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 Whether the sample of Abbott's popular "Phensedyl" was a genuine
product or a fake has not been established, but the suspect batch of
80,000 bottles has not been recalled.
The state laboratory in West Bengal first raised the alarm last
November.
The previously unreported case underlines the weakness of India's
unwieldy and poorly resourced drug and food regulatory system, the
uncertainty it creates for foreign and domestic companies operating
there and the potential risk to consumers.
Abbott Healthcare is a unit of U.S.-based Abbott Laboratories.
Abbott Laboratories also has a listed subsidiary in India, Abbott
India Ltd.
Three months ago, Nestle was forced to withdraw its Maggi instant
noodles from Indian shelves because the food safety authority banned
the snack after its tests showed excess lead.
A court later overturned the ban in a partial victory for the Swiss
food giant, but the allegations hurt the company's reputation and
that of the country's regulators, who operate with few staff and
poorly equipped facilities.
In the latest dispute, the laboratory found that a sample of
Phensedyl contained more than twice the labeled amount of codeine,
according to several state drug officials and correspondence between
regulators and Abbott seen by Reuters.
Phensedyl sales are estimated to be more than 3 percent of Abbott's
$1 billion India revenue. The sales are dwarfed by Abbott's global
annual sales of over $20 billion, but, as the Nestle case shows,
fallout from safety scandals is unpredictable.
The excessive codeine, an opium derivative, would violate Indian
drugs law. It triggered a "show cause" notice against Abbott, which
was sent in March by the drug regulator in Himachal Pradesh state,
where Phensedyl is manufactured.
In its response in late April, Abbott denied the allegations and
urged regulators to not take any action. Abbott said it had found
nothing unusual in its own and third party testing of a retained
sample from the same batch of Phensedyl.
The company also asked regulators to give it more information about
the source of the suspect sample and the manner in which it was
collected, so that it could establish whether it was genuine and
proper process was followed.
"We are awaiting response from the authorities," the company said in
answer to Reuters questions.
DRUG SEIZURE
The original test was carried out by West Bengal after Phensedyl
bottles were seized near the border with Bangladesh, said Samit Saha,
a state drug inspector involved in the case.
Codeine-based cough syrups are banned in Bangladesh, and smuggling
is rife as people profit from higher prices there compared to India.
According to a copy of the inspector's report, the sample contained
21.37 mg of codeine per 5 ml dosage, instead of 10 mg specified on
the label.
Saha said two other samples from different batches, however, showed
normal codeine levels.
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Excessive consumption of cough syrup with high levels of codeine can
lead to health implications such as sedation, behavioral changes and
drug dependence, said Amitabh Parti, a doctor at Fortis Memorial
Research Institute.
In February, West Bengal listed the potentially tainted batch as
"not of standard quality" in a monthly publication.
The bulletin, which is posted on the regulator's website, is
supposed to alert consumers and pharmacies in the state to suspect
drugs. But the West Bengal drug controller, C. M. Ghosh, said he
does not have the resources to follow it up.
STATES OF CONFUSION
Navneet Marwaha, the drug controller in Himachal Pradesh, said in an
interview that Phensedyl, which accounts for about a third of the
Indian cough syrup market, is often copied by counterfeiters. He
said Abbott's stocks of codeine were accounted for.
"They (Abbott) are saying 'show us the sample so we can see whether
it is genuine.' They have not been provided with the sample,"
Marwaha said.
He added that it was up to West Bengal to provide the information to
Abbott.
West Bengal's Ghosh said it was Himachal Pradesh's prerogative and
the company can only challenge the test's findings at a federal drug
lab with a court's permission.
Safety breaches and scares are common in India. According to a 2012
parliamentary report, nearly one in 22 locally produced drug samples
is of sub-standard quality in India.
India has just 1,500 drug inspectors responsible for more than
10,000 factories, supplying medicines for a population of 1.2
billion and exporting to nearly 200 countries.
Ghosh said he has 140 drug inspectors to monitor more than 50,000
pharmacies in the state.
The federal government wants to improve regulation of the key
sector, and plans to spend $263 million in the next three years to
strengthen the national and state regulatory system with additional
equipment and staff and new laboratories.
(Additional reporting by Sujoy Dhar in Kolkata and Zeba Siddiqui in
Mumbai; Editing by Mike Collett-White)
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