Get Your
AYUSH License
for Ayurveda, Siddha, Unani & Homeopathy
- Starting @
₹9,999
Only
Schedule T GMP Compliance. State Drug Controller Approval. Pan-India Coverage.
Manufacturing License (ASU&H)
Wholesale & Retail License
Loan License & Repacking License
Schedule T GMP Compliance
AYUSH Mark Certification Support
License Renewal & Amendment
FREE ConsultationGet Started @ ₹299 ₹0
Get Expert Consultation
Talk to our business executives in minutes
What Sets Us Apart
5,000+ AYUSH Licenses Processed
97% First-Attempt Approval
Expert Pharma Regulatory Consultants
0
Companies Incorporated
Successfully incorporated across India
0
Client Satisfaction
Rated excellent by our customers
0
Years of Experience
Serving businesses since 2020
0
Expert Consultants
Specialists in company formation
Testimonials
Hear What Our Customers Have to Say
India's one of the highest-rated legal tax and compliance guidance platform.
4.9 out of 5
(8521+ ratings)
Verified
Siddhu ManojFounder & CEO of Two-LYP Computations Pvt. Ltd.
“Incorporating my Startup with IncorpX was an incredibly smooth and hassle-free experience. The team was highly professional, guiding us every step of the way with clear communication and prompt support. The registration process was fast, and every detail was handled with precision and accuracy. Highly recommend IncorpX for anyone starting a business.”
Abhishek LohaniDirector at Lohani Learnings
“Company is good and service is also smooth. I used their compliance service and the response was timely with no delay and price are also convenient. They are always available to cater your need.”
Chandan Kr. ChaudharyFounder of Creative Minds
“I am very satisfied with the team of IncorpX for providing the top notch services. Team of IncorpX was giving the update on daily basis was one of the best thing which I experience in Corporate. keep doing it. Thank you!”
Jayavijaya SJFounder of Agro Farms
“Don't think twice.Got my company incorporates here. Tbh very impressed by the quality of service provided by this team. Very organized and friendly team. Had a smooth and peaceful experience. Timely regular updates were provided by the team. Overall a great experience.”
Anoop KrishnanFounder of EIGHTH DAY FORGE
“It's rare to find a service provider who makes the process feel personal - IncorpX absolutely did. From day one, they patiently explained every detail without any jargon, making it easy to understand and stress-free. There was zero chasing, no delays-just efficient, smooth execution all the way through. I felt supported, heard, and confident at every step of registering my company EIGHTH DAY FORGE (OPC) Private Limited. Thanks to Mr. Sriram and his wonderful team.”
Ramesh LankeFounder of EKnal Technologies
“IncorpX made the entire registration process for our company, EKnal Technologies, smooth and stress-free. Their team was professional, efficient, and incredibly supportive from start to finish. Highly recommend them to any founder looking for a reliable partner in their business journey! Special shoutout to Sriram and Aswin-your support, clarity, and responsiveness made the whole process incredibly smooth.”
700+
Businesses Incorporated Every Month
1000+
Ratings Trusted by 2000+ Clients
250+
Professional Network
Why Choose Us
Why Choose Us?
Expert Legal Team
Experienced legal experts in company formation and corporate law.
Fast Turnaround
Kickstart your venture with efficient company setup, generally processed within a week.
Dedicated Support
Personal manager by your side, every step of the way and beyond.
Complete Documentation
We handle all paperwork and ensure full legal compliance.
Business Growth Tools
Free business resources to fuel your company's success from day one.
24/7 Customer Service
Round-the-clock assistance for all your concerns.
Get Your AYUSH License Approved?
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!
Simple Process
Here's How It Works
01
Fill the Form
Simply fill the above form to get started.
02
Call to discuss
Our startup expert will connect with you & complete legalities.
03
Get Your AYUSH License Done
Our pharma regulatory experts handle the complete AYUSH License application from Schedule T compliance to State Drug Controller approval.
Pricing
Simple & Transparent Pricing
MOST POPULAR
AYUSH License Registration Package
From ₹9999 one-time professional fee
Complete within 7 days
7-day turnaround 100% guaranteed
Free Consultation
License Type Assessment
Document Preparation
Schedule T GMP Guidance
Application Drafting & Filing
State Drug Controller Liaison
Factory Inspection Coordination
Query Resolution & Follow-up
License Certificate Procurement
Renewal Reminders & Support
*Government fees are additional and vary based on company structure
4.9/5 based on 1000+ reviews
Money back guarantee
Secure payment
Top rated service
AI-Powered Platform
Meet IncorpX Nova
Our proprietary AI engine streamlines every step of business setup, from intelligent name suggestions to automated document drafting and compliance tracking.
