Saturday August 24, 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.

0
//
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.

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)

Next Story

Two of Four Experimental Ebola Drugs Tests in Congo Saving Lives

The preliminary findings prompted an early halt to a major study on the drugs and a decision to prioritize their use in the African country

0
Ebola, Drugs, Congo
FILE - Health workers wearing protective gear check on a patient isolated in a plastic cube at an Ebola treatment center in Beni, Congo, July 13, 2019. VOA

Two of four experimental Ebola drugs being tested in Congo seem to be saving lives, international health authorities announced Monday.

The preliminary findings prompted an early halt to a major study on the drugs and a decision to prioritize their use in the African country, where a yearlong outbreak has killed more than 1,800 people.

The early results mark “some very good news,” said Dr. Anthony Fauci of the U.S. National Institutes of Health, which helped fund the study. With these drugs, “we may be able to improve the survival of people with Ebola.”

The two drugs — one developed by Regeneron Pharmaceuticals and the other by NIH researchers — are antibodies that work by blocking the virus.

Ebola, Drugs, Congo
FILE – A man receives a vaccine against Ebola from a nurse outside the Afia Himbi Health Center in Goma, July 15, 2019. VOA

While research shows there is an effective albeit experimental vaccine against Ebola — one now being used in Congo — no studies have signaled which of several potential treatments were best to try once people became sick. During the West Africa Ebola epidemic several years ago, studies showed a hint that another antibody mixture named ZMapp worked, but not clear proof.

So with the current outbreak in Congo, researchers compared ZMapp to three other drugs — Regeneron’s compound, the NIH’s called mAb114 and an antiviral drug named remdesivir.

On Friday, independent study monitors reviewed how the first several hundred patients in the Congo study were faring — and found enough difference to call an early halt to the trial. The panel determined that the Regeneron compound clearly was working better than the rest, and the NIH antibody wasn’t far behind, Fauci explained. Next, researchers will do further study to nail down how well those two compounds work.

The data is preliminary, Fauci stressed. But in the study, significantly fewer people died among those given the Regeneron drug or the NIH’s — about 30% compared to half who received ZMapp. More striking, when patients sought care early — before too much virus was in their bloodstream — mortality was just 6% with the Regeneron drug and 11% with the NIH compound, compared to about 24% for ZMapp, he said.

Also Read- Trump Administration Significantly Weakens U.S. Endangered Species Act

Among people who receive no care in the current outbreak, about three-fourths die, said Dr. Michael Ryan of the World Health Organization. All of Congo’s Ebola treatment units have access to the two drugs, he added, saying he was hopeful that the news would persuade more patients to seek care — as soon as symptoms appear.

Quick care ‘vital’

Tackling Congo’s outbreak has been complicated both by conflict in the region and because many people don’t believe Ebola is real and choose to stay at home when they’re sick, which spurs spread of the virus.

“Getting people into care more quickly is absolutely vital,” Ryan said. “The fact that we have very clear evidence now on the effectiveness of the drugs, we need to get that message out to communities.”

Ebola, Drugs, Congo
Two of four experimental Ebola drugs being tested in Congo seem to be saving lives, international health authorities announced Monday. Pixabay

Fauci said Regeneron and Ridgeback Biotherapeutics, which has licensed the NIH compound, told authorities enough doses are readily available.

Also Read- Amazon Launches its Marketplace Appstore in India

One issue researchers will have to analyze: Occasionally people who receive the Ebola vaccine still become sick, including some in the treatment study, which raises the question of whether their earlier protection inflated the drugs’ survival numbers. (VOA)