Health Ministry bans 328 fixed dose combination drugs

Agencies
September 13, 2018

New Delhi, Sept 13: The Ministry of Health and Family Welfare has prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) with immediate effect. 

It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.

'The Ministry of Health and Family Welfare has, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940, prohibited the manufacture for sale, sale or distribution for human use of 328 FDCs through its gazette notifications dated September 7, 2018; it has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions. These notifications will take immediate effect,'a statement by the ministry said on Wednesday.

Earlier, the Central Government had, through its notifications published on March 10, 2016 in the Gazette of India, prohibited the manufacture for sale, sale and distribution for human use of 344 FDCs under section 26 A of the Drugs and Cosmetics Act, 1940. 
Subsequently, the Government had prohibited five more FDCs in addition to the 344 under the same provisions.

However, the matter was contested by the affected manufacturers in various High Courts and the Supreme Court. 

In compliance with the directions given by the Supreme Court in its judgment dated December 15, 2017, the matter was examined by the Drugs Technical Advisory Board constituted under section 5 of the Drugs and Cosmetics Act, 1940 which furnished its report on these drugs to the Central Government.

The Drugs Technical Advisory Board recommended, amongst other things, that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings. 

The Board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under section 26 A of the Drugs and Cosmetics Act, 1940 in the larger public interest. 

With regard to six FDCs, the Board recommended that their manufacture, sale and distribution be restricted subject to certain conditions based on their therapeutic justification. 

Fifteen FDCs out of the 344 prohibited on March 10 , 2016, which were claimed to be manufactured prior to September 21, 1988, have been kept out of the purview of current notifications.

Earlier, an Expert Committee appointed by the Central Government had also examined these FDCs and made recommendations in line with those of the Board as indicated above.

The Central Government considered the recommendations of the Expert Committee and Drugs Technical Advisory Board, and based on such consideration, it was concluded that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of these 328 FDCs in the country.

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News Network
June 13,2020

Dehradun, Jun 13: Chief of Army Staff General M M Naravane on Saturday said the country is passing through difficult times and its safety and honour depend on the ability of its young officers as military leaders.

Addressing gentlemen cadets at the Indian Military Academy here as the reviewing officer of a passing out parade, Gen Naravane said they are being commissioned as officers into the army under the most daunting of circumstances and the high standards of their military training will help them overcome the challenges lying in store for them.

The parade saw a total of 423 cadets being commissioned into the army including 333 from the country and 90 from friendly foreign countries.

"These are difficult times for the country. Its safety, honour and respect depend on your abilities as military leaders. You have to live up to the expectations of your countrymen. You have to ensure that whatever you do is for their welfare," he said.

The army chief said there are no good or bad regiments but only good officers.

"Become one with your men. Win their trust and affection and they will win battles for you," Naravane said.          

He asked the gentlemen cadets to throw themselves into their new role as commissioned officers with passion but also be compassionate towards their men.

"When the going gets tough and all seems lost, it is the spirit of your men that helps you win," he said.          

He said the gentlemen cadets who are taking their first step as commissioned officers will have to make decisions in the tactical and operational domain as well as resolve ethical issues and they will have only their conscience to guide them.          

"In such critical moments let the core values enshrined in the preamble of the constitution of India be your guiding light," the Army Chief said.

Asking them to rise above petty considerations of caste, creed and religion, he said the army does not discriminate.

Apart from containing the external threats, you may also have to defang internal forces out to destabilise the country.

He said the precise drill movements of the cadets had convinced him they will do their respective countries proud.

"In the autumn of your careers what will matter is not the position you finally attain but how honourably you have served your nation," he said.              

In a message to the gentlemen cadets' parents, who were not allowed to attend the event due to the coronavirus pandemic, the Army Chief said, "Till yesterday they (gentlemen cadets) were your children but from tomorrow they will be ours."

He promised to be with them through thick and thin.

The parade looked slightly off-colour this time with the enthusiastic crowds of parents and some usual features missing like the showering of the drill square with flower petals by helicopters.

