Drug Regulatory In India

US Pharmaceutical Companies Testing Drugs on India's Poor

U.S. pharmaceutical companies have moved their operations overseas in the past decade, testing their drugs on poor people in such lands as Russia, China, Brazil and Romania. It is a $30 billion business, and today around 105 countries are allowing such large corporations as Merck and AstraZeneca to conduct clinical trials on their soil.

One country that has experienced a boom like no other in this industry is India, with its widely spoken English, an established medical infrastructure and welcoming attitudes towards foreign industry. Most importantly, these pharmaceutical companies are exploiting the country’s vast number of illiterate and poor people who are willing to become guinea pigs.

Zeina Awad, a reporter for Al Jazeera’s “Fault Lines” program, traveled to India to investigate clinical research being conducted there. She explored what role the United States regulatory agencies are playing in overseeing the clinical trials, and whether the testing complies with international ethical standards. 

Her report, “ Outsourced: Clinical Trials Overseas,”  aired on Al Jazeera English recently. 

New America Media Health Editor Viji Sundaram interviewed Awad about what she found.

Viji Sundaram: Your report seems to suggest that a combination of poverty and inadequate public health care is what drives many Indians to enroll in clinical drug trials as guinea pigs. Do they actually know what they are getting into?

Zeina Awad: The growth of the clinical-trial industry in India needs to be seen within the social and economic context of the country. According to the United Nations, 40 percent of people in India are illiterate. The gap between rich and poor continues to grow. Many risk not knowing whether the treatment their doctor is prescribing is [a proven] treatment or a part of a clinical trial. That aside, it’s also important to remember that in certain societies – and India is one of them – doctors are respected to the point of being revered. Their word is rarely questioned, so the likelihood of a person questioning their doctor about specific treatments is low.

Economics plays a role in a person’s decision-making. We met a young man in the impoverished community of Dharavi (Asia’s largest slum) in Mumbai, who told us that he enrolls in clinical trials as a way to make a living because he makes more money that way then when he works as a laborer. He also told us that he has many friends who do the same. Most of them don’t tell their families because there is some shame associated with doing this.

EU may relax generics drug transit shipment regulations ...

India’s dispute with the European Union over the passage of generics drugs through EU territory is close to a resolution, or so it appears. The dispute dates back to 2008 when the EU began seizing drug shipments, of generic drugs being shipped to countries via the EU. India’s position as a leading supplier of generic drugs saw it being one of the worst affected.

India and Brazil (which was one among the countries these consignments were intended for) went to the World Trade Organisation to settle the dispute, as their initial approaches to the EU regulatory authorities met with little success. Subsequent to this, both parties appear to have moved towards reconciliation and have worked out what India’s commerce ministry calls an informal settlement. Interesting, India and the EU are also in talks for a bilateral free trade agreement, which would confer benefits on both parties, but open India’s markets for imports from the EU.

According to a release from the commerce ministry, the European Commission sent them a letter on 17 June 2011, proposing a settlement by confirming the agreed upon principles pertaining to enforcement of intellectual property rights at the border by customs authorities. It has also agreed to include these principles as part of a proposal to amend the existing regulations, Regulation 1383/2003.

The core principle that India wants to see in the regulation is that mere transit of medicines through an EU country, even if these medicines have patent protection in that country, should not be sufficient grounds for suspecting patent infringement. That is, the customs officials cannot confiscate the goods merely because they violate a patent valid in that country. But this is not an absolute rule. If there is reason to believe that the goods could be diverted into the EU market, then they can be suspected of patent infringement and action taken, including seizure.

The change to the regulations has been proposed and has been sent to the European parliament for approval. Once it comes back, it will become law.

But it is implementation that counts, especially because a call needs to be taken whether the officials believe there is scope for diversion. Still, the fact that the officials may have to exercise more diligence in determining patent infringement should lower the incidence of such cases.

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