AYUSH Manufacturing Licence in Bihar
Planning to manufacture Ayurvedic, Siddha or Unani medicines? Worldtel Business Consultancy provides end-to-end consultancy assistance for AYUSH manufacturing licence applications, documentation, application filling, technical compliance coordination, inspection readiness and departmental follow-up.
Discuss Your Licence Explore the ProcessFrom initial eligibility assessment to application follow-up — structured support for manufacturers and businesses across Bihar.
What Is an AYUSH Manufacturing Licence?
An AYUSH drug manufacturing licence is the regulatory approval required for eligible businesses manufacturing covered Ayurvedic, Siddha or Unani medicines for sale. Applicants must comply with applicable provisions of the Drugs and Cosmetics Act and Rules, premises and equipment requirements, technical staffing conditions, product requirements and applicable Good Manufacturing Practices.
Own Manufacturing Unit
For businesses proposing to manufacture eligible medicines at their own premises, with the required facilities, equipment, qualified personnel and compliance systems.
Application route: Form 24D, subject to applicable rules and portal requirements.
AYUSH Loan Licence
For eligible businesses intending to use the manufacturing facilities of an existing licensed manufacturer instead of establishing their own complete manufacturing arrangement.
Application route: Form 24E, subject to eligibility and applicable requirements.
GMP & Schedule T Compliance
Assistance with understanding applicable manufacturing premises, hygiene, equipment, quality control, documentation and Good Manufacturing Practices requirements.
Why Worldtel Is the Right Choice for AYUSH Licence Consultancy
Worldtel Business Consultancy aims to make complex licensing procedures easier to understand through structured documentation, application assistance and practical compliance coordination.
Complete Application Support
From identifying the appropriate application route to preparing the supporting document set and checking application details.
Compliance-Focused Review
We help identify potential gaps in the premises, technical staffing, product information and documents before submission.
Departmental Coordination
Assistance with official communications, application status, inspection scheduling and responses to deficiencies through lawful channels.
Technical Requirements Guidance
Guidance on the applicable qualifications and responsibilities of manufacturing and quality-control personnel.
Document Management
Organised checklists and document coordination help applicants prepare a more complete submission.
Patna-Based Consultancy
Serving businesses in Bihar with application support and guidance for the relevant state and central regulatory processes.
Documents Required for AYUSH Manufacturing Licence
The exact checklist depends on the licence type, products, applicant constitution, state requirements and current e-AUSHADHI instructions. Commonly requested documents may include:
Business & Premises Documents
- PAN card of applicant/entity
- Certificate of Incorporation, partnership deed or proprietorship documents, as applicable
- GST registration, where applicable or required
- Identity and address proof of proprietor, partners or authorised signatory
- Ownership document or valid lease/rent agreement for premises
- Premises layout plan and area details
- Site plan, room-wise layout and manufacturing section details, as required
- Authorisation letter or board/partner resolution, where applicable
- Applicable local, fire, building or other permissions, where required
Technical & Manufacturing Documents
- Names and details of proposed products and dosage forms
- Product formula/composition and applicable authoritative references
- Details and qualification certificates of competent technical staff
- Appointment letters and experience documents, where applicable
- Machinery and equipment list
- Quality-control/testing arrangements and supporting details
- Applicable Schedule T/GMP compliance documents
- Water analysis report and other test reports, where required
- Prescribed affidavits, declarations, SOPs and undertaking documents
- Pollution Control Board consent/NOC, where applicable
This is a preliminary checklist, not an exhaustive or universal list. The applicable authority may request additional documents depending on the case.
Technical Staff, Premises & GMP Requirements
Qualified Technical Personnel
Manufacturing must be conducted under the direction and supervision of competent technical staff who satisfy the qualifications and experience prescribed under the applicable rules. Manufacturing and quality-control requirements may differ according to the product and facility.
Suitable Manufacturing Premises
The unit must meet applicable requirements for premises, hygiene, storage, manufacturing sections, equipment, quality control and documentation under the relevant rules, including Schedule T where applicable.
Product Classification & Formula
Product names, formulations, ingredients, dosage forms and supporting references must be assessed against the relevant regulatory requirements before being included in an application.
