AYUSH License

Overview

AYUSH licenses are granted by the Government of India to individuals or entities seeking to establish businesses in Ayurvedic, Unani, Siddha, or similar products. These licenses are issued by the Ministry of AYUSH, which was established on November 9, 2014. Previously, it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H), established in March 1995.

Ayurveda, the ancient medicinal system, has been practiced in India for millions of years. Known for its efficacy and lack of side effects, Ayurveda’s popularity is increasing worldwide, with many countries becoming importers of Ayurvedic products.

Points to Consider When Applying for AYUSH License in India

Legal Requirement: It is essential to obtain a valid license from the Ministry of AYUSH before starting or continuing any drug or cosmetic business in India. This is mandated by the Drug & Cosmetic Act of 1940.

Scope of Business: The license covers various forms of drug businesses, including allopathic, homeopathic, ayurvedic, herbal, or Unani drugs, falling under the purview of the Drug & Cosmetic Act of 1940.

Ministry of AYUSH License: Individuals intending to manufacture Ayurvedic medicines must obtain a specific license from the Ministry of AYUSH. This license is necessary to ensure compliance with regulatory standards and legal requirements.

Benefits of Obtaining the AYUSH License

Nationwide Operation: With the AYUSH License, individuals or entities can operate in any state across India, irrespective of the location of the manufacturing company. This provides flexibility and scalability to businesses.

Marketing Focus: Those holding the AYUSH License can focus solely on marketing their products, as all compliance requirements related to manufacturing are handled by the licensed manufacturing company. This streamlines operations and allows for efficient resource allocation.

Health Insurance Coverage: Products manufactured under the AYUSH License may be eligible for coverage under health insurance policies. This provides added benefits to consumers and encourages the use of Ayurvedic and herbal medicines.

Regulation of Ayurvedic Medicine: The AYUSH License helps regulate and restrict the improper use of Ayurvedic medicines, ensuring quality and safety standards are maintained. This promotes consumer trust and confidence in Ayurvedic products.

Government Support: With the government’s “go local” approach, there is increased encouragement for entities and consumers to rely on domestically produced Ayurvedic and herbal medicines. Holding an AYUSH License aligns with this initiative, fostering support and recognition from governmental bodies.

Low Risk of Side Effects: Ayurvedic and herbal medicines produced under the AYUSH License are known for their low risk of side effects. This enhances user trust and satisfaction, leading to increased adoption and usage of these natural remedies.

Types of AYUSH Licenses

AYUSH Manufacturing License:

The AYUSH Manufacturing License is obtained when an individual or entity intends to both manufacture and market AYUSH products. To acquire this license, the producer must establish a manufacturing unit.

Requirements under the AYUSH Act for Obtaining an AYUSH Manufacturing License:

Unit Location: The manufacturing unit must be located in an industrial area as per the state’s regulations.

Minimum Size of Unit: The minimum size of the manufacturing land required for producing one drug should be 1200 square feet. Additional space may be required for producing multiple drugs.

GMP Certification: The manufacturing unit must be certified by Good Manufacturing Practices (GMP) to ensure adherence to quality standards.

Inspection Team Specification: The manufacturing unit must have at least two Ayurvedic experts and two pharmacists onboard.

Loan Manufacturing Agreement: Access to all manufacturing and packaging machinery is necessary.

Drug Inspector Inspections: Regular inspections of the manufacturing unit will be conducted by drug inspectors to ensure compliance with regulations.

Each state may have its own specific requirements for setting up such manufacturing units, and it is essential to comply with all regulations set forth by the state authority of AYUSH.

Unani Manufacturing License: Unani Medicine is a revered healing system known for its unique approach to preventing and curing diseases. It has gained widespread recognition as an alternative medical system.

Siddha Manufacturing License: Siddha Medicine focuses on maintaining a balance between the mind, body, and spirit. It emphasizes restoring harmony to various psychological and physiological functions through treatments that integrate yoga, meditation, diet, and lifestyle practices.

AYUSH Loan License: In this setup, the manufacturing unit is not owned by the applicant. Instead, a third-party manufacturer produces the products. The applicant applies for a Loan License with a GMP certified manufacturer, who then manufactures the products on behalf of the applicant organization. Product approval is required from the authorities before distribution.

Documents Required for AYUSH License Application

– Personal details of the applicant, including Name, Address, Email, and Contact Number

– Copy of the Manufacturing License issued by the relevant authority

– Comprehensive product list intended for issuance of Certificate of Pharmaceutical Product (COPP), including product composition

– Site Master file or Manufacturing Plant Layout detailing the manufacturing facilities

– Manufacturing formula and process for each product

– Method of analysis and finished product specification reports

– List of approved products

– Stability study analysis for each product batch, including manufacturing and expiry dates

– Process validation report for at least three batches

– List of technical staff with their qualifications and approval status

– Inventory of equipment and instruments utilized or planned for use

– Diagrams illustrating the Water System and HVAC System used in manufacturing

– Export data for the past two years, where applicable

– Evidence of safety and effectiveness as per regulatory guidelines

– Undertakings regarding the absence of non-herbal substances and compliance with domestic regulations, particularly for herbal products

Procedure to Obtain an AYUSH License

Manufacturers dealing with Ayurvedic or herbal articles must obtain a license from the Ministry of AYUSH. Each state operates its own AYUSH website. Here are the steps to obtain the license:

1. Visit the State AYUSH Website Navigate to the AYUSH website specific to your state and download the application form for an AYUSH license. Ensure all required Good Manufacturing Practices (GMP) and Certificate of Pharmaceutical Product (COPP) affidavits are included with your application.
2. Submission of Application Complete the application form, attach necessary supporting documents, and submit it for review to the Commissioner of the AYUSH Department.
3. Approval Process Upon satisfactory review by the Commissioner, approval is typically granted within 15 days.
4. Receipt of License The AYUSH license will be issued and sent to the applicant by post.

Involvement of Loan License Holder

For manufacturers operating under a Loan License:

• The Loan License holder can supply raw materials and packaging materials, or the manufacturer may procure these from other sources.
• The manufacturer processes these raw materials into finished products and supplies them accordingly.
• The Loan License holder can seek another Loan License with a new GMP-certified manufacturer for subsequent batches.

Charges Imposed by the Manufacturer on Loan License Holder

Manufacturers may impose the following charges:

• Conversion charges for manufacturing the desired product at their facility.
• Product approval fees.

Legal Drafting for Protection

To safeguard interests between the manufacturer and the Loan License holder, a legally sound agreement should be drafted. This agreement should explicitly state ownership rights, ensuring that the company retains ownership of the product under all circumstances.

How Corporate Raasta Consulting Assists in Obtaining the AYUSH License

Expert Consultation: Our experts are just a call away, providing professional guidance and addressing all your queries regarding the AYUSH license.

Application Filing: We handle the entire application filing process efficiently on your behalf, ensuring accuracy and compliance with regulatory standards.

Document Collection: Our team collects all necessary documents required for the AYUSH license application, simplifying the process for you.

Timely Completion: A dedicated professional is assigned to ensure the timely completion of the entire process, keeping you informed at every step.

Regular Updates: We keep you informed throughout the process, providing regular updates and maintaining transparency at every stage.

At Corporate Raasta Consulting, we are committed to delivering on our promises, ensuring a smooth and hassle-free experience for our clients.