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AYUSH License is mandatory for manufacturing and selling Ayurvedic, Siddha, Unani & Homeopathic medicines under the Drugs & Cosmetics Act, 1940. Don't risk penalties - get licensed today!
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AYUSH License is a mandatory permit required under the Drugs & Cosmetics Act, 1940 for any person or entity engaged in the manufacturing, wholesale, retail sale, or repacking of Ayurvedic, Siddha, Unani, and Homeopathic (ASU&H) medicines in India. The term AYUSH stands for Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy - the five recognized systems of traditional medicine under the Ministry of AYUSH, Government of India.
The State Drug Controller (also known as the State Licensing Authority) is the primary authority responsible for issuing AYUSH Licenses within each state. The licensing framework is governed by the Drugs & Cosmetics Act, 1940 (Chapter IV-A) and the Drugs & Cosmetics Rules, 1945 (Part XVI to Part XVI-B), which lay down the conditions for manufacture, sale, and distribution of ASU&H drugs.
For manufacturing units, compliance with Schedule T of the Drugs & Cosmetics Rules is mandatory. Schedule T prescribes the Good Manufacturing Practices (GMP) specifically for Ayurvedic, Siddha, and Unani medicines - covering premises design, equipment standards, quality control protocols, documentation requirements, and hygiene norms. This is distinct from Schedule M, which applies to allopathic drugs.
The Government of India, through the Ministry of AYUSH, has been actively promoting the traditional medicine sector through initiatives like the National AYUSH Mission (NAM), AYUSH Mark certification, and integration of AYUSH systems into mainstream healthcare. This has led to a significant increase in demand for AYUSH products both domestically and internationally, making proper licensing more important than ever.
At IncorpX, we provide end-to-end AYUSH License Registration services across all states in India. Our team of pharma regulatory consultants handles everything from Schedule T GMP advisory, document preparation, and application drafting to State Drug Controller liaison, factory inspection coordination, and license procurement - ensuring a seamless experience for manufacturers, wholesalers, and retailers alike.
Whether you are setting up a new Ayurvedic manufacturing unit, opening an AYUSH retail pharmacy, planning to export traditional medicines to global markets, or seeking a Loan License to launch your brand without factory investment - our experts provide tailored guidance based on your specific business model and the regulatory requirements of your state.
What is an AYUSH License?
An AYUSH License is a statutory authorization issued by the State Drug Controller (State Licensing Authority) that grants legal permission to manufacture, sell, stock, distribute, or repack Ayurvedic, Siddha, Unani, and Homeopathic medicines. It is governed by the Drugs & Cosmetics Act, 1940 (Chapter IV-A) and the Drugs & Cosmetics Rules, 1945 (Part XVI to Part XVI-B).
All AYUSH products must comply with the standards laid down in authoritative pharmacopoeial texts such as the Ayurvedic Pharmacopoeia of India (API), Unani Pharmacopoeia of India (UPI), Siddha Pharmacopoeia of India (SPI), and the Homoeopathic Pharmacopoeia of India (HPI). Proprietary medicines require additional documentation including approved formulations and clinical evidence.
Manufacturing units must comply with Schedule T GMP requirements (for ASU medicines) or Schedule M-I (for Homeopathic medicines). This is fundamentally different from Schedule M that governs allopathic drug manufacturing. The AYUSH License is both location-specific and product-specific - any change in premises or product range requires amendment or fresh application.
The licensing process involves submission of a detailed application to the State Drug Controller along with prescribed documents, payment of government fees, and - for manufacturing licenses - a factory inspection to verify Schedule T or Schedule M-I compliance. The entire process is designed to ensure that only qualified and compliant entities handle ASU&H medicines, thereby protecting public health and maintaining product quality across the supply chain.
It is important to note that AYUSH Licenses are non-transferable - they cannot be transferred from one person or entity to another, or from one premises to another. Any change in ownership, constitution, or location of the business requires a fresh application or formal amendment process with the State Drug Controller.
Key Aspects of AYUSH License:
Legal Mandate:
Mandatory under the Drugs & Cosmetics Act, 1940 for all ASU&H drug activities - manufacturing, sale, distribution, and repacking.
