To check the import of unauthorised active pharmaceutical ingredients (APIs) from China, India may send drug inspectors to examine certain bulk drug production units there. “There were reports that some companies were importing APIs produced at unauthorised manufacturing units in China. We have sent a proposal to the commerce ministry to send a team of drug inspectors to get the real picture,” a senior government official said on the condition of anonymity. Active pharmaceutical ingredients are the raw materials used for producing medicines meant for human as well as veterinary purposes.
Following similar reports, national drug regulator Drug Controller General of India had cancelled the import registration of 10 APIs from China last week. “... We have found that certain Chinese companies are exporting bulk drugs to India at very cheap prices. And later, after some investigation, it was found that these APIs were manufactured at facilities that were not certified by any agency,” the official said.
The official, however, did not disclose names of either companies, or imported APIs. According to the information available, this is the first time that India will send drug inspectors to another country to check their facilities.