AI-Powered Business Name Approval Check
Auto-Generated MoA & AoA Drafts
Real-Time Compliance Monitoring
3x Faster Processing Than Traditional CAs
24/7 AI Chatbot + Human Expert Support
NOVA AI
Premium Plan
IncorpX Prime
An all-inclusive solution for startups and expanding enterprises seeking a streamlined, compliant incorporation process.
Key Benefits
Personalised support from dedicated incorporation specialists.
Application prepared and filed within 2 days.
24/7 customer assistance.
Important Notes
We strive to register your preferred business name whenever feasible.
Alternative name suggestions are provided if the preferred name is not approved.
Package includes first-year compliance services: auditor appointment, annual filings, and related obligations.
AYUSH License is a mandatory regulatory permit required for the manufacturing, wholesale distribution, retail sale, and repacking of Ayurvedic, Siddha, Unani, and Homeopathic (ASU&H) medicines in India. It is issued by the State Drug Controller (State Licensing Authority) under the provisions of the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945.
The acronym AYUSH stands for Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy - the five recognised systems of traditional and alternative medicine in India. The Ministry of AYUSH, established as a full-fledged ministry in 2014, oversees policy, regulation, and promotion of these systems. However, the actual licensing authority remains with state-level drug controllers who enforce compliance through factory inspections and market surveillance.
Manufacturing units must comply with Schedule T of the Drugs & Cosmetics Rules, which prescribes Good Manufacturing Practices (GMP) specifically for AYUSH drugs. This covers factory premises, equipment, quality control, raw material testing, production hygiene, labelling, and documentation. Non-compliance with Schedule T can lead to license cancellation, product recalls, and criminal prosecution.
At IncorpX, we provide end-to-end AYUSH License Registration services across all Indian states. From Schedule T GMP compliance advisory and document preparation to State Drug Controller application filing and factory inspection coordination, our team of pharma regulatory consultants ensures a smooth, first-attempt approval for your AYUSH business.
What is an AYUSH License?
An AYUSH License is a legal authorisation granted by the State Drug Controller that permits an entity to manufacture, stock, sell, or distribute medicines belonging to the Ayurvedic, Siddha, Unani, or Homeopathic systems of medicine. It is governed by the Drugs & Cosmetics Act, 1940 (Chapter IV-A for Ayurvedic, Siddha & Unani drugs) and the Drugs & Cosmetics Rules, 1945 (Part XVI to Part XVIB).
The licensing framework ensures that AYUSH medicines reaching consumers are safe, effective, and manufactured under controlled quality conditions. Every product must be prepared according to formulations described in authoritative texts - such as the Ayurvedic Pharmacopoeia of India, Siddha Pharmacopoeia of India, National Formulary of Unani Medicine, or Homeopathic Pharmacopoeia of India - or as proprietary medicines with documented evidence of safety and efficacy.
Unlike a general Drug & Cosmetic License that covers allopathic medicines under Schedule C/C1 with Schedule M GMP, the AYUSH License specifically applies to traditional medicine systems and requires compliance with Schedule T GMP. The licence is location-specific and product-specific - any change in premises, product range, or manufacturing process requires prior approval from the licensing authority.
Key Aspects of AYUSH License:
Legal Mandate:
Required under the Drugs & Cosmetics Act, 1940 for all AYUSH drug-related activities - manufacturing, sale, stocking, and distribution.
Schedule T GMP:
Manufacturing units must comply with Good Manufacturing Practices under Schedule T covering premises, equipment, quality control, and documentation.
State-Level Authority:
Issued by the State Drug Controller; each state may have slightly different procedural requirements and fee structures.
5-Year Validity:
Typically valid for 5 years with mandatory renewal before expiry to ensure uninterrupted operations.
Did You Know?
India's AYUSH industry is valued at over ₹40,000 crore (USD 5+ billion) and is growing at 15-20% annually. The Ministry of AYUSH has set a target to make India the global hub for traditional medicine, with AYUSH exports crossing ₹12,000 crore in recent years. Proper licensing is the foundation for tapping into this rapidly expanding market.
