Sunday October 22, 2017

Negligence of drug side effects data in India

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New Delhi: While 3.63 trillion medicines popped worldwide have a scientific reason for adverse side effects, India still remains the world’s third-largest medicine market.

In 2013, India reported no more than two percent of globally occurring adverse drug reactions (ADRs), jargon for side effects of medicines, logged in Vigibase, maintained by the Uppsala Monitoring Centre, a World Health Organisation collaborating centre for international drug monitoring.

India has equal side effects of medicines as in other countries.

According to a study in 2014, serious effects were seen in 6.7 percent of patients. Drug side effects have been sited as the reason for 3.4 percent of hospital admissions in India, 3.7 percent hospital readmission and 1.8 percent mortality. In the developed world, adverse reactions are believed to be the fourth-leading cause of death.

Within India, the ADR reporting rate (ADRs reported per million population) has almost doubled in the last three years to 40, but it is lower than 130

The reality is India has been ignoring the problem of adverse drug reactions or not reporting the data. That could prove costly, said experts, if it isn’t already.

Ignoring data makes drugs more unsafe.

Reporting the side effects of a drug could help determine if the medicine should stay or be pulled off shelves. A medicine labelled safe for clinical use after trials could still be found to be dangerous –as happened with Rofecoxib, a non-steroidal anti-inflammatory drug, a runaway success after its 1999 launch.

Between its launch and 2004, Rofecoxib reportedly caused between 88,000 and 140,000 cardiac events. This forced Merck, the drug’s maker, to voluntarily withdraw it from the US market and so was ban in India, although no significant cardiac event was reported.

In 2004, pharmacovigilance existed only on paper in India. Although formal monitoring began in 1986, and India signed up to the WHO Programme for International Drug Monitoring in 1997. Reporting was lax until the launch of the Pharmacovigilance Programme of India in 2010.

Carelessness and insensitivity are among reasons for India’s poor reporting of side effects.

Some key reasons behind India’s poor track record in reporting ADRs:

Nurses, who are most likely to see a patient suffering from a side effect, are expected to inform the treating doctor but seldom do.

“Doctors in India are careless in prescribing medicines because they know they will not be held accountable for their actions, and are equally careless about reporting ADRs,” said Kunal Saha, a US-based doctor who’s wife Anuradha Saha died of side effects of a drug overdose while treated for a skin allergy in 1998.

Settling Saha’s case, the Supreme Court ruled that medical negligence includes not informing patients about the possible side effects of a drug. “Physicians prescribe new drugs at the behest of medical representatives even without reading the drug pharmacology, driven by the promise of gifts, despite this being illegal,” said Saha. “Patients are prescribed excessive doses, unwarranted drugs or unwarranted combinations.”

Some doctors don’t know that drug side effects should be reported to any one of 150 ADR monitoring centres across India, nor are they adept at recognising a drug side effect.

Half of India’s population depends on drug stores not ran by pharmacists, and on doctors holding alternative medicine qualifications who aren’t permitted to prescribe allopathic medicines in many states.

Scarce data preclude regulatory action on questionable drugs

Drug side effects in India are scarcely reported, even in scientific literature.

A 65-year-old woman with cardiovascular disease developed chest pain after being put on Nimesulide, a popular pain-killer, for fracture-related pain, as this 2003 study reported. Swapping Nimesulide with an alternative, Ibuprofen, quickly alleviated the chest pain.

A 78-year-old man with heart disease was prescribed Nimesulide for a wrist injury. He developed breathlessness, blue pallor and restlessness, and quickly succumbed to further complications, another 2004 study reported.(IANS)

NewsGram view- In India a large number people suffer because of taking wrong medicines, even that has become a business that doctors don’t try to find the core of disease and prescribe medicine first. There should be data kept for drug side effects.

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India Demands Data on UN Staff Misconduct, Use of Immunity

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India has demanded the secretariat disclose information about misconduct by UN staff. Flickr

United Nations, Oct 7: In an attempt to break the wall of silence around the crimes and UN staff misconduct and those on its assignments, India has demanded the secretariat disclose information about such cases and the immunity invoked against prosecutions.

Yedla Umasankar, the legal advisor in India’s UN Mission, touched a raw nerve here by criticising the UN on Friday for not vigorously following up allegations of serious wrongdoing by its employees who enjoy the equivalent of diplomatic immunity, a prized possession of its staff.

“It appears that the UN system itself may be reluctant to waive immunity even for serious misconduct carried out by its personnel while serving on its missions, so that such cases can be prosecuted by the host governments,” he told the General Assembly’s committee on legal affairs.

“Even a few of such instances or allegations of crimes committed by UN personnel is highly damaging for the image and credibility of the United Nations system and its work around the world,” he added.

His statement also touched on the practice of some countries that protect their wrongdoers at the UN.

Umasankar demanded that secretariat disclose how many cases of serious misconduct by UN personnel were registered and the number of cases where the UN refused to waive immunity to allow their prosecution.

He also wanted to know in how many cases the host country wanted the immunity waived so it can prosecute those accused; the number of times the UN asked the host country or the country that sent them to prosecute them; how many times it consulted countries before waiver of the immunity of their personnel and how many of them refused UN’s request to waive their citizens’ immunity.

