How India tackles adverse drug reactions - by ignoring data
With 10 percent of 3.63 trillion medicines popped worldwide in 2015, India is the world’s third-largest medicine market. It stands to scientific reason that these drugs will have side effects.
 
Yet, 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.
 
It isn’t as if drugs have fewer side effects in India. Serious effects were seen in 6.7 percent of patients, a 2014 study reported. Other studies have cited drug side effects as the reason for 3.4 percent of hospital admissions in India, 3.7 percent hospital readmissions 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 average ADR reporting rate for high-income countries, and clearly disproportionate to the country’s population and medicine consumption.
 
In other words, India addresses the problem of adverse drug reactions by ignoring or not reporting the data. That could prove costly, said experts, if it isn’t already.
 
Ignoring Indian 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, in turn prompting a ban in India, although no significant cardiac event was reported as a side effect.
 
In 2004, pharmacovigilance in India existed only on paper, although formal monitoring began 18 years before that, 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, insensitivity 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 suffer 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 has waged a decade-long legal battle after his wife Anuradha Saha died of side effects of a drug overdose when she was being 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 run 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.
 
On the Naranjo scale — a scale developed by Canadian pharmacologist Claudio Naranjo and others to assess the causality for an adverse drug reaction — the complications the 78-year-old patient developed after taking Nimesulide scored two, indicating the drug could ‘possibly’ have been the cause of cardiac artery insufficiency, a shortage of blood in one or more coronary arteries.
 
Nimesulide has been available in India since 1997. It currently sells as Nice (listed as a ‘top brand’ on Dr Reddy’s Laboratories) and Nimulid MD (on Panacea Biotech). Nimesulide has never been licensed for use in the US, UK, Australia, New Zealand and Canada.
 
Over a decade later, a group of experts ruled that Nimesulide adversely affects the liver in children and should not be prescribed, said Gupta. So, Nimesulide was banned for children in 2011 (the Panacea website still lists Nimulid MD Kid as being available.)
 
To ban or not to ban: India needs data-driven action
 
Reporting adverse drug reactions makes the experience of a few physicians available to the entire country.
 
Or, the manufacturer could be asked to add further information on the drug label or insert.
 
For instance, in 2015, Indian authorities recommended the inclusion of advisory notes mentioning hepatotoxicity, haemorrhage and cardiovascular events as possible side effects of Sunatinib Malate, an anticancer drug, and cardiac dysfunction as a possible side effect of Pazopanib HCl, another anticancer drug.
 
However, sometimes in India, a drug ban has been reversed in court or by the regulatory authority.
 
Watch out for side effects with a slow onset
 
Side effects are usually thought of as an immediate adverse drug reaction. That’s not always the case.
 
For instance, a blockbuster diabetes drug, Metformin, reduces the absorption of Vitamin B12 from dietary sources, according to a 2014 study.
 
“A deficiency of vitamin B12 can, in turn, cause mental disabilities, slowness, forgetfulness, and, most significantly, exacerbate the onset and progression of diabetic neuropathy, a disease of the nerves that commonly occurs in advanced diabetes patients,” said study co-author, Atul Gogia, consultant, Internal Medicine, at Sir Ganga Ram Hospital, New Delhi.
 
While his finding has not led Gogia to change his prescriptions for diabetes patients, it has made him more conscious about the potential impact of his prescriptions.
 
“Vegetarian diabetes patients could especially be at high risk of developing vitamin B12 deficiency because of the combination of their diet and prescription,” said Gogia. “Now we get patients’ vitamin B12 levels tested and prescribe them supplements if needed.”
 
Disclaimer: Information, facts or opinions expressed in this news article are presented as sourced from IANS and do not reflect views of Moneylife and hence Moneylife is not responsible or liable for the same. As a source and news provider, IANS is responsible for accuracy, completeness, suitability and validity of any information in this article.
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COMMENTS

Subramani P K

3 years ago

The side effects of drugs are very seldom recognized and even if recognized not taken serious care of as a matter of caution to avoid such drugs or report to the appropriate authorities for further investigation & study. In many cases it is ignored & continue to be prescribed and the patient who reports the side effects is advised not to worry & continue the drug as if the side effect is a blessing for cure. After all the medicine manufacturers decide the treatment & dosage based on what research they have done God only knows & doctors blindly follow seeing the compliment offered by such companies for prescribing those medicines. Every one has to be at the mercy of God & believe his/her fate and that is the only answer for this predicament.

Cold is gold for tourism industry
New Delhi : Micro light flying in Mysore, heli-skiing in Auli, scuba diving in Netrani Island, dune bashing in Jaisalmer, zip lining at Neemrana Fort, spelunking in Meghalaya, bunjee jumping in Rishikesh... All this and more! The harsh winter is no more an impediment to a great holiday.
 
Tourism industry comes alive in winters, offering a wide range of adventure activities for those who do not shy away from experimenting.
 
Film editor Sandeep Singh finds snow-capped landscape and cold winds exhilarating. For this travel junkie, winter is best suited to pack bags and set off to a new destination.
 
“I love travelling during the winter. I take off to the mountains. The biting cold seems to open up all my senses and makes them sharper,” Singh, an avid traveller, told IANS.
 
“Be it para-gliding, trekking or bunjee jumping, I do it all. My wife and friends are game for it. Winter certainly is the best time for such adventure."
 
Winter travellers are by no means rare species any more.
 
More Indians are finding winter travel exciting. That is perhaps the reason why men and women, with children in tow, make a beeline for the Himalayan spots for a glimpse of the first snowfall, or just to brave the chill.
 
The travel industry is exploiting the season with attractive packages.
 