Types of AYUSH Licenses in India:
The Drugs & Cosmetics Rules prescribe different license types based on the nature of business activity. Each license type has distinct application forms, eligibility criteria, and compliance requirements. Here is a comprehensive breakdown:
License Type
Applicable Forms
Purpose & Scope
Key Requirements
Manufacturing License
Form 25-D (ASU) / Form 25-C (Homeopathic)
Manufacture of Ayurvedic, Siddha, Unani, or Homeopathic medicines for sale and distribution
Wholesale stocking, distribution, and sale of ASU&H drugs to retailers, hospitals, and dispensaries
Adequate storage space, proper temperature control, qualified person, stock maintenance records
Retail Sale License
Form 20-C
Retail sale of AYUSH medicines directly to consumers from a pharmacy or dispensary
Registered pharmacist or qualified person, proper storage conditions, record of sales
Loan License
Form 25-D (with Loan License endorsement)
Manufacture AYUSH medicines using another licensee's approved factory and equipment
Agreement with host manufacturer, own formulations and technical staff, separate batch records
Repacking License
Form 25-D (Repacking endorsement)
Repacking bulk AYUSH drugs into retail-sized packages for sale
Clean repacking area, proper labelling as per Rule 161, batch traceability, source verification
Important Note!
Proprietary medicines - formulations not listed in classical AYUSH texts but created by the manufacturer - require additional documentation including composition details, safety data, and shelf-life studies. The State Drug Controller may request clinical evidence or post-marketing surveillance data for proprietary formulations before granting or renewing a manufacturing license.
Who Needs an AYUSH License?
The following businesses and individuals are required to obtain an AYUSH License under the Drugs & Cosmetics Act, 1940:
1. AYUSH Drug Manufacturers
Companies and units manufacturing Ayurvedic, Siddha, Unani, or Homeopathic medicines - whether classical formulations or proprietary medicines - for commercial sale.
2. Wholesale Dealers
Entities engaged in wholesale stocking, distribution, and supply of ASU&H drugs to retailers, hospitals, clinics, government dispensaries, and export houses.
3. Retail Pharmacies
Pharmacies, dispensaries, and retail outlets selling Ayurvedic, Unani, Siddha, or Homeopathic medicines directly to consumers or patients.
4. Loan Licensees
Brands and companies that do not own manufacturing facilities but produce AYUSH medicines through another licensee's approved GMP plant under a loan license arrangement.
5. Repackers
Entities that procure bulk AYUSH drugs and repack them into smaller retail units for sale under their own or third-party brand names.
6. Exporters of AYUSH Products
Companies exporting AYUSH medicines to international markets. Export units often require WHO-GMP certification in addition to the standard AYUSH License.
7. AYUSH Hospitals & Clinics
Hospitals and clinics dispensing medicines prepared in-house require a manufacturing license. Those purchasing and dispensing commercially available medicines need a retail license.
8. E-Commerce Sellers
Online sellers listing AYUSH medicines on e-commerce platforms must hold a valid wholesale or retail AYUSH License. Platforms are increasingly mandating license verification.
AYUSH License vs Drug License vs FSSAI - Key Differences:
Businesses in the health and wellness sector often confuse these three licenses. Understanding the differences is critical for ensuring correct regulatory compliance. Here's a detailed comparison:
Note: If your product is a food supplement (e.g., Chyawanprash marketed as a food) without therapeutic claims, it may fall under FSSAI regulations. However, the same product with therapeutic claims (e.g., "boosts immunity", "cures cough") would be classified as an Ayurvedic drug requiring an AYUSH License. At IncorpX, we help you determine the correct regulatory pathway for your product.
Step-by-Step AYUSH License Registration Process:
The AYUSH License application is filed with the State Drug Controller. At IncorpX, we handle the entire process on your behalf. Here's the detailed step-by-step procedure:
Step 1: Determine License Type & Prepare Business Plan
Identify the appropriate license type - Manufacturing, Wholesale, Retail, Loan, or Repacking - based on your business model. Prepare a detailed business plan including the product range, target market, and formulation references from authoritative AYUSH texts.
