Coming clean for World Environment Day
Ever since it was first celebrated in 1973, UNEP has used World Environment Day (June 5) to create awareness around environment-related challenges. Our June 1-15 issue attempts to provide a status check on the efforts of the pharmaceutical industry on this front. We are happy to report that there seems to be a genuine attempt among Indian pharma companies to come clean; never mind if its really their exports that are driving this change rather than any real concern for Mother nature.
In fact, Andhra Pradesh, one of the key defaulters on this front, bagged top honours in the Environmental Performance Index in 2012. But pharma companies claim that while they have upgraded to some of the latest technologies, the regulators are still stuck in a time warp. (See stories, Thinking green, page 9 and Effluents: Treating it with technology, page 32).
Similarly, a TARI report (See Sustainability in pharma supply chain, page 21) on the regulatory mechanisms of two states — Maharashtra and Gujarat, two pharma hubs — shows that there are few efforts to monitor if such norms are followed by the small and medium enterprises (SME) in this sector. With Ranbaxy’s recent $500 million fine still in the news, it is all the more imperative for regulators to monitor pharma SMEs before larger companies who source from them fail global compliance norms.
Whether its rules for pollution control or clinical research and trials, industry has a common grouse. Regulators ignore the warning signs of shady practices until they are forced to react, thanks to activists’ PILs or parliamentarians who seize the opportunity to appease vote banks. Regulators then swing to the other extreme, drafting and releasing laws, without thinking them through.
Clinical research in India is presently going through one such phase and May 20, International Clinical Trials Day, saw yet another effort by industry to give clinical research a fresh context.
To mark the occasion, the Indian Society for Clinical Research (ISCR) chose to ‘highlight the positive difference’ made by clinical research at a panel discussion held in the KEM Hospital campus. The audience was an assorted mix: mostly clinicians, clinical researchers, representatives of CROs, a few reporters. Going with the chosen theme, the panelists made the pitch that perceptions of clinical research and trials needed to change in India.
(See full coverage at this link: http://pharma.financialexpress.com/latest-updates/2181-a-positive-spin-to-clinical-research).
But beyond the usual rhetoric, the discussion served to further air some key issues. It was interesting to see how stakeholders at different ends of the process viewed the same crucial step: the informed consent. While a cancer survivor was OK with a filming of the consent process, others were wary of the logistical nightmare of archiving and transferring this audio visual documentation, what level of AV equipment doctors would need (an investigator seemed skeptical whether his clinic could ever morph into a studio), etc.
The compensation guidelines seemed to be the other big concern, leading to a lively debate on when compensation became inducement and who drew that line.
The consensus was that there needs to be India-centric guidelines and here may I add my two bits to the debate. As a representative of the media, I would like to see these same companies coax their parent companies to adopt India-centric guidelines when it comes to dealing with the lay public and media. Whatever the mandated degree of separation between spokesperson and press/lay public followed by their global offices, if they can agree to more transparency, they will certainly inspire more trust.
At the panel discussion, the suggestions went back and forth, and it became clear that each stakeholder knew best what the other needed to do. But as is so often the case, any transformation has to start from within. We really have to be the change we want to see.
Viveka Roychowdhury
Editor
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