No Point in being Rigid

Aman GuptaAman Gupta, Health Policy Analyst, elaborates about how Indian pharmaceuticals companies evolves as the true pharmacy of the world


The Indian pharmaceutical industry has been witness to some high level regulatory issues in recent times. Whether, it is the heightened activity of the USFDA that started last year, with Ranbaxy agreeing to pay a fine of $500 million after pleading guilty to felony charges relating to the manufacturing and distribution of adulterated drugs,to the growing concerns voiced by the US Chambers of Commerce on the existing Intellectual Property environment or lack of policies for clinical trials, the reputation of the Indian pharmaceutical sector, referred to as the Pharmacy of the World, has only taken a beating.

While the issue will continue to be a high-pitched deliberation for some time in the future, what is important and needs to be understood is that the industry and its regulatory systems needs an overhaul, taking into consideration the current realities, and the road ahead.
The US Food and Drug Administration (USFDA) Commissioner Margaret Hamburg, during her recent 10-day visit to India, not only stressed on the need for Indian drug makers to comply to the global standards, but also announced co-operation from the administration in this regard.

Ms Hamburg may be right in her own wayswhen she said that there is an increasing need for a global coalition of regulators with the Indian Aman Gupta, Health Policy Analyst, elaborates about how Indian pharmaceuticals companies evolves as the true pharmacy of the world No Point in being Rigid side actively participating in global forums.


While not everyone here in India may agree to Ms Hamburg suggestion, one aspect that emerges clearly is the need for the Indian drug makers, the regulator and various other stakeholders to align themselves with global systems and approaches and build an ecosystem that ensures a shift from Access to Medicines to Access to Healthcare.

This may be easier said that done, but here a few baby steps that can be initiated:

*Increased spend by Indian government for health and building of healthcare infrastructure
*Innovative offerings by the health insurance industry considering the spending capabilities of the diverse Indian population
*Delink innovation with access to healthcare
*Greater thrust on awareness and disease prevention
*Collaborative approach between different stakeholder groups

It is high time that we all realize that Access to Healthcare is not just a function of the health ministry. What required today is a futuristic yet realistic blueprint that is able to transform this into reality. As for the Indian pharmaceutical industry, the players need to evolve from just being a manufacturer of generics drugs to a contributor towards ensuring global health. As is the case with all other sectors, it is time that effective steps are taken, not just to move up the value chain, but also focus on the need for innovation to address future needs.

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