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- According to the Drugs and Cosmetic Act, 1940, a drug manufacturing license is required for drug production in India.
- Licenses are issued by the Drug Controller General of India after all documentation and locations are verified successfully.
- The significant documents include the company registration certificate, GMP certificate, and site master file.
- Applications can be submitted either online or in paper format. Approval of all applications depends on meeting drug license criteria.
- Having a current drug license certificate shows compliance with regulations and builds trust with stakeholders.
Introduction
In 2019, a mid-sized pharmaceutical company based in Maharashtra, incurred substantial financial losses when it was forced to cease operations due to their Drug Manufacturing License expiring, demonstrating the importance of obtaining approvals in a timely manner. It is illegal to manufacture, prepare, import, export or sell a drug without a Drug Manufacturing License and one may also have to face inspections or receive severe repercussions or penalties in addition to damaged reputation. Any new enterprise that is planning to enter the pharmaceutical space, must understand the process involved with receiving a Drug Manufacturing License, specifically under the Drugs and Cosmetic Act, 1940.
As the pharmaceutical market continues to grow in India, acquiring a Drug Manufacturing License is not only mandatory; it serves as the framework from which to operate a legitimate enterprise. The Drugs and Cosmetics Act, 1940 states that every suitable manufacturer of pharmaceuticals must obtain permission/approval from the Drug Controller General of India (DCGI) prior to commencing any manufacturing.
Consider that in 2023, 200+ pharmaceutical establishments were closed down because they were found to be operating without an operational license; this loss would have contributed to their financial demise or other issues. This is the harsh reality and it emphasizes how critical knowledge and understanding of the Drug Manufacturing License process supports the incentive of any eventual and interested operator.
What is a Drug Manufacturing License?
A Drug Manufacturing License is a formal permission granted by the concerned authorities that allows individuals or companies to manufacture, process and distribute drug products. The license verifies compliance with the quality standards prescribed under the Drugs and Cosmetic Act, 1940.
- The Drug Controller General of India has a categorization of licenses depending on the type of drug products manufactured.
- Schedule C & C1 Licenses: Life saving drugs, antibiotics and hormones
- AYUSH Licenses: Traditional and herbal medicines
- Wholesale Drug Licenses: wholesale distribution activities
Key Requirements for Manufacturing Drug License
Before you apply online for a drug license, make sure you meet basic eligibility criteria:
Requirements Related to the Corporate Structure:
- Valid company registration (i.e., Private Limited, LLP or Partnership)
- Minimum capital requirements as prescribed
- Documented registered office
Requirements Related to Technical Personnel:
- Registered pharmacist /technical person with prescribed degrees
- In possession of experience certificates and qualifications
- Available continuously during the manufacturing process
Requirements Related to the Infrastructure:
- Manufacturing facility compliant with Good Manufacturing Practice (GMP)
- Appropriate and adequate storage and quality control facility
- Appropriate waste management systems
Document Required for Drug Licence
The document required for drug licence application is extensive and requires careful preparation. The Drug Controller General of India mandates specific documentation to ensure compliance with the Drugs and Cosmetic Act, 1940.
Essential Documentation Categories
1. Company Registration Documents
- Certificate of Incorporation/Partnership Deed
- Memorandum and Articles of Association
- PAN and GST registration certificates
- Company resolution for license application
2. Technical Personnel Documentation
- Educational qualification certificates
- Experience certificates and resume
- Registration with State Pharmacy Council
- Affidavit of continuous availability
3. Infrastructure and Compliance Documents
- Site master file with detailed manufacturing process
- GMP compliance certificate
- Environmental clearance certificates
- Fire safety and pollution control approvals
4. Financial and Legal Documents
- Bank statements and financial projections
- Rent agreement or property ownership documents
- Insurance certificates for facility and operations
- Legal compliance certificates
How to Drug License Apply Online: Step-by-Step Process
The digitization of the licensing process has made it easier to apply for drug license apply online through official portals. Here’s a comprehensive guide to navigate the Manufacturing Drug License application process:
Phase 1: Pre-Application Preparation
Step 1: Portal Registration
- Visit the CDSCO portal (Drugs Controller General of India)
- Create user account with valid email and phone number
- Verify account through OTP authentication
- Complete profile setup with company details
Step 2: Application Type Selection
- Choose appropriate Drug Manufacturing License category
- Select manufacturing schedules (C, C1, M, etc.)
