E-Drug: Banned Fixed Dose Combination Antibiotic Marketed in India
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Dear E-druggers,
I am copying a news item at the end of this note which mentions that a
banned fixed-dose combination combination of cefixime and azithromycin
antibiotic is being marketed in India by Abbott and at least 15 domestic
companies. What appears to be surprising is that this product is being
supposedly marketed without approval from the central government and for
indications such as cold.
It will be interesting to know if this FDC antibiotic is being exported by
Indian companies in other countries.
Perhaps E-druggers can email me in private and I will post an email with the list of countries as a follow-up to this email.
Thank you,
Rizwan
Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP
Consultant with a Special Interest to Strengthen
National Medicines Regulatory Authorities in Resource-limited Settings
Ex-Consultant/Safety Reviewer, U.S. FDA (1998-2013)
Associate Professor (adjunct), Rutgers School of Public Health, NJ, USA
Assistant Professor (adjunct), Georgetown University School of Medicine,
Washington, DC, USA
Syed Ahmad <drugsafetyconsultant@gmail.com>
Sun Mar 13, 2016 6:02pm IST
Antibiotic combination marketed by Abbott in India on list of banned drugs
MUMBAI | BY ZEBA SIDDIQUI AND ADITYA KALRA
A powerful antibiotic combination that is marketed in India by U.S.
pharmaceutical giant Abbott Laboratories is among 344 drug combinations
that have been banned by the Indian health authorities.
A Reuters investigation revealed in December that a unit of Abbott in India
was selling a combination of the antibiotics cefixime and azithromycin
without approval from the central government. The combination is not
approved for sale in major pharmaceutical markets, including the United
States, United Kingdom, Germany, France and Japan.
Abbott markets the combination of cefixime and azithromycin under the
Zimnic AZ brand. At least 15 other companies in India manufacture and
market the same combination under different brand names.
A notice issued by the Indian Health Ministry at the weekend said that a
government-appointed committee of experts had found that the banned
combinations were 'likely to involve risk to human beings, whereas safer
alternatives to the said drug are available.'
The government notice said the ban would take effect immediately. Besides
antibiotic combinations, the list of banned drugs also included analgesic
combinations containing nimesulide, and codeine-based drugs.
Anand Kadkol, a spokesman for Abbott in India, said the government
announcement had been made late on Saturday and the company was 'reviewing
the notification.'
Fixed-dose combination drugs, or FDCs, combine two or more drugs in a
single pill. In India, many pharmaceutical companies have obtained a
license from a state to make FDCs, like Abbott's Zimnic AZ, and sell them
across the country without the consent of the central government.
India's drug regulators have made intermittent efforts over the years to
shut down this avenue, but enforcement has been patchy and success limited.
In 2007, for instance, the government instructed states to withdraw close
to 300 combination drugs that were being sold without the approval of the
central government. But drug companies and industry associations took the
government to court and the order was stayed.
D.G. Shah, the secretary general of the Indian Pharmaceutical Alliance,
which represents 20 of India's biggest drugmakers, questioned the legality
of the government's decision and said 'the lack of transparency raises
doubts about the merits and the process followed or not followed.'
Shah said companies that were affected by the ban could challenge the order
in court.
K.L. Sharma, a senior Health Ministry official who issued the ban order,
was not immediately available for comment.
In its notice, the government said a panel of experts had found that there
was 'no therapeutic justification' for any of the 344 FDCs it was banning.
The panel reviewed 6,700 drug combinations.
In its investigation, Reuters interviewed former and current medical
representatives for Abbott who said Zimnic AZ had been promoted and
administered as a treatment for a broad array of illnesses, including
colds, fevers, urinary tract infections, drug-resistant typhoid and
sexually transmitted diseases. Reuters also found chemists who were selling
the drug to prevent post-operative infection and for respiratory problems.
Medical experts told Reuters that combining cefixime and azithromycin was
risky, and said that prescribing the combination for cold symptoms did not
make sense.
While combination drugs are used worldwide to improve patients' compliance,
in India they have proliferated to the point where in 2014 nearly half the
drugs on the market were combinations. Companies in India have increasingly
added ingredients to existing drugs so they can promote a new product to
doctors and chemists in an effort to increase market share.
Doctors and health experts say the spread and misuse of antibiotic
combinations may be contributing to antibiotic resistance in India. Some
superbugs, which are strains of bacteria that have become resistant to
antibiotics, have been found in patients who traveled from India to
countries including the United States and Britain.