What is AYUSH License?
The ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) is associated with developing education, research and propagation of indigenous alternative medicine systems in India. Manufacturers who are involved in producing Ayurvedic or Herbal products or the sellers of such products in India are required to possess AYUSH license controlled by the Ministry of AYUSH. It is mandatory to have AYUSH license if one want to sell Ayurvedic or Unani or Siddha medicines or any product related to Ayurveda in India.
Types of AYUSH licenses issued in India
- AYUSH Manufacturing License
- Ayurveda Manufacturing License
- Unani Manufacturing License
- Siddha Manufacturing License
- AYUSH Loan License
- AYUSH Wholesale License
- AYUSH Retail License
- AYUSH Contract or third party manufacturing licenses
AYUSH Manufacturing License
AYUSH manufacturing license is required when a person or a firm manufactures Ayurvedic or herbal medicines in India. For this purpose the producer needs to set up his own manufacturing unit. For setting such manufacturing units, one need to obey all the state requirements issued by the AYUSH state authority.
According to the Drug and Cosmetic Act and Rule define the Ayurvedic, Unani and Siddha drugs which includes all the medicines intended for external or internal use in human beings or animals and are manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurveda, Unani and Siddha systems of medicine, specified in the first schedule.
There are three different types of AYUSH manufacturing licenses
1. Ayurveda Manufacturing License
Ayurvedic medicine is a healthy system of lifestyle that people in India have used for more than 5000 years. It focusses on good health and prevention and treatment of illness through lifestyle practices and the use of herbal remedies. To manufacture Ayurvedic or herbal products in India, the license from the AYUSH is required
The Unani system is originated in Greece. This is a system of alternative medicine involving the use of herbal remedies, dietary practices and alternative therapies. To manufacture Unani medicines in India, Unani Manufacturing License is required
Siddha is an ancient Indian traditional method of treatment which evolved in South India. Siddha is based on a combination of ancient medicinal practices and spiritual disciplines as well as alchemy and mysticism. To manufacture Siddha medicines in India, Siddha Manufacturing License is required.
AYUSH Loan License
AYUSH Loan License is a manufacturing license where one loan a manufacturing unit of a third party manufacturer to make the products. The manufacturing unit is not owned by the candidate. The third party manufactures the products. It is required to apply for a Loan license with a GMP certified manufacturer and then it will be issued to the company. After that product approval is needed to be obtained from the authorities. The loan license holder provide the raw materials. The manufacturer convert them in to finished products and then it is supplied. It is also possible to manufacture the products in the factory of the manufacturer. The product label will say that it is manufactured and marketed by the loan license holder.
AYUSH Wholesale/Retail License
The persons or agencies involved in the wholesale/retail of Ayurvedic and herbal drugs are required to obtain AYUSH Wholesale License. This is issued to those who directly engages themselves in the wholesale business of drugs and medicines.
What are the certificates required for AYUSH License?
GMP Certification: GMP stands for Goods Manufacturing Practice. It is a framework where by it is ensured that the items are reliably produced and controlled as per the quality standards as prescribed by the World Health Organization.
This certificate ensures that the manufacturing organization has gone through the examination and passed it conducted by the regulatory body of that country.
CoPP: CoPP stands for Certificate of Pharmaceutical Product. It is the legal document that certifies that the manufacturing organization is permitted to sell their pharmaceutical item in the nation they are creating.
What are the documents required for AYUSH License registration?
Documents required for AYUSH Manufacturing License:
- Details about the applicant such as name, address, telephone, email etc.
- Manufacturing license copy.
- Products list applied for issuance of CoPP and their composition.
- Site master file.
- Master manufacturing formula along with the manufacturing process.
- Method of analysis and finished product specification.
- List of approved products.
- Products list for which the firm has already availed the CoPP.
- Evaluation of stability study batch wise, along with the date of manufacturing, date of expiry, stability study condition, the name of drug etc.
- Process validation report for three batches. (Applicable in case of herbal products)
- Validation report of the analytical method.
