2,644 died during clinical trial of drugs in 7 years: Govt to SC

April 25, 2013

Clinical_trial

New Delhi, Apr 25: As many as 2,644 people, called subjects, died during the clinical trials of 475 new drugs on human beings in last seven years and only 17 of the medicines were approved for marketing in India, the Centre has informed the Supreme Court.

Responding to allegations by NGO, Swasthya Adhikar Manch, in its PIL that Indians were used as guinea pigs by foreign pharmaceutical majors for human trial of their new drugs, the Union health and family welfare ministry said of the 57,303 enrolled subjects, 39,022 completed the clinical trials.

"Serious adverse events of deaths during the clinical trials during the said period were 2,644, out of which 80 deaths were found to be attributable to the clinical trials," health secretary Keshav Desiraju said in an affidavit on behalf of the ministry of health and family welfare.

"Around 11,972 serious adverse events (excluding death) were reported during the period from January 1, 2005 to June 30, 2012, out of which 506 events were found to be related to clinical trials," he said.

Clinical trial of two drugs - Bayer's Rivaroxaban and Novartis's Aliskiren vs. Enalapril - accounted for maximum number of deaths.

Bayer's Rivaroxaban was first used for human trials in 2008 resulting in death of 21 of which it claimed that only five were related to clinical trial but it has till date paid compensation to kin of only two. Two years later, the same drug was again put on human trial and this time 125 deaths were reported, of which it was stated that five were related to clinical trial.

Novartis used the investigational product listed as Aliskiren vs. Enalapril last year and it resulted in death of 47 of which only one has been attributed to clinical trial of the new drug. Only another clinical trial of new drug on humans, Sun Pharma's Paclitaxel injection concentrate for nano-dispersion, registered a double-digit death figure (12) during the last seven years. Majority of the pharmaceutical companies, whose drugs were permitted for clinical trial on human beings, were of foreign origin.

The secretary promised to the court for stringent regime on clinical trials on the recommendations of the Parliamentary Standing Committee, which faulted the Drugs and Cosmetics (Amendment) Bill, 2007.

He said: "On the advice of the ministry of law, the health ministry has proposed to withdraw the 2007 Bill and introduce a new Bill in its place after incorporating the recommendations of the Standing Committee. Accordingly, the ministry will introduce Drugs and Cosmetic (Amendment) Bill, 2013 in Parliament during the Budget session."

On January 3, the apex court had pulled up the Centre for its insensitivity to scores of deaths and serious adverse effects to thousands during clinical trial of new drugs and asked the health secretary to monitor implementation of the supervisory and scrutiny mechanism for human experiment of new drugs.

Referring to a parliamentary committee's stinging report pointing out involvement of foreign pharmaceutical multinational companies in a big way in the clinical trial of new drugs and the need for a thorough review of the existing mechanism, a bench of Justices R M Lodha and A R Dave had said, "The government has slipped into a deep slumber and doing nothing."

It was about to issue an order banning all fresh clinical trial of new drugs on humans, but additional solicitor general Siddharth Luthra had pulled out the government from an embarrassing spot by promising that the health secretary would personally monitor implementation of the new stricter regime.

The health secretary stressed the importance of clinical trials of new drugs on humans. "During the last 40 years, about 900 drug molecules of different therapeutic categories have been approved for marketing in India. Out of these 900, only seven drug molecules have been discovered and approved in India. Rest of them are discovered and developed in other countries like US, EU, Japan after going through complex process of research and drug development including clinical trial in human beings," he said.

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News Network
February 14,2020

New Delhi/Washington, Feb 14: India has offered to partially open up its poultry and dairy markets in a bid for a limited trade deal during US President Donald Trump's first official visit to the country this month, people familiar with the protracted talks say.

India, the world's largest milk-producing nation, has traditionally restricted dairy imports to protect the livelihoods of 80 million rural households involved in the industry.

But Prime Minister Narendra Modi is trying to pull all the stops for the US President's February 24-25 visit, aimed at rebuilding bonds between the world's largest democracies.

In 2019, President Trump suspended India's special trade designation that dated back to 1970s, after PM Modi put price caps on medical devices, such as cardiac stents and knee implants, and introduced new data localization requirements and e-commerce restrictions.

President Trump's trip to India has raised hopes that he would restore some of the country's US trade preferences, in exchange for tariff reductions and other concessions.

The United States is India's second-largest trade partner after China, and bilateral goods and services trade climbed to a record $142.6 billion in 2018. The United States had a $23.2 billion goods trade deficit in 2019 with India, its 9th largest trading partner in goods.

India has offered to allow imports of US chicken legs, turkey and produce such as blueberries and cherries, government sources said, and has offered to cut tariffs on chicken legs from 100 per cent to 25 per cent. US negotiators want that tariff cut to 10 per cent. The Modi government is also offering to allow some access to India's dairy market, but with a 5 per cent tariff and quotas, the sources said. But dairy imports would need a certificate they are not derived from animals that have consumed feeds that include internal organs, blood meal or tissues of ruminants.

New Delhi has also offered to lower its 50 per cent tariffs on very large motorcycles made by Harley-Davidson, a tax that was a particular irritant for President Trump, who has labelled India the "tariff king." The change would be largely symbolic because few such motorcycles are sold in India.

