Loan License for Drug Manufacturing
What is a Loan License?
In India, a Loan License is permission granted by the drug regulatory authorities (State Drug Controller), allowing a company to manufacture drugs and cosmetics at a facility owned by another licensed manufacturer. Essentially, you don’t have to own a manufacturing unit; instead, you can utilize someone else’s plant to produce your formulations, provided the facility meets all the regulatory and quality compliance standards.
Obtaining a Loan License requires navigating through a series of regulatory procedures, including documentation, quality assurance protocols, and compliance with legal and safety standards. The process ensures that even though the manufacturing is outsourced, the responsibility for the quality of the drugs remains with the license holder.
Significance of Loan License for Medicine Manufacturing
Reduced Investment
New or smaller pharmaceutical companies may not have the resources to invest in constructing, maintaining, and managing a manufacturing unit. A Loan License allows them to produce their products without making a substantial initial investment.
Compliance and Quality Assurance
Loan Licenses mandate adherence to Good Manufacturing Practices (GMP) and regulatory standards, ensuring high-quality drug production. This compliance safeguards public health and fortifies brand credibility, asserting that all products are safe, efficacious, and consistent, fostering trust among consumers and professionals alike.
Market Expansion
Loan Licenses facilitate swift market expansion and product diversification. Companies can efficiently explore new markets and respond to consumer demands without substantial investment in facilities or equipment. This flexibility boosts market adaptability, resilience, and sustained business growth.
Focus on Core Competencies
By bypassing manufacturing concerns, companies with Loan Licenses can prioritize core business aspects like product innovation, branding, and customer engagement. This strategic focus enhances business growth, market differentiation, and quick adaptation to industry changes, providing a competitive edge.
Documents Required for a Loan License
Following documents are required by the Loanee and Host firm to ger a Loan License for Medicine Manufacturing.
- Loanee firm –
- Aadhar card and PAN Card of all directors
- GST certificate
- Loan License Agreement
- Form 20B 21B
- Host firm –
- Manufacturing license form 25,28
- Technical staff documents
- Site master file
- Stability study data
- Product approval copy
How Pharmadocx Consultants can help you get a Loan License?
We make the process of getting a loan license for Medicine/Drug Manufacturing easy and seamless for you so that you can focus on your growing your business.
Documentation
At Pharmadocx Consultants, we streamline the preparation of all necessary documents, ensuring they are in perfect alignment with government regulatory body guidelines. Our expertise eliminates common pitfalls, saving you time and accelerating the application process.
Audit Preparation
Our team prepares you for this critical step, coaching your staff, organizing your records, and ensuring your facility meets the stringent standards set by the authorities. We leave no stone unturned, ensuring you’re prepared to face and ace the audit with confidence.
License Application Filing
The complexity of applying for a loan license is simplified with our assistance. We guide you through the completion of Form 24 A, ensuring every detail is accurate for the application. Our team’s experience and attention to detail provide confidence and clarity, making the filing process seamless and straightforward.
Grant of License
We don’t just stop at application filing; we extend our services to ensure a successful grant of the license. This includes monitoring the progress of your application, liaising with regulatory bodies, and resolving any hiccups along the way. Upon approval, we assist in procuring Form 25 A
Let's Talk!
We'd love to hear from you! Whether you have questions about our pharmaceutical plant setup consultation services or want to discuss a potential project, our team is here to help. Simply fill out the form below, and we'll get back to you as soon as possible. Alternatively, you can reach out to us directly using the phone number or email address listed on this page. We look forward to connecting with you!
Phone / Whatsapp
Address
- Sonipat Office - Opposite Dewan Mill, Old D.C. Road Sonepat - 131001 Haryana, India
- Delhi Office - G-12, Pearls Best Heights-I, Netaji Subhash Place, Delhi, 110034
Government Fees as per The Drugs and Cosmetics Rules, 1945 (Section 75A) for Loan License
For a New Loan License
- License Fee = ₹6,000 up to 10 items from Schedule M and Schedule M-III
- Inspection Fee = ₹1,000
- For additional items, ₹300 per item
For Renewal of Loan License
- Renewal Fee = ₹6,000
- Inspection Fee = ₹1,500
- Late Fee = ₹1,000 per month
Important Points about Loan License for Medicine Manufacturing
- Regulatory Basis: The concept of a Loan License is established under Rule 75A and Form 28 of the Drugs and Cosmetics Rules, 1945, allowing companies to manufacture drugs using another firm’s facilities and personnel.
- A loan license agreement involves transferring trademark and product specifications to the manufacturing firm, enabling production under the loan licensee’s guidance.
- Quality Assurance: The loan license holder bears full responsibility for the drug’s quality, efficacy, and safety, ensuring compliance with all regulatory standards.
- Labeling Requirements: Product labels must clearly indicate the loan licensee’s name and the manufacturing site to maintain transparency and trust.
- State-Level Permissions: Producers must seek permission from state drug licensing authorities. Operations extending across multiple states require licenses from each respective state.
- License Scope: Loan licenses are issued for the production, sale, or distribution of drugs excluding those listed in Schedules C, C1, or X of the Drugs and Cosmetics Rules.
- Mandatory Inspection: Before license approval, the Licensing Authority (LA) or Central License Approving Authority (CLAA) mandates an inspection, assessing the facility’s compliance and the qualifications of the technical personnel involved.
Call/Whatsapp us at 9996859227 or write to us at [email protected] to get your license today!
Frequently Asked Questions (FAQs)
What is a Loan License for Drugs Manufacturing?
A loan License is a permission granted by the State FDA, allowing a company to manufacture drugs and cosmetics at a third-party facility owned by another licensed manufacturer. This is especially useful for companies that do not own a manufacturing plant but want to produce drugs or medications under their brand name.
Which license do we need for third-party manufacturing of medicines/drugs?
A Loan License on Form 25A is required for third-party manufacturing of pharmaceutical/drugs/medicines. It’s granted by the State FDA.
What documents are required to apply for a Loan License?
For the Loanee firm
1. Aadhar card and PAN Card of all directors
2. GST certificate
3. Loan License Agreement
4. Form 20B 21B
For the Host firm
1. Manufacturing license form 25,28
2. Technical staff documents
3. Site master file
4. Stability study data
5. Product approval copy
What is Form 24 A in pharma?
Form 24 A is the Application for grant or renewal of a loan license to manufacture for sale 22(or for
distribution of) drugs other than those specified in Schedule C, C(1) and X
What is Form 25 A in pharma?
Form 25 A is the Licence to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C(1) and X.
What is Form 27 A in pharma?
Form 27 A is the Application for grant or renewal of a loan license to manufacture for sale or for distribution
of drugs specified in Schedules C and C (1) excluding those specified in Schedule XB and Schedule X.
How long does it take to obtain a Loan License?
It takes around 1 month to get a loan license for the manufacture of pharmaceuticals in India. Pharmadocx Consultants makes this process quick and easy for you.
What is the government fee for Loan License for Drugs Manufacturing?
- License Fee = ₹6,000 up to 10 items from Schedule M and Schedule M-III
- Inspection Fee = ₹1,000
- For additional items, ₹300 per item
What is the government fee for renewal of Loan License for Drugs Manufacturing?
- Renewal Fee = ₹6,000
- Inspection Fee = ₹1,500
- Late Fee = ₹1,000 per month
What are Schedule C drugs according to Drugs and Cosmetics Act, 1945?
Schedule C drugs are the drugs that contain biological products in them. Examples: Serums, Adrenaline Vitamins etc.
