Drug Manufacturing Licences

• Examination and approval of layout plans
• Processing applications for new licences
• Processing applications for renewal of licensces and inspections
• Inspection of units through panel of Experts / FIDs for grant and renewal of licences.
• Miscellaneous issues related to the licences
• Execution of orders of the Central Licensing Board.

(2) Scrutiny of applications for advertisements and their approvals, through committee on Advertising.

(3) Processing of requests for inclusion of raw materials in various SROs

(4) The legislative matters like amendment in the Act and Rules.

(5) Issues and matters related to basic manufacture in the country.

(6) Convening the meetings of the Central Licensing and Registration Board.

(7) Miscellaneous and general matters not related specifically to other sections of the DCA, like      coordination with the Provincial Governments on matters concerning Drugs Act., 1976,      coordination with the other Ministries and Departments on various subject matter related to      drugs.

Quality Control

•   To scrutinize the substandard, misbranded, spurious, adulterated etc test reports of CDL,      Karachi for obtaining complete investigation reports from the Federal Inspector of Drugs      /Assistant Drugs Controllers.

•    To process the cases of substandard, misbranded, spurious, adulterated etc drugs for      presentation to the Central Licensing and Registration Boards.

•    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 convene the meetings of the Expert Committee of Central Licensing and Registration Board      on quality Control Cases, preparation working papers, agendas, minutes and presents the      recommendations of the committee to the Boards for final decision. The decisions of the Board      are also conveyed to the concerned section for implementation.

•    To receive and store Board’s portion of the samples of drugs sent by all FID/ADCs. In case of      appeals, to process the said samples for appellate testing and presentation of the cases to the      Central Licensing and Registration Board.

•    To receive, scrutinize, maintain, compile and process the monthly progress reports of the      Government Analysts of the Federal and the Provincial Government Analysts.

•    To initiate actions on various complaints regarding quality control received from individuals,      various agencies through FIDs.

•    To inform all the Provincial Governments and Federal Inspector of Drugs for ensuring effective      recall of drugs is received.

Central Research Fund
•     Collection of Central Research Fund
•      Reconciliation of Central Research Fund
•      Auditing of Central Research Fund

Development & Litigation
•      Preliminary scrutiny of proposals for funding from Central Research Fund
•      Reference to experts for the evaluation of proposals for funding of Central Research Fund.
•      Follow up of the projects approved from Central Research Fund.
•      Preliminary plans for the development of pharmaceutical sector.

Local Manufacturing
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 cases for the change of inactive ingredients of already registered drugs
•      Processing of cases of changes in master formulae, finders, diluents, colours and flavours.
•      Processing of requests for the additional packing of already registered drugs.
•      Preparations of material for reply to adjournment motions, resolutions and questions in                  National Assembly and Senate.
•      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.
•      Preparation of price comparisons for registration of Me-Too drugs
•      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 parawise comments on Writ petitions.
•      Organization of Seminars, Workshops to promote CGMP, Quality Assurance and Rational Use        of Drugs
•      Compilation of list of registered drugs
•      Supply of unbiased information about drugs to health professionals.

Import
Initiating action for:-
•      Preliminary scrutiny of registration applications
•      Registration of Veterinary drugs both for locally manufactured and import.
•      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 cases for cases for the change of inactive ingredients of already registered drugs
•      Processing of cases of changes in master formulae, finders, diluents, colours and flavours.
•      Processing of requests for the additional packing of already registered drugs.
•      Preparations of material for reply to adjournment motions, resolutions and questions in                  National Assembly and Senate.
•      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.
•      Preparation of price comparisons for registration of Me-Too drugs
•      Preparation of reports and parawise comments on Writ petitions.
•      Compilation of list of registered drugs for import
•      Supply of unbiased information about drugs to health professionals.

Pakistan National Formulary
•      Compilation, Publication of Pakistan National Formulary.
•      Compilation, Publication of Pakistan Pharmacopoeia
•      Supply of Drug Information 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 excipients and packing        materials