Indian court temporarily blocks government ban on sales of FDCs
- After the Indian Health Ministry banned 344 questionable fixed-dose combinations (FDCs) on March 10, a number of pharmaceutical companies pushed back and requested court intervention. The Delhi High Court has issued a stay on the ban until March 28.
- The companies made the case that the notification was done without issuing them a "show cause" document.
- The companies that manufacture the FDCs, including Abbott Labs Pfizer, Cipla, Mannkind, Glaxo SmithKline and others, want the drugs to be reviewed on a case-by-case basis. Since that will take time, Judge Rajiv Sahai Endlaw has ordered that the next hearing be put off until March 28.
For almost a decade, the Indian Health Ministry has been trying to clamp down on the FDC market, because in many cases the combo drugs in question are approved by state authorities but not by the central regulatory authorities in India.
After the health ministry ordered that the drugs be banned, Pfizer was the first company to approach the court regarding its cough syrup, Corex. It got the ban temporarily lifted, and soon 30 other companies followed Pfizer's lead and also got the ban stayed until the court hearing.
In response to the court's decision to stay the ban, the government issued an affidavit saying that the stay is "against the public interest" and could endanger patient safety, according to a report from Reuters.