The AYUSH sector, which includes Ayurveda, Yoga, Unani, Siddha, and Homoeopathy, plays a vital role in India’s healthcare system by offering traditional and natural remedies. To maintain public trust and ensure safety, the Government of India has established a strict legal framework that regulates the preparation, marketing, and distribution of these medicines. This framework emphasizes quality, authenticity, and compliance with recognized standards so that consumers receive genuine and effective products.

To legally manufacture, sell, or market AYUSH products, businesses are required to obtain an AYUSH License. This license is granted under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. The relevant provisions are found in Part XVI (Rules 151–159) for Ayurvedic, Siddha, and Unani (ASU) drugs, while Rules 85A–85I govern Homoeopathic medicines. These rules provide clarity on licensing, labeling, and quality checks, ensuring that AYUSH products meet statutory safety and efficacy standards.

In this article, CA Manish Mishra talks about AYUSH License Registration in India: Process and Documentation.

Legal Framework Governing AYUSH License

Core Legislations

Drugs and Cosmetics Act, 1940

The foundation for regulating medicines in India, including Ayurveda, Siddha, Unani, and Homoeopathy (AYUSH), is laid down by the Drugs and Cosmetics Act, 1940. It provides the statutory authority to oversee the manufacture, sale, distribution, and import of all types of drugs. The Act’s inclusion of AYUSH medicines ensures that traditional systems are subject to quality standards and consumer safety, while still respecting their classical formulations and methods of preparation.

Drugs and Cosmetics Rules, 1945

To give practical effect to the Act, the Drugs and Cosmetics Rules, 1945 were framed. These Rules detail the licensing procedures, specify the forms required for manufacturing and marketing permissions, and set compliance obligations for businesses. They also classify medicines, prescribe labeling standards, and provide mechanisms for inspections and testing. Thus, the Rules act as the operational guidebook for enforcing the Act in relation to AYUSH medicines.

Relevant Rules and Schedules

Rules 151–159 (ASU drugs)

These provisions govern Ayurvedic, Siddha, and Unani medicines. They cover aspects such as conditions for licensing, product approvals, labeling requirements, and obligations for maintaining proper manufacturing records. These rules make sure that ASU products are manufactured responsibly and in compliance with regulatory expectations.

Rules 85A–85I (Homoeopathic medicines)

Separate provisions exist for Homoeopathic medicines. They provide the framework for licensing homoeopathic manufacturers, conditions for maintaining quality, and rules for retail and wholesale distribution.

Schedule T (GMP for ASU drugs)

Schedule T prescribes Good Manufacturing Practices (GMP) for ASU drugs. It emphasizes hygienic conditions, proper plant and machinery layout, adequate laboratory facilities, documentation of processes, and quality control measures. Compliance with Schedule T is a pre-condition for the grant and renewal of manufacturing licenses.

Schedule M-1 (GMP for Homoeopathic drugs)

For Homoeopathy, Schedule M-1 sets GMP standards tailored to the unique nature of homoeopathic preparations. It lays down requirements for infrastructure, raw material handling, quality assurance, batch documentation, and storage to maintain consistency and authenticity in homoeopathic medicines.

Authorities Involved

State Licensing Authorities (SLAs)

Each State/Union Territory appoints Licensing Authorities under the Act and Rules. These SLAs are responsible for granting, renewing, suspending, or canceling AYUSH licenses. They also conduct site inspections, review compliance with GMP standards, and ensure that manufacturers follow the provisions of the Act and Rules.

Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H)

The PCIM&H functions as a central authority for setting pharmacopoeial standards for AYUSH medicines. It develops monographs for raw materials and finished formulations, publishes pharmacopoeias and formularies, and operates as the Central Drug Testing-cum-Appellate Laboratory. Its role ensures that quality benchmarks are uniform and legally enforceable across the country.

Ministry of AYUSH

At the policy level, the Ministry of AYUSH is the apex body responsible for formulating regulations, issuing guidelines, amending rules, and coordinating with states. It also promotes the growth of the AYUSH sector, updates the legal framework in line with modern requirements, and introduces new systems such as e-AUSHADHI (online licensing portal) to ensure transparency and efficiency.

Types of AYUSH Licenses

Manufacturing License

This is the most common license required for producing Ayurvedic, Siddha, and Unani (ASU) medicines. It is granted in Form 25-D under Rule 154 of the Drugs and Cosmetics Rules, 1945. To obtain it, the applicant must establish a full-fledged manufacturing facility with proper infrastructure, trained technical staff, and laboratory facilities. The unit must strictly comply with Schedule T, which prescribes Good Manufacturing Practices (GMP) for ASU drugs. Without this license, no company can legally manufacture ASU medicines.

