Sunday April 22, 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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Big reforms made India fastest growing major economies globally: Garg

It also has enormous implications for emerging markets and developing countries

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The RBI building in Mumbai. Photo credit: AFP/Sajjad Hussain

The major reforms undertaken by the Indian government for raising economic growth and maintaining macroeconomic stability have made the country one of the fastest growing major economies in the world, said Subhash Chandra Garg, Secretary, Department of Economic Affairs (DEA).

Garg was addressing the Special Event hosted by US-India Strategic Partnership Forum on ‘Indian Economy: Prospect and Challenges’ in Washington D.C on Friday.

Indian economy needs big reform.

He said the launch of the Goods and Services Tax (GST) represented an “historic economic and political achievement, unprecedented in Indian tax and economic reforms, which has rekindled optimism on structural reforms.” He further emphasized that India carried-out such major reforms when the global economy was slow.

“With the cyclical recovery in global growth amid supportive monetary conditions and the transient impact of the major structural reforms over, India will continue to perform robustly,” Garg said.

During his meetings, Garg highlighted that the digital age technologies have profound implications for policies concerning every aspects of the economy. It also has enormous implications for emerging markets and developing countries.

Also Read: Biggest Bank Frauds Which Shook The Indian Economy

He expressed that the response to such a transformation will have to shift from ‘catch up’ growth to adoption/adaption of digital technologies for development and growth.

Garg also informed that India has started adopting policies and programmes for transforming systems of delivery of services using digital technologies and connecting every Indian with digital technologies and access through Aadhaar and other such means.

Indian economy should be on rise. www.mapsofindia.com

While citing the example of expanding mobile data access, he mentioned that India is now the largest consumer of mobile data in the world with 11 gigabytes mobile data consumption per month. He informed that India is investing in digital technologies, encouraging private sector to adapt these technologies and also addressing the taxation related issues by introducing equalisation levy.

Garg is currently on an official tour to Washington D.C. to attend the Spring Meetings of the International Monetary Fund and the World Bank and other associated meetings. He is accompanied by Urjit Patel, Governor, Reserve Bank of India and other senior officials. IANS