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Agencies
February 14,2020

Lucknow, Feb 14: Uttar Pradesh doctor Kafeel Khan was on Friday booked under the National Security Act (NSA) over his alleged anti-CAA speech at Aligarh Muslim University on December 12, 2019.

The Uttar Pradesh slapped NSA on Kafeel Khan on Friday even as the doctor waited to be released from jail despite being granted bail on Monday in connection with his alleged inflammatory speech.

SP Crime Dr Arvind said that there were sufficient grounds to book the doctor under NSA.

The suspended pediatrician, Kafeel Khan, was arrested for allegedly delivering a controversial speech during Anti-CAA protests on December 12 at the Aligarh Muslim University or AMU. While he was granted bail on Monday, his family members claimed on Thursday that he was yet to be released.

Dr Kafeel Khan's brother Adeel Ahmed Khan had issued a statement saying that despite being granted bail Mathura jail authorities had not honoured the court's order.

Dr Kafeel Khan was arrested by the UP Special Task Force from Mumbai on January 29 for participating anti-CAA protest at AMU. A case was registered against him at the Civil Lines police station here for promoting enmity between different religions.

After his arrest in Mumbai, Dr Khan was brought to Aligarh, from where he was shifted to the district jail in neighbouring Mathura.

According to police, this was done as a precautionary measure in view of the anti-CAA protests on the AMU campus and at the Eidgah grounds in the old city. Police had said that the Dr Khan's presence in the Aligarh jail could have aggravated the law and order situation in the city.

The doctor was earlier arrested for his alleged role in the death of over 60 children in one week at the BRD Medical College in Gorakhpur in August 2017. Short supply of oxygen at the children's ward was blamed at that time for the deaths.

About two years later, a state government probe cleared Khan of all major charges, prompting him to seek an apology from the Yogi Adityanath government.

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News Network
February 26,2020

Feb 26: China’s massive travel restrictions, house-to-house checks, huge isolation wards and lockdowns of entire cities bought the world valuable time to prepare for the global spread of the new virus.

But with troubling outbreaks now emerging in Italy, South Korea and Iran, and U.S. health officials warning Tuesday it’s inevitable it will spread more widely in America, the question is: Did the world use that time wisely and is it ready for a potential pandemic?

“It’s not so much a question of if this will happen anymore, but rather more a question of exactly when this will happen — and how many people in this country will have severe illness,” said Dr. Nancy Messonnier of the U.S. Centers for Disease Control and Prevention.

Some countries are putting price caps on face masks to combat price gouging, while others are using loudspeakers on trucks to keep residents informed. In the United States and many other nations, public health officials are turning to guidelines written for pandemic flu and discussing the possibility of school closures, telecommuting and canceling events.

Countries could be doing even more: training hundreds of workers to trace the virus’ spread from person to person and planning to commandeer entire hospital wards or even entire hospitals, said Dr. Bruce Aylward, the World Health Organization’s envoy to China, briefing reporters Tuesday about lessons learned by the recently returned team of international scientists he led.

“Time is everything in this disease,” Aylward said. “Days make a difference with a disease like this.”

The U.S. National Institutes of Health’s infectious disease chief, Dr. Anthony Fauci, said the world is “teetering very, very close” to a pandemic. He credits China’s response for giving other nations some breathing room.

China locked down tens of millions of its citizens and other nations imposed travel restrictions, reducing the number of people who needed health checks or quarantines outside the Asian country.

It “gave us time to really brush off our pandemic preparedness plans and get ready for the kinds of things we have to do,” Fauci said. “And we’ve actually been quite successful because the travel-related cases, we’ve been able to identify, to isolate” and to track down those they came in contact with.

With no vaccine or medicine available yet, preparations are focused on what’s called “social distancing” — limiting opportunities for people to gather and spread the virus.

That played out in Italy this week. With cases climbing, authorities cut short the popular Venice Carnival and closed down Milan’s La Scala opera house. In Japan, Prime Minister Shinzo Abe called on companies to allow employees to work from home, while the Tokyo Marathon has been restricted to elite runners and other public events have been canceled.

Is the rest of the world ready?

