Tuesday December 11, 2018

Drugs Controller of India to Introduce New Vaccine Specific Regulations

Reddy underlined the need to communicate to media the facts about the deaths due to clinical trials. He told the gathering that media gives a wrong projection about the number of deaths.

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The Drugs Controller General of India plans to come out with vaccine specific regulatory policy and a manual for regulatory requirements for commercialization of new drug and on how to conduct clinical trials in India, it was announced on Saturday.
Different vaccines for children. Pixabay
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The Drugs Controller General of India plans to come out with vaccine specific regulatory policy and a manual for regulatory requirements for commercialization of new drug and on how to conduct clinical trials in India, it was announced on Saturday.

S. Eswara Reddy, Drugs Controller General of India, Central Drugs Standard Control Organisation said that since pneumococcal is one of the major priority vaccines, they would first come out a policy to facilitate introducing indigenously-produced vaccine.

Speaking at a symposium on ‘research and development of vaccines: issues, challenges and opportunities’ organized by PC2 Scientific Services, a strategic and technical consulting company in association with Federation of Asian Biotech Associations (FABA) and CR RAO AIMSCS at University of Hyderabad, he listed out the steps being taken by his organisation to promote innovation through transparent system and regulatory changes.

Reddy said they were also in process of making new regulations for conducting clinical trials and new drugs. “We will fix time lines. 30 days will be maximum timeline for giving response to their applications. If response is not received within 30 days, the application will be deemed approved,” he said.

He also proposed to conduct symposiums across India and invite research institutions to know their regulatory challenges. The regulator will reach out to research and innovation centres by disseminating information about the regulatory requirements for commercialization of their products.

Reddy underlined the need to communicate to media the facts about the deaths due to clinical trials. He told the gathering that media gives a wrong projection about the number of deaths.

He said media reports that during last 7-8 years, 25,000 patients died during clinical trials in India while the fact is that only 5 percent of these deaths are actually due to clinical trials. “For example, during clinical trials related to cancer, patients who are already in terminal stage die. The death of such patients is not due to clinical trials,” he said.

The Drugs Controller General of India plans to come out with vaccine specific regulatory policy and a manual for regulatory requirements for commercialization of new drug and on how to conduct clinical trials in India, it was announced on Saturday.
Drugs controller to announce new vaccines regulation. Pixabay

With the drug developers and researchers raising concern about the restrictions on import of animal models, the Drug Controller General hoped that the Union Environment and Forests Ministry would look into the issue.

He said the import of animals was restricted by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) guidelines and suggested that the innovators, industry and regulator make a joint representation on the issue.

Mosquito Saliva: Immune System Can Be in Danger For An Entire Week Due to Mosquito Saliva

Some participants spoke how the researchers were forced to go abroad because of non-availability of such animals in the country for studies and the restrictions on the import. Reddy said the issues was relating in the country losing its credibility and the forex reserves.

Manuel Elkin Patarroyo, the malaria vaccine scientist from Columbia, was the keynote speaker. The symposium was attended by delegates from scientific research & academic and industry both from India and abroad.

Dr. Dasari V Ravi Kumar, Director of PC2 Scientific Services, pointed out that Hyderabad is producing about 33 per cent of global vaccines dosages and 35 per cent to the pharmaceutical production in the country.(IANS)

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To Fight The U.S. Opioid Epidemic, Bloomberg Donates $50Mn

Bloomberg, who has been an independent, a Republican and a Democrat, declared lifetime allegiance to the Democratic Party.

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Opioid Epidemic
Former mayor of New York City Michael Bloomberg speaks to the media in Jackson, Miss., Nov. 29, 2018. Bloomberg’s philanthropy has announced a $50 million donation to help fight the nation’s opioid epidemic. VOA

Former New York Mayor Michael Bloomberg’s charity has announced a $50 million donation to help fight the nation’s opioid epidemic.

Bloomberg Philanthropies said over the next three years it will help up to 10 states address the causes of opioid addiction and strengthen prevention and treatment programs. Its initiative involves a partnership with the Centers for Disease Control and Prevention, The Pew Charitable Trusts, Johns Hopkins University and Vital Strategies.

Bloomberg, who has been considering a 2020 Democratic presidential bid, was expected to discuss the funding Friday during his keynote address at The Bloomberg American Health Summit in Washington. A spokeswoman said there was “no stated link” between his political aspirations and the $50 million investment to fight opioids.

Bloomberg’s charity said CDC data shows there were more than 70,000 U.S. drug overdose deaths last year, including more than 47,000 from opioids, the highest numbers on record. It said those numbers are a leading factor in the decline of U.S. life expectancy over the past three years.

Bloomberg called the sobering numbers part of “a national crisis.”

opioid epidemic
Cataldo Ambulance medics and other first responders revive a 32-year-old man who was found unresponsive and not breathing after an opioid overdose on a sidewalk in the Boston suburb of Everett, Massachusetts, Aug. 23, 2017. VOA

“For the first time since World War I, life expectancy in the U.S. has declined over the past three years — and opioids are a big reason why,” he said. “We cannot sit by and allow this alarming trend to continue — not when so many Americans are being killed in what should be the prime of their lives.”

He said in a statement he hoped his charity’s work in Pennsylvania, one of the states hardest hit by the opioids crisis, would lay the groundwork “for more effective action across the country.”

The partnership focuses on identifying new approaches to tackle opioids and plugging gaps in current treatment and prevention programs. Staff members from partner organizations will support state and local programs to reduce opioid-related deaths, and successful initiatives and guidelines will be replicated elsewhere, with the goal of creating a model for the rest of the nation.

Pennsylvania Governor Tom Wolf said he was “deeply grateful” for the financial and technical resources his state will receive through the partnership with Bloomberg Philanthropies.

Melania Trump, epidemic
Melania Trump calls opioid epidemic ‘worst drug crisis’ in US.

“From our first responders and health care professionals to teachers and social service providers, heroes across our commonwealth are saving lives and protecting residents in our communities every day from this awful scourge,” Wolf, a Democrat, said in a statement issued by the Bloomberg charity. “We are doing everything we can to help them, and I am confident that this partnership will mark a turning point in our efforts.”

Also Read: Melania Trump Calls Opioid Epidemic The ‘Worst Drug Crisis’ in American Histroy

The Drug Enforcement Administration said this month in its National Drug Threat Assessment that heroin, fentanyl and other opioids continue to be the highest drug threat in the nation.

Bloomberg, who has been an independent, a Republican and a Democrat, declared lifetime allegiance to the Democratic Party and outlined an aggressive timeline for deciding whether to run for president in an interview with The Associated Press this month. He has regularly criticized President Donald Trump and spent a fortune to help elect Democrats in the midterm elections. (VOA)