One hopes that those media houses in Ghana that usually back wealthy wrongdoers in the Ghanaian business world's pharmaceutical sector, when industry regulators sanction such wrongdoers, will read this eye-opening article, and turn over a new leaf - by resolving that, going forward, they will thoroughly investigate all allegations of non-compliance with pharmaceutical industry regulations, made by the Food and Drugs Authority (FDA), against players in the industry.
Most of the pharmaceutical manufacturing companies in Ghana are reputable and ethical companies that strive to maintain the highest standards. However, there are a number of such companies, which cut corners and collude with dishonest overseas pharmaceutical manufacturers, to import fake and untested drugs into Ghana.
When such unethical practices come to the notice of the FDA, and the regulator moves to sanction errant drug importers, for the common good, the media in Ghana must openly back the FDA, if their own investigations confirm the regulator's claims - for the FDA is only acting in the public interest in such cases to save lives: by preventing fake and untested drugs from being sold in Ghana. Please read on:
"Medicines Made in India Set Off Safety Worries
NEW
DELHI — India, the second-largest exporter of over-the-counter and
prescription drugs to the United States, is coming under increased
scrutiny by American regulators for safety lapses, falsified drug test results and selling fake medicines.
Dr.
Margaret A. Hamburg, the commissioner of the United States Food and
Drug Admministration, arrived in India this week to express her growing
unease with the safety of Indian medicines because of “recent lapses in quality at a handful of pharmaceutical firms.”
India’s
pharmaceutical industry supplies 40 percent of over-the-counter and
generic prescription drugs consumed in the United States, so the
increased scrutiny could have profound implications for American
consumers.
F.D.A.
investigators are blitzing Indian drug plants, financing the
inspections with some of the roughly $300 million in annual fees from
generic drug makers collected as part of a 2012 law requiring increased
scrutiny of overseas plants. The agency inspected 160 Indian drug plants
last year, three times as many as in 2009. The increased scrutiny has
led to a flood of new penalties, including half of the warning letters
the agency issued last year to drug makers.
Dr.
Hamburg was met by Indian officials and executives who, shocked by
recent F.D.A. export bans of generic versions of popular medicines —
like the acne drug Accutane, the pain drug Neurontin and the antibiotic
Cipro — that the F.D.A. determined were adulterated, suspect that she is
just protecting a domestic industry from cheaper imports.
“There
are some people who take a very sinister view of the F.D.A.
inspections,” Keshav Desiraju, India’s health secretary until this week,
said in a recent interview.
The
F.D.A.'s increased enforcement has already cost Indian companies dearly
— Ranbaxy, one of India’s biggest drug manufacturers, pleaded guilty to
felony charges and paid a $500 million fine last year, the largest ever
levied against a generic company. And many worry that worse is in
store.
“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 unease culminated Tuesday
when a top executive at Ranbaxy — which has repeatedly been caught
lying to the F.D.A. and found to have conditions such as flies “too
numerous to count” in critical plant areas — pleaded with Dr. Hamburg at
a private meeting with other drug executives to allow his products into
the United States so that the company could more easily pay for fixes.
She politely declined.
India’s
drug industry is one of the country’s most important economic engines,
exporting $15 billion in products annually, and some of its factories
are world-class, virtually undistinguishable from their counterparts in
the West. But others suffer from serious quality control problems. The
World Health Organization estimated that one in five drugs made in India are fakes. A 2010 survey of New Delhi pharmacies found that 12 percent of sampled drugs were spurious.
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 100,000 useless pills continued to be dispensed.
More
tests of hospital medicines found dozens more that were substandard,
including a crucial intravenous antibiotic used in sick infants.
“Some
of the fake tablets were used by pregnant women in the post-surgical
prevention of infections,” said Dr. M. Ishaq Geer, senior assistant
professor of pharmacology at the University of Kashmir. “That’s very
serious.”
Investigations of the deaths are continuing, but convictions of drug counterfeiters in India are extremely rare.
Satish
Reddy, president of the Indian Pharmaceutical Alliance, said Indian
drug manufacturers were better than the F.D.A. now contends. “More
rigorous enforcement is needed, for sure, but this impression that India
is overrun with counterfeits is unjustified,” Mr. Reddy said.
