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
January 1,2020

Jammu, Jan 1: As many as 160 terrorists were killed in Jammu and Kashmir this year, while 250 terrorists, including 102 of Pakistani origin, were active in the Valley, Director General of Police (DGP) Dilbag Singh said on Tuesday, noting that terror incidents and the number of local youths turning towards terrorism have decreased.

"250 terrorists have been active in Jammu and Kashmir. There is a decrease in number of active terrorists as compared to last year," Mr Singh said at the annual press conference at police headquarters in Jammu.

The DGP said that there is 30 per cent fall in terrorist incidents, less civilian killings and 36 per cent decrease in law and order incidents as compared to 2018.

"218 such (local) youths joined militant outfits in 2018 but only 139 joined in 2019," he said. Out of these new recruits only 89 have survived.

"The rest have been eliminated as their shelf life is between 24 hours to 2-3 months after joining militancy. There are hardly few old terrorists surviving, which include Jehangir Saroori and Riyaz Nayikoo", he said.

There have been only 481 law and order incidents this year as compared to 625 last year, he said.

There were 80 per cent successful anti-terror operations in which 160 terrorists, including foreigners, have been killed during the year.

Mr Singh said 102 terrorists have been arrested and 10 terrorists surrendered during the year.

He said that 102 Pakistan origin terrorists are still operating in Kashmir.

"Eleven valiant police personnel from Jammu and Kashmir besides 72 from other other security forces have been martyred," he said.

There was no collateral damage during anti-terror operation as people fully cooperated. "There was zero law and order problem this year (during anti terror operations)," he added.

The DGP said that "there has been a high degree of incidents of infiltration attempts from across the border this year and also ceasefire violations. But security forces have successfully foiled these attempted as 130 infiltrators have entered in 2019 as compared to 143 last year".

He said Jammu and Kashmir Police has set an example by handling the law and order situation in the most "exemplary" way following the abrogation of Article 370 provisions.

It was the biggest challenge faced by the force in 2019, but "we handled the most critical phase in the best way" and there was no civilian casualty during the period, he said.

Dismissing claims of minors being arrested by police in Kashmir, he said that it is being used as propaganda by some people and asserted that the J-K police has acted within the limits of law.

"We are open to scrutiny. The issue reached the Supreme Court which referred it to Jammu and Kashmir high court. The matter was inquired by the HC committee. The SC said that there is no misuse of law by law enforcement agency. J-K police has acted within the limits of law," he said.

Replying to queries on restoration of internet, the DGP said it is under consideration. "I think J-K is moving towards such a situation (on law and order front). Very soon you will hear positive announcement," Mr Singh said.

He said that though some people will try to misuse internet, "in the past, we took care of them and we will take care of such people in the future too".

Internet services in all government-run hospitals and SMS to all mobile phones will be restored from December 31 midnight in the Kashmir Valley, Jammu and Kashmir official spokesman Rohit Kansal said on Tuesday.

On December 10, some short message service (SMS) were enabled on mobile phones in order to facilitate students, scholarship applicants, traders and others. It has now been decided to fully restore the service throughout Kashmir from midnight of December 31, Kansal said.

Mobile Internet services were restored in Kargil district of Ladakh on Friday after remaining suspended for 145 days in the wake of the Centre abrogating provisions of Article 370 of the Constitution, officials said.

Internet services were suspended on August 4, a day before the Centre announced abrogation of Article 370 and division of the state into the union territories of Jammu and Kashmir, and Ladakh.

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News Network
January 24,2020

New Delhi, Jan 24: Although India's Ujjwala programme encouraged adoption of liquefied petroleum gas (LPG) for cooking among the poor, households availing the scheme have not shifted away from using highly polluting fuels like firewood, a study reveals.

The researchers, including those from the University of British Columbia (UBC) in Canada, found that additional incentives to encourage regular use of cooking gas are necessary for a complete transition to clean cooking fuel among poor rural households.

They noted that about 2.9 billion people across Asia, Africa, and Latin America burn solid fuels like firewood to meet their cooking energy needs.

This has significant negative implications for public health, the environment, and societal development, according to the researchers.

Through the Pradhan Mantri Ujjwala Yojana (PMUY), India has provided capital cost subsidies to poor women to adopt a clean-burning cooking fuel or LPG.

The researchers explained that within the first 40 months of the scheme, more than 80 million households obtained LPG stoves.

However, the full benefits of LPG adoption depend on near complete replacement of polluting fuels with LPG, according to a research-based policy brief published in the journal Nature Energy.

The scientists said this cannot be assumed solely on the basis of LPG presence in the household.

"Our research shows that Ujjwala was able to attract new consumers rapidly, but those consumers did not start using LPG on a regular basis," Abhishek Kar, a postdoc at Columbia University in the US, told PTI.

The study analysed LPG sales data for over 25,000 consumers, including PMUY beneficiaries, as well as general rural LPG consumers in Koppal district of Karnataka.

The scientists employed data covering all LPG purchases of PMUY beneficiaries through their first year in the programme.

They also assessed the general rural population's purchases during their first five years as consumers to assess the effect of experience on use.

The findings estimate that an average rural family needs to purchase five 14.2 kilogramme-cylinders annually to meet half of their cooking needs.

However, the study said just seven per cent of PMUY beneficiaries in Koppal purchased five or more cylinders annually, suggesting that the beneficiaries seldom use LPG.

The general (nonPMUY) consumers in this region use on average two times more LPG cylinders than PMUY beneficiaries, the researchers noted.

Yet, only 45 per cent of nonPMUY consumers use five or more cylinders per year -- even after several years of experience with LPG, they said.

The team assessed price and seasonal factors affecting LPG use among the general population over a three-year period.

It found that LPG consumers are sensitive to price and seasonality -- LPG cylinder refill rates are lower in the summer when agricultural activity is limited, and cash is scarce.

"There was no scheme incentives to promote use, except general LPG subsidies which is available to all, including the urban middle class," said Kar, who was a Ph.D. scholar at UBC when the research was published.

"If there is no additional income, what cost would a poor family on an already tight budget cut to pay for an extra expense on a regular basis.

"Ujjwala has started the scheme of 5 kg-cylinder in response, but the impact of that on LPG sales is still publicly unknown," he said.

These findings, the researchers noted, suggest the need for additional measures to promote regular LPG use for all rural populations.

Although the finding come from a single district in Southern India, it may also apply to other areas with similar socio-economic conditions, they said.

A more expansive evaluation of PMUY would help design targeted incentives to transform infrequent users to regular users, according to the researchers.

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News Network
May 15,2020

New Delhi, May 15: The World Bank on Friday approved $1 billion 'Accelerating India's COVID-19 Social Protection Response Program' to support the country's efforts for providing social assistance to the poor and vulnerable households, severely impacted by the pandemic.

This takes the total commitment from the World Bank towards emergency COVID-19 response in India to $2 billion.

A $1 billion support was announced last month to support India's health sector.

The response to the COVID-19 pandemic around the world has required governments around the world to introduce social distancing and lockdowns in unprecedented ways, said Junaid Ahmad, World Bank Country Director in India in a webinar interaction with the media.

These measures, intended to contain the spread of the virus have, however, impacted economies and jobs – especially in the informal sector. India with the world's largest lockdown has not been an exception to this trend, he said.

Of the $1 billion commitment, $550 million will be financed by a credit from the International Development Association (IDA) – the World Bank's concessionary lending arm and $200 million will be a loan from the International Bank for Reconstruction and Development (IBRD), with a final maturity of 18.5 years including a grace period of five years.

The remaining USD 250 million will be made available after June 30, 2020.

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