The information he wanted does not cover the diplomats sent by member countries to represent them at UN bodies and enjoy diplomatic immunity with the nations hosting the UN facilities.

After scores of serious allegations of sexual misconduct by peacekeepers, especially exploitation of children, the UN vowed to uphold a policy of zero tolerance and began publishing data on such cases in peacekeeping operations including how they were dealt with.

Starting with the year 2015, it began identifying the nationalities of those accused.

However, it has not made public a roster detailing all the allegations and proven cases of serious misconduct across the entire UN.

While the focus has been on sexual exploitation and abuse reported on peacekeeping operations, Umasankar said that “at a broader level, the issue of accountability has remained elusive in some cases”.

He attributed it to “the complexities of legal aspects relating to sovereignty and jurisdiction”, the immunity or privileges that may be necessary for UN operations, and the capability or willingness of countries to investigate and prosecute the accused.

He noted that the UN itself cannot make criminal prosecutions.

While Indian laws has provisions for dealing with crimes committed abroad by its citizens, not all countries have them, he said.

Those countries should be encouraged and helped to implement such measures, he added. (IANS)

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Indo-Pak Peace Talks Futile Unless Islamabad Sheds Links with Terrorism, says Study

A Study by a U.S. think tank calls India and Pakistan talks futile, until Pakistan changes its approach.

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India and Pakistan
India and Pakistan. Wikimedia.

A Top United States of America (U.S.) think tank, Carnegie Endowment for International Peace called the relations between India and Pakistan futile, unless Islamabad changes its approach and sheds its links with Jihadi terrorism.

A report “Are India and Pakistan Peace Talks Worth a Damn”, authored by Ashley J Tellis stated that such a move supported by foreign countries would be counterproductive and misguided.

The report suggests that International community’s call for the India and Pakistan talks don’t recognize that the tension between the two countries is not actually due to the sharp differences between them, but due to the long rooted ideological, territorial and power-political hatred. The report states that these antagonisms are fueled by Pakistani army’s desire to subvert India’s powerful global position.

Tellis writes that Pakistan’s hatred is driven by its aim to be considered and treated equal to India, despite the vast differences in their achievements and capabilities.

Also ReadMilitant Groups in Pakistan Emerge as Political Parties : Can Violent Extremism and Politics Co-exist? 

New Delhi, however, has kept their stance clear and mentioned that India and Pakistan talks cannot be conducted, until, the latter stops supporting terrorism, and the people conducting destructive activities in India.

The report further suggests that Pakistan sees India as a genuine threat and continuously uses Jihadi terrorism as a source to weaken India. The report extends its support to India’s position and asks other international powers, including the U.S., to extend their support to New Delhi.

Earlier in September, Union External Affairs Minister Sushma Swaraj in the United Nations General Assembly (UNGA) slammed Pakistan for its continuous terror activities. She attacked the country by saying that India has produced engineers, doctors, and scholars; Pakistan has produced terrorists.

Sushma Swaraj further said that when India is being recognised in the world for its IT and achievements in the space, Pakistan is producing Terrorist Organisations like Lashkar-e-Taiba. She said that Pakistan is the world’s greatest exporter of havoc, death and inhumanity.

-by Megha Acharya  of NewsGram. Megha can be reached at @ImMeghaacharya. 

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Delhi University Students Win the Enactus World Cup 2017

India wins the Enactus World Cup 2017

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India wins Enactus World Cup 2017. Twitter.

New Delhi, Sep 30: After an extremely tough competition between different students across the world in the Enactus World Cup 2017, Team India, represented by Shaheed Sukhdev College of Business Studies (SSCBS), Delhi University emerged as the winner. The winning projects were project UDAAN and Mission RAAHAT.

Supporting the Government of India’s Digital India and Swachh Bharat Abhiyan mission, RAAHAT strives to effectively eliminate open defecation and provide safe sanitation in the urban slums; whereas, UDAAN aims at narrowing the digital divide between rural and urban India by setting up computer centres.

The Delhi University college team was led by the college’s faculty advisor, Anuja Mathur and student president of SSCBS Student President Aditya Sharma. The winning projects included 34 more members. The Enactus India and Enactus SSCBS were presented the Ford Better World Award of USD 50,000.

Also Read: Three Indian Women on Fortune’s Most Powerful Business Women

President and Global CEO, Enactus, Rachael A. Jarosh congratulated the Indian for winning the world cup and called the projects- RAAHAT and UDAAN, inspirational success stories of Enactus students, who are sowing businesses. She said that the projects address the real world challenges efficiently and innovatively. Enactus India President Farhan Pettiwala said that the two projects created by Delhi University students contribute to the country’s betterment, as they support the Government’s civil and social agenda.

Enactus is an international nonprofit organisation, with 72,000 students from 1,700 universities in 36 countries, which held its annual global event in London from September 26 to 28. A selected group of 3,500 students, business, government leaders and academicians across the globe were present at the event. Participants for the final competition round are qualified from over 72,000 university students. Each team has about 17 minutes to present their projects of entrepreneurial action.

Enactus works to nurture the entrepreneurial skills of students, and to address fundamental, social and economic challenges by developing innovative and experiential learning opportunities for students.

-by Megha Acharya of NewsGram. Megha can be reached at @ImMeghaacharya.