Drugs Control Administration
The Drugs Control Administration, Department of Health Gilgit-Baltistan functions mainly as Secretariat of Central Licensing and Registration Boards under the Drugs Act 1976. The Secretary Health & Population Welfare Gilgit-Baltistan is its chairman. The Drugs Act, 1976 comprises Federal and Provincial subjects. The Federal Govt. regulates manufacture, registration, pricing, import and export of drugs. Eighty percent of country’s requirements being met from the drugs manufactured in Pakistan while twenty percent requirement is being met from import of drugs.The Drugs Control Administration, Department of Health Gilgit-Baltistan Scrutinizes the reports of the Drugs Inspector & Government Analyst pertaining to Quality and recommends the appropriate authority for action to be taken.
Aims & Objectives
There is a marked urban bias for both the health facilities and hospital of the public and private sectors, with little linkage between the two. Therefore, a cadre of the Lady Health Worker (LHWs) was established at the grassroots level in 1994 , in order to ensure that health education, reproductive health, vaccination, control of diarrhea and other communicable diseases.
Drug Manufacturing Licenses
- Examination and approval of layout plans
- Processing applications for new licenses
- Processing applications for renewal of licenses and inspections
- Inspection of units through panel of Experts / FIDs for grant and renewal
- Miscellaneous issues related to the licenses
- Execution of orders of the Central Licensing Board.
Quality Control
- To scrutinize the substandard, misbranded, spurious, adulterated etc test reports for obtaining complete investigation reports from the Inspector of Drugs/Assistant Drugs Controllers.
- To process the cases of substandard, misbranded, spurious, adulterated etc drugs.
- To process the cases of prosecution of the accused under the Drugs Act., 1976 in the Drugs Courts referred to by the FID/ADCs.
- To receive, scrutinize, maintain, compile and process the monthly progress reports.
- To initiate actions on various complaints regarding quality control received from individuals, various agencies through FIDs.
Local Manufacturing and Import
Initiating action for:
- Preliminary scrutiny of registration applications
- Preparation of agenda and working paper form Drug Registration Board
- Communication of decisions of Drug Registration Board
- Reference to experts for evaluation and report on new chemical entities.
- Approval of labels and cartons
- Processing of cases for change of name of the brand name
- Processing of requests for the transfer of registration from import to local manufacture.
- Processing of cases for the change of inactive ingredients of already registered drugs
- Processing of cases of changes in master formulae, finders, diluents, colors and flavors.
- Processing of requests for the additional packing of already registered drugs.
- Preparations of material for clarifying the incorrect or biased press reports.
- Defence of appeals preferred by the firms aggrieved by the decisions of the Drugs Registration Board.
- Initiating action for de-registration of drugs due to adverse drug reaction.
- Preparation of proposals for promoting rational use of drugs.
- Preparation of reports and para wise comments on Writ petitions.
- Organization of Seminars, Workshops to promote Quality Assurance and Rational Use of Drugs.
- Compilation of list of registered drugs
- Supply of unbiased information about drugs to health professionals.
Adverse Drug Reaction Monitoring
- Compilation and supply of unbiased information on Poison Control
- Compilation and submission of report about Adverse Drug Reaction
- Compilation and submission of reports about Clinical Trials.
Pricing
- Price fixation
- Compilation and supply of data on prices of registered drugs.
E&M
- Compilation and supply of data on the prices of raw materials including recipients and packing materials
Provincial Quality Control Board (PQCB)
- Established under Drugs Act 1976 and Secretary Health as its Chairman
- Scrutinize the reports of the Drugs Inspector & Government Analyst pertaining to Quality
- Recommendations to the appropriate authority for action to be taken
Functions Of Quality
- Established under Drugs Act 1976: Secretary Health as its Chairman
- Scrutinize the reports of the Drugs Inspector & Government Analyst pertaining to Quality
- Recommendations to the appropriate authority for action to be taken