Earlier this month, India’s Department of Health and Family Welfare issued a notification in its public journal the Gazette of India banning 344 fixed dose combination (FDC) drugs.
Among the products banned was Sanofi’s Amaryl MP, used to lower and control the blood sugar levels in patients with type 2 diabetes, which comprises of the active ingredients glimepiride, metformin, and pioglitazone.
The Government claiming that the use of the drug fixed dose combination “is likely to involve risk to human beings whereas safer alternatives to the said drug are available.”
The notification continued: “The Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug fixed dose combination of Glimepiride + Pioglitazone + Metformin with immediate effect.”
Sanofi India, however, is disputing the order. According to a letter submitted to the Bombay Stock Exchange (BSE) yesterday the firm filed a Writ Petition on March 19 in the Delhi High Court, which has delayed pursuing the impugned notification.
“Accordingly, the notification under which the Company’s product Amaryl MP is sought to be covered, will not be enforced until 28th March 2016,” Sanofi India said in its letter.
The firm also said that if the ban on manufacture was to stand, the product will not have any material impact on the firm’s financial statements.
“The turnover of the said product constituted only around 0.40% of the turnover of the Company for the financial year ended 31st December 2015.”
In-Pharmatechnologist.com received no response from both Sanofi and Sanofi India on either the Writ, or the production of Amaryl MP.
According to a Facebook post by the Chandrapur Chemist & Drugist Association, the Notification has affected products made from companies including Piramal Healthcare, Wockhardt, Novartis India, Zydus Cadila Healthcare and Lupin Laboratories.