Sun Pharmaceutical, Abbott, AstraZeneca, Lupin and Boehringer Ingelheim have come under the scanner of India's National Pharmaceutical Pricing Authority (NPPA) for excluding products from the price control regime without first applying for such an exemption, reported The Economic Times.
The NPPA noted that the companies had launched anti-diabetes drugs under para 32 of the Drug Price Control Order (DPCO), without submitting the requisite application.
"Self-invoking of para 32 of DPCO 2013 would tantamount to bypassing the regulatory framework and lead to chaos in product pricing, grievously impacting choices before the hapless consumers," said the NPPA.
The companies have been asked to provide data on manufacturing, import and sales since the launch of the products, with the NPPA indicating it "shall take further necessary action as applicable."
Responding to the query, AstraZeneca said it is fully compliant to DPCO 2013 and has been in touch with regulatory authorities regarding the launch of these products, adding "we have not received a show-cause notice or any notice seeking information on data pertaining to manufacturing, import, sales etc. of these drugs from NPPA [to] date."
However, the NPPA claims that Lupin and Boehringer Ingelheim had launched empagliflozin-metformin combination tablets and Sun Pharma and AstraZeneca had launched dapagliflozin-metformin combination tablets without seeking prior approval.
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