Drug License Requirements for Cell-Based & Tissue-Based Products in India
The field of restorative medicine is growing rapidly around the world, including in India. This includes cell-based and tissue-based products that are used to treat various medical conditions. These products are different from traditional drugs because they are made from living cells or tissues. Due to their complex nature, special care is needed in their development, testing, approval, and use.
In India, the sale, manufacture, import, and distribution of such products are regulated under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. Recent updates have also been made through New Drugs and Clinical Trials Rules, 2019 to cover new areas like stem cell-based and tissue-engineered products.
This article explains the drug license requirements for cell-based and tissue-based products in simple terms.
What Is Cell-Based and Tissue-Based Products?
Cell-based products are made from living cells. These could be stem cells or other types of cells taken from the patient (autologous), from another person (allogeneic), or even from animals (xenogeneic). These cells can be modified or unmodified before being used in treatment.
Tissue-based products involve the use of tissues (like skin, bone, or cartilage), which may be processed in labs and used for medical purposes. Like cell-based products, these can also be from the same patient, a donor, or animals.
These products are often used in treatments related to:
- Wound healing
- Joint repair
- Heart disease
- Neurological conditions
- Organ support or repair
Why Are Special Licenses Needed?
Unlike traditional drugs, cell and tissue-based products are living therapies. They can change, grow, or interact in complex ways once inside the body. Because of this, strict rules are needed to:
- Ensure product safety
- Maintain quality and consistency
- Confirm effectiveness
- Prevent abuse or unethical practices
Regulatory Authorities in India
The key government bodies responsible for regulating these products include:
- Central Drugs Standard Control Organization: It is the major body under the Ministry of Health and Family Welfare.
- Drugs Controller General of India (DCGI): The head of CDSCO who grants approval for clinical trials and new drug applications.
- Indian Council of Medical Research (ICMR): Works on ethics and scientific research.
- The National Apex Committee for the Stem Cell Research and Therapy: Looks into ethical and scientific matters related to stem cells.
Categories of Cell and Tissue-Based Products
The regulatory path depends on how the product is classified. According to CDSCO and NDCTR, these products are mainly classified into:
1. Minimally manipulated and homologous use – These are simple processes like cleaning, cutting, or freezing tissues. If used for the same function in the body, they may be regulated less strictly.
2. More-than-minimally manipulated or non-homologous use – If the cells or tissues are grown in labs, genetically modified, or used for a different function, then they are treated as new drugs and need strict regulation.
License Requirements
Let’s look at the types of licenses needed at various stages:
1. Manufacturing License
If an organization wants to manufacture a cell-based or tissue-based product, it must get a Form 28 license under the Drugs and Cosmetics Act, along with permission from the DCGI.
For new drugs like stem cell products, a separate approval is required under the New Drugs and Clinical Trials Rules, 2019.
Steps involved:
- Submit a dossier with product details: source of cells, processing steps, quality checks, sterility, safety, etc.
- Get approval from DCGI.
- Inspection of the manufacturing site for compliance with Good Manufacturing Practices (GMP).
- Licensing through the State Licensing Authority (SLA) after central clearance.
2. Import License
If a product is imported from another country, a license must be obtained under Form 10 (for finished products) and Form 11 (for samples for clinical trials, testing, or analysis).
The importer must submit:
- Free Sale Certificate from the exporting country
- Product information
- Safety and efficacy data
- Label and packaging details
- Good Manufacturing Practice (GMP) certificate
3. Clinical Trial Permission
Before the product is sold in India, it must go through clinical trials to show it is safe and effective.
Key points:
- Permission is needed from the DCGI and Institutional Ethics Committee (IEC).
- Application is made in Form CT-04 under the NDCTR.
- Trials must follow Good Clinical Practices (GCP) guidelines.
- Adverse events must be reported promptly.
If the product is already approved in another country and has a good safety record, India may allow an abridged trial or even a waiver in some cases.
4. Market Authorization/New Drug Approval
After clinical trials are successful, the company can apply for approval to sell the product in India.
Steps include:
- Submit results of trials, manufacturing details, and quality assurance data.
- Apply under Form CT-21 for marketing approval of a new drug.
- DCGI will assess whether the product is safe, effective, and manufactured properly.
This is a detailed process and may take time, especially for complex products like stem cells or engineered tissues.
5. Post-Marketing Surveillance (PMS)
Even after approval, companies must keep track of how the product performs in the real world.
They must:
- Report adverse drug reactions (ADR)
- Collect feedback from doctors and patients
- Submit Periodic Safety Update Reports (PSURs)
This is important to detect any long-term side effects or rare complications.
Guidelines and Ethical Considerations
India follows the National Guidelines for Stem Cell Research, jointly prepared by ICMR and DBT (Department of Biotechnology). These provide ethical standards for:
- Sourcing of cells or tissues
- Donor consent
- Genetic modification
- Commercialization
Some key rules:
- No use of embryonic stem cells without proper ethical approvals.
- No offering of unproven therapies to patients.
- All clinical uses must be backed by scientific evidence and regulatory approvals.
Penalties for Non-Compliance
Using or selling cell-based or tissue-based products without a license considered as unauthorized, i.e. illegal. Penalties include:
- Fines
- Jail term
- Cancellation of license
- Blacklisting of the company or researcher
Unregulated stem cell clinics or tissue banks are a major concern, and regulatory bodies have started cracking down on them.
| Read More:- Understanding the Pharmaceutical Supply Chain and Licensing |
Conclusion
Cell-based and tissue-based products offer hope for treating many complex diseases. But because they involve living materials and complex processes, strict rules are necessary. In India, such products are treated as new drugs and require a proper license for manufacturing, import, clinical trials, and marketing. Following ethical and regulatory standards ensures that patients get safe, effective, and high-quality treatments. If you are seeking for professional assistance related to drug license then feel free to contact our CRSPL Business Consultants
As science evolves, regulations will continue to develop, but patient safety and product quality will always remain the top priority.