Schedule T GMP:
Manufacturing premises must comply with Schedule T Good Manufacturing Practices covering premises, equipment, quality control, and documentation.
State-Level Authority:
Issued by the State Drug Controller / State Licensing Authority of the respective state where the business operates.
5-Year Validity:
AYUSH Licenses are typically valid for 5 years from the date of issue. Renewal must be applied at least 6 months before expiry.
Did You Know?
The Indian AYUSH industry is valued at over ₹40,000 crore and growing at 15-20% annually. With increasing global demand for traditional medicines and the Indian government's push through the National AYUSH Mission, having a valid AYUSH License opens doors to both domestic and international markets for manufacturers and exporters. Countries like the USA, Germany, Japan, and the Middle East are major importers of Indian AYUSH products.
Types of AYUSH Licenses in Junagadh:
AYUSH Licenses are categorized based on the nature of activity - manufacturing, wholesale distribution, retail sale, loan manufacturing, or repacking. Each type has specific application forms, eligibility requirements, documentation needs, and regulatory conditions under the Drugs & Cosmetics Rules, 1945. Choosing the correct license type is critical as applying for the wrong category leads to rejection and delays.
The table below provides a detailed comparison of the five main types of AYUSH Licenses available in Junagadh:
License Type
Applicable Forms
Purpose & Scope
Key Requirements
Manufacturing License
Form 25-D / Form 25-C
Manufacture of ASU&H drugs for sale and distribution; covers classical and proprietary formulations
Wholesale stocking, distribution, and supply of ASU&H medicines to retailers and institutions
Adequate storage facility, qualified person, proper record-keeping, temperature control
Retail Sale License
Form 20-C
Retail sale of ASU&H medicines directly to consumers through pharmacy or shop
Registered pharmacist or qualified person, proper storage conditions, sales records
Loan License
Form 25-D (Loan)
Manufacture ASU&H products using another licensee's facility without owning a factory
Agreement with licensed manufacturer, own technical staff, product responsibility
Repacking License
Form 25-D (Repacking)
Repacking of bulk ASU&H medicines into smaller consumer packs under own label
Repacking area with GMP standards, labelling compliance, source traceability
Important Note!
Proprietary medicines (patented or branded formulations not found in classical texts) require additional documentation including approved formulation composition, shelf-life data, and label claims. The licensing process for proprietary medicines may take longer due to additional scrutiny by the State Drug Controller.
Who Needs an AYUSH License in Junagadh?
Any person or entity involved in the manufacture, sale, distribution, or handling of Ayurvedic, Siddha, Unani, or Homeopathic medicines must obtain the appropriate AYUSH License. Operating without a valid license is a criminal offence under Section 27 of the Drugs & Cosmetics Act, 1940, punishable with imprisonment and fines. Here are the key categories of entities that require AYUSH licensing:
1. AYUSH Drug Manufacturers
Companies or individuals manufacturing Ayurvedic, Siddha, Unani, or Homeopathic medicines - both classical formulations from pharmacopoeia and proprietary branded formulations.
2. Wholesale Dealers
Distributors, stockists, and C&F agents who supply ASU&H medicines in bulk to retailers, hospitals, clinics, government institutions, and other intermediaries.
3. Retail Pharmacies
Pharmacies, AYUSH medicine shops, and medical stores that sell ASU&H medicines directly to consumers and patients over the counter.
4. Loan Licensees
Entities that get their AYUSH products manufactured at another licensee's facility without owning a factory - common for new brands, startups, and marketing companies.
5. Repackers
Businesses that repack bulk AYUSH medicines into smaller consumer packs and sell under their own brand or label with proper labelling compliance.
6. Exporters
Companies exporting AYUSH medicines to international markets - export license is required in addition to the base manufacturing or wholesale license.
7. AYUSH Hospitals & Clinics
Healthcare facilities that prepare and dispense ASU&H medicines in-house for their patients require appropriate licensing for their pharmacy or dispensing unit.
8. E-Commerce Sellers
Online platforms and sellers distributing AYUSH medicines through e-commerce channels must hold valid wholesale or retail licenses to legally sell these products.
