India's CDSCO issues flurry of fixed-dose application bans

SINGAPORE--India's Central Drugs Standard Control Organisation (CDSCO) has named and shamed several companies for submitting falsified data on fixed-dose combination and New Drug Applications.

Among those banned from submitting any applications for 5 years was an earlier reported Kivi Labs, and also named was Arion Healthcare. The agency has also ordered a review of all applications submitted by a Dr. Shahbaz, the owner of Meher Pharma International, after it was discovered that he had submitted "fabricated documents" in support of a number of new drug applications.

- here are the CDSCO's notifications on Kivi, Arion, and Shahbaz (PDF)