Loan License

A Loan License, issued in Form 25-E, allows a company to manufacture its products by using another manufacturer’s licensed facilities. It is especially useful for marketers or brand owners who want to sell AYUSH products but do not own a factory. Although the physical manufacturing is done by the contracted facility, the applicant remains legally responsible for ensuring product quality, labeling, and compliance with the AYUSH laws.

Homoeopathy License

For Homoeopathic medicines, a separate license is required. It is granted in Form 25-C under the Rules 85A–85I of the Drugs and Cosmetics Rules. This license demands compliance with Schedule M-1, which sets GMP standards specifically for homoeopathic preparations. The rules focus on hygienic conditions, raw material testing, batch-wise documentation, and strict quality controls to ensure that medicines are safe, consistent, and authentic.

Retail/Wholesale Outlet License (Proposed)

At present, AYUSH licenses mainly regulate manufacturing. However, recent proposals aim to extend regulation to retail and wholesale outlets selling ASU medicines. Once implemented, pharmacies and herbal stores dealing in AYUSH products would also need to obtain a license. This move is intended to create a stronger compliance framework, ensure proper storage and distribution, and prevent the sale of spurious or misbranded products in the AYUSH sector.

Good Manufacturing Practices (GMP)

Importance of Schedule T

Schedule T of the Drugs and Cosmetics Rules, 1945 lays down the Good Manufacturing Practices (GMP) for Ayurvedic, Siddha, and Unani (ASU) drugs. Its purpose is to ensure that medicines are manufactured in a clean, controlled, and consistent environment. The provisions cover:

• Hygiene and sanitation of premises to prevent contamination.

• Proper plant layout and machinery to facilitate smooth production.

• Safe water supply and raw material storage to maintain purity.

• In-process quality checks at different stages of production.

• Recordkeeping and documentation for traceability of every batch.

A GMP certificate is mandatory for every ASU manufacturer and is generally valid for five years. Renewal before expiry is essential to continue manufacturing legally.

Proposed Amendments

The Ministry of AYUSH has introduced draft notification GSR 140(E) to strengthen and modernize GMP standards for ASU drugs. These proposed amendments aim to bring traditional medicine facilities closer to modern pharmaceutical benchmarks. Key changes include:

• Stricter documentation requirements to improve transparency.

• Process validation to ensure consistency in product quality.

• Data integrity measures for maintaining reliable manufacturing and testing records.

Once enforced, these reforms will raise the compliance bar and require manufacturers to upgrade facilities, systems, and recordkeeping practices.

For Homoeopathy – Schedule M-1

Homoeopathic medicines follow a different standard under Schedule M-1, which specifies GMP for Homoeopathic preparations. The rules emphasize:

• Premises requirements, including clean environments and proper storage.

• Quality control processes, ensuring raw materials and finished products meet standards.

• Batch manufacturing documentation, with complete records for every product prepared.

This ensures that Homoeopathic medicines, though prepared differently from ASU drugs, are also manufactured under controlled, reliable, and compliant conditions.

Application Process for AYUSH License

Step 1: Prepare Premises and Documents

Before applying, the applicant must set up a manufacturing facility that meets the statutory standards. The plant layout, machinery, utilities, and infrastructure should comply with Schedule T (for ASU medicines) or Schedule M-1 (for Homoeopathic medicines). Adequate arrangements for water supply, storage, quality control, and sanitation must be in place. Additionally, the applicant must appoint technically qualified staff such as Ayurvedic/Homoeopathic experts and quality control officers, as their presence is a mandatory requirement.

Step 2: Compile Application

The applicant should choose the correct license type:

• Form 25-D: Manufacturing License for ASU drugs.

• Form 25-E: Loan License for companies without their own plant.

• Form 25-C: Manufacturing License for Homoeopathic medicines.

The application must include business incorporation documents, proof of premises, technical staff qualifications, product list, manufacturing SOPs, and equipment details. This documentation ensures that the regulator can assess both operational and compliance readiness.

Step 3: Online Filing via e-AUSHADHI Portal

Applications are filed online through the e-AUSHADHI portal, a centralized system developed by the Ministry of AYUSH. The applicant must:

• Create a profile and provide details of the business, manufacturing unit, and products.

