In order 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 are 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
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 the name of either the companies, or the 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.
The practice of sending drug inspectors to other countries before allowing them to export goods is strictly followed in developed countries such as US, UK and Japan, where even a slight deviation from the set benchmark is not tolerated.
India mostly imports anti-infective bulk drugs from China.