Step-by-Step Process for AYUSH License Registration in Junagadh:
The AYUSH License application process involves multiple stages from preliminary assessment to final license issuance. The complexity varies based on the license type - manufacturing licenses require factory setup and inspection, while wholesale and retail licenses have a simpler process. At IncorpX, our pharma regulatory experts guide you through every step. Here's the detailed process:
Step 1: Determine License Type
Identify the correct license type based on your business activity - manufacturing (Form 25-D/25-C), wholesale (Form 20-B), retail (Form 20-C), loan license, or repacking. Each type has different application forms, eligibility criteria, documentation requirements, and fee structures under the Drugs & Cosmetics Rules, 1945.
Step 2: Set Up Premises & Schedule T GMP
For manufacturing licenses, ensure your factory premises comply with Schedule T GMP requirements - including layout design with separate areas for manufacturing, quality control, storage, packaging, and quarantine. Adequate ventilation, water supply (with purification), equipment calibration, waste disposal systems, and environmental controls must all meet prescribed standards.
Step 3: Appoint Technical Staff
Appoint qualified technical personnel as mandated by the rules - BAMS for Ayurvedic, BUMS for Unani, BSMS for Siddha, BHMS for Homeopathic products. The technical director must have the prescribed qualification, be registered with the state medical council, and provide an undertaking for whole-time employment at the manufacturing premises.
Step 4: Prepare Documents
Compile all required documents including prescribed application forms, site master file with layout plans, product list with formulation references from authoritative texts, technical staff qualification certificates, premises ownership or lease documents, equipment list with validation records, SOPs, and water analysis reports from an approved laboratory.
Step 5: Submit Application
File the completed application with the State Drug Controller along with prescribed government fees and the complete document set. Some states now offer online submission portals, while others still require physical filing at the state drug control office. IncorpX handles the submission process across all states.
Step 6: Factory Inspection
For manufacturing licenses, a team of drug inspectors will visit your premises to verify Schedule T GMP compliance. They inspect the production area, quality control laboratory, raw material and finished goods storage, equipment, water systems, documentation, and overall hygiene. The inspection report is submitted to the State Drug Controller for decision.
Step 7: Address Queries
Respond promptly to any queries, observations, or deficiency notices raised by the inspectors or State Drug Controller. This may include submission of additional documentation, minor premises modifications, equipment calibration certificates, staff qualification clarifications, or compliance gap remediation.
Step 8: License Issuance
Upon successful verification, satisfactory inspection report, and compliance confirmation, the State Drug Controller issues the AYUSH License in the prescribed form. The license is valid for 5 years and specifies the products, premises, and conditions under which the licensee may operate. Renewal must be applied at least 6 months before expiry.
Get your AYUSH License in 30-45 days with IncorpX!
What Are the Documents Required for AYUSH License Registration in Junagadh?
The documents required for AYUSH License vary based on the license type (manufacturing, wholesale, retail) and the system of medicine (Ayurveda, Siddha, Unani, Homeopathy). Manufacturing licenses have the most extensive documentation requirements due to Schedule T GMP compliance. Here's a comprehensive list of commonly required documents for AYUSH License Registration:
Category
Document Type
Specific Details
Purpose
Application & Identity
Application Form
Form 25-D/25-C (Manufacturing), Form 20-B (Wholesale), Form 20-C (Retail)
Prescribed application as per the license type being applied for
Identity & Address Proof
PAN Card, Aadhaar Card, Passport of applicant/partners/directors
Establishes identity and address of the applicant or authorized signatory
Premises & Factory
Site Master File
Detailed layout plan, floor plan, area statement, water supply plan, drainage system
Comprehensive overview of manufacturing premises for inspection and verification
Ownership / Lease Documents
Sale Deed, Lease Deed, Rent Agreement, NOC from Landlord for drug manufacturing
Establishes legal right to use the premises for drug manufacturing or sale activities
Utilities & Infrastructure
Electricity connection proof, water analysis report from approved lab, waste disposal arrangement certificate
Ensures adequate infrastructure for GMP-compliant manufacturing or storage operations
Technical Staff
Qualification Certificates
BAMS / BUMS / BSMS / BHMS degree certificate, state medical council registration
