Thousands of FDC drug manufacturers in the country engaged in production
of drugs licensed prior to September 21, 1988, can now heave a sigh of
relief as the Drugs Controller General of India (DCGI) has excluded such
drugs from the requirement of proving the safety and efficacy of FDC
drugs licenced by the SLAs without due approval from the DCGI.
On
January 15 last year, the DCGI had asked the manufacturers to prove the
safety and efficacy of the FDCs approved before October 1, 2012 and had
made it clear that those FDCs approved by the State licencing
authorities (SLAs) from October without the permission of the DCGI will
be considered for ban.
No comments:
Post a Comment