Sunday August 19, 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.

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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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Get Success with These 3-in-1 Hypertension Pills: Study

The findings could impact guidelines on treating hypertension globally.

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'3-in-1' hypertension pill offers better success: Study
'3-in-1' hypertension pill offers better success: Study. Flickr

With over a billion people struggling to control their high blood pressure globally, an Australian study suggests a “three-in-one” pill for better results for hypertension.

The trial involved three drugs, each at half dose, in a single pill for early treatment. It met with success in 70 per cent of the cases in a targeted group, the George Institute for Global Health (GIGH) said on Wednesday.

In conventional medication, patients are treated with one drug at a very low dose, which is increased over time with additional drugs added and increased in dosage to try to reach targets.

Hypertension, 3in 1 pill Flickr
With over a billion people struggling to control their high blood pressure,try a three-in-one” pill for better results. Flickr

However, the Australian-led trials showed that low-dose of the “three-in-one” pill helped almost three-fourth patients to lower their blood pressure compared to just around half receiving normal care, Xinhua news agency reported.

“Our results could help millions reduce their risk of heart attack or stroke,” said Ruth Webster of GIGH said. The study was published in JAMA, a journal of the American Medical Association.

Also Read: Multi-Vitamin Pills May Lower Cataract Risk

The findings could impact guidelines on treating hypertension globally, said the institute. (IANS)