No online sale of medicines till norms in place, says HC

Agencies
December 18, 2018

New Delhi, Dec 18: The Delhi High Court on Tuesday said its stay on sale of drugs and prescription medicines by online pharmacies will continue till rules are framed to regulate such entities.

A bench of Chief Justice Rajendra Menon and Justice V K Rao said that "once the rules come into play, you (online pharmacies) can start selling it (medicines). Problem is that today there are no rules regulating it".

The observations by the bench were made while hearing the applications moved by some online pharmacies seeking to be impleaded in the matter.

The pharmacies urged the court to remove the prohibition on online sale of drugs, saying they held licences and no medicines were sold illegally.

They also contended that even prescription drugs were sold only if there was a valid prescription from a doctor.

The applications for impleadment were filed in a PIL by Zaheer Ahmed seeking a ban on "illegal" sale of drugs and medicines online.

During the hearing, the petitioner informed the bench that the Madras High Court on Monday had banned online sale of medicines till the Union Health Ministry and the Central Drugs Standard Control Organisation (CDSCO) notified the proposed Drugs and Cosmetics Amendment Rules, 2018 in the gazette at the earliest by January 31.

The Madras High Court, however, kept the operation of its order in abeyance till December 20, to enable the online pharmacies to challenge the decision.

On being informed of the development, the Delhi High Court listed the matter for hearing on December 20.

In his petition, Ahmed has said that the online illegal sale of medicines would lead to a drug epidemic, drug abuse and mis-utilisation of habit forming and addictive drugs.

It has claimed that the Ministry of Health, CDSCO and an expert committee appointed by the drug consultative committee have already concluded that the online sale of medicines was in contravention of the provisions of Drugs and Cosmetics Act, 1940 and the other allied laws.

Still lakhs of drugs are being sold on the Internet every day, it has said, adding that some of the drugs/ medicines contain narcotic and psychotropic substance and some can cause antibiotic resistant-bacteria which is a threat not only to the patient but to the humanity at large.

"It is a matter of public knowledge that e-commerce websites have been caught on numerous occasions of selling fake products. Unlike consumer items, drugs are extremely potent substances and consuming wrong dose or fake medicine can have fatal consequences on the patient," it said.

The petition said that as of now there is no mechanism to control the sale of medicines on the Internet and this puts health and lives of people at a high risk and affects their right to a safe and healthy life under Article 21 of the Constitution.

"Online pharmacies are operating without a drug licence and cannot be regulated in the present regime. Unregulated and unlicensed sale of medicines will increase risk of spurious, misbranded and sub-standard drugs being sold," the plea has said.

The plea has sought direction to the authorities to take action against the entities distributing, selling or exhibiting drugs on the internet.

It has also sought direction for constitution of an expert committee to find out the total number of websites which are distributing and selling the drugs in the country and to impose a ban on the online sale and purchase of medicines.

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Agencies
May 26,2020

Tedros Adhanom Ghebreyesus, the World Health Organisation's (WHO) Director-General, said that a clinical trial of hydroxychloroquine (HCQ) on COVID-19 patients has come to "a temporary pause", while the safety data of the the anti-malaria drug was being reviewed.

According to the WHO chief, The Lancet medical journal on May 22 had published an observational study on HCQ and chloroquine and its effects on COVID-19 patients that have been hospitalized, reports Xinhua news agency.

The authors of the study reported that among patients receiving the drug, when used alone or with a macrolide, they estimated a higher mortality rate.

"The Executive Group of the Solidarity Trial, representing 10 of the participating countries, met on Saturday (May 23) and has agreed to review a comprehensive analysis and critical appraisal of all evidence available globally," Tedros said in a virtual press conference on Monday.

The review will consider data collected so far in the Solidarity Trial and in particular robust randomized available data, to adequately evaluate the potential benefits and harms from this drug, he said.

"The Executive Group has implemented a temporary pause of the HCQ arm within the Solidarity Trial while the safety data is reviewed by the Data Safety Monitoring Board. The other arms of the trial are continuing," Tedros added.

WHO initiated the Solidarity Trial, a plan to evaluate the safety and efficacy of four drugs and drug combinations against COVID-19 more than two months ago, which include HCQ.

According to the WHO, over 400 hospitals in 35 countries are actively recruiting patients and nearly 3,500 patients have been enrolled from 17 countries under the Solidarity Trial.

Tedros added that the safety concern over the drug related only to the use of HCQ and chloroquine in COVID-19, and "these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria".

"WHO will provide further updates as we know more," he added.

