Monday, September 6, 2010

WSJ: Delhi's Fake Drug Whitewash

“The (Indian) government's flawed research study endangers lives and crucial pharmaceutical investment.”

Roger Bate, a Legatum Fellow at the American Enterprise Institute and one of Secure Pharma Chain’s favorite international pharmaceutical counterfeiting experts, once again writes an excellent opinion piece in the September 2nd issue of the Wall Street Journal.

Mr. Bate focuses a very critical eye on the Indian Governments Central Drugs Standard Control Organization’s study on spurious drugs within the Indian Supply Chain.

Mr. Bate challenges CDSCO’s sampling methods, the contradictions with past accepted issues and reports of pharmacies likely knowing of inspections in advance.

This is especially worrisome given the fact as Mr. Bate points out that 45% of a Indian’s pharmaceutical market is exported to more than 200 countries and that every second child in the world is vaccinated with a vaccine made in India.

Mr. Bate questions examines CDSCO’s testing and sampling protocols which ultimately he determines to be "a whitewash of a crucial problem".

Highlighted in the WSJ opinion piece:

· The proliferation of fake drugs is one of the greatest dangers facing India today. It threatens lives, discourages patients from using life-saving innovations and deters much-needed pharmaceutical investment. So it's more than a bit worrying to see the Indian government touting a new study that is little more than a whitewash of this crucial problem.

· After literally months of leaks about the results, the "Report on Countrywide Survey For Spurious Drugs" was released by the Central Drugs Standard Control Organization in July. The report, conducted over a period of seven months last year, found that of 24,136 samples, 11 or 0.045%, were fake.

· The CDSCO took pains to point out that their results flatly contradict reports over the past decade from scholars and industry groups claiming fake drug rates ranging from 3% to 35%. Indeed, the author expresses a clear aim to overcome the "apprehensions about the availability of safe and genuine medicines in India."

· But the report's results fail to pass even the most cursory of inspections. Not only are there discrepancies with international studies, but there are unexplained internal inconsistencies which undermine the findings. The report says, for instance, that its authors had no useful information about areas known for counterfeit drugs. This is inconceivable: New Delhi's Bhagirath Palace and certain markets in Agra and Aligarh are known to me, a foreigner, as major locations of the fake drugs trade.

· It's reasonable to assume the report generated untrustworthy findings because the samples were biased. Vijay Karan, a former Delhi police chief, told me that many pharmacists are routinely aware of when and by whom government surveys would be done. The report itself notes retail pharmacists in cities "refused to sale. . . the schedule drug without prescription." But of the 70 or more pharmacies in cities we visited in our studies at the American Enterprise Institute, none demanded prescriptions. Either pharmacists voluntarily and drastically changed policy in the past year—or they were alerted to who the covert buyers really were and reacted by following the letter of the law, not their usual practice.

· Conducting covert surveys requires following a careful protocol. In our peer-reviewed studies for the Public Library of Science One Journal, we were grilled by reviewers about how interviews were conducted, since poor sampling might have biased the results. Yet the CDSCO report includes only a single sentence on the importance of sampling protocols. Nowhere in the report is the drug-collection protocol actually discussed.

In the final analysis, the CDSCO report is a well-conducted analysis of probably dubious data, which makes the results useless. If this were a minor report, that might be a passable error. But given the life-threatening nature of fake drugs, it's not something the government should tolerate. A Pew poll last month found that 54% of Americans distrust drugs made in India. No wonder.

Mr. Bate’s critical analysis of the CDSCO survey is important in that it calls out those who are entrusted with a population's public safety who have fallen short of their responsibility of accurately summarizing this important issue.

Adulterated, fraudulent and counterfeit drugs are an international crime and a health care epidemic; a government that turns a blind eye and chooses to ignore the issue and proclaim a supply chain safe when common sense and history dictates otherwise invites deadly consequences.

Secure Pharma Chain encourages the pharmaceutical supply chain to protect itself by deploying technologies to protect their inventories and defend consumers from bogus, deadly medicines.

To read the entire Wall Street Journal Opinion, visit:

To learn more about anti-counterfeiting technologies, visit:

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