Quality Systems & Records
Manufacturers may need documented procedures, batch records, raw-material and finished-product controls, testing arrangements, storage practices and other quality records appropriate to the applicable rules.
AYUSH Manufacturing Licence: Complete Application Process
Worldtel supports the applicant through the key stages of preparing and managing an application. The final requirements and approval decision remain with the competent licensing authority.
1. Initial Consultation
Understand the product range, proposed manufacturing location, business constitution and intended licensing route.
2. Licence Route Assessment
Assess whether an own-unit manufacturing application or a loan-licence route may be appropriate.
3. Premises & Facility Review
Review the proposed premises, layout, equipment, manufacturing sections and applicable Schedule T/GMP requirements.
4. Technical Staff Review
Check the proposed personnel’s qualifications, experience, responsibilities and supporting documents against applicable criteria.
5. Product & Document Preparation
Compile product details, formula references, business records, facility documents, declarations and the prescribed checklist.
6. e-AUSHADHI Registration & Application
Assist with applicant registration and the relevant online application, including Form 24D or Form 24E as applicable.
7. Official Fee & Submission
Confirm the applicable official fee with the current portal instructions and assist the applicant with the submission process.
8. Inspection Readiness
Help organise documents and prepare for an inspection or scrutiny by the competent authority. Actual inspection decisions remain with officials.
9. Deficiency & Query Response
Assist in understanding official observations and preparing appropriate responses or additional documents.
10. Licence Outcome & Follow-Up
Help the applicant review the licensing outcome and understand relevant product additions, GMP and post-approval compliance obligations.
Official Application Portal & Regulatory Resources
e-AUSHADHI — Ministry of AYUSH:
https://www.e-aushadhi.gov.in/
Official e-AUSHADHI User Manuals:
Registration and Fresh Licence application guides ↗
Acts & Rules:
Official AYUSH rules and notifications ↗
Bihar AYUSH Department:
https://ayush.bihar.gov.in/
Bihar Drug Control Portal:
https://xln.bihar.gov.in/
Use the portal and licensing authority applicable to the particular product and licence category. Portal instructions and requirements may change.
Frequently Asked Questions
What is Form 24D?
Form 24D is the prescribed application form for a licence to manufacture Ayurvedic, Siddha or Unani drugs for sale, subject to the applicable rules and current e-AUSHADHI process.
What is Form 24E?
Form 24E is the application route for a loan licence for eligible applicants who intend to use the manufacturing facilities of another appropriately licensed manufacturer, subject to regulatory requirements.
Is GMP compliance required?
Applicable AYUSH manufacturing units must comply with the relevant Good Manufacturing Practices and premises requirements under the rules, including Schedule T where applicable. Requirements should be confirmed for the proposed facility.
Can Worldtel arrange the licence without a manufacturing facility?
A loan-licence route may be available for eligible applicants using an existing licensed manufacturer’s facilities. Eligibility, product scope and required agreements must be assessed by the competent authority. A consultancy cannot bypass statutory requirements.
How much time does the licence take?
Processing time depends on application completeness, inspection, technical scrutiny and responses to any deficiencies. Any statutory processing period is subject to the applicable rules and the applicant meeting requirements.
Does Worldtel guarantee approval?
No. Worldtel provides consultancy, application preparation and coordination. The licensing authority independently assesses the application and decides whether to grant the licence.
Can I manufacture herbal cosmetics under an AYUSH licence?
Not automatically. Products must be classified under the appropriate regulatory framework. Cosmetics, food products and AYUSH medicines can have different licensing and compliance requirements.
Start Your AYUSH Manufacturing Licence Journey
Planning a new Ayurvedic, Siddha or Unani manufacturing unit? Contact Worldtel for an initial discussion about your product category, premises, technical staff, documentation and application route.
Email: info@worldtel.co.in Open e-AUSHADHI PortalDisclaimer: This page is for general information and consultancy enquiries. Licence eligibility, document requirements, fees and processing are subject to applicable laws, rules, portal instructions and the decision of the competent authority. Worldtel Business Consultancy is an independent consultancy and is not a government authority.