Step 2: Set Up Premises & Achieve Schedule T GMP Compliance
For manufacturing licenses, set up the factory with separate areas for raw material storage, manufacturing, quality control, packaging, and finished goods as per Schedule T of the Drugs & Cosmetics Rules, 1945. Install required equipment, establish water purification systems, and set up a QC laboratory.
Step 3: Appoint Qualified Technical Staff
Engage qualified technical personnel - a BAMS, BUMS, BSMS, or BHMS degree holder depending on the AYUSH system. The competent person must be present during manufacturing operations and is responsible for batch release and quality oversight.
Step 4: Prepare & Compile Documents
Gather all required documents including the application form, site master file, product list with formulations, technical staff qualifications, factory layout plan, SOPs, water analysis report, equipment list, and premises ownership/lease proof.
Step 5: Submit Application to State Drug Controller
File the completed application with the State Licensing Authority (State Drug Controller) along with all supporting documents and the prescribed government fee. Some states accept applications through online portals such as SUGAM.
Step 6: Factory Inspection by Drug Inspector
A State Drug Inspector is deputed to conduct an on-site inspection. The inspector verifies Schedule T GMP compliance, equipment calibration, raw material quality, staff qualifications, production records, labelling compliance, and overall factory hygiene. Our team coordinates the inspection and ensures your premises are fully compliant.
Step 7: Address Queries & Deficiencies (If Any)
If the inspector raises any observations or the licensing authority issues a deficiency notice, IncorpX helps you address all queries promptly. We prepare corrective action reports and submit supplementary documents to expedite clearance.
Step 8: License Issuance & Compliance Setup
Upon satisfactory inspection and document verification, the State Drug Controller issues the AYUSH License (typically valid for 5 years). Display the license at your premises. IncorpX sets up compliance reminders for renewal, annual returns, and regulatory updates.
Get your AYUSH License in 30-45 days with IncorpX!
Schedule T GMP Requirements for AYUSH Manufacturing:
Schedule T of the Drugs & Cosmetics Rules, 1945 prescribes Good Manufacturing Practices specifically for Ayurvedic, Siddha, and Unani drug manufacturing units. Compliance is mandatory for obtaining and retaining a manufacturing license. Here are the key requirements:
1. Factory Premises
Adequate factory building with separate, designated areas for raw material storage, manufacturing, quality testing, packaging, and finished goods. Premises must be clean, well-ventilated, and pest-free.
2. Water System
Clean, potable water supply meeting pharmacopoeial standards. Water purification systems must be validated. Regular testing of water quality with documented records is mandatory.
3. Equipment & Machinery
Non-reactive, food-grade equipment that is easy to clean and maintain. All equipment must be calibrated periodically. Equipment cleaning and maintenance logs must be maintained.
4. Quality Control Laboratory
In-house QC lab with trained analysts, reference standards, and testing equipment for raw material identity, purity, and finished product testing. Batch release only after QC clearance.
5. Raw Material Control
Proper identification, authentication, and testing of herbal and mineral raw materials. Quarantine procedures for incoming materials. Traceability from source to finished product.
6. Documentation & SOPs
Comprehensive batch manufacturing records, SOPs for every process, stability testing data, distribution records, and complaint handling procedures. Records must be retained for at least 5 years.
7. Qualified Personnel
Full-time competent technical staff with recognised AYUSH qualifications (BAMS/BUMS/BSMS/BHMS). Staff training records and hygiene certifications must be maintained.
8. Labelling Compliance
Product labels must comply with Rule 161 of the Drugs & Cosmetics Rules - including product name, ingredients, batch number, manufacturing date, expiry date, dosage, and manufacturer's license number.
WHO-GMP for Exports
AYUSH manufacturers targeting international markets must additionally obtain WHO-GMP certification, which has more stringent requirements than Schedule T. The Ministry of AYUSH actively encourages WHO-GMP compliance for export-oriented units and provides support through the AYUSH Export Promotion Council. At IncorpX, we assist with both Schedule T and WHO-GMP compliance.
What Are the Documents Required for AYUSH License Registration?