“A winter break has become almost as mandatory for Indians as vacationing in the summer. In fact, Indians have started exploring not only domestic but also international destinations during the shorter winter break,” Sharat Dhall, president, Yatra.com, told IANS.
 
The popular travel portal claimed that its bookings were 132 percent higher than the previous year in the winter season.
 
Added Ranjeet Oak, Chief Business Officer-Holidays, MakeMyTrip.com, India’s leading online travel company: “Winter tourism as a concept has picked up in India. 
 
“With the growing popularity of adventure tourism in India, winter snow sports have become a hot tourist attraction. Gulmarg (Kashmir) is considered one of the best skiing destinations in the world.”
 
Yatra.com offers special packages like “Alluring Gangtok” (starting from Rs.10,650) to “Manali Super Saver” (starting from Rs.5,999) and “Hilly Escapades in Himachal” (starting from Rs.10,900) to woo travellers.
 
The Associated Chambers of Commerce and Industry (Assocham) acknowledges that winter is the best season for the tourism industry's growth.
 
Assocham secretary general D.S. Rawat told IANS that winters were ideally the best season across India.
 
As per Assocham estimates, over 15 lakh domestic and foreign travellers would have visited tourist attractions across India in the winter (December-February).
 
Most demand has been for Himachal Pradesh, Jammu and Kashmir, Rajasthan, Uttarakhand and Uttar Pradesh.
 
Those going abroad prefer Dubai, Hong Kong, Malaysia, the Maldives, Mauritius, Sri Lanka, Singapore and other affordable destinations.
 
Hari Nair, founder and CEO of Holiday IQ, told IANS that Thailand, Malaysia and Singapore were among the popular international destinations for Indians in winter.
 
Indians on an average spent Rs.82,000 in 2014. This rose to Rs.100,000 in 2015, said Nair, adding that average trip length of an international destination has gone up by 14 days.
 
Adventure travel is the biggest attraction among couples. 
 
Nair said 52 percent of adventure travel business goes to couple-travellers. Families comprise 21 percent and only nine percent are single tourists.
 
He said the top 10 winter activities included trekking, wildlife safaris, paragliding, skiing, rock climbing, jet skiing, river rafting and surfing.
 
So get ready and strap your boots!
 
Disclaimer: Information, facts or opinions expressed in this news article are presented as sourced from IANS and do not reflect views of Moneylife and hence Moneylife is not responsible or liable for the same. As a source and news provider, IANS is responsible for accuracy, completeness, suitability and validity of any information in this article.
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Wearable Gadgets
Wearable tech devices are more like  fashionable toys than necessary tools
 
You say ‘wearable device’ and the very first name that comes to mind is Apple Watch. Although it is not the first smartwatch, perhaps, it is the most ambitious and well-designed (in terms of functionality) smartwatch. Then there are fitness bands that track user’s movement, steps, heart rate and offer other similar information. Both, the smartwatches and fitness bands or wristbands from reputed brands, are still beyond the reach of ordinary buyers.
 
The first wearable device, many of us would remember, was a digital watch with calculator. Today’s smartwatch can do more than that; but again, its usage is still limited, especially looking at the features these devices offer. In 2013, Pebble, a crowdfunding-backed start-up, reinvented the smartwatch and was a successful launch. By end-2014, Pebble claimed to have sold one million devices. The company is now selling its second-generation Pebble Time. Using Google’s Android operating system, in March 2014, Motorola launched its Moto 360 smartwatch. This was powered by Android Wear, the modified and customised version of Android. Later, in September that year, Apple joined the bandwagon with its Apple Watch. 
 
Jawbone and Fitbit Flex have been receiving a very good response to their fitness bands, since 2013. Besides these two, several other players, like Garmin, have entered the market. However, sales of wristbands are not very encouraging. 
 
This may be due to the limits on their ability to connect with other devices and battery power, constrained by the sizes available and higher price tag. The last factor is the main reason for lower sales in a country like India known for consumers who want value for money. 
 
All these smartwatches, or wristbands, perform as they are supposed to. But, when it comes to seamless interconnecting or communicating with other devices, they have limitations. For example, you can connect an Apple Watch with all other devices from Apple, but it takes some time to make it compatible with devices from other manufacturers. 
 
Another issue is ease of use. Take the example of interconnected smartwatch and mobile handset. For both devices, you need to use your hands. Now, if at all, I have to attend a call or reply to a message, wouldn’t it be better to use a mobile handset instead of the smartwatch? Nevertheless, things are changing and I hope these issues would get resolved in future.
 
One of the most important qualities any wearable device should have is to make technology pervasive by interweaving it with our daily life and usage. Except a few, most of today’s wearable gadgets are still learning this. These devices are useful but more as  fashionable toys rather than as necessities. For example, a few months ago, London-based fashion company, CuteCircuit, created special costumes for singer Katy Parry. These costumes had LED (light emitting diode) lighting that changed colour during stage shows and appearances on the red carpet for the singer. 
 
But, you do not wear such costumes daily; right? Or even if you wear a smart T-shirt, its usage would be limited, for a particular time. You may use it only for some specific activity, like jogging, or walking, or even partying. 
 
Remember Google Glass, the optical head-mounted display gadget? Google Glass was aimed at delivering rich text and notifications through a heads-up display worn as an eyeglass. It also had a 5MP camera to record videos at 720 pixels. It went into customer beta in March 2013; but its adoption by users remained limited. Finally, in early 2015, Google halted its sales after criticism of the design and a towering price tag of $1,500. Maybe, with changing technology and innovations, we may have more useful wearable devices in future.
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