In June, European regulators banned products from three plants of an Indian drugmaker they said was ignoring customer complaints over its active pharmaceutical ingredients and whose records were not at all in order. Health Canada followed suit a couple of weeks later, and now the FDA is piling on.
In an import alert, the FDA has banned all human and animal products produced by Polydrug Laboratories at its plant in Maharashtra, India. The FDA does not provide specifics in its import alerts but the report from the European Medicines Agency (EMA) laid out a host of problems that have come up regularly with Indian drugmakers.
Slovenian regulators told the EMA they found 17 deficiencies, 5 of which they listed as major. The inspectors said the drugmaker was "deliberately" not documenting customer complaints. They found problems with cross-contamination and said there were contamination issues with the anesthetic chlorobutanol hemihydrate. It also found that records were not sufficiently protected. Health Canada banned the products citing "data integrity concerns."
Indian drugmakers make about 40% of the generic and over-the-counter drugs imported into the U.S., but in the last 5 years, Western regulators have been cracking down on practices that they say put into question the quality and effectiveness of the products coming out of many Indian drugmakers, including some of its largest. It has bans against plants operated by Wockhardt, the former Ranbaxy Laboratories, now part of Sun Pharma, as well as a legacy Sun plant.
According to Reuters, with the ban on Polydrug, 44 Indian drugmaking facilities are currently banned from shipping products into the U.S. India, which has seen revenues from drug exports significantly cut by the bans, has promised to step up its own oversight of its domestic industry. Its regulatory system remains far behind those in the U.S. and Europe, its biggest customers.