- Specify product categories and therapeutic areas
- Confirm manufacturing capacity requirements
Phase 2: Online Application Submission
Step 3: Form Completion
- Fill comprehensive application form online
- Enter facility details and technical personnel information
- Specify manufacturing processes and equipment details
- Upload all document required for drug licence
Step 4: Fee Payment
- Calculate fees based on license type and scale
- Make online payment through secure gateway
- Download payment receipt for records
- Track payment status in application dashboard
Phase 3: Post-Submission Process
Step 5: Document Verification
- Authorities review submitted documents
- Respond promptly to any clarification requests
- Ensure all document required for drug licence are complete
- Track application status regularly
Step 6: Facility Inspection
- Schedule inspection with regulatory officials
- Prepare facility for GMP compliance review
- Ensure technical personnel availability
- Address any compliance gaps immediately
Step 7: License Issuance
- Receive drug license certificate upon approval
- Download digital copy from portal
- Ensure physical certificate display at facility
- Plan for renewal before expiry date
Understanding the Drugs and Cosmetic Act, 1940
The Drugs and Cosmetic Act, 1940 is the main governing legislative document relating to pharmaceutical manufacturing law in India. This act provides a broad basis for drug regulation, quality assurance, and licensing processes.
- Significant provisions that affect manufacturing
- Quality Standards and Testing
- Quality assurance testing for all products is mandatory
- Drug inspectors are required to sample products regularly
- Products must conform to standards in the Indian Pharmacopoeia
- Manufacturers must test batches and issue a batch release
- Manufacturing Practices
- Manufacturers must comply with Good Manufacturing Practices (GMP)
- Manufacturing facilities are regularly inspected and audited for compliance
- Records must be maintained for documentation and auditing
- A qualified person must be designated and perform certain duties
Role of Drug Controller General of India (DGCI)
The Drug Controller General of India is the primary regulatory agency responsible for the licensing and regulation of drugs and drug products. It is important to recognize the key functions for a successful application for a Manufacturing Drug License from the agency.
Key Functions
- License Regulation
- Issuing and renewing Drug Manufacturing Licenses
- Reviewing and conducting inspections/audits of the manufacturer’s facilities
- Ensuring compliance to the Drugs and Cosmetic Act, 1940
- Collaborating with state drug regulators
- Quality of Drug Products
- Establishing standards and guidelines for the manufacturing of drugs
- Reviewing and approving new drug applications
- Monitoring adverse drug reactions and safety of drug products
- Coordinating with international regulatory agencies
Obtaining Your Drug License Certificate
The drug license certificate represents the culmination of your licensing journey. This official document authorizes your manufacturing operations under the Drugs and Cosmetic Act, 1940.
Certificate Components
Essential Information
- License number and validity period
- Authorized manufacturing schedules
- Facility address and capacity limits
- Technical person details and qualifications
Compliance Requirements
- Prominent display at manufacturing facility
- Regular renewal before expiry
- Notification of any changes in operations
- Maintenance of manufacturing records
Fees, Expenses, and Timeline for Obtaining a Drug Manufacturing License
Drug Manufacturing License Fee Structure
The fees associated with a drug manufacturing license varies by drug types and the amount of production. The overall process includes application fee, inspection fee, and the cost of compliance, but the overall costs have different values depending on your facility, drug type, and state.
To obtain specific estimates and more up-to-date fees with its application fee, inspection fees, and costs related to complying with the Drug License Regime, please contact Diligence Certifications for clarification and support. Diligence experts will give you communication or direction that improves your understanding of the way costs are constructed based on the manufacturing unit.
Timeline
The timeline process for obtaining a Drug Manufacturing License is dependent on the completion of the application and readiness for inspection.
- The initial application typically has a processing period of 2–4 weeks.
- State or Federal inspection will occur after document submission and evaluated prior to state or federal reviews and approvals.
- The timeline for final approval will range from 2–6 months depending on the drug type (Schedule M, C/C1, or AYUSH), and depending on how ready each business is for complying with the overall drug license regime.
- Leveraging your relationship with Diligence Certification will assist with a more efficient timeline and any documentation that does not conform to the practitioner regulatory framework.
