How to Obtain DRAP Manufacturing License and Product Registration for Surgical Disposable Business in Pakistan

Local manufacturing helps meet domestic healthcare needs, reduces import costs, and supports export opportunities in the expanding healthcare landscape.

This guide outlines the process for starting as a manufacturer under Drug Regulatory Authority of Pakistan (DRAP) regulations. For legal manufacturing and sale of surgical disposables (classified as medical devices per the Medical Devices Rules 2017, with some under Schedule E like disposable syringes treated with special requirements), secure an Establishment License to Manufacture via Form 1. Follow with product registration or enlistment.

Note: Manufacturing requires Form 1, but not Form 2 (which is for import). For distribution, obtain a DSL using Form 11 (as the license is issued on Form 11).

Why Start Manufacturing Surgical Disposables in Pakistan?

Pakistan's healthcare market is growing, with steady demand for affordable surgical disposables in hospitals and clinics. Manufacturing offers supply chain control, job creation, and the ability to price against imports rather than alongside them. Margins vary widely by product line, scale and input costs — build your own costing rather than working from a headline figure.

Legal Framework for Manufacturing Medical Devices

Governed by DRAP Act 2012 and Medical Devices Rules 2017 (amended), the Medical Devices Division handles licensing. Requirements include Establishment License to Manufacture (5 years validity) and product enlistment (Class A) or registration (higher classes). Schedule E items (e.g., disposable syringes, catheters) require immediate compliance without exemption.

Step 1: Business and Facility Preparation Before Applying

Set up properly:

• Register as a private limited company (SECP) for scale.
• Get NTN, sales tax (FBR), and local approvals.
• Acquire facility with separate zones for production, quality control, storage, sterilization (GMP standards: clean rooms, HVAC).
• Install machinery (e.g., injection molding for syringes).
• Hire qualified staff: Production in-charge with pharmacy/biomedical degree and 4+ years experience.

Step 2: Applying for Establishment License to Manufacture (DRAP Manufacturing License)

Foundational step, issued by Medical Device Board (MDB).

Process:

1. Register on MDMC Online System (e.dra.gov.pk).
2. Submit online application for Establishment License to Manufacture.
3. Fill Form 1 (Application for Grant or Renewal of an Establishment License to Manufacture Medical Devices).
4. Upload documents (checklist below).
5. Submit hard copy to Medical Devices Division, DRAP.
6. Pay the prescribed fee — Rs. 100,000 for an establishment licence to manufacture medical devices (Schedule C, Medical Devices Rules, 2017).
7. Undergo GMP inspection by DRAP panel.
8. MDB approval and issuance on Form 3.

Prescribed fees for local manufacturers

Set out in Schedule C of the Medical Devices Rules, 2017 (see rule 63). All figures in Pakistani Rupees:

Note the gap between the two routes: manufacturing costs five times what an import licence costs (Rs. 100,000 against Rs. 20,000), and registering a Class B–D device locally is cheaper than registering the same device as an importer. A change in particulars of a licensed establishment is charged at fifty percent of the licensing fee. Both the licence and the product enlistment or registration are valid for five yearsfrom issuance unless earlier suspended or cancelled. Fee schedules are revised periodically — confirm the current Schedule C before budgeting.

Step 3: Required Documents for DRAP Manufacturing License Application

Include:

• CNIC/photos of owners.
• Business registration (SECP/NTN).
• Premises layout, ownership/lease.
• List of surgical disposables to manufacture.
• Technical staff qualifications/experience.
• Undertaking on stamp paper (per Form 1).
• Fee proof.
• GMP outline.

Step 4: Product Enlistment/Registration After Manufacturing License

Apply for each product:

• Class A (e.g., surgical gloves): Enlistment via Form 6 (local manufacture).
• Higher classes/Schedule E (e.g., disposable syringes): Registration via appropriate forms.

Submit device specs, manufacturing process, quality data, labeling. No exemption for Schedule E. Register immediately.

Step 5: Obtaining Drug Sale License (DSL) for Distribution

For distributing manufactured surgical disposables, obtain DSL (wholesale type) via Form 11, as manufacturing license covers production but distribution often requires DSL for sale.

Use Form 11 for the license (application via provincial portals, e.g., Punjab).

Process:

1. Apply on provincial portal.
2. Submit documents: Business details, pharmacist registration, premises plan.
3. Inspection.
4. Issuance on Form 11.

Step 6: Implementing Good Manufacturing Practices (GMP)

Comply with DRAP GMP:

• Cleanroom validation.
• ISO 13485 quality system.
• Batch records, audits.

Ongoing inspections.

Step 7: Production, Quality Control, and Market Launch

Post-approvals:

• Implement production with FIFO, packaging.
• In-house testing.
• Market to hospitals, use online catalog.

Step 8: Challenges and Best Practices

• Costs (Rs. 50-100 lakhs initial).
• Inspection delays: Prepare GMP early.
• Updates: Monitor DRAP for Schedule E changes.

Quick Takeaways

• Use Form 1 for DRAP manufacturing license, not Form 2 (import).
• Secure product enlistment/registration immediately for Schedule E items like disposable syringes.
• Obtain DSL on Form 11 for distribution.
• Prepare GMP-compliant facility for inspection.
• Use online portal for faster submissions.
• Start with high-demand items like syringes for quick revenue.

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