The documents required for AYUSH License vary based on the license type (Manufacturing, Wholesale, Retail) and the state of application. Here's a comprehensive list of commonly required documents:
Category
Document Type
Specific Details
Purpose
Application & Identity
Prescribed Application Form
Form 24-D / 25-D (ASU) or Form 24-C / 25-C (Homeopathic)
Official license application as per Drugs & Cosmetics Rules
Applicant Identity Proof
PAN Card, Aadhaar Card, Passport of proprietor / directors / partners
Establishes identity of applicant and authorised signatories
Premises & Factory
Site Master File
Factory layout, floor plan, area allocation for each section
Demonstrates Schedule T GMP compliance of premises
Premises Ownership / Lease
Sale Deed, Property Tax Receipt, Registered Lease Agreement
Establishes right to use the premises for manufacturing/sale
Utility & Infrastructure Documents
Water analysis report, electricity connection proof, waste disposal plan
Verifies infrastructure readiness and environmental compliance
Technical Staff
Qualification Certificates
BAMS / BUMS / BSMS / BHMS degree, registration with state medical council
Proves competent person meets minimum qualification requirements
Employment Proof
Appointment letter, undertaking of full-time employment
Confirms the qualified person is employed at the manufacturing premises
Product Information
Product List & Formulations
Complete list of products with references to classical texts or proprietary formulation details
Defines the scope of the license and products to be manufactured
Standard Operating Procedures
SOPs for manufacturing, quality testing, packaging, labelling, storage, and distribution
Demonstrates systematic approach to quality and compliance
Business Entity
Business Registration Proof
Certificate of Incorporation, Partnership Deed, GST Certificate, Udyam Registration
Establishes the legal entity applying for the license
Board Resolution / Authorisation
Resolution authorising the signatory, Power of Attorney
For companies and LLPs, authorises the person filing the application
Equipment
Equipment List & Calibration Records
Detailed list of manufacturing and QC equipment with calibration certificates
Verifies the unit has adequate machinery for the proposed products
Fees & Validity of AYUSH License (State-wise Overview):
AYUSH License fees are determined by each state and vary based on the license type and number of products. The license is typically valid for 5 years. Here's an indicative overview:
License Type
Govt. Fee Range
Validity
Renewal Fee
Manufacturing License (ASU)
₹3,500 - ₹10,000
5 years
₹2,500 - ₹7,500
Manufacturing License (Homeopathic)
₹2,500 - ₹8,000
5 years
₹2,000 - ₹6,000
Wholesale License
₹1,000 - ₹5,000
5 years
₹750 - ₹3,500
Retail Sale License
₹500 - ₹3,000
5 years
₹400 - ₹2,000
Loan License
₹3,000 - ₹8,000
5 years
₹2,000 - ₹6,000
Repacking License
₹1,500 - ₹5,000
5 years
₹1,000 - ₹3,500
Note: Government fees shown above are indicative and vary by state. Additional charges may apply for product additions, premises changes, or late renewal. The IncorpX all-inclusive package at ₹9,999 covers consultation, document preparation, application filing, inspection coordination, and follow-up - making it the most hassle-free way to obtain your AYUSH License.
Ministry of AYUSH Initiatives & Quality Standards:
The Ministry of AYUSH has launched several initiatives to strengthen the quality, safety, and global acceptance of AYUSH products. Understanding these helps manufacturers align with regulatory direction:
AYUSH Mark Scheme
A voluntary quality certification in partnership with QCI. Products with the AYUSH Mark enjoy higher consumer trust, premium positioning, and preferred listing on government e-marketplaces.
AYUSH Quality Control Labs
Network of Pharmacopoeial Laboratories - PLIM (Ayurvedic/Siddha/Unani) and HPL (Homeopathic) - for testing drug quality, establishing standards, and supporting regulatory enforcement.
AYUSH Export Promotion
AYUSH Export Promotion Council facilitates WHO-GMP certification, international marketing, and regulatory harmonisation to boost AYUSH product exports globally.
SUGAM Portal
Online portal for digitising AYUSH drug licensing processes, enabling electronic application submission, tracking, and approval - reducing processing time and improving transparency.
Pharmacopoeia Development
Continuous updating of Ayurvedic, Siddha, Unani, and Homeopathic Pharmacopoeia of India with standardised monographs, quality parameters, and testing methods.
Strengthened Schedule T
Revised Schedule T GMP requirements with enhanced standards for premises, equipment, documentation, and quality control - progressively aligning with WHO-GMP benchmarks.
Join thousands of licensed AYUSH businesses with IncorpX!
Why Choose IncorpX for AYUSH License Registration?