• Upload scanned copies of required documents in the prescribed format.

• Pay the government fees online to initiate processing.

This digital system enhances transparency and allows applicants to track the status of their application.

Step 4: Inspection by Authorities

Once the application is submitted, the State Drug Inspector or licensing authority conducts a site inspection. The inspection verifies whether the unit complies with GMP standards, has proper facilities, and is capable of producing quality medicines. If deficiencies are found, a deficiency report is issued. The applicant must address and rectify these shortcomings within the stipulated time before re-inspection.

Step 5: Grant of License

If the inspection is successful and the documents are in order, the State Licensing Authority (SLA) issues the relevant license form. In many States, manufacturing licenses are treated as perpetual, provided the licensee pays periodic retention fees and remains compliant with regulations. However, the GMP certificate which proves compliance with Schedule T or Schedule M-1 is valid for five years and must be renewed separately.

Documents Required

Business Documents

Every applicant must first prove the legal identity and constitution of the business. Depending on the business structure, this may include:

• Partnership Deed for partnerships.

• LLP Agreement for limited liability partnerships.

• Memorandum of Association (MOA) and Articles of Association (AOA) for private/public limited companies.

  In addition, PAN and Aadhaar of promoters/directors/partners are mandatory. A Certificate of Incorporation or business registration certificate is also needed to confirm the entity’s legal existence.

Premises Documents

Since AYUSH licenses are tied to the manufacturing facility, proof of premises is crucial. Documents include:

• Ownership documents (if owned) or lease agreement (if rented).

• Approved factory layout plan showing plant design, machinery placement, and hygienic flow of production.

• Utility bills such as electricity or water bills for address verification. These documents prove that the premises meet infrastructure and compliance requirements under Schedule T (ASU) or Schedule M-1 (Homoeopathy).

Technical Staff Details

Regulations require the appointment of qualified technical personnel to oversee production and quality. For example:

• BAMS (Bachelor of Ayurvedic Medicine and Surgery) graduates for Ayurveda units.

• BHMS (Bachelor of Homoeopathic Medicine and Surgery) graduates for Homoeopathy units.

  Their educational certificates, experience letters, and appointment letters must be submitted as proof. This ensures that production is supervised by professionals with the required expertise.

Quality Control & Production Details

The AYUSH license application must demonstrate that the unit can ensure product quality and safety. For this, the following are required:

• List of quality control (QC) laboratory equipment available in-house or proof of tie-up with a Government-approved laboratory.

• Standard Operating Procedures (SOPs) for production, labeling, testing, packaging, and recall processes.

• Batch manufacturing records showing traceability of each batch produced.

• Sample labels to confirm compliance with statutory labeling requirements under the Drugs and Cosmetics Rules.

Standards and Testing Requirements

Pharmacopoeial References

To ensure the quality, purity, and safety of AYUSH medicines, manufacturers must follow the standards laid down in official pharmacopoeias. These act as authoritative reference books specifying the identity, strength, and quality of raw materials and finished formulations.

• Ayurvedic Pharmacopoeia of India (API): Provides official standards for Ayurvedic raw herbs, minerals, and formulations.

• Siddha Pharmacopoeia of India (SPI): Lists monographs for Siddha medicines, ensuring uniform quality and authenticity.

• Unani Pharmacopoeia of India (UPI): Defines standards for Unani drugs, covering their properties, formulations, and quality requirements.

• Homoeopathic Pharmacopoeia of India (HPI): Prescribes specifications for Homoeopathic mother tinctures, potencies, and dosage forms.

All AYUSH manufacturers must test their raw materials and finished products against these pharmacopoeial standards before releasing them into the market.

Role of PCIM&H

The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) plays a central role in maintaining and updating these standards. Its functions include:

• Regular Updates: It publishes new monographs and revises existing ones to reflect modern testing methods and evolving industry needs.

• “One Herb–One Standard” Initiative: In collaboration with the Indian Pharmacopoeia Commission (IPC), PCIM&H is harmonizing standards for medicinal plants. Instead of multiple standards in different publications, each herb will have a single, unified quality standard, making compliance easier for industry and ensuring global recognition.

This dual approach official pharmacopoeial references backed by PCIM&H’s continuous updates ensures that AYUSH medicines are consistent, reliable, and accepted both nationally and internationally.