Verifies that the technical director holds the prescribed qualifications for the system
Employment Records
Appointment letter, experience certificates, undertaking of whole-time employment
Confirms dedicated technical supervision of manufacturing or dispensing operations
Product Information
Product List & Formulations
Complete list of products with formulation references from pharmacopoeia or approved classical texts
Defines scope of manufacturing - classical and proprietary formulations with ingredients
SOPs & Quality Documents
Standard Operating Procedures for manufacturing, packaging, QC testing, batch records
Demonstrates adherence to Schedule T GMP documentation and quality control requirements
Business Entity
Entity Registration Proof
Certificate of Incorporation, Partnership Deed, LLP Agreement, GST Registration Certificate
Establishes legal entity status and business registration of the applicant organization
Equipment
Equipment List & Validation
List of machinery with make, model, capacity; calibration certificates, validation records
Verifies manufacturing capability, equipment suitability, and Schedule T compliance
Understanding Schedule T GMP Compliance for AYUSH Manufacturing in Junagadh:
Schedule T of the Drugs & Cosmetics Rules, 1945 prescribes the Good Manufacturing Practices (GMP) for Ayurvedic, Siddha, and Unani medicines. Compliance with Schedule T is the most critical aspect of obtaining and maintaining an AYUSH Manufacturing License. Here are the key areas covered:
Premises & Layout: Separate designated areas for manufacturing, quality control, storage, packaging, quarantine, and rejected goods. Adequate ventilation, lighting, and pest control.
Water System: Purified water supply meeting pharmacopoeial standards. Regular water analysis from approved laboratory. Proper distribution and storage system.
Equipment & Machinery: Suitable equipment for the type of manufacturing. Regular calibration, validation, and maintenance records. Non-reactive materials for product-contact surfaces.
Raw Materials: Procurement from approved suppliers. Identity testing and quality check before use. Proper storage with segregation of different materials.
Quality Control Lab: In-house QC laboratory with qualified analyst. Testing of raw materials, in-process samples, and finished products. Retention samples for each batch.
Documentation: Batch manufacturing records, analytical reports, SOPs, master formulae, stability data, distribution records, and complaint handling procedures.
Personnel Hygiene: Health check-ups for production staff. Protective clothing, hand washing, and personal hygiene protocols. Training records maintained.
Waste Management: Proper disposal system for manufacturing waste. Effluent treatment plant where required. Compliance with environmental regulations.
Penalties for Operating Without AYUSH License in Junagadh:
The Drugs & Cosmetics Act, 1940 prescribes strict penalties for manufacturing, selling, or distributing drugs without a valid license. Given the health implications of unregulated medicines, enforcement is rigorous. Here are the key penalties:
Violation
Penalty (First Offence)
Penalty (Repeat Offence)
Manufacturing without license (Section 27)
Imprisonment up to 3 years + fine up to ₹5,000
Imprisonment up to 5 years + enhanced fine
Selling/distributing without license
Imprisonment up to 3 years + fine up to ₹5,000
Imprisonment up to 5 years + enhanced fine
Manufacturing adulterated drugs (Section 27-A)
Imprisonment 3-5 years + fine up to ₹1,00,000
Imprisonment up to 10 years + higher fine
Manufacturing spurious drugs (Section 27-B)
Imprisonment 10 years to life + fine up to ₹10,00,000
Life imprisonment
Violating license conditions
License suspension/cancellation + fine
Permanent cancellation + prosecution
Operating with expired license
Product seizure + penalty as per unlicensed operation
Criminal prosecution + premises sealing
Note: In addition to criminal penalties, the State Drug Controller can order seizure and destruction of products, seal manufacturing premises, and blacklist the entity from future licensing. At IncorpX, we ensure your AYUSH License is always current and compliant to avoid any regulatory risk.
Why Choose IncorpX for AYUSH License Registration in Junagadh?
Navigating the AYUSH licensing landscape requires deep expertise in pharma regulations, Schedule T GMP compliance, and state-specific procedures. With over 5,000 AYUSH Licenses processed and a 97% first-attempt approval rate, IncorpX brings all of this together in one comprehensive service package:
End-to-End Service: From Schedule T GMP advisory and factory layout consultation to document preparation, application filing, inspection coordination, and license procurement - we handle the entire process so you can focus on building your AYUSH business.
Transparent Pricing: All-inclusive package at ₹14,999 with no hidden charges. Government fees, if any, are communicated upfront and paid separately by the applicant directly.