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Agencies
May 10,2020

Washington D.C., May 9: Do the middle age feel much stressful now, and seems to have changed over time, if compared to the life in the 90s? Well, this recent study indicates that it might be true.

The study has signalled to the fact that life may become more stressful majorly for middle-aged people than it was in the 1990s. The researchers reached this analysis even before the novel coronavirus started sweeping the globe.

A team of researchers led by Penn State found that across all ages, there was a slight increase in daily stress in the 2010s compared to the 1990s. But when researchers restricted the sample to people between the ages of 45 and 64, there was a sharp increase in daily stress.

"On average, people reported about 2 percent more stressors in the 2010s compared to people in the past," said David M. Almeida, professor of human development and family studies at Penn State.

"That's around an additional week of stress a year. But what really surprised us is that people at mid-life reported a lot more stressors, about 19 percent more stress in 2010 than in 1990. And that translates to 64 more days of stress a year."

Almeida said the findings were part of a larger project aiming to discover whether health during the middle of Americans' lives has been changing over time.

"Certainly, when you talk to people, they seem to think that daily life is more hectic and less certain these days," Almeida said.

For the study, the researchers collected data from 1,499 adults in 1995 and 782 different adults in 2012.

Almeida said the goal was to study two cohorts of people who were the same age at the time the data was collected but born in different decades. All study participants were interviewed daily for eight consecutive days.

During each daily interview, the researchers asked the participants about their stressful experiences throughout the previous 24 hours.

They asked questions related to arguments with family or friends or feeling overwhelmed at home or work, so and so. The participants were also asked how severe their stress was and whether those stressors were likely to impact other areas of their lives.

"We were able to estimate not only how frequently people experienced stress, but also what those stressors mean to them," Almeida said.

"For example, did this stress affect their finances or their plans for the future. And by having these two cohorts of people, we were able to compare daily stress processes in 1990 with daily stress processes in 2010," Almeida added.

After analyzing the data, the researchers found that participants reported significantly more daily stress and lower well-being in the 2010s compared to the 1990s.

Additionally, participants reported a 27 percent increase in the belief that stress would affect their finances and a 17 percent increase in the belief that stress would affect their future plans.

Almeida said he was surprised not that people were more stressed now than in the 90s, but at the age group that was mainly affected.

"We thought that with economic uncertainty, life might be more stressful for younger adults. But we didn't see that. We saw more stress for people at mid-life," Almeida said.

"And maybe that's because they have children who are facing an uncertain job market while also responsible for their own parents. So it's this generational squeeze that's making stress more prevalent for people at mid-life," he concluded.

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Agencies
June 4,2020

The World Health Organisation on Wednesday said that anti-malarial drug hydroxychloroquine (HCQ) will return to the solidarity trial for the potential treatment of coronavirus disease.

At a press conference in the WHO headquarters in Geneva, Director General Tedros Adhanom Ghebreyesus said: "On the basis of the available mortality data, the members of the committee recommended that there are no reasons to modify the trial protocol. The Executive Group received this recommendation and endorsed continuation of all arms of the solidarity trial, including hydroxychloroquine."

The world health body had temporarily suspended the usage of HCQ from the solidarity trial for coronavirus treatment on May 25 soon after a study published in one of the most reliable medical journals, which had suggested that the drug could cause more fatalities among COVID-19 patients.

However, the WHO chief said that the decision was taken as a precaution while the safety data was reviewed.

Ghebreyesus also said that the Data Safety and Monitoring Committee will continue to closely monitor the safety of all therapeutics being tested in the solidarity trial.

"So far, more than 3,500 patients have been recruited in 35 countries. WHO is committed to accelerating the development of effective therapeutics, vaccines and diagnostics as part of our commitment to serving the world with science, solutions and solidarity," he said.

Soon after HCQ was suspended from the trial, the Indian government had said that the antimalarial drug has been known for its benefits for a long time and its usage will be continued on the frontline workers, including police and healthcare professionals, as prophylaxis. The government had also said that studies were being conducted and the drug would be included in the clinical trial also for the treatment of coronavirus disease.

US President Donald Trump also had strongly advocated the use of HCQ and called it a "game-changer". He went to the extent of saying that he had taken the medicine.

Launched by WHO and partners, solidarity trial is an international clinical trial to find an effective treatment for COVID-19, including drugs to slow the progression of the disease or improve survival. The trial, which enrols patients from different countries, "will compare four treatment options against standard of care to assess their relative effectiveness against COVID-19", said WHO. 

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