Procedure for Grant of Drugs Manufacturing License in Pakistan
In this article, we will discuss about how to start Pharmaceutical Manufacturing Unit in Pakistan. The Drugs Act, 1976 of Pakistan regulates the import, export, manufacture, storage, distribution and sale drugs in Pakistan. The grant of licenses to manufacture drugs is regulated by Central Licensing Board (CLB) setup under section 5 of the Drugs Act, 1976.
The Central Licensing Board (CLB) comprises of desired members including experts from the fields of Manufacturing and Quality Control of Pharmaceuticals, Professors of renowned universities, representatives of Health Departments Government of Punjab, Sindh, Khyber Pakhtun Khwa, Balochistan and a Law expert.
Procedures and Requirements may be change with change in Rules and Regulations as per Government of Pakistan.
Types of Licenses:
- License to manufacture by way of Formulation
- License to manufacture by way of Basic Manufacture
- License to manufacture by way of Semi Basic Manufacture
- License to manufacture by way of Repacking
- License to manufacture by way of Experimental purpose
A pharmaceutical manufacturing unit (facility) can possess more than one licenses depending upon the nature of activity being under taken by the manufacturer / licensee
- Approved Site
- Layout Plan as Per Current Good Manufacturing Practice (cGMP)
- Approved Constructed Facility
- Technical Staff i.e. Production-in-Charge and Quality-in-Charge
- Equipment and Machinery for Manufacture and Quality Control
- Copy of fee Challan
A Pharmaceutical Manufacturing Unit is used to manufactured different dosage form. Different dosage form manufacturing requires different machinery and different sections for preventing contamination and following GMP protocols. Few sections that are required in pharmaceutical manufacturing unit is as follow:
- Tablet/Capsule Manufacturing Section
- Liquid/Syrup Manufacturing Section
- Parenteral (Liquid/Dry Injection) Section
- Ophthalmic/Eye/Ear/Nasal Drop Section
- Powder (Protein powder, Medicated powder etc) Section
- Inhaler/Spray Section
- Surgical/Medical Device Section
- Suppositories Section
Documents for manufacturing License:
- Application on Prescribed Form-1
- Fee Challan Copy
- Legal Status of firm (For proprietorship firm: – name and address of proprietor, for partnership firm: – name and addresses of partners, for company: – name and address of company and directors)
- Premises details including layout plan of the factory
- Section-wise equipment and machineries details for manufacture and quality control
- Qualification and training of Production-in-charge and Quality-in-Charge, and other technical staff for manufacturing and quality control department
- List of drugs to be manufactured including name, class/es of drugs and dosage form/s of the drug
Procedure for granting of Pharmaceutical Manufacturing License in Pakistan:
The salient features of the procedure for grant of a license by way of formulation / basic/ semi basic/ re-packing are as under: –
- First submit an application Central Licensing Board for establishment of a pharmaceutical unit.
- Area FID/Field Officer of Drug Regulatory Authority of Pakistan (DRAP) will inspect proposed site if fulfillment of pre requisites documents finds in submitted application.
- Filed Officer will recommend or reject for establishment of pharmaceutical unit as per requirements under Schedule B of the Drugs (Licensing, Registering and Advertising) Rules, 1976 framed under the Drugs Act, 1976
- Application will be processed to competent authority for site approval.
- Competent authority will communicate with applicant if site is compile with provisions of rule otherwise application will be rejected.
- For approved site, applicant is required to submit layout plan, drawn inline with cGMP requirements etc.
- If layout plan is found as per cGMP requirement, the same is processed for the approval of competent authority. The approval is communicated to the applicant for construction of the facility.
- After complete construction of unit, applicant has to submit application for grant of Drug Manufacturing License (DML) on prescribed Form-1 along with necessary documents.
- If application is fulfill all formalities then inspection is carried out by constituted panel.
- If inspection is found to be as per rules and regulations, constituted panel will placed report before CLB in its meeting.
- After that CLB passes its order on the recommendations of the panel report.
- License at Form-2 will be issued in case of approval of Drug Manufacturing License for five years which is subject to renewal further such time period till suspended and/or surrendered.
- The procedural requirements for other types of Drug Manufacturing Licenses are similar as that of the Formulation, with some variations of conditions depending upon the type of the license.