Fast Processing: Get your AYUSH License in 30-45 days for wholesale/retail licenses and 60-90 days for manufacturing licenses including factory inspection and Schedule T verification.
Pharma Regulatory Experts: Dedicated consultants with deep experience in AYUSH drug licensing, Schedule T GMP compliance, and State Drug Controller procedures across multiple states in India.
Pan-India Coverage: AYUSH License registration services across all states and union territories - from major pharmaceutical manufacturing hubs to emerging AYUSH industry centres.
Renewal & Compliance: Timely renewal reminders well before the 6-month deadline, amendment support for product additions or premises changes, and ongoing regulatory advisory to keep your license active and compliant.
Join 5,000+ AYUSH businesses licensed with IncorpX!
FAQs on AYUSH License Registration in Junagadh:
Understanding AYUSH License requirements can be complex due to the interplay of central and state regulations, different systems of medicine, and varying license types. We've compiled answers to the most frequently asked questions to help you navigate the process confidently.
Whether you're starting a new AYUSH manufacturing unit, opening a retail pharmacy for traditional medicines, planning to export Ayurvedic products, or need a wholesale license for distribution - these FAQs cover everything you need to know about AYUSH License registration in India.
An AYUSH License is a mandatory permit issued by the State Drug Controller (State Licensing Authority) under the Drugs & Cosmetics Act, 1940. It authorizes the holder to manufacture, sell, stock, distribute, or repack Ayurvedic, Siddha, Unani, and Homeopathic medicines. The license is governed by Chapter IV-A of the Act and Parts XVI to XVI-B of the Drugs & Cosmetics Rules, 1945. Without this license, any commercial activity involving ASU&H drugs is illegal and punishable under Section 27 of the Act.
There are five main types of AYUSH Licenses: Manufacturing License (Form 25-D/25-C) for producing ASU&H drugs in your own factory, Wholesale License (Form 20-B) for bulk distribution and supply to retailers and institutions, Retail Sale License (Form 20-C) for direct consumer sales through pharmacy or shop, Loan License for manufacturing at another licensee's facility without owning a factory, and Repacking License for repackaging bulk medicines under your own label. Each type has distinct eligibility criteria, documentation requirements, and fee structures.
AYUSH License covers traditional systems of medicine - Ayurveda, Siddha, Unani, and Homeopathy - governed by Schedule T GMP requirements under Parts XVI to XVI-B of the D&C Rules. Drug License (commonly referred to) covers allopathic/modern medicines governed by Schedule M GMP under Parts X to XII of the D&C Rules. The regulatory framework, qualified personnel requirements (BAMS/BUMS/BSMS/BHMS vs B.Pharm/D.Pharm), inspection standards, and product formulation references differ significantly between the two systems.
FSSAI License is for food products and supplements regulated under the Food Safety & Standards Act, 2006 and issued by the Food Safety & Standards Authority of India. AYUSH License is for medicines with therapeutic claims regulated under the Drugs & Cosmetics Act, 1940 and issued by the State Drug Controller. The key distinction is the product claim: if a product makes medicinal or therapeutic claims (e.g., cures, treats, prevents disease), it falls under AYUSH/Drug licensing. If it's a food supplement without therapeutic claims, FSSAI applies. Some products may require both licenses depending on their positioning and claims.
Schedule T is part of the Drugs & Cosmetics Rules, 1945 and prescribes the Good Manufacturing Practices (GMP) specifically for Ayurvedic, Siddha, and Unani medicines. It covers comprehensive requirements for: factory premises design and layout, ventilation and environmental controls, equipment standards and calibration, raw material procurement and testing, production processes and batch manufacturing, quality control laboratory and testing protocols, documentation and record-keeping, labelling and packaging standards, storage conditions and distribution, and hygiene and sanitation standards. Compliance with Schedule T is mandatory for obtaining a manufacturing license for ASU medicines.
Any entity involved in commercial activities related to ASU&H medicines needs an AYUSH License. This includes: manufacturers of Ayurvedic, Siddha, Unani, or Homeopathic medicines, wholesale dealers and distributors, retail pharmacies and medicine shops, loan licensees using another's manufacturing facility, repackers repackaging bulk medicines, exporters shipping AYUSH products to international markets, AYUSH hospitals and clinics preparing medicines in-house, and e-commerce sellers distributing AYUSH products online. Even educational and research institutions producing ASU&H medicines for sale may need licensing.
