India bans 328 combination drugs in setback for pharma companies

Abbott India

13/09/2018 09:37

NEW DELHI, Sept 13 (Reuters) - The Indian government has
banned 328 combination drugs in a blow to both domestic and
foreign pharmaceutical firms, but the ban has been cheered by
health activists worried about growing antibiotic resistance due
to the misuse of medicines.
    The Indian government had in 2016 banned about 350 such
drugs, referred to as fixed-dose combinations (FDCs), but the
industry mounted various legal challenges that prompted the
Supreme Court to call for a review by an advisory board.
    The health ministry on Wednesday said the board had found
there was "no therapeutic justification for the ingredients
contained in 328 FDCs and that these FDCs may involve risk to
human beings".
    It said it was prohibiting the "manufacture for sale, sale
or distribution for human use" of the 328 FDCs with immediate
effect. It did not name the drugs or give any brands.
    The president of the Indian Drug Manufacturers' Association,
Deepnath Roychowdhury, said the order would have an impact on a
market worth an estimated 16 billion rupees ($222 million) a
year for such drugs, which are produced by both small and large
pharmaceutical companies.
    He said the verdict would be respected.
    Combination drugs are used to improve patients' compliance,
as it is easier to get patients to take one drug rather than
several. 
    But inconsistent enforcement of drug laws in India has led
to a proliferation of such medicines based on state approvals,
rather than from the federal government.
    Health authorities have warned that the increasing use of
antibiotic combinations may be contributing to antibiotic
resistance, with India of particular concern because of the
large volume of combination drugs being taken.
    Malini Aisola of the All India Drug Action Network welcomed
the government ban, saying it was a step towards addressing a
"grave situation". 
    "The people of India have been made the consumers of unsafe
medicines for too long," she said.    
    Companies such as Indian unit of Abbott Laboratories  ABT.N 
 ABOT.NS  had filed court appeals against the government's 2016
order. 
    Abbott did not respond to a request for comment and it was
not immediately clear how the ban would impact it.
    The ministry also said 15 FDCs had been kept out of the
purview of the current ban.  

 (Reporting by Aditya Kalra
Editing by Robert Birsel)
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Messaging: aditya.kalra.thomsonreuters.com@reuters.net (Twitter:
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