In Africa, three-quarters of countries have a flu pandemic plan, but most are outdated, according to authors of a modeling study published last week in The Lancet medical journal. The slightly better news is that the African nations most connected to China by air travel — Egypt, Algeria and South Africa — also have the most prepared health systems on the continent.

Elsewhere, Thailand said it would establish special clinics to examine people with flu-like symptoms to detect infections early. Sri Lanka and Laos imposed price ceilings for face masks, while India restricted the export of personal protective equipment.

India’s health ministry has been framing step-by-step instructions to deal with sustained transmissions that will be circulated to the 250,000 village councils that are the most basic unit of the country’s sprawling administration.

Vietnam is using music videos on social media to reach the public. In Malaysia, loudspeakers on trucks blare information through the streets.

In Europe, portable pods set up at United Kingdom hospitals will be used to assess people suspected of infection while keeping them apart from others. France developed a quick test for the virus and has shared it with poorer nations. German authorities are stressing “sneezing etiquette” and Russia is screening people at airports, railway stations and those riding public transportation.

In the U.S., hospitals and emergency workers for years have practiced for a possible deadly, fast-spreading flu. Those drills helped the first hospitals to treat U.S. patients suffering from COVID-19, the disease caused by the virus.

Other hospitals are paying attention. The CDC has been talking to the American Hospital Association, which in turn communicates coronavirus news daily to its nearly 5,000 member hospitals. Hospitals are reviewing infection control measures, considering using telemedicine to keep potentially infectious patients from making unnecessary trips to the hospital and conserving dwindling supplies of masks and gloves.

What’s more, the CDC has held 17 different calls reaching more than 11,000 companies and organizations, including stadiums, universities, faith leaders, retailers and large corporations. U.S. health authorities are talking to city, county and state health departments about being ready to cancel mass gathering events, close schools and take other steps.

The CDC’s Messonnier said Tuesday she had contacted her children’s school district to ask about plans for using internet-based education should schools need to close temporarily, as some did in 2009 during an outbreak of H1N1 flu. She encouraged American parents to do the same, and to ask their employers whether they’ll be able to work from home.

“We want to make sure the American public is prepared,” Messonnier said.

How prepared are U.S. hospitals?

“It depends on caseload and location. I would suspect most hospitals are prepared to handle one to two cases, but if there is ongoing local transmission with many cases, most are likely not prepared just yet for a surge of patients and the ‘worried well,’” Dr. Jennifer Lighter, a pediatric infectious diseases specialist at NYU Langone in New York, said in an email.

In the U.S., a vaccine candidate is inching closer to first-step safety studies in people, as Moderna Inc. has delivered test doses to Fauci’s NIH institute. Some other companies say they have candidates that could begin testing in a few months. Still, even if those first safety studies show no red flags, specialists believe it would take at least a year to have something ready for widespread use. That’s longer than it took in 2009, during the H1N1 flu pandemic — because that time around, scientists only had to adjust regular flu vaccines, not start from scratch.

The head of the World Health Organization, Tedros Adhanom Ghebreyesus, said the U.N. health agency’s team in China found the fatality rate between 2% and 4% in the hard-hit city of Wuhan, the virus’ epicenter, and 0.7% elsewhere.

The world is “simply not ready,” said the WHO’s Aylward. “It can get ready very fast, but the big shift has to be in the mindset.”

Aylward advised other countries to do “really practical things” now to get ready.

Among them: Do you have hundreds of workers lined up and trained to trace the contacts of infected patients, or will you be training them after a cluster pops up?

Can you take over entire hospital wards, or even entire hospitals, to isolate patients?

Are hospitals buying ventilators and checking oxygen supplies?

Countries must improve testing capacity — and instructions so health workers know which travelers should be tested as the number of affected countries rises, said Johns Hopkins University emergency response specialist Lauren Sauer. She pointed to how Canada diagnosed the first traveler from Iran arriving there with COVID-19, before many other countries even considered adding Iran to the at-risk list.

If the disease does spread globally, everyone is likely to feel it, said Nancy Foster, a vice president of the American Hospital Association. Even those who aren’t ill may need to help friends and family in isolation or have their own health appointments delayed.

“There will be a lot of people affected even if they never become ill themselves,” she said.

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