Biotech Values

[DewDiligence]

India’s Fake Drugs Are a Real Problem—Part Deux

This is a cover story in today’s NY Times; the title above is mine, not theirs, but I think it applies. (The 2010 article in #msg-50473238 is “part one.”)

The problem described in this article is the premise for ABT’s (not ABBV’s) becoming the leading supplier of branded generic drugs in India, a business that has a very high profit margin, according to ABT’s most recent quarterly CC.

http://www.nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html

“If I have to follow U.S. standards in inspecting facilities supplying to the Indian market,” G. N. Singh, India’s top drug regulator, said in a recent interview with an Indian newspaper, “we will have to shut almost all of those.”

…The World Health Organization estimated that one in five drugs made in India are fakes. A 2010 survey of Delhi pharmacies found that 12 percent of sampled drugs were spurious. [These factoids are consistent with what was stated in #msg-50473238.]

In one recent example, counterfeit medicines at a pediatric hospital in Kashmir are now suspected of playing a role in hundreds of infant deaths there in recent years. One widely used antibiotic was found to contain no active ingredient after being randomly tested in a government lab. The test was kept secret for nearly a year while some 100,000 useless pills continued to be dispensed.

…Investigations of the deaths are continuing, but convictions of drug counterfeiters in India are extremely rare.

…India’s Central Drugs Standard Control Organization, the country’s drug regulator, has a staff of 323, about 2% [!] the size of the F.D.A.'s, and its authority is limited to new drugs. The making of medicines that have been on the market at least four years is overseen by state health departments, many of which are corrupt or lack the expertise to oversee a sophisticated industry. Despite the flood of counterfeit drugs, Mr. Singh, India’s top drug regulator, warned in meetings with the F.D.A. of the risk of overregulation.