Negligence of drug side effects data in India


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.