[Ip-health] Novartis may be fined for submitting 'fake' document to Drug Controller General of India

Shailly Gupta shailly.gupta at geneva.msf.org
Tue Mar 4 22:14:30 PST 2014



NEW DELHI: Swiss drug innovator firm Novartis may face penalties in India
for submitting 'fake' document to the Drug Controller General of India
(DCGI) for a veterinary medicine. The

Indian arm of Novartis has admitted before the DCGI that it had submitted a
document that was later found to be 'fake' with regard to its site of
manufacturing for Tiamulin Hydrogen Fumarate

(80% granule). 


Top officials of Novartis India, who appeared during a hearing in the drug
regulator's office last week, have 'tendered an unconditional apology for
the commission of the act', according to an

order passed by the DCGI and reviewed by ET. 


The drug regulator has cancelled the import licence and registration for the
drug used for respiratory problems in animals and ordered its immediate
recall from the market, said the

order. The matter of furnishing a fake certificate to get registration of a
drug has been forwarded by the watchdog to the health ministry for further
'legal action'. A Novartis spokesperson told ET that its application for the
re-registration of the drug has been rejected by the DCGI. 


"While we will reapply for the registration, Novartis had already stopped
further marketing and distribution of the product," she said, adding that
the company has a "strong code of conduct with zero tolerance for


The drug regulator has also identified another 26 of Novartis' imported
products, documents of which are being assessed for their authenticity at


The DCGI may follow up the investigation with inspection at some of the
company's European manufacturing sites, according to another order of the
drug regulator reviewed by ET. 

The development comes at a time when manufacturing facilities of many Indian
pharma companies have also been hauled up by the US drug regulator for 'data
integrity' violations that has resulted in import ban on a number of plants.
Novartis has annual sales of $58 billion globally while its Indian arm, a
listed entity, earns Rs 900 crore yearly. The Indian drug regulator became
suspicious of the document that claimed the drug was manufactured in one of
its Austrian facility at Tyrol after it spotted another application of the
company displaying an identical certificate number, but citing a different
manufacturing site at Trento, Italy. 


Subsequently on the drug regulator's request, director, European Directorate
of Quality Medicine, Council of Europe, confirmed its suspicion and said
that the certificate of Novartis claiming that the drug was manufactured at
its Austrian site was 'fake'. A DCGI team of four officials headed by deputy
drug controller K Bangarurajan conducted an inspection at Novartis India's
office in Mumbai for four days towards the end of January to get to the
bottom of the matter. The mail from the headquarters said that the company
is requesting EDQM for a fresh certificate for the drug now.




Shailly Gupta

Advocacy and Communication Officer

MSF Access Campaign

K-30 First Floor, Jangpura Extension

New Delhi -  14

Ph: +91-11-41823783/84

M: +91-9899976108


Please sign MSF's DR-TB Manifesto today:
<http://www.msfaccess.org/TBManifesto> www.msfaccess.org/TBManifesto







More information about the Ip-health mailing list