But
Heather Bresch, chief executive of Mylan, which has plants in the
United States and India, said regulatory scrutiny outside the United
States was long overdue. “If there were no cops around, would everyone
drive the speed limit?” Ms. Bresch asked. “You get careless, start
taking risks. Our government has enabled this.
For
Dr. Hamburg, the trip is part of a long-running effort to create a
global network of drug and food regulators to help scrutinize the
growing flood of products coming into the United States, including 80
percent of the seafood consumed in the United States, 50 percent of the
fresh fruit, 20 percent of the vegetables and the vast majority of
drugs.
She
has gone to conclaves of regulators from Europe and elsewhere to
coordinate policing, but Indian officials have so far not attended such
meetings.
Many
of India’s drug manufacturing facilities are of top quality. Cipla, one
of the industry’s giants, has 40 plants across the country that
together can produce more than 21 billion tablets and capsules annually,
and one of its plants in Goa appeared just as sterile, automated and
high tech on a recent tour as those in the United States.
Cipla
follows F.D.A. guidelines at every plant and on every manufacturing
line, and the company exports more than 55 percent of its production,
said Yusuf Hamied, the company chairman.
But
Benjamin Mwesige, a pharmacist at the Uganda Cancer Institute in
Kampala, said in an interview in July that the institute had stopped
buying cancer drugs from India in 2011 because it had received shipments
of drugs that turned out to be counterfeit and inactive, with Cipla
labels that Mr. Mwesige believed were forged.
He
became suspicious when doctors began seeing chemotherapy patients whose
cancer showed none of the expected responses to the drugs — and who
also had none of the usual side effects. The drugs that had been
prescribed were among the mainstays of cancer treatment — methotrexate,
docetaxel and vincristine.
Laboratory tests confirmed that the drugs
were bogus, and Mr. Mwesige estimated that in 2011 20 percent of the
drugs that the institute bought were counterfeit.
Enforcement
of regulations over all is very weak, analysts say, and India’s
government does a poor job policing many of its industries. Last month,
the United States Federal Aviation Administration downgraded India’s aviation safety ranking because the country’s air safety regulator was understaffed, and a global safety group found that many of India’s best-selling small cars were unsafe.
India’s
Central Drugs Standard Control Organization, the country’s drug
regulator, has a staff of 323, about 2 percent 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.
This
absence of oversight, however, is a central reason India’s
pharmaceutical industry has been so profitable. Drug manufacturers
estimate that routine F.D.A. inspections add 25 percent to overall
costs. In the wake of the 2012 law that requires the F.D.A. for the
first time to equalize oversight of domestic and foreign plants, India’s
cost advantage could shrink significantly.
Some top manufacturers are already warning that they may leave, tough medicine for an already slowing economy.
“I’m
a great nationalist, an Indian first and last,” Dr. Hamied said. “But
companies like Cipla are looking to expand their businesses abroad and
not in India.”
American
businesses and F.D.A. officials are just as concerned about the quality
of drugs coming out of China, but the F.D.A.'s efforts to increase
inspections there have so far been frustrated by the Chinese government.
“China
is the source of some of the largest counterfeit manufacturing
operations that we find globally,” said John P. Clark, Pfizer’s chief
security officer, who added that Chinese authorities were cooperative.
Using
its new revenues, the F.D.A. tried to bolster its staff in China in
February 2012. But the Chinese government has so far failed to provide
the necessary visas despite an announced agreement in December 2013
during a visit by Vice President Joseph R. Biden Jr., said Erica
Jefferson, an F.D.A. spokeswoman.
The
United States has become so dependent on Chinese imports, however, that
the F.D.A. may not be able to do much about the Chinese refusal. The
crucial ingredients for nearly all antibi4otics, steroids and many other
lifesaving drugs are now made exclusively in China.
Denise Grady contributed reporting from Kampala, Uganda, and Hari Kumar from Srinagar, Kashmir."
End of culled article from the New York Times, by Gardiner Harris. It was published in the online version of the New York Times on 14th February, 2014.
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