- The Indian Health Ministry has banned nearly 350 fixed-dose combination (FDCs) drugs because of the likely risk of harm to humans, the Times of India reports. Abbot Laboratories' Aimnic AZ brand, a combination of the antibiotics cefixime and azithromycin, was one of the banned FDCs, as was Pfizer's Corex cough syrup.
- Some Indian companies have been aggressive in creating FDCs, which combine two or more drugs in one tablet. Usually used to boost patient compliance, FDCs made up almost half of all drugs on the market in India, according to Reuters.
- However, many of these drugs are not approved by the Indian Health Ministry. Instead, companies have apparently relied on state approvals for one FDC and then sold the drug nationwide.
This is not the first time the Indian government has attempted to clamp down on the permissiveness surrounding FDCs. In 2007, the central government told state governments to withdraw almost 300 FDCs from the market—but the industry took the government to court and the order was not implemented.
A similar outcome may already be developing. Reuters reported an Indian court had granted a stay on the ban of Pfizer's Corex cough syrup, citing Indian TV channels.
But here's what has changed: Although the Indian biopharma industry is robust and growing rapidly, it is also facing an unprecedented amount of negative publicity because of ongoing quality-related issues at its plants and facilities. Problems range from product recalls to revoked approvals, hundreds of millions of dollars in fines, and falsified data.
FDA surveillance has been high recently. The US regulator currently lists 42 Indian firms on its import ban list and has sent warning letters to a number of major firms over the past year.