PROCEDURE TO GET DRUGS MANUFACTURING LICENSE FOR FIRM

PROCEDURE FOR GRANT OF DRUGS MANUFACTURING LICENSE

1.The Drug Act of 1976 regulates the import, export, manufacture, storage, distribution and sale of drugs.
2. Licensing to manufacture medicines is regulated by the configuration of the Central License Board (CLB) under section 5 of the Drug Law, 1976. The C.L.B. It is made up of highly technical, professional and experienced people from the pharmaceutical field, including representatives of renowned pharmaceutical institutions, representatives of all provincial health departments and an expert in law (representative of the Law and Justice Division), etc. The nominees of those interested, that is, the pharmaceutical manufacturers of Pakistan The Association (PPMA), the Pharmaceutical Office (representative body of multinational companies), the Association of Chemicals and Pharmaceuticals of Pakistan (PCDA), etc., can also attend to the CLB meeting The composition of CLB it is established under rule 8 of the Drug Rules (Licenses, Registration and Advertising), 1976 framed under the Drug Law, 1976.
3. The Central Licensing Board (CLB) is currently composed of 14 members, including experts from the fields of Manufacturing and Quality Control of Pharmaceutical Products, professors from renowned universities, representatives of the Department of Health of the Government of Punjab, Sindh, Khyber Pakhtun Khwa, Balochistan and a Law Expert.
4. In accordance with rule 3 of the Drug Rules (Licenses, Registration and Advertising), 1976 framed in the Drug Law, 1976, five (5) types of licenses are issued depending on the nature of the Manufacturing activity Pharmaceutical:
a) License to manufacture by Formulation
b) License to manufacture through Basic Manufacturing
c) License to manufacture by means of semi-basic manufacturing
d) License to manufacture by repacking
e) License to manufacture for experimental purposes.
A pharmaceutical unit (facility) may have more than one license, depending on the nature of the activity performed by the manufacturer / licensee.
5. The most outstanding features of the procedure for granting a license in the form of formulation / basic / semi-basic / repackaging are as follows:
i) When a request is made to the Central License Board for the establishment of a pharmaceutical unit, it is examined and analyzed in the light of the required documents and after compliance with the prerequisites, the proposed site is inspected by Area IDF / Field Officer of the Pakistan Drug Regulatory Authority (DRAP). If the proposed site is recommended for the establishment of a pharmaceutical unit in the light of the requirements established in Annex B of the Drug Rules (Licenses, Registration and Advertising), 1976 framed in the Drug Law, 1976, the case is processes for the approval of the site by the competent authority. Subsequently, the approval of the site is communicated to the applicant if it is in compliance with the provisions of the rules; otherwise, the competent authority rejects it, if the site does not meet the criteria established in the aforementioned rules and this is informed by the official / IDF field involved.
ii) In the event that the site is approved, the applicant must submit a design plan, drawn up in line with the current requirements of Good Manufacturing Practices (cGMP), for the construction of the proposed unit. The guidelines for this purpose (cGMP requirements) are given in Annex B-1 of the rules mentioned above. Once the design plan is in order according to the cGMP requirement, it is processed for approval by the competent authority. The approval is communicated to the applicant for the construction of the facility.
iii) The applicant after completing the construction of the unit submits the application for the granting of the Drug Manufacturing License (DML) on the Form I prescribed along with the necessary documents / information. The request is examined and analyzed and, if all the formalities have been fulfilled, a panel for the inspection of the unit is constituted. CLB members include member of experts / inspectors, facilities to evaluate the facilities provided for the production and quality control of the medicines that will be manufactured and submits its report accordingly. The inspection report is presented to the CLB at its meeting for consideration and decision in the light of the panel recommendations and the provisions of the relevant law / standards.
iv) The CLB, which meets every six or eight weeks, passes its orders on the panel's recommendations as mentioned in the report. If the CLB approves a case for the grant of DML, a license is issued on Form 2 prescribed for a period of five years after which it is renewable for another period in a request submitted by the applicant on Form IA prescribed along with all Required documents Once a DML renewal request has been submitted on time, the license continues to run until the CLB approves the decision / orders on the renewal request.
v) A license may be suspended or canceled or renewal may be denied if the licensee does not comply with the conditions of the license or cGMP as provided in the Drug Rules (Licenses, Registration and Advertising), 1976 framed in the Law on Drugs, 1976.
6. For other type of Drug Manufacturing Licenses procedure are similar for those formulations,some variations depend on type of license.