- List of technical staff along with their qualification, experience and approval status.
- List of instruments and equipment used or to be used.
- Manufacturing plant layout.
- Water system diagram.
- HVAC system diagram.
- Export data for the last two years, wherever revalidation of CoPP is applicable.
- Product summary sheet.
- Actual labels of the products which are required to be applied for WHO-CoPP.
- Safety and effectiveness proof as per rule 158B of Drug and Cosmetic Rules, 1945.
- Certificates of analysis for three batches of each product. (Applicable in case of herbal products)
- Undertaking regarding the absence of any non-herbal such as metals or minerals etc. in the products applied for WHO-CoPPs.
- Undertaking regarding compliance with the provisions of domestic regulations inter-alia Drugs and Cosmetics Act, 1940 and rules there under, Drugs and Magic remedies (Objectionable Advertisements) Act, 1954 and rules there under.
Documents required for AYUSH Loan License:
- Manufacturing license copy of the manufacturer.
- Documents related to marketing firm or company.
- Competent person’s detail and qualification certificates.
- Any other documents asked by the authority.
Documents required for AYUSH Wholesale or Retail License:
- MOA and AOA of the company.
- Address proof (Copy of the rent agreement) of the premises.
- Photo ID proof of the proprietor or director or partner of the company.
- Details pertaining to the refrigerator.
- Affidavit regarding the compliance of MPD 2021.
- Qualification proof.
- Registration of Delhi AYUSH council.
- Appointment letter and bio data of the director of the company.
What is the procedure for applying for AYUSH license?
- Visit the individual state website of AYUSH.
- Download the necessary form, attachment, list of documents which also comprises of affidavits and other certification such as GMP and CoPP as the case may be.
- If appropriate apply for GMP and CoPP.
- Submit all the prerequisite documents to the directorate of AYUSH.
What if you violate the law?
In India, the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 regulate the import, manufacture, distribution, sale, packaging and labelling of drugs, including Ayurvedic, Unani and Siddha drugs (ASU drugs), and cosmetics.
The regulation of advertisements for drugs, including ASU drugs is governed by the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1955.
- Adulterated Drugs: One who manufactures for sale or distribution of any adulterated ASU drugs (as per section 33-EE) will be liable to a penalty of one year imprisonment or a fine up to Rs. 2000.
- Spurious Drugs: One who sells or markets spurious ASU drugs (as per section 33-EEA) will be liable to a penalty of one to three years of imprisonment or a fine up to Rs. 2000 – 5000.
- Misleading advertisements: The eleventh amendment of Drugs and Cosmetics Rules, 2018 seeks to regulate advertisements of Ayurvedic, Unani and Siddha drugs (ASU drugs) in an attempt to curb misleading advertisements. The Rule 170 (1) of the amendment prohibit the manufacturer or his agent from publishing any advertisements relating to the use of ASU drugs for diagnosis, cure, mitigation, treatment or prevention of any ailment, disorder, syndrome or condition.
The amendment lays down the need of a Unique Identification Number (UIN) for advertising any ASU drugs for purposes other than that prohibited under the rule 170 (1).
The prohibited category includes the drugs which suggests,
- The prevention of miscarriage or the prevention of conception in women.
- The maintenance or improvement of the ability of human beings for sexual pleasure.
- The correction of menstrual disorder in women.
- The diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition which may be specified in the rules made under this act.
The manufacturers of the Ayurveda, Unani, or Siddha drugs shall apply for the Unique Identification Number (UIN) for the advertisement issued or aired before this notification within the period of three months from the date of the publication of the notification.
The manufacturers of the ASU medicines have to abide by these rules, when violated may lead to cancellation of the licenses.
Being the manufacturer of Ayurvedic and herbal medicines in India, one must possess the AYUSH license. There are five different types of AYUSH licenses. It is required for the manufacturers and sellers to strictly follow the rules and regulations by AYUSH. Failing to comply with these will lead to punishable offenses under the act.