Building a Harmonised Pharmacovigilance Framework in Asia

Pharma IQ

By the end of 2011 China's pharmaceutical market will be the third largest in the world, contributing more than $40 billion (£25 billion) in annual sales by 2013, according to analysis from IMS Health.

India's pharmaceutical market will be contributing between $5 billion and $15 billion during the same period.

These pharmerging economies, will play an increasingly important role in the global pharmaceutical industry.

Yet in comparison with more established markets their systems for monitoring adverse drug reactions still require a lot of development.

Pharmacovigilance in Asia

India has only very recently a nationwide pharmacovigilance network has been put in place to provide a thorough assessment of adverse drug reactions.

Vice President Dr. M Hamid Ansari, at a recent speech in New Delhi, signified the country understood the importance of a comprehensive pharmacovigilance framework, citing among other things the perception of drugs produced in emerging countries in more developed markets.

"It is imperative that we have in place a vibrant and robust pharmacovigilance system to protect our citizens and regulate the pharma and clinical research industry," he said.

For the financial year 2011/12, the second year the programme is up and running, plans are for participants in the framework to receive software training at the WHO's Uppsala Medical Centre, boost public awareness of drug safety and enrol an additional 60 medical colleges.

"Keeping in view the scale of the logistics, the National Programme envisages several Peripheral Centres pooling data at Regional Centres and thereafter at Zonal Centres," Ansari added.

Such a system was said to be essential due to the sheer size and diversity of India's population and the potential the country holds as a pharmaceuticals hub.


For pharmacovigilance networks to be at their most effective, they must be harmonised to internationally recognised standards.

In its comprehensive report on the Importance of Pharmacovigilance, released in 2007, the WHO said since the late 1990s steps have been taken to harmonise standards at regional and inter-regional levels. 

"The driving force of these efforts was the increase of global trade in pharmaceutical products and the growth in complexity of technical regulations related to drug safety and quality," it noted.

The report went on to say "there needs to be better consultation and communication between developed and developing countries when discussions on international harmonization of pharmacovigilance issues are taking place."

India plans to begin interacting with international pharmacovigilance bodies in 2013/14, by which time it will be among the biggest pharmaceutical markets in the world, before creating an Asia-Pacific centre of excellence for pharmacovigilance in 2014/15.

Jean Christophe Delumeau, head of pharmacovigilance Asia-Pacific for Bayer Healthcare Global R&D Centre, said last year he expects the success of such efforts in the region in the years leading up to 2020 to depend on China.

He highlighted, however, that currently the State Pharmaceutical Administration of China is not concentrating much on this area, although the WHO recently gave its approval to the SFDA's overall regulatory framework for vaccines "especially the adverse reactions to immunisation."

"It is a validation of the capability of the Chinese regulatory authority..." WHO China representative Dr. Michael O'Leary said, suggesting it could be capable of stepping up to the pharmacovigilance challenge.