Health & Environment
Government Proposes Immediate Suspension Licences for Substandard Drugs
The Hindu2h
THE BRIEF
1
The Union Health Ministry proposed amendments to the Drugs Rules, 1945, to immediately suspend manufacturing licences for drugs declared Not of Standard Quality on critical parameters.
2
The suspension by the Central or State Licensing Authority will require manufacturers to perform root cause analysis and implement CAPA before revocation.
3
Consequential amendments to Form 13 will endorse the Government Analyst's report to the DCGI, concerned licensing authorities, manufacturers, and marketers.