President Trump will be feted in PM Modi's home state of Gujarat, then hold talks in New Delhi and attend a reception that the hosts have promised will be bigger than the one organised for former president Barack Obama in 2015.

But it is far from clear whether India's offers will be enough to satisfy US Trade Representative Robert Lighthizer, who cancelled plans for a trip to India this week. Instead, he has held telephone talks with Commerce Minister Piyush Goyal.

The US dairy industry remained sceptical on Thursday that a viable deal is at hand.

"We're always looking for market access, but in terms of India, as of today I'm not aware of any real progress going on," said Michael Dykes, president of the International Dairy Foods Association and a member of USTR's agricultural trade policy advisory committee.

Mr Dykes said the US dairy industry was looking for access in viable commercial quantities.

A USTR spokesman and India's trade ministry did not respond to requests for comment.

A parliament panel is reviewing a draft data privacy law that imposes stringent controls over cross-border data flows and gives the government powers to seek user data from companies.

It is not clear whether it will be passed, or in what form, but the possibilities have unnerved US companies and could raise compliance requirements for Google, Amazon.com Inc, and Facebook.

The draft law is not part of the trade discussions, Indian officials say, because the issue is too difficult to resolve at the same time.

"The privacy and localization piece will be raised independently and in concert with the trade discussions," said a Washington-based source with knowledge of the US administration's thinking.

President Trump on Tuesday was non-committal about sealing a trade deal before his visit. "If we can make the right deal, we'll do it," he told reporters.

Two US sources said progress had been made on proposed alterations to the medical device price caps. India's new import tariffs on medical devices, walnuts, toys, electronics and other products on February 1 surprised US negotiators, however.

The new tariffs were aimed at China, which also makes medical devices, according to an Indian government source. "We have to protect our market and our companies," the source said.

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News Network
February 2,2020

Mumbai, Feb 2: Kerala Chief Minister Pinarayi Vijayan on Sunday slammed the BJP-led central government on the Citizenship Amendment Act (CAA) and said that the new law only serves the objectives of the Sangh Parivar of turning India into a Hindu Rashtra.

He said that in order to achieve their objectives, the "communal elements" are trying to divide India's people through the same strategy as employed by the British colonisers in the past.

Lauding people in Mumbai for their protests against CAA, the National Register of Citizens (NRC) and the National Population Register (NPR), the Kerala chief minister also outlined three reasons for his government's decision to reject the Citizenship Amendment Act.

"Over the last several weeks, Mumbai citizens made clear their unyielding opposition to efforts made by Hindutva elements to tear apart the secular fabric of our society. I express solidarity with struggles being made across the city in defence of secularism and the Indian Constitution," Vijayan said at an event here.

The chief minister was addressing the 'Mumbai Collective' here on the topic of 'National struggle against communalism'.

"The government of Kerala is acting as per the Constitution. Like Kerala, other states are also looking at CAA as against the fundamentals of the Constitution. It (CAA) violates basic human rights and is divisive and deeply discriminatory," CM Vijayan said, adding that the new citizenship law only furthers the Sangh Parivar's objective of creating a Hindu Rashtra.

He said the CAA needs to be rejected for three basic reasons.

"First, it is against the letter and spirit of our Constitution. Secondly, it is highly discriminatory and violative of human rights. Thirdly, it seeks to impose philosophy of Sangh Parivar with its mission of Hindu Rashtra," the chief minister said.

Vijayan also participated in the human chain organised by Left Democratic Front (LDF) against CAA and NRC and said that "the law is a threat to the secularism of this country".

The newly enacted law is facing stiff opposition across the country with several non-NDA states including Kerala, West Bengal, Rajasthan and Punjab refusing to implement it.

Rajasthan, Kerala and Punjab have passed resolutions against the recently amended law in their respective state Assemblies.

The CAA grants citizenship to Hindus, Sikhs, Jains, Parsis, Buddhists and Christians fleeing religious persecution from Pakistan, Afghanistan and Bangladesh and who came to India on or before December 31, 2014.

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News Network
February 27,2020

New Delhi, Feb 27: An Indian Air Force aircraft on Thursday evacuated 76 Indians and 36 foreign nationals from the coronavirus-hit Chinese city of Wuhan.

The C-17 Globemaster III transport aircraft was sent to Wuhan on Wednesday and it carried 15 tonnes of medical supplies for coronavirus-affected people in China.

On its return, the aircraft brought back 112 people, including 23 citizens from Bangladesh, six from China, two each from Myanmar and the Maldives and one each from South Africa, the US and Madagascar.

Earlier, India had evacuated around 650 Indians from Wuhan in two Air India flights.

“In all 723 Indian nationals and 43 foreign nationals have been evacuated from Wuhan, China, in these three flights,” the Ministry of External Affairs (MEA) said.

On the medical supplies delivered by India to China, the MEA said they would help augment the country’s efforts to control the coronavirus outbreak which had been declared as a public health emergency by the World Health Organisation.

“The assistance is also a mark of friendship and solidarity from the people of India towards the people of China as the two countries also celebrate 70th anniversary of establishment of diplomatic relations this year,” it said.

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