Thursday February 21, 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)

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Women Are More Prone To Drug Addiction Than Men

Women represent a particularly vulnerable population, with higher rates of addiction following exposure to drugs, said researcher Erin Calipari, Assistant Professor at Vanderbilt University in the US.

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Women represent a particularly vulnerable population, with higher rates of addiction following exposure to drugs, said researcher Erin Calipari, Assistant Professor at Vanderbilt University in the US. Pixabay

Women’s hormonal cycles may not only make them prone to drug addiction but are also affected by triggers that lead to relapse, new research has found.

When fertility-related hormone levels are high, females learn faster, make stronger associations to cues in their environment and are more inclined to seek rewards, according to a study published in the journal Neuropsychopharmacology.

Women represent a particularly vulnerable population, with higher rates of addiction following exposure to drugs, said researcher Erin Calipari, Assistant Professor at Vanderbilt University in the US.

woman

Females were willing to “pay” more in the presence of these cues to get cocaine, the findings showed. Pixabay

“Women becoming addicted to drugs may be a fundamentally different process than men,” she said. “It’s important to understand this, because it’s the first step in developing treatments that are actually effective,” Calipari said.

The next step, she said, would be to figure out specifics of how hormonal shifts affect women’s brains and, ultimately, develop medications that could help override those.

In this study, male and female rats were allowed to dose themselves with cocaine by pushing a lever, with a light set up to come on during dosing.

That’s similar to the environmental cues, such as drug paraphernalia, present when humans are taking drugs.

women
The results are transferable to humans through behavioural economic analysis, which uses a complicated mathematical equation with values for the most and least a subject will do to get a payoff, said the study. Pixabay

When hormone levels were high, female rats made stronger associations with the light and were more likely to keep pushing the lever as much as it took to get any amount of cocaine.

Also Read: Conflicts with Your Mother in Childhood May Reduce Purpose in Life Later

Females were willing to “pay” more in the presence of these cues to get cocaine, the findings showed.

The results are transferable to humans through behavioural economic analysis, which uses a complicated mathematical equation with values for the most and least a subject will do to get a payoff, said the study. (IANS)