In an interview with in-PharmaTechnologist.com, India’s Deputy Drug Controller, S. Eshwar Reddy, said some pretty honest – and frightening things about his nation’s perspective on global good manufacturing practices (GMP) – or purposeful lack thereof.
When asked if Indian manufacturers -- which produce more than 40 per cent of the API used in the US and Europe -- should be more sympathetic with Western guidelines and regulations, Reddy said the opposite should be true.
He said any additional requirements made are the sole responsibility of the authority which issues them.
“If the importing country has specific GMP requirements, that is their responsibility to audit the facilities. It is the responsibility of the importing country not the exporting country.”
Talk about passing the rupee.
“Being the Indian drug regulatory authority we don’t have any monitoring mechanism of other countries’ regulations. Each country has their own set of laws so Indian regulatory authorities don’t have any control.
So much for global regulatory fraternity.