Key documents include: application form (Form 25-D/25-C) duly filled and signed, site master file with detailed layout plans and area statements, Schedule T GMP compliance report covering all prescribed areas, product list with formulation references from authoritative pharmacopoeial texts, technical staff qualifications (BAMS/BUMS/BSMS/BHMS degrees with medical council registration), premises ownership/lease proof, water analysis report from an approved laboratory, equipment list with calibration certificates, SOPs for manufacturing and quality control, entity registration documents (incorporation certificate, partnership deed, etc.), and passport-size photographs of the applicant and technical staff.
The technical director/competent person must hold the prescribed degree for the respective system of medicine: BAMS (Bachelor of Ayurvedic Medicine & Surgery) for Ayurvedic manufacturing units, BUMS (Bachelor of Unani Medicine & Surgery) for Unani manufacturing units, BSMS (Bachelor of Siddha Medicine & Surgery) for Siddha manufacturing units, and BHMS (Bachelor of Homeopathic Medicine & Surgery) for Homeopathic manufacturing units. They must be registered with the respective state medical council and provide an undertaking for whole-time employment at the manufacturing premises. Some states may also require minimum years of experience.
The timeline depends on the license type and state: Wholesale and Retail Licenses typically take 30-45 days from application submission to license issuance. Manufacturing Licenses may take 60-90 days due to the additional factory inspection and Schedule T GMP verification process. Timelines also vary by state - some states with online portals process faster - and depend heavily on the completeness of the application, query resolution speed, and availability of inspection teams. At IncorpX, we ensure applications are complete to minimize delays.
AYUSH Licenses are typically valid for 5 years from the date of issuance. Renewal applications must be submitted at least 6 months before expiry to ensure continuity of operations. The renewal process involves re-verification of compliance, updated documentation, and in some cases, re-inspection of premises. Operating with an expired license is illegal and can result in penalties, product seizure, and criminal prosecution under Section 27 of the Drugs & Cosmetics Act.
Government fees vary by state and license type: Manufacturing License government fees range from ₹2,500 to ₹10,000 depending on the state and number of products, Wholesale License fees range from ₹1,000 to ₹5,000, and Retail License fees range from ₹500 to ₹3,000. These are government fees only. At IncorpX, our all-inclusive professional service package starts at ₹14,999 covering end-to-end support: consultation, license type assessment, document preparation, application drafting and filing, State Drug Controller liaison, factory inspection coordination, query resolution, and license certificate procurement.
A Loan License allows you to manufacture AYUSH medicines using another licensee's factory, equipment, and infrastructure without owning your own manufacturing facility. This is ideal for new brands, startups, and marketing companies that want to launch AYUSH products without the heavy capital investment required for factory setup and Schedule T GMP compliance. The loan licensee must have their own qualified technical staff, must enter a formal agreement with the host manufacturer, and retains full responsibility for the quality and safety of products manufactured under their license.
It depends on the product's claims and positioning. If the product makes therapeutic or medicinal claims (e.g., treats skin diseases, cures hair fall, heals wounds), it is classified as an ASU drug and falls under AYUSH License requirements. If it's a cosmetic product without therapeutic claims (e.g., herbal shampoo for cleansing, face wash for cleaning), a Cosmetic License under the Drugs & Cosmetics Act, 1940 is required instead. The distinction lies in whether the product claims to treat, cure, mitigate, or prevent any disease or disorder.
The AYUSH Mark is a voluntary quality certification scheme launched by the Ministry of AYUSH in collaboration with the Quality Council of India (QCI). It certifies that the AYUSH product meets prescribed quality standards, is manufactured in a GMP-compliant facility, and has been tested for safety and efficacy. While obtaining the AYUSH Mark is voluntary and not a legal requirement, it significantly enhances consumer trust, brand credibility, and marketability. Products with the AYUSH Mark are preferred by health-conscious consumers and e-commerce platforms.
