Saturday December 7, 2019

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

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.

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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)

Next Story

Research Finds That Drug Can Curb Dementia’s Delusions

About 8 million Americans have dementia, and studies suggest that up to 30% of them develop psychosis.

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Television actor Barbara Windsor and her husband Scott Mitchell talks about Drugs
Television actor Barbara Windsor and her husband Scott Mitchell pose with a placard in front of Downing Street ahead of a meeting with Britain's Prime Minister Boris Johnson in London, Britain. VOA

A drug that curbs delusions in Parkinson’s patients did the same for people with Alzheimer’s disease and other forms of dementia in a study that was stopped early because the benefit seemed clear.

If regulators agree, the drug could become the first treatment specifically for dementia-related psychosis and the first new medicine for Alzheimer’s in nearly two decades. It targets some of the most troubling symptoms that patients and caregivers face — hallucinations that often lead to anxiety, aggression, and physical and verbal abuse.

Results were disclosed Wednesday at a conference in San Diego.

Unmet need for treatment

“This would be a very important advance,” said one independent expert, Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation.

Although the field is focused on finding a cure for dementia and preventing future cases, “there is a huge unmet need for better treatment” for those who have it now, said Maria Carrillo, the Alzheimer’s Association’s chief science officer.

The drug is pimavanserin, a daily pill sold as Nuplazid by Acadia Pharmaceuticals Inc. It was approved for Parkinson’s-related psychosis in 2016 and is thought to work by blocking a brain chemical that seems to spur delusions.

Dementia Drugs
Dementia is a syndrome in which there is deterioration in memory, thinking, behaviour and the ability to perform everyday activities. Pixabay

About 8 million Americans have dementia, and studies suggest that up to 30% of them develop psychosis.

“It’s terrifying,” said Dr. Jeffrey Cummings of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. “You believe that people might be trying to hurt you. You believe that people are stealing from you. You believe that your spouse is unfaithful to you. Those are the three most common false beliefs.”

How the study worked

He consults for Acadia and helped lead the study, which included about 400 people with dementia and psychosis. All were given a low dose of the drug for three months, and those who seemed to respond or benefit were then split into two groups. Half continued on the drug and the others were given dummy pills for six months or until they had a relapse or worsening of symptoms. Neither the patients nor their doctors knew who was getting what.

Independent monitors stopped the study when they saw that those on dummy pills were more than twice as likely as those on the drug to relapse or worsen — 28% versus nearly 13%.

There were relatively few serious side effects — 5% in the drug group and 4% in the others. Headaches and urinary tract infections were more common among those on the drug. Two deaths occurred, but study leaders said neither was related to the drug.

The drug could become the first treatment for dementia
The drug could become the first treatment specifically for dementia-related psychosis. Pixabay

Carrillo said the study was small, but the drug’s effect seemed large, and it’s not known whether the federal Food and Drug Administration would want more evidence to approve a new use.

Risk of death

Current anti-psychotic medicines have some major drawbacks and are not approved for dementia patients.

“They’re often used off label because we have very few other options,” Fillit said.

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All carry warnings that they can raise the risk of death in elderly patients, as does Nuplazid.

Cost could be an issue — about $3,000 a month. What patients pay can vary depending on insurance coverage. (VOA)