November 02, 2001

'31'

       The Government has amended Rule 51 and 52 of the Drugs and Cosmetics Rules, 1945 in respect of periodicity of inspections prescribed for Drugs Inspectors. The amended rules provide that statutory requirement for inspection of manufacturing and sale premises of drugs by Drugs Inspector would now be once a year only. Earlier, it was mandatory to inspect these premises twice a year.

        This amendment was necessitated because it was felt that well planned and effectively executed inspection would ensure better quality control as compared to the frequent visits by the field officers. There are already other enabling provisions under the Drugs and Cosmetics Rules which allows the inspection of a premise when found necessary. Internationally, the regulatory inspections are programmed, based on the performance status of respective drugs manufacturing establishments.