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SC issues notice to central government on blocking websites selling prohibited drugs

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New Delhi: The Supreme Court on Friday issued notice to the central government on a plea by NGO Bachpan Bachao Andolan seeking a clamp down on websites selling and delivering prohibited drugs which were being used by children on a large scale.

Photo Credit: http://www.bba.org.in
Photo Credit: http://www.bba.org.in

The social justice bench of Justice Madan B. Lokur and Justice Uday Umesh Lalit issued notice after senior counsel H. S. Phoolka appearing for the NGO told the court that a survey has revealed that about two crore children are using these drugs, tobacco, and other narcotic products.

Describing the situation as “alarming”, Phoolka said that these drugs were being “openly used in the schools.”

As he handed over a paper to the bench carrying the names of the drugs sold on websites, the court said that these are old ones and now many new drugs have come and are circulating in the market.

Meanwhile, in the missing children matter, the social justice bench on Friday warned that it would take a stern view and initiate contempt proceedings against the officials if it was provided with “misleading” information.

The court said this as it let-off Navin Yadav, an under secretary in the women and child development ministry, summoned to the court for allegedly giving figures in an affidavit that were at variance with what the minister had told parliament in response to an question.

The court forgave the official after being satisfied that the error in furnishing figures to the court was “bonafide” and also waived the Rs. 25,000 fine that it had imposed on the ministry in the last hearing of the matter on July 31.

The court on July 31 had taken a strong exception to huge discrepancy in the figures of the number of missing children as told to it and those placed before the parliament and had said that such a situation would not be “tolerated”.

“Ideas can change but numbers can’t change,” the court had said observing that somebody was misleading it.

The court had directed the personal presence of Navin Yadav in the last hearing after Bachpan Bachao Andolan had told the court that the minister had told the Rajya Sabha that 79,721 children had gone missing during 2013-2015 whereas the ministry’s affidavit before the court was putting the figures at 25,834.

(IANS)

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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)