The demand for Indian Ayurvedic medicines in the market keeps growing the demand is for high-effective formulas and herbal supplements. But the selling and marketing requires a manufacturing license. The license plays an important part in establishing a complication and hassle free business.
The license helps the manufacturer to acquire a legal permit to manufacture and sell ayurvedic drugs. The license falls under the legal act of drugs and cosmetic, 1940. The act says the manufacturing unit must follow GMP standards. The license is granted by State incense authority.
Types of Ayurvedic Licenses
Choosing the right type at the start saves months of delay.
| License | Application form | Best for |
| Manufacturing license | Form 24-D (granted in Form 25-D) | You own and run the manufacturing facility |
| Loan license | Form 24-E (granted in Form 25-E) | You make products at another licensed unit |
| Sale license | State-specific | You sell or distribute without manufacturing |
| WHO-GMP / COPP | Separate application | You plan to export |
Eligibility and Requirements for getting a Manufacturing Licence for Ayurvedic Medicines
There are basic criteria that you have to cover before applying for a licence. The criteria include:
Premises – The individual must choose a location with large enough space to cover storage area, processing unit, packaging space, and testing.
Staff – The applicant must have a team of qualified and certified experts with technical staff. The team must include an Ayurvedic expert and a quality control expert.
Infrastructure – The infrastructure should include complete documentation, water quality, equipment standards, and hygiene facilities.
Business entity – The legal business entity includes proprietorship, LLP, or company.
What are the Documents Required for Manufacturing licence
The documents may vary by state, but the most commonly used documents are:
- Ownership proof or rent/lease proof
- Application with prescribed fee
- Business registration proof or ID
- Address proof for partners/directors
- Site plan and layout for the manufacturing unit
- Qualification and registration certificates of staff
- Pollution control board consent
- Water and HVAC system diagram
- List of machinery and equipment
- List of products to be manufactured, with formulations
- Non-conviction certificate or declaration
Step-by-Step Process for getting a Manufacturing Licence for Ayurvedic Medicines
Finalize product list
First, finalize the product list and business structure for classic formulations and proprietary products. This can affect the fees and documentation.
Set up the unit
Design the unit layout and get equipment compliant with a GMP certificate before applying. Working on the requirements may cost more.
Registration
The application can be applied from e- AUSHADHI portal. The application form contains all the basic information.
Obtain NOCs
Some states does not requires NOCs in their application process. Check in for your state’s Ayush department for sequence on NOCs.
File form 24-D
Under the rules you are required to apply for manufacturing license to forward to the licensing authority in form 24-D along the fees. The fees can vary by product category and state.
Inspection
The authority pay a visit to inspect the unit for equipment, staff, record and safety.
license grant
A successful inspection will lead to issues lince i form 24-D.
Get GMP certificate
Apply for GMP certificate soon after being establish. The certificate can be revalidated after every 5 years.
Overall Cost for Manufacturing License
Add all the fees as part of the budget to avoid financial complications
- Fees for application for licence
- Fees for GMP certificate
- Machinery, equipments and location
- Documentation charges
- Lab setup
- Fees for pollution control board consent
Mistakes to Avoid
- There are some common mistakes that leads to unnecessary complication, avoid these for smooth application process
- Ensure to apply before the facility completes Schedule T compliance
- Ignore state – specific forms
- Avoid claims that violates the legal acts
- Provisioning incomplete documentation on staff
- Getting a manufacturing licence when loan license can work instead
Looking for a Ready Route? Explore Navayur Herbals
Starting with a your own manufacturing unit can be inconvenience for getting a license or certification for quality assurance and capital investment which can take months or more than a year of time. But you can enter the growing market of ayurveda sooner by partnering with a reliable and trusted established brand.
The navayur herbals are a reputed Ayurvedic and herbal product company. They provide a diverse portfolio which includes syrups, oils, tablets, capsules, and much more. All the products are manufactured in ISO-GMP, WHO-certified facilities. The company also holds AYUSH approval on their extensive range of products. The medicines offered by the company are a safe and quick-healing solution for the buyer. The company offer franchise and third- party manufacturing services across India for new entrepreneurs, and distributors.
Why consider other company?
- You can start without waiting for months
- The investment is lower than getting a manufacturing unit
- You can start slowly and expand later
Factors to check before partnering with any other company
The factors can help you choose the right company for marketing the business. The factors include to checking and verifying manufacturing licence. Ensure to check if GMP certificate is valid. Ensure if products carry proper license numbers on the label. You can check and verify all these requirements on the official site of state licensing authority.
Conclusion
The timeline for getting a licence can vary, some states can take few months and other can more than 6 months for process and establishment of the unit can take more than that. Some delays comes due to incomplete documents. To get fast approval you can get a consultant and use the state Ayush department checklist for your state. Start the business with fewer products and build the business. Focus on growth and follow instructions.