No. Selling AYUSH medicines through any channel - online or offline - without a valid wholesale or retail license is illegal under the Drugs & Cosmetics Act, 1940. E-commerce platforms like Amazon, Flipkart, and 1mg are also increasingly required to verify seller licenses before allowing AYUSH product listings. Violations can result in product seizure, account suspension on platforms, monetary penalties, and criminal prosecution under Section 27 of the Act.
Under Section 27 of the Drugs & Cosmetics Act, manufacturing or selling drugs without a valid license is a cognizable offence punishable with imprisonment up to 3 years and a fine up to ₹5,000 for the first offence. Repeat offences carry imprisonment up to 5 years with higher fines. Additionally, products can be seized, destroyed, and the business premises sealed. For adulterated or spurious drugs, penalties are even more severe, including imprisonment up to 10 years or life imprisonment.
The State Drug Controller (also called the State Licensing Authority or Commissioner of Drug Control) is the primary regulatory authority for AYUSH licensing at the state level. Their responsibilities include: processing and approving license applications, deputing drug inspectors for factory inspections, issuing, renewing, and amending licenses, monitoring ongoing compliance with GMP and licensing conditions, taking enforcement actions against violations including cancellation, and coordinating with the Central Drugs Standard Control Organisation (CDSCO) and Ministry of AYUSH on regulatory matters.
IncorpX provides end-to-end AYUSH License registration services covering every stage of the process: initial consultation and license type assessment, Schedule T GMP advisory and factory layout guidance, comprehensive document preparation and review, application form drafting and filing with the State Drug Controller, ongoing liaison with the licensing authority, factory inspection coordination and preparation support, prompt query resolution and deficiency response, license certificate procurement and delivery, and post-license services including renewal reminders, product addition amendments, and ongoing compliance advisory. Our pharma regulatory experts ensure a smooth, hassle-free process across all states.
The team was very responsive and helpful. I received daily updates from the WhatsApp group, and their guidance made everything much simpler to comprehend. If you want a simple and hassle-free way to launch your business, I would highly recommend them!
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Simon Job
4.9/5
I recently used IncorpX to register my limited liability partnership, and I had an amazing experience! There were no hidden fees, and the team was helpful, quick to respond, and open. They provided thorough explanations of each step, and their services are reasonably priced without sacrificing quality. The entire process was made simple by IncorpX's professionalism, attention to detail, and sincere support. Strongly advised!
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Jay R
4.8/5
The experience was flawless; the team completed each task with care and always responded quickly. Throughout the process, I never felt stuck. We would especially like to thank Saksham and Sriram for making everything run so smoothly! The IncorpX team offers extremely competitive pricing; anyone just starting out should definitely get in touch with them.
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Mohammed Affan
4.9/5
I'm really grateful to the wonderful team at IncorpX for helping bring my co-founder's and my dream to life. The whole process was super smooth - fast service, great support, and no hassles at all. I'd highly recommend IncorpX to any new entrepreneur or founder looking to register their company. Excited to continue working with them in the long run. Thank you, IncorpX!
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Riyom Taipodia
4.6/5
One of the best agency I have ever experienced. Team members are very friendly as if we know each other from before and came communicate and share easily. My work has been done in a very short period and I am so happy. Thank you so much.
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Ayyappa Swamy
5/5
Highly recommend... IncorpX services regarding incorporation of our company and roc filing and all are very impressive.. the team IncorpX is polite and friendly. Our Lands Time pvt ltd has incorporated through IncorpX... And thanks to IncorpX team..
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Ramesh Babu
4.9/5
Trouble free service, Rendering good co-operation for company incorporation. Trust worthy team to have better knowledge.
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Pravesh Kudesia
5/5
IncorpX is providing best service... And user experience! Thank You IncorpX Team
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Balaji Gutte
4.9/5
I recently got my Private Limited Company incorporated through IncorpX, and the experience was seamless! The team was professional, supportive, and quick to respond throughout the process. Highly recommend IncorpX for a smooth and stress-free company registration experience.
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Dia
5/5
I'd been planning to register my Private Limited Company for months but didn't know where to start - until I found IncorpX. The team guided me step by step, explained everything clearly, and completed the registration smoothly within the promised timeline. Their pricing was transparent with no hidden charges. Highly recommend IncorpX to anyone starting a business!
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