Other Categories – Ayurveda Āhāra

Ayurveda Āhāra – A Separate Regulatory Category

While most traditional medicines come under the Drugs and Cosmetics Act, 1940 and are licensed by the State Licensing Authorities (SLA) of AYUSH, certain Ayurveda-based products fall into a food category. These are regulated as Ayurveda Āhāra, which refers to Ayurveda-inspired food products meant for daily consumption rather than therapeutic drug use.

Governance by FSSAI

The regulation of Ayurveda Āhāra does not fall under the D&C Act. Instead, it is governed by the Food Safety and Standards Authority of India (FSSAI) under the Food Safety and Standards (Ayurveda Āhāra) Regulations, 2022. These regulations were introduced to provide clear standards, permitted ingredients, and labeling norms for such products.

Key Features of Ayurveda Āhāra Regulations

• They define the scope and classification of Ayurveda-based foods.

• They ensure that such products do not make therapeutic or medicinal claims, which are reserved for licensed drugs.

• They mandate FSSAI licensing, quality control, and proper labeling before products reach the market.

Separation Between Drugs and Food

A clear distinction exists between drugs and foods in the AYUSH ecosystem:

• Drugs: Ayurvedic, Siddha, Unani, and Homoeopathic medicines licensed by AYUSH State Licensing Authorities under the D&C Act and Rules.

• Foods: Ayurveda Āhāra products licensed by FSSAI under the Ayurveda Āhāra Regulations, 2022.

This separation prevents regulatory overlap, ensures consumer safety, and provides clarity for businesses about which license they must obtain depending on whether their product is a medicine or a food supplement.

Renewal, Retention, and Cancellation

Validity

AYUSH manufacturing licenses, once granted, are often treated as perpetual in many States. This means they remain valid until surrendered or canceled. However, to keep the license active, license holders must pay periodic retention fees as prescribed by State Licensing Authorities (SLAs). In contrast, the Good Manufacturing Practice (GMP) certificate, which certifies compliance with Schedule T (ASU drugs) or Schedule M-1 (Homoeopathy), is granted for a fixed validity of five years. GMP must be renewed before expiry, as it is a mandatory requirement to continue legal manufacturing.

Cancellation Grounds

A license can be canceled or suspended by the SLA if the manufacturer fails to comply with the regulatory framework. Common grounds include:

• Non-compliance with GMP standards, such as poor hygiene, lack of documentation, or unsafe facilities.

• Manufacturing or selling misbranded, spurious, or adulterated medicines, which pose serious risks to consumers.

• Violation of labeling or advertising rules, including false claims, misleading promotions, or unauthorized therapeutic claims.

Such violations can result not only in cancellation but also in penalties and prosecution under the Drugs and Cosmetics Act, 1940.

Revocation of Cancellation

If a license is canceled, the manufacturer may seek revocation by filing an appeal with the appropriate authority. To succeed, the applicant must demonstrate that corrective measures have been taken for example, upgrading facilities, hiring qualified staff, or changing labeling to meet compliance. If the licensing authority is satisfied with these rectifications, the license may be reinstated, allowing the business to resume operations.

Recent Updates

Draft Amendment to Schedule T (2022–2023): Modern GMP Standards

The Ministry of AYUSH has proposed amendments to Schedule T of the Drugs and Cosmetics Rules, 1945, which governs GMP for Ayurvedic, Siddha, and Unani (ASU) drugs. The draft (GSR 140(E)) aims to modernize GMP practices by aligning them more closely with modern pharmaceutical standards. Key focus areas include:

• Strengthening documentation and recordkeeping.

• Mandatory process validation to ensure consistent product quality.

• Greater emphasis on data integrity, equipment qualification, and in-process checks.
  This proposed reform will raise compliance requirements and compel manufacturers to upgrade facilities and quality systems.

e-AUSHADHI Portal: Digital Licensing

To bring transparency and efficiency in licensing, the Ministry of AYUSH has launched the e-AUSHADHI portal. It is a centralized digital platform that allows manufacturers and laboratories to:

• Apply for new licenses and renewals.

• Upload required documents online.

• Track application status in real time.

• Maintain a centralized database of licensed entities.
  This system reduces paperwork, enhances accountability, and speeds up the licensing process across States.

Ayurveda Āhāra Regulations, 2022

The Food Safety and Standards Authority of India (FSSAI) introduced the Ayurveda Āhāra Regulations, 2022 to regulate Ayurveda-based foods. These rules create a clear separation between drugs and foods:

• Drugs → Licensed by State AYUSH Authorities under the Drugs and Cosmetics Act, 1940.

