Updated on 10 March 2014
The release said harmonization of regulatory standards has not yet been achieved even among the three major regions - North America, Europe and Japan. A product from India complying with the US standards would still have to comply with the regulatory requirements of Japan if it has to be exported to Japan. India has its own law governing the regulatory norms and standards. Manufacturers have to conform to these norms and standards. However, any Indian pharmaceutical product entering the US market complies with the US standards.
It added that Indian laws and India's robust regulatory framework ensure high standards of quality, safety and efficacy of drugs manufactured in the country.