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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Agencies
June 14,2020

Mumbai, Jun 14: A 42-year old man suddenly collapsed and died due to natural causes onboard Air India's Lagos-Mumbai flight on Sunday, the national carrier said.

The flight was part of Vande Bharat Mission, under which the Central government is operating special repatriation flights to bring back stranded Indians from abroad amid the coronavirus pandemic.

Air India's flight AI 1906 departed from Lagos in Nigeria at 7 pm Indian Standard Time on Saturday and landed in Mumbai at 3.45 am on Sunday.

"A passenger aboard AI 1906 of June 13 from Lagos to Mumbai passed away due to natural causes today.

"A doctor onboard along with our crew, trained to handle such medical emergencies, made a valiant attempt to revive the passenger, aged 42, who had suddenly collapsed, through resuscitation etc but all their efforts went in vain," the airline's spokesperson said.

He was declared dead onboard by the attending doctor. Mumbai International Airport Limited doctors attended to the passenger after the flight landed at 3.45 am and after all the procedures were complete, the body was sent to a hospital as per protocol, the spokesperson noted.

Relatives of the deceased were informed and aircraft was taken for full fumigation as per the norms, the spokesperson said.

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News Network
May 29,2020

May 29: Over 45,000 stranded Indians were brought back home from abroad under the Vande Bharat mission and another 1,00,000 will be evacuated till June 13, the Ministry of External Affairs said on Thursday.

The mega evacuation mission was launched on May 7.

MEA Spokesperson Anurag Srivastava said the government is also assisting return of stranded Indians from remote locations in Latin America and Caribbean, Africa, and parts of Europe.

"This is being done by taking advantage of foreign carriers flying to India primarily for evacuation of their nationals," he said during an online media briefing.

He said a total of 45,216 Indians were brought back till Thursday afternoon and they include 8,069 migrant workers, 7,656 students and 5,107 professionals.

About 5,000 Indians have returned through land border from Nepal and Bangladesh.

In the first phase of the mission from May 7 to 15, the government evacuated around 15,000 people from 12 countries. The second phase of the evacuation mission was scheduled from May 17 to 22. However, the government has extended it till June 13.

Srivastava said a total of 3,08,200 people have registered their request with Indian missions abroad for repatriation to India on compelling grounds.

"During the phase two, a total of 429 Air India flights (311 international flights + 118 feeder flights) from 60 countries are scheduled to land in India. The Indian Navy will be making four more sorties to bring back returnees from Iran, Sri Lanka and the Maldives," Srivastava said.

The MEA spokesperson said the government is targeting to bring back 1,00,000 people from 60 countries by the end of phase two of the Vande Bharat mission.

"Preparations for third phase of Vande Bharat Mission are well underway," he said.

As per the government's policy for evacuation, Indians having "compelling reasons" to return like pregnant women, elderly people, students and those facing the prospect of deportation are being brought back home.

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Agencies
February 18,2020

Mumbai, Feb 18: A group of citizens on Tuesday demanded a thorough inquiry into the death of special CBI judge Brijgopal Harkishan Loya in 2014.

The group has written a letter to Maharashtra Chief Minister Uddhav Thackeray, seeking a time-bound probe into the death of Loya.

Loya, who was hearing the high-profile Sohrabuddin Sheikh fake encounter case of Gujarat, died of a cardiac arrest in Nagpur on December 1, 2014, when he had gone to attend the wedding of a colleague's daughter.

Social activist Ashok Pai, addressing a press conference on behalf of the group, also demanded proper compensation for the judge's family, saying he was on an "official" tour.

Pai said on Tuesday he met NCP president Sharad Pawar, whose party is a key constituent of the Maha Vikas Aghadi (MVA) government in Maharashtra, and raised these demands with him.

Pawar assured to look into the demands, he said at the press conference at the Mumbai Marathi Patrakar Sangh.

"We have handed over a letter to Maharashtra Assembly speaker Nana Patole and dispatched a copy of the letter to Chief Minister Uddhav Thackeray (seeking a probe into Loya's death)," Pai said.

As the matter relates to "mysterious" death of a sitting judge of the CBI, all facts about it must be made public after a detailed and time-bound probe, Pai said.

The Loya death case had reached the Supreme Court.

The Supreme Court had held that Loya had died of "natural causes" and had rejected PILs seeking an SIT probe into the death, questioning their motive.

The SC had held that petitions were moved by political rivals to settle scores which was a serious attempt to scandalise the judiciary and obstruct the course of justice through a "frontal attack" on its independence.

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