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The Hindu Newspaper 28/06/2020

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1)News:- Coronavirus | Government approves use of dexamethasone

Dexamethasone is a corticosteroid drug used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects. The drug was tested in hospitalised patients with COVID-19 in the ‘RECOVERY’ clinical trial in the United Kingdom and was found to have benefits for the critically ill patients and reduce mortality by one-third for patients on ventilators and one-fifth for patients on oxygen therapy.

The drug is also a part of the National List of Essential Medicines (NLEM) and is widely available.

CDSCO :– The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices.

The Central Drugs Standard Control Organisation(CDSCO )under Directorate General of Health Services,Ministry of Health & Family welfare, Government of India is the National Regulatory Authority (NRA) of India.

The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics.

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

2)Explained : The Hindu Explains | Why is there a stress on randomised controlled trials?

Why in News: On June 23, the claim by Patanjali Ayurved [Haridwar (Uttrakhand)] that its preparations, ‘Coronil’ and ‘Swasari’, would cure COVID-19 in only seven days.

The government, through the Ministry of AYUSH (ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) responding a short while later, told the company to stop advertising the drug as a cure for COVID-19, pointing out that it would attract provisions of Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.

As per definition, a randomised controlled trial, or RCT, is a study in which people are allocated at random, entirely by chance, to receive one of several clinical interventions.

One of these interventions is the standard of comparison or control. The control may be standard practice/treatment options, a placebo (a drug without an active substance, or a ‘sugar pill’), or no intervention at all.

The idea is to measure and compare the outcomes against the control after the participants receive the treatment.

RCTs are based on multiple factors, including type of interventions being evaluated, and number of participants.

In single-blind trials, the participants, or the investigators do not know who is assigned what;

In double-blind trials, both participants and investigators do not know; and

Triple and quadruple-blind trials, where three or four of the relevant groups are not aware of the treatment assignment.

What should a Good RTC have :-
A good RCT (for COVID-19) should enrol enough numbers, define clinical endpoints, including mortality and morbidity, also whether intubation was needed and days of stay in hospital:

The hurry, hype and marketing for drugs (Ayurveda and Favipiravir) even before results were published were ‘just not science’.

In well-designed RCTs, researchers, after random assignment of participants, assess whether randomisation was done sufficiently to eliminate the influence of confounding factors, and avoid selection bias.

Like in Case of Coronil: RCT conducted on behalf of the company, that 100 patients who had tested positive were given the medicine (five dropped out midway). The clinical trial tested the drug on 45 people and another 50 were given a placebo. The claim was that 69% (31 persons) of those on the drug tested negative on the third day, and 25 of those on the placebo arm of the trial had also tested negative.

Ethically, an RCT can only be employed when researchers think/hope that the interventions will offer benefits. Participants can be enrolled in a randomised controlled trial that is expected to leave them better off. The dexamethasone study where mortality was reduced by a third, is a classic example here.

The Solidarity(WHO) and RECOVERY (or Randomised Evaluation of COVid-19 thERapY) trials are examples of large-scale RCTs done with multiple partners at many locations, bang in the middle of an epidemic. They have already been instrumental in setting the standard of care — for instance, hydroxychloroquine was hyped up as a drug but studies conclusively proved no ameliorative effect in using it. The Remdesivir study, on the other hand, showed some improvement in reducing intensive care unit stay, while there was no great impact on mortality.

3)Impact of Donald Trump’s Visa Ban on India : –

Background:- On June 22, the White House made a proclamation halting the processing and issuance of non-immigrant work visas of several types, with the stated aim of this sweeping policy being to stop foreign workers snagging American jobs, especially at a time of deep economic distress brought on by the COVID-19 pandemic.

The order by the Donald Trump administration includes the

H-1B visa for skilled workers, a large proportion of which goes to Indian nationals, dependents of the H-1B who are seeking the H4 visa, the H-2B visa issued to seasonal workers in the landscaping and hospitality industries, the L-1 visa for intra-company transfers and their dependents on the L-2 visa, and the J-1 visa for students on work-study summer programmes and related occupations.

Will the Ban beneficial for Americans as stated : –Not much

The reason is that the latest restrictions do not apply to visa-holders who are already within the U.S., or those who are outside the country and have already been issued valid visas.

Given that the ban will remain in force until the end of the 2020 calendar year, this implies that U.S. firms or others with U.S. operations who rely on skilled foreign nationals working in the U.S. will be unable to make new hires as long as the ban stands.

The move is more of a political gimmick keeping in mind the upcoming 2020 Republican presidential candidacy.

How will the move impact India : The prospects of Indian IT majors building up their order books as they limp back through an economic recovery in India are, in the interim, likely to be seriously undermined by this move.

The major services exports from India to the U.S. are in the telecommunications, computer and information services, research and development, and travel sectors.

Facts : Until now, the U.S. issued 85,000 H-1B visas annually, of which 20,000 went to graduate students and 65,000 to private sector applicants, and Indian nationals would garner approximately 70% of these. Now the Migration Policy Institute has been cited predicting that up to 219,000 workers would be blocked as a result of Mr. Trump’s proclamation.

4)The Hindu Explains | Why is there a controversy over a film project on the protagonist of 1921 Malabar Rebellion? :

Malayalam film director Aashiq Abu, on June 22, announced a new film project, Variyamkunnan, on Variyamkunnath Kunhamed Haji, the main protagonist of the Malabar Rebellion of 1921 who was executed by the British. Soon, three more directors, Ibrahim Vengara, P.T. Kunju Muhammed and Ali Akbar, announced their own films on the same historic figure. The announcement of Abu, a Left supporter, sparked a controversy.

The Malabar Rebellion (also called the Mappila or Moplah Rebellion by the British) broke out in the southern taluks of Malabar in August 1921. By the time the government troops captured Haji in January 1922, the rebellion had fizzled out. It largely took the shape of guerrilla-type attacks on janmis (feudal landlords, who were mostly upper caste Hindus) and the police and troops.

Mappilas had been among the victims of oppressive agrarian relations protected by the British.

Haji, who was one of the three most important rebel leaders, was the face of the rebellion. British officers viewed him as the “most murderous”.

The Khilafat movement launched in 1919 provided a fresh stimulus to the grievances of Mappilas. Now their sense of local injustice was sought to be linked with the pan-Islamic sentiments created in the aftermath of the collapse of the Ottoman Empire.

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