In 74th meeting of Drugs Technical Advisory Board (DTAB), committee agreed for the proposal that the manufacturing and sale licences once issued, shall remain valid forever, unless suspended or cancelled by the Licensing Authority.
DTAB suggested that such inspection for grant of licence shall be carried jointly by State and Central involving relevant experts of respective area considering the category of the drug for GMP / GLP inspection.
Further the committee recommended for one time grant of licence the number of Drug inspectors and other regulatory officials in respective areas at the State and Central level shall commensurate with the number of manufacturing units in specific area / jurisdiction.
As per DTAB, such licensees shall be subjected to minimum of one annual inspection until unless justified otherwise on the basis of risk evaluation. The observations of the inspection report shall be shared with the licensee or proposed licensee immediately after the inspection and the report of observation of the inspection shall be made available to public on website of State or Centre.
State wise data about manufacturing units inspected and found satisfactory, should be maintained and uploaded on the website by State and Central drug regulatory authorities involved in issue of such licences.