End-to-End Service: From Schedule T GMP advisory to license procurement - we handle everything.
Transparent Pricing: All-inclusive packages starting at ₹9,999. No hidden charges.
Fast Processing: 30-45 days for most AYUSH License applications.
Pharma Regulatory Experts: Dedicated consultants with deep expertise in AYUSH regulations.
Pan-India Coverage: AYUSH License services in all Indian states and union territories.
Understanding AYUSH License requirements can be complex due to varying state rules and multiple license types. We've compiled answers to the most frequently asked questions to help you navigate the process.
Whether you're setting up an Ayurvedic manufacturing unit or opening a Homeopathic pharmacy, 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 and Drugs & Cosmetics Rules, 1945. It authorises the manufacturing, sale, stocking, and distribution of Ayurvedic, Siddha, Unani, and Homeopathic (ASU&H) medicines in India. Without a valid AYUSH License, no entity may legally produce or sell these traditional medicines.
The main types include: Manufacturing License (Form 25-D for Ayurvedic/Siddha/Unani; Form 25-C for Homeopathic), Wholesale License (Form 20-B), Retail Sale License (Form 20-C), Loan License (manufacture on borrowed premises with another licensee's facility), and Repacking License (for repacking bulk drugs into retail packs). Each type has distinct compliance requirements under the Drugs & Cosmetics Rules.
A Drug License under Schedule C/C1 of the Drugs & Cosmetics Act covers allopathic (modern) medicines and is governed by Schedule M GMP. An AYUSH License covers traditional medicines - Ayurvedic, Siddha, Unani, and Homeopathic drugs - and is governed by Schedule T GMP. The licensing authority is the same (State Drug Controller), but the application forms, GMP requirements, and technical staff qualifications differ significantly.
An FSSAI License is required for food products and food supplements under the Food Safety & Standards Act, 2006. An AYUSH License is required for medicinal products making therapeutic claims under the Drugs & Cosmetics Act, 1940. If your product is classified as a medicine (makes health or disease-related claims), you need an AYUSH License. If it is a food or nutraceutical without therapeutic claims, FSSAI applies.
Schedule T of the Drugs & Cosmetics Rules, 1945 prescribes the Good Manufacturing Practices (GMP) specifically for Ayurvedic, Siddha, and Unani medicines. It covers factory premises requirements, equipment standards, quality control testing, raw material storage, water quality, production hygiene, and documentation. Compliance with Schedule T is mandatory for obtaining and retaining a manufacturing license.
An AYUSH License is required for: manufacturers of Ayurvedic, Siddha, Unani, or Homeopathic medicines; wholesale dealers distributing ASU&H drugs; retail pharmacies selling AYUSH medicines; entities undertaking loan manufacturing or repacking of AYUSH drugs; and exporters of AYUSH pharmaceutical products. Even traditional practitioners dispensing medicines from their own clinic may need specific permits.
Key documents include: prescribed application form (Form 24-D or 24-C), site master file with factory layout, Schedule T GMP compliance report, list of products with formulations referencing authoritative texts, technical staff qualifications (BAMS/BUMS/BHMS degree holders), premises ownership or lease proof, water and effluent analysis reports, equipment list, and standard operating procedures (SOPs).
The technical staff (competent person) must hold a recognised degree in the relevant AYUSH discipline: BAMS (Bachelor of Ayurvedic Medicine and Surgery) for Ayurvedic units, BUMS (Bachelor of Unani Medicine and Surgery) for Unani units, BSMS for Siddha units, or BHMS (Bachelor of Homeopathic Medicine and Surgery) for Homeopathic units. A pharmacist with specialisation in the relevant system may also qualify, depending on state rules.
The typical processing time is 30-45 days from submission of a complete application. However, manufacturing licenses may take longer - up to 60-90 days - due to mandatory factory inspection and GMP verification by the State Drug Inspector. Delays can occur if documents are incomplete or the premises fail the Schedule T inspection. At IncorpX, we ensure inspection-ready compliance to minimise delays.
AYUSH Licenses are typically valid for 5 years from the date of issue, though this may vary by state. Renewal applications must be filed at least 6 months before expiry to ensure continuity. An expired license means the holder must cease all manufacturing or sale activities until renewal is granted. Some states may issue licenses with shorter validity for new applicants.
