MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) have issued
NOTIFICATION Dated 8th March, 2016
The Ministry of Health and Family Welfare have notified for Post Marketing Surveillance.-
(i) The applicant shall have a pharmacovigilance system in place for collecting, processing and forwarding the report to the licensing authority for information on adverse drug reactions emerging from the use of the drug manufactured or marketed by the applicant in the country.
(ia) The system shall be managed by qualified and trained personnel and the officer in-charge of collection and processing of data shall be a medical officer or a pharmacist trained in collection and analysis of adverse drug reaction reports.
The Ministry have also informed about Periodic Safety Update Reports (PSURs).
The Ministry have also substituted entries under sub-heading “Oral or Parenteral or Transdermal”