Keep an eye on Indian drugs to prevent rare side-effects: Pharmacovigilance expert

Chennai: Pharmacovigilance is a scientific discipline and industry that deals with the detection, assessment, understanding and prevention of adverse effects of drugs after it enters the market.

In recent times, India has emerged as a key market for assessing outsourced pharmacovigilance data of big pharma companies in developed countries.

However, when it comes to collecting adverse drug reactions data from Indian citizens, the pharmacovigilance programme here has a lot of room for improvement.

News Today’ caught up with the MD and CEO the pharmacovigilance company Oviya MedSafe, Dr J Vijay Venkatraman to understand more about pharmacovigilance and to shed light on its growth and way forward in India.


Why do drugs have adverse effects?

There is no drug without adverse effects. It is important to understand that if a drug does not have any adverse effect, it probably does not have a positive effect also. So, we need to assess, in how many people the adverse effects occur and how serious it happens. This is called benefit vs risk assessment of a drug. If benefits far outweigh risks, the drug can be used. If the risk is more, it should be stopped.

Dr J Vijay Venkatraman

Why do we need pharmacovigilance?

Even though drugs undergo many stages of testing, including human trials before it is available in the market, the number of human test subjects during clinical research would only be in thousands even for large pharma companies.

So, rare side effects that may affect one in every 10,000 individuals consuming the drug, will only be known after it enters the market. During clinical testing, pregnant and lactating women are also excluded from the trials.

Drugs may also react differently to people from different races and ethnicities based on their body type or geographical location. So, pharmacovigilance is needed in every country to collect, assess and understand data of the real world efficacy and adverse effects of the drug and thereby prevent these adverse reactions.

Tell us about pharmacovigilance in India

India can be called as the pharmacovigilance outsourcing capital of the world as our pharmacovigilance companies assess the drug adverse effect data of top 20 pharma companies in the world. But it was only after 2010, the Central Government’s Pharmacovigilance Programme of India (PvPI) run by Indian Pharmacopoeia Commission (IPC), Ghaziabad became stronger and we started taking decisions on drugs based on how it performs in Indian conditions.

Now, government medical colleges here have a pharmacovigilance centre that collects drug adverse event reports from within the hospital and also from outside. The data is processed and sent to IPC. They analyse and submit it to Uppsala monitoring centre in Sweden, which is a nodal agency running the UNWHO’s International Drug Monitoring Programme. In terms of PvPI, the data collected from hospitals and centres in Chennai are usually excellent.

But why is pharmacovigilance not mainstream yet?

There is a lack of awareness among the public, consumers, private hospitals and doctors regarding pharmacovigilance. The doctors and hospitals sometimes fear to report adverse effects to the government as they think it may be confused with medical negligence. But both are not the same and adverse drug reactions can happen to anyone.

The basic understanding is lacking among the healthcare community. Even doctors were not aware of pharmacovigilance as it was not a big part of their MBBS curriculum. When an adverse effect occurs to a drug they usually change the drug without recording or analysing the events. However, things are now changing. The new MBBS syllabus talks more about pharmacovigilance.

What can be done to improve the pharmacovigilance programme in India?

More private medical colleges and hospitals must be inducted into the programme to collect adverse effect data. Efforts already there. For hospitals to get NABH accreditation, one of the criteria is adverse events reporting. But there must also be cultural changes in hospitals. Hospitals and doctors must develop more confidence in government and report adverse outcome voluntarily. The government must give protection to doctors in case of adverse events.

A Harsha Vardhan