How to Renew and Maintain Your Drug Manufacturing License
Your drug license certificate typically remains valid for 5 years, after which renewal becomes mandatory. The renewal process requires:
Updated Documentation
- Current GMP compliance certificate
- Financial statements and tax clearances
- Technical personnel qualification updates
- Facility modification details (if any)
Compliance Review
- Recent inspection reports
- Batch testing records and quality data
- Adverse event reports and corrective actions
- Market surveillance and feedback records
Online Drug License Application: Moving from Paper to Digital
The drug license apply online system has revolutionized the pharmaceutical licensing landscape in India. Digital platforms offer several advantages:
Benefits of Online Application
Efficiency Improvements
- Faster processing times
- Real-time application tracking
- Digital document submission
- Online fee payment options
Transparency Enhancements
- Clear status updates
- Direct communication with authorities
- Audit trails for all transactions
- Reduced corruption opportunities
Blockchain Integration
- Immutable licensing records
- Supply chain traceability
- Counterfeit prevention measures
- International regulatory cooperation
Drug Manufacturing License and Global Market Access
Holding a valid Manufacturing Drug License opens doors to international markets. Many countries recognize Indian pharmaceutical manufacturing standards, especially when backed by WHO-GMP certification.
Export Market Benefits
Regulatory Recognition
- FDA recognition for certain categories
- EU compliance pathways available
- WHO prequalification opportunities
- Emerging market access simplified
Business Expansion
- Contract manufacturing opportunities
- Technology transfer agreements
- Joint venture possibilities
- Global supply chain integration
How Diligence Certification Assists in Acquiring a Drug Manufacturing License
The complex web of applications, inspections, and compliance under the Drugs and Cosmetics Act, 1940 can be overwhelming, particularly for established pharmaceutical companies. Diligence Certification fulfills a critical need in areas of:
- Guidance from Start to Finish
From identifying the appropriate category of Drug Manufacturing License to creating technical documents, - Documentation and Compliance
Diligence Certifications assists organizations in preparing applicants, reviewing documents, or submitting electronic documents to comply with the Drugs Controller General of India and Central Drugs Standard Control Organization. - Liaison with Authorities
Interactions with the Drug Controller General of India or state regulatory bodies need to be undertaken with precision and experience. - Speeding up your Timeline
Applications can take a long time because potential applicants need to know about the digital application process or be ready and prepared for inspections. Diligence Certifications can help organizations substantially reduce the waiting time.
Conclusion
Obtaining a Drug Manufacturing License under the Drugs and Cosmetic Act, 1940 means complying to laws, but it also means your participation in the growing pharmaceutical industry of India.
The steps of formulating an application for a extraction for a drug manufacturing license to your applying for a drug manufacturing license online allows only engaged and skilled manufacturers to enter the marketplace. Every Drug Controller General of India implemented more effective operating management and they expect good quality systems for any real manufacturer or wholesaler drug license to be identified and verified by the Drug Controller General.
To acquire a manufacturing drug license requires substantiation and legitimacy of all plans, documents, and intent to follow quality and compliance. Your drug license certificate means the same and more – you are the subscribing person for the intent for health and good quality practice of the pharmaceutical premise. Now that India is still the “pharmacy of the world,” your licensed facility can assist and contribute to this process of safe – approach safe, accessible cost, affordable – to healthcare using the drug license.
At Diligence Certifications, we assist businesses just like yours to transform compliance, not just in your industry, but across all industries, into opportunity. From documentation to inspection, our skilled team takes the guesswork out of the licensing process. With Diligence Certifications, you’ll be able to begin your application now – the sooner you put us to work, the sooner your pharmaceutical business will grow.
Frequently Asked Questions
How long does it take to receive Drug Manufacturing License?
Approval of the Drug Manufacturing License generally take 4-7 months based on how complete the drug manufacture license application is, how ready the manufacturing facility are and the scheduling of the Drug Controller General of India to do the inspections.
Can I see where my application is at after I drug license apply online?
You can monitor the status of your Manufacturing Drug License and the scheduled inspections through the online portal.
What happens if my drug license certificate expires?
If you continue to operate outside of the date stamped on your drug license certificate, this would be in violation of the Drugs and Cosmetic Act, 1940. Your facility could be shut down or issued penalties and charged legally. You need to make sure you are current before the Drug License Certificate expires.
Are there different category of Manufacturing Drug License?
Yes, The Drug Controller General of India issues Manufacturing Drug License in different types (Schedule C, C1, and M) based on the drug schedules and conditions of manufacturing in the Drugs and Cosmetic Act, 1940.
What documents are required when I drug license apply online?
Required documents for licensing drug manufacture application include company registration, technical personnel qualifications, GMP certificate, site master file and compliance certificates
Can I manufacturer different types of drugs with one license?
Your drug license certificate will state which schedules the drugs you are authorized to manufacture.
