Pharmaceutical companies are required to get mandatory approval from the Drug Controller General of India (DCGI) to export medicines from next month and the DCGI will be the sole authority to issue good manufacturing practices or GMP certification, reported the media quoting health ministry official. This follows World Health Organization's (WHO) concerns on multiple certifying authorities in the country.
The DCGI said that certificates will be issued by the Central Drugs Standard Control Organisation (CDSCO) after inspection of manufacturing facilities by CDSCO regulatory officials.
At present, Pharma companies are getting approval from state drug regulators that issue Certificates of Pharmaceutical Product or COPP. The DCGI has asked the state regulators to stop issuing such approvals and WHO compliance certification for good manufacturing practices.
Source : rttnews.com