Government fees vary by state and license type. Manufacturing licenses typically cost ₹2,500-₹10,000 in government fees. Wholesale licenses range from ₹1,000-₹5,000, and retail licenses from ₹500-₹3,000. At IncorpX, our comprehensive AYUSH License package starts at ₹9,999, which includes consultation, document preparation, application filing, inspection coordination, and follow-up until license issuance.
A Loan License allows an entity to manufacture AYUSH medicines using another licensee's approved facility and equipment, without owning a separate manufacturing plant. The loan licensee must have their own approved formulations and technical staff. This is ideal for startups and small brands who want to launch AYUSH products without heavy capital investment in setting up a GMP-compliant factory.
Products marketed as Ayurvedic medicines with therapeutic claims require an AYUSH Manufacturing License. However, cosmetic products using Ayurvedic ingredients without therapeutic claims fall under the Cosmetic License category under Schedule S of the Drugs & Cosmetics Act. If the product claims to treat or cure a condition, it is classified as a drug and requires the appropriate AYUSH drug license.
The AYUSH Mark is a voluntary certification scheme launched by the Ministry of AYUSH in partnership with the Quality Council of India (QCI). It certifies that an AYUSH product meets prescribed quality standards beyond the minimum regulatory requirements. Products with the AYUSH Mark enjoy greater consumer trust, premium positioning, and preferred listing on government e-marketplaces. It is not a replacement for the AYUSH License but a supplementary quality seal.
Schedule T GMP requirements include: adequate factory premises with separate areas for manufacturing, storage, and quality testing; clean water supply meeting pharmacopoeial standards; proper equipment that is non-reactive and easy to clean; qualified technical staff; raw material testing for identity and purity; batch manufacturing records; quality control laboratory with testing equipment; proper labelling as per Rule 161; and stability testing protocols.
No. Selling any Ayurvedic, Siddha, Unani, or Homeopathic medicine - whether online or offline - without a valid Retail Sale License or Wholesale License is illegal under the Drugs & Cosmetics Act, 1940. E-commerce platforms are increasingly required to verify seller licenses. Violation can lead to prosecution, fines, and imprisonment. Even marketplace sellers must hold their own license.
Under Section 27 of the Drugs & Cosmetics Act, 1940, manufacturing or selling drugs without a valid license is punishable with imprisonment up to 3 years and a fine up to ₹5,000 for first offence. For subsequent offences, the penalty increases to imprisonment up to 5 years and a fine up to ₹10,000. Manufacturing substandard or adulterated drugs attracts even harsher penalties under Sections 27A and 28.
File the renewal application using the prescribed form with the State Drug Controller at least 6 months before expiry. Submit updated documents including GMP compliance report, updated product list, technical staff details, and fee receipt. A fresh inspection may be conducted. If the application is filed on time and the premises remain compliant, the license is typically renewed without interruption in operations.
The State Drug Controller (also called the State Licensing Authority or Drug Controller of the State) is the primary authority for AYUSH licensing. They receive and process license applications, conduct or depute factory inspections, verify Schedule T GMP compliance, issue and renew licenses, conduct market surveillance, take action against violations, and coordinate with the Central Drugs Standard Control Organisation (CDSCO) on policy matters.
Yes, the Ministry of AYUSH has introduced several reforms: mandatory barcode/QR code labelling, strengthened Schedule T GMP standards, the AYUSH Mark certification scheme, push for WHO-GMP certification for export units, and digitisation through the SUGAM portal. Regarding multiple licenses - a single entity can hold multiple AYUSH Licenses simultaneously (e.g., manufacturing + wholesale, or Ayurvedic + Unani). Each license requires a separate application, inspection, and fee payment. IncorpX keeps clients updated on all regulatory changes and offers bundled packages for entities needing multiple licenses and registrations.
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!
S
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!
J
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.
M
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!
R
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.
A
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..
R
Ramesh Babu
4.9/5
Trouble free service, Rendering good co-operation for company incorporation. Trust worthy team to have better knowledge.
P
Pravesh Kudesia
5/5
IncorpX is providing best service... And user experience! Thank You IncorpX Team
B
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.
D
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!
Trusted by 15,000+ Entrepreneurs
Get Expert Guidance for Your Business
Fill out the form and our team will connect with you to understand your requirements and recommend the best way forward.
