies and was approved by the Task Force on March 22 for prophylaxis of high-risk persons. The eligible individuals were, one, asymptomatic health workers involved in the care of suspected or confirmed cases of COVID-19 and, two, asymptomatic household contacts of laboratory symptomatic cases. The drug was not to be given to children under 15 years of age or to persons with known case of retinopathy nor was it to be given over the counter without a medical prescription.

The protocol was approved by the Drugs Controller General of India for restricted use in emergency situations. In line with this policy, on March 26, the Health Ministry issued a notification that “satisfied that the drug was essential to meet the requirements of the emergency arising due to the pandemic and in public interest, it is necessary and expedient to regulate and restrict the sale and distribution of drug Hydroxychloroquine and preparation thereon for preventing their misuse.”

The orders were issued under the Drugs and Cosmetics Act 1940. There was, therefore, no question of exporting the drug, which was much needed for four dozen or more health care providers who were already infected.

The Communist Party of India (Marxist) and the Congress objected to the decision to export stating that the needs of Indians ought to be prioritied and met first. In a statement, the CPI (M) Polit Bureau demanded that the decision be rescinded in the “supreme interest of our people’s health and safety.”

The statement said: “Trump’s threat of retaliation for easing restrictions on the export of vital generic drugs including Hydroxychloroquine is a plain attempt at arm twisting. The government’s capitulation to this brazen blackmail undermines the vital concerns in our battle against the viral pandemic. This also signals yet another surrender to U.S. interests. In the recent past, our government has shown unplanned fiddling with the export of all sorts of PPE like surgical masks, gloves, ventilators, etc., with a disastrous impact on the safety of our frontline health workers. Trump’s threat to India is in tune with the obnoxious attempts to secure drugs and other pandemic related material and in diverting supplies meant for other countries in pure self-interest.”

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