• Ayurveda Āhāra (Foods) → Licensed by FSSAI under the Food Safety and Standards Act.
  The regulations specify permitted ingredients, labeling norms, and restrictions on therapeutic claims. This ensures consumer safety and avoids overlap between medicines and food products.

Proposed Regulation of Retail Outlets

A recent policy proposal suggests bringing retail and wholesale outlets dealing in AYUSH products under a licensing framework, similar to allopathic drug stores. Once implemented, herbal pharmacies and distributors will need to:

• Obtain a retail/wholesale AYUSH license.

• Maintain proper records and ensure compliant storage.

• Follow uniform standards for distribution and sale.
  This step aims to improve quality control throughout the supply chain and prevent the sale of spurious or misbranded AYUSH medicines.

Compliance Obligations After License

Maintain Batch Manufacturing Records

Every manufacturer must maintain detailed batch records of all products manufactured. These records include raw material usage, in-process checks, test results, and final product release details. They ensure traceability and are critical during inspections, recalls, or disputes about product quality.

Submit Products for Pharmacopoeial Testing

Finished products and raw materials must conform to the standards specified in the official pharmacopoeias (Ayurvedic, Siddha, Unani, or Homoeopathic). Manufacturers are required to send samples for testing, either in their in-house quality control labs (if approved) or at government-approved laboratories. This safeguards product quality and assures compliance with legally enforceable standards.

Ensure Proper Labeling (Rules 161 & 106)

Labeling must strictly follow the rules under the Drugs and Cosmetics Rules, 1945:

• Rule 161: Applies to Ayurvedic, Siddha, and Unani (ASU) medicines. Labels must include product name, ingredients, dosage, manufacturer details, licence number, and cautionary instructions.

• Rule 106: Applies to Homoeopathic medicines. Labels must mention potencies, batch number, expiry (if applicable), and manufacturer details.

Failure to comply can lead to products being treated as misbranded drugs under the Act.

Report Changes to State Licensing Authority (SLA)

Any significant change such as appointment of new technical staff, change of factory premises, or expansion of product range must be promptly reported to the State Licensing Authority. Approval is often required before implementing such changes. This ensures transparency and that the licensed facility continues to meet statutory requirements.

Allow Periodic Inspections by Drug Inspectors

Licensed manufacturers are subject to regular and surprise inspections by AYUSH Drug Inspectors appointed under the Act. Inspectors verify GMP compliance, batch records, labeling, and testing standards. Cooperation during inspections is mandatory, and non-compliance may lead to warnings, suspension, or even cancellation of the license.

Conclusion

The AYUSH License Registration is more than a regulatory formality; it is a structured compliance process that ensures the safety, authenticity, and quality of traditional medicines. It is governed by the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and the GMP requirements outlined in Schedule T for Ayurvedic, Siddha, and Unani drugs and Schedule M-1 for Homoeopathic medicines. To secure this license, businesses must prepare thoroughly by setting up compliant premises, hiring qualified technical staff, and maintaining proper documentation and quality standards.

In recent years, regulatory updates have further strengthened this framework. Initiatives such as the digital e-AUSHADHI portal, the introduction of the Ayurveda Āhāra regulations, 2022, and proposed modern GMP amendments highlight the shift toward transparency and stricter oversight. A valid AYUSH license not only ensures compliance but also builds consumer trust and supports the global recognition of India’s traditional medicine sector.

Frequently Asked Questions (FAQs)

Q1. What is an AYUSH License?

Ans. An AYUSH License is a mandatory approval granted by the State Licensing Authority to manufacture, market, or sell Ayurvedic, Siddha, Unani, and Homoeopathic (ASU&H) medicines in India.

Q2. Which law governs AYUSH License Registration?

Ans. It is governed by the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, with specific provisions in Schedule T (ASU) and Schedule M-1 (Homoeopathy).

Q3. Who issues AYUSH Licenses in India?

Ans. Licenses are issued by the State Licensing Authority (SLA) of the respective State or Union Territory where the unit is located.

Q4. What documents are required for AYUSH License registration?

Ans. Key documents include business incorporation papers, proof of premises, factory layout, technical staff qualifications, QC lab details, SOPs, batch records, and sample labels.

Q5. How is the application for an AYUSH License filed?

Ans. Applications are filed online via the e-AUSHADHI portal, where applicants upload documents, provide business details, and pay government fees.

Q6. Is inspection mandatory for AYUSH License approval?

Ans. Yes. A State Drug Inspector visits the facility to verify compliance with GMP standards before granting the license.