Thursday January 18, 2018

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 successfully test fires n-capable Agni-V ballistic missile

The missile was earlier tested successfully in 2012, 2013, 2015 and 2016.

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Nirbhay
The Defence Research and Development Organisation (DRDO) sources said the Nirbhay missile test was "successful".(Representative image) VOA
  • India successfully tests the Agni-V ballistic missile on Thursday
  • This was the fifth test that missile underwent
  • With this success India is now in ranks with US, UK, China and Russia

India on Thursday successfully test fired its indigenously developed intercontinental surface-to-surface nuclear-capable ballistic missile Agni-V — the most potent and with the longest range in the Agni series – that can reach targets as far as Beijing.

The test took place at the Abdul Kalam Island facility off the Odisha coast. Defence Minister Nirmala Sitharaman tweeted about its success, congratulating its makers DRDO, the armed forces and the defence industry.

You may also like : Ballistic missile Agni-IV test fired as part of user trial

India has many high tech and powerful missiles to its name. Wikimedia Commons
India has many high tech and powerful missiles to its name. Wikimedia Commons

She said the successful test of the 5,000-km-range missile that can carry a one-tonne warhead, was “a major boost to the defence capabilities of our country”.

“The Made in India canistered missile, having three stages of propulsion, was successfully test fired,” she tweeted.

Developed by the Defence Research and Development Organisation (DRDO), the Agni-V is the most advanced version of the Agni series, part of the Integrated Guided Missile Development Programme that started in the 1960s.

The missile was earlier tested successfully in 2012, 2013, 2015 and 2016.

This was the fifth test of the missile and likely to be its first user trial, though there was no official word on it.

India is developing new technologies everyday to strengthen its defence.
India is developing new technologies everyday to strengthen its defence.

Thursday’s test brings the missile closer to its induction in the tri-service Strategic Forces Command.

The missile has a much longer shelf life, with its container being made of special steel that absorbs the blast of the takeoff.

In the canisterised launch, a gas generator inside ejects the missile up to a height of about 30 metres. A motor is then ignited to fire the missile.

Also Read : Nikki Haley says North Korea Could Face Stronger Sanctions due to its 7th Missile test in 2017 .

With this missile, India joins the super-exclusive club of ICBM (missiles with a range of over 5,000-5,500 km) capable countries of the US, Russia, the UK, France and China. IANS