The Singh brothers have appealed against the order in Singapore as well.Rs 3,500 crore.
Roche sued Zydus Cadila and the DCGI last week, alleging that the Indian company launched its product, Vivitra, in the country without generating its own clinical trial data.
This result also implies that substandard drugs sold in India has dipped from 2011-2015, when roughly 4-5% of the total samples were declared substandard.
"India has a high incidence of non-communicable diseases, especially diabetes, and it is mostly because it is poorly regulated," said Sørensen.
The petition states the approval of Cadila’s drug as a biosimilar has caused Roche “irreparable damage” in violation of applicable law for testing and approval of biosimilar drugs.
NPPA’s latest list on defaulters show that total amount outstanding from the industry has snowballed to more than Rs 4,500 crore, ET has found.
The health ministry notified that an investigator can handle as many clinical trials as approved by the Ethics Committee—a reversal from an earlier order.
The Drugs Technical Advisory Board had in May called for a ban on PET for bottling medicines used by children and pregnant women.
Drug companies use PET as it’s lighter and cheaper than glass besides being less prone to breakage, making pharmaceuticals a key market for the Rs 20,000 crore .
Ethics committee, registered with DCGI according to the Drugs & Cosmetics Rules, can also decide whether a site is suitable for conducting these procedures.
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