WHAT IS AYUSH LICENSE?

AYUSH stands for Ayurveda, Yoga and Naturopathy, Unani, Siddha and SOWA-Rigpa and Homoeopathy systems of medicines. These are all ancient forms of medicine and treatments which have been quite popular in India since decades. Prior to 2014, these products and treatments were in extensive use but remained completely unregulated. However, since the establishment of a dedicated AYUSH Ministry under the Central and State governments, in the year 2014, AYUSH businesses have received a robust regulatory framework for manufacturing, sale, marketing, and export of products within and outside India.



AYUSH licenses are a significant part of this regulatory framework, whereby the Government prohibits unlicensed AYUSH businesses from operating in India. The AYUSH license is granted by the AYUSH Ministry of the state government, under the jurisdiction of which the AYUSH business operates. The license must be obtained by all businesses dealing in Ayurvedic, Unani, Siddha, Herbal, and Homeopathy, Drugs / cosmetics, and other related treatments. As far as the application for the grant of license is concerned, the provisions for the same are mentioned in the Drugs and Cosmetics Rules, 1945.



BENEFITS OF AYUSH

Holistic approach to health: Ayush systems of medicine focus on the overall well-being of an individual, taking into account physical, mental, and emotional aspects of health.

Natural treatments: Ayush treatments are based on natural remedies and therapies, using herbs, spices, oils, and other natural substances. This makes them safer and free from harmful side effects.

Effective in chronic conditions: Ayush treatments are often effective in treating chronic conditions such as arthritis, asthma, diabetes, and hypertension.

Stress relief: Yoga and meditation, which are part of Ayush, are effective in reducing stress and anxiety, promoting relaxation, and improving overall mental health.

Personalized treatment: Ayush treatments are often customized to the individual's unique needs and constitution, taking into account factors such as age, gender, lifestyle, and medical history.

Cost-effective: Ayush treatments are often less expensive than conventional medicine, making them more accessible to a wider range of people.

Sustainable: Ayush emphasizes the use of natural resources and sustainable practices, promoting environmental awareness and conservation.

WHAT ARE THE DIFFERENT TYPES OF AYUSH LICENSES?
1. AYUSH Manufacturing License Required if the business wants to manufacture and market its own ASU products / treatments, for which it will use its own manufacturing facility.
2. AYUSH Wholesale & Retail License Required if the business wants to sell ASU products in wholesale or retail to the customers, and owns a shop for the same.
3. AYUSH Loan License customers, and owns a shop for the same. Required by a manufacturing business which does not own a manufacturing unit, and is renting it from some other manufacturer, along
4. AYUSH Third-Party Manufacturing License Required by businesses that are only involved in advertising and selling their products, and outsource the manufacturing process entirely to third-party manufacturers on contract.

DOCUMENTS REQUIRED FOR AYUSH LICENSE

  • Site layout of the manufacturing facility
  • Details of Manufacturing formula and manufacturing process
  • Finished product specification report
  • List of applied and approved products for COPP certification
  • Process Validation Report for 3 batches
  • Details of the technical staff, their names, experience, and qualifications
  • List of equipment to be used for manufacturing
  • Water & HVAC (Heating, Ventilation, and Air Conditioning) system diagrams
  • Proof of Safety & Effectiveness according to Rule 158B of Drugs & Cosmetics Rules, 1945
  • Undertaking regarding the absence of non-herbal ingredients, applicable in case of herbal products
  • Undertaking regarding compliance with the Drugs and Cosmetics Act, Drugs and Cosmetic Rules, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954, and its< corresponding rules (applicable in case of herbal products only)
  • KYC details of the applicant
  • Address Proof of the Premises (Rent Agreement)
  • Constitution Document of the business


  • Validity

    Prior to introduction of the Drugs (4th Amendment) Rules, 2021, the validity of the AYUSH License extended up to 5 years only. It was regularly needed to be renewed before the expiry of its term of validity. However, after the said rules were introduced and enforced on the 1st of October, 2021, the validity of the AYUSH license has been extended for lifetime, subject to online submission of self- compliance declaration every year or unless the license is suspended or cancelled. Other than that, the manufacturing facility will be inspected and the GMP Certificate will have to be validated every 5 years.

    Corporate Mitra provides support to get AYUSH registration and licenses all over India.

    Documents Required for AYUSH Registration

    Documents that would be required are as follows:

    - Duly signed an application form.
    - Copy of AYUSH code issued by GOVT.
    - Bank Certificate duly signed by the authorities.
    - Bank A/c. statement of the bank account of the firm (for latest 2 months)
    - Cancelled cheque.