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 India's Cipla stopped making the product last year owing to
regulatory demands, and U.S.-based Abbott Laboratories and Pfizer
have had to reduce batch sizes by up to half, cutting how much
medicine their factories can produce.
But they are pushing back against other demands, a Reuters review of
correspondence between companies and regulators showed, including
selling one batch to only one buyer and printing labels that specify
where the drug would be sold. Regulators want to make it easier for
law enforcement agencies to track cough syrup abuse in the country
and bottles smuggled to neighboring Bangladesh, where it was banned
in the 1980s but is still sought by addicts.
Retailers worried about liability from potential abuse by people
addicted to the opiate codeine are in some cases refusing to stock
the cough syrup, said J.S. Shinde, president of pharmaceutical lobby
group All India Organization of Chemists and Druggists.
Sales of the drug in India fell 4 percent to 121 million bottles in
the year through August, and 15 percent in the year before,
according to IMS Health, a healthcare statistics provider. For drug
regulators, the challenge is to strike a balance.
"Any non-therapeutic usage is a concern, but you have to weigh the
risks versus benefits," said an official at the federal drugs
controller in New Delhi.
RISING COSTS
According to an industry executive, the likes of Pfizer and Abbott,
who control most of the $103 million market for the drug, face a
"significant" increase in costs as plants run well below capacity
because of changes demanded of them. And the regulatory regime could
get tougher.
According to minutes of a July meeting of state and federal drug
regulators, there was a recommendation to ban the sale of the syrup
altogether because of "rampant misuse and its illegal exports to
neighboring countries."
"A large number of regulators were in favor of strict control," said
Akun Sabharwal, drugs controller for southern Telangana state, who
attended the meeting.
The federal drugs official, who spoke on condition of anonymity,
said an outright ban would not be easy to impose, given the
medicine's importance. Abbott estimates roughly 60 million people
suffer from regular dry cough in India. Pfizer's India unit said in
a statement the company takes all steps to maintain the highest
standards of regulatory compliance, including supply-chain audits.
Abbott India said they believed existing Indian drug laws were
adequate to control the abuse and the company had taken steps to
support enforcement agencies.
RUINED LIVES
Last year, the International Narcotics Control Board (INCB) billed
the abuse of medicines containing narcotics and their smuggling from
India among the "greatest drug-related challenges" facing South
Asia.
About 83,000 bottles of codeine-based cough syrups were seized in
India in the six months through March. In meetings with companies,
Indian regulators called the "menace of abuse" a "growing concern".
Abuse is particularly common in Bangladesh. At a treatment center in
the capital Dhaka, tales abound of ruined careers and family
struggles.
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A 40-year-old former banker at the Bangladesh Rehabilitation and
Assistance Center for Addicts said his addiction was so bad he felt
he loved cough syrup more than his four-year-old son. "I felt I must
recover from this menace," he said, requesting anonymity because of
the shame associated with addiction.
The regulatory crackdown in recent years appears to have curtailed
smuggling. About 750,000 bottles were seized in Bangladesh in 2014,
24 percent lower than 2013, the INCB said.
Still, a fifth of Bangladesh's estimated 4 million drug users are
addicted to such syrups, said Sayedur Rahman, a professor at the
Bangabandhu Sheikh Mujib Medical University.
Inside Bangladesh, the cost of a bottle has more than tripled,
indicating scarcity. Still, drug officials say the problem is
underreported and more should be done.
INCREASING PRESSURE
The latest crackdown on companies dates back to at least February
2014, the review shows.
Indian narcotics officials told companies to take several measures,
including reducing batch sizes and printing where it would be sold
on the label.
They also asked them to sell drugs from one batch to one stockist
only, a measure the executive said was impractical.
That summer, regulators temporarily held back Cipla's allocation of
codeine, manufactured solely in government factories, after the
company failed to inform the government about steps it had taken to
comply with the directive. Cipla said it never received the request
for information.
A Cipla spokeswoman said the company stopped making the drug last
year after "considering the business environment ... and the fact
that this product was regulated by multiple agencies."
At another meeting in October, government officials again pressured
pharmaceutical companies to comply with their demands.
In August this year, regulators sent a letter asking for updates on
further steps they had taken, an industry executive said.
(Additional reporting by Serajul Quadir in Dhaka; Editing by Mike
Collett-White)
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