Understanding AYUSH Licence in India: An Overview

Introduction

The AYUSH licence, by the Indian government, allows people and companies to make and sell traditional drugs Ayurvedic, Unani, Siddha, and similar preparations. This is controlled by the Ministry of AYUSH, which was formed on November 9, 2014; it dates back from the Department of Indian System of Medicine and Homeopathy in which it started its stream in 1995. Rules followed are for traditional medicine in conformation with India’s rich history and growing interest globally for the same products.

The Relevance of Ayurveda and Other Traditional Medicines

Ayurveda is the oldest medical system in the world and holds strong connections to Indian culture. It focuses on healing naturally with a minimum of side effects. Today, more people around the world are choosing Ayurvedic products as many countries are bringing these remedies in. Because of their long history and gentle effects, Ayurvedic, Unani, and Siddha medicines are often chosen for prevention and treatment.

Things to Know Before Applying for an AYUSH Licence

According to the Drug and Cosmetic Act 1940, any person or firm desirous of manufacturing or selling Ayurvedic medicines needs to get a licence. The act applies to every kind of medicines, whether Ayurvedic, herbal, homoeopathic, or allopathy drugs. For the Ayurvedic product, he/she has to go for the AYUSH licence, assuring quality, authenticity, and legal safety of the manufacturing process.

Types of AYUSH Licences

The Ministry of AYUSH issues diverse types of manufacturing licences that are rather beneficial for several business models in the traditional medicine sector:

1. Ayush Manufacturing Licence: It is given to the people or business which has a place to manufacture and sell products. The applicants have to set up a manufacturing unit and fulfil the requirements of their state.
2. Unani manufacturing Licence: Unani is the ancient healing practice that also needs a separate licence. Also, due to its preventive approach and holistic method, Unani medicine has gained popularity worldwide.
3. Siddha manufacturing licence: Siddha medicine pertains to balance in body, mind, and spirit; it aims at teaching yoga, meditation, and a healthy diet. This licence would enable the production of Siddha remedies within the confines of this ancient holistic healing modality.
4. AYUSH Loan Licence: In this case, the business does not have its own factory. However, it has a licensed manufacturer who does manufacture and packs the products for them. Even in such a scenario, they still require product approval from relevant authorities.

Documentation Required for an AYUSH Licence

An extensive list of documents is required before applying for the AYUSH licence.

• Personal Information: Applicants name, address, email and contact number.
• Manufacturing Licence: Copy of manufacturing licence approved by GMP.
• Product portfolio and formulation: Description of the product line and formulation.
• Manufacturing Facility Layout: Presenting the site master file.
• Manufacturing Process: Elaborated process conducted on each product.
• Analysis and validation reports: Stability studies and process validation.
• Technical Staff Information: Key personnel qualifications and experience.
• HVAC and Water Systems Diagrams: Critical for GMP compliance.
• Export Data: Only if re-applying for COPP validation.
• Safety and Efficacy Deviance: As per adherence to Rule 158B of the Drugs & Cosmetic Rules, 1945.
• Herb and Herbal Products Business Assurances on non herbals ingredients and compliance with the internal regulations.

Step-by-Step Procedure to Obtain the AYUSH Licence

The process of AYUSH licensing follows:

1. Website Visit: Candidates must visit the respective state-specific website of AYUSH to download the application form and affidavits.
2. Form Submission: The filled up form along with attachments will be submitted for assessment.
3. Commissioner’s Approval: The commissioner of AYUSH Department examines the application and approval is done in approximately 15 days.
4. Licence Issuance: After the review, the AYUSH licence is issued to the applicant.

Conclusion

AYUSH licence is an essential legal system, which aids in the growth of traditional medicine industries in India. A licence encourages businesses to follow rules, ensures safe products, and facilitates them entering the market. Such a licence aids in the regulated growth of Ayurveda, Unani, and Siddha drug production. As more people seek natural and holistic remedies, the AYUSH licence cultivates consumer trust while forming sustainable development opportunities for Indian businesses in the traditional medicines field.