AYUSH is a branch of traditional medicine including Ayurveda, Unani, Siddha, and Homeopathy drugs. They are distinctly defined under the Drugs and Cosmetics Act of 1940 which clearly mentions that their commercial production needs an AYUSH manufacturing license. On the other hand, the license requirement for selling AYUSH drugs is a grey area that we’ll explore in this blog.
AYUSH drugs are sold both in retail and wholesale sectors. Compared to generic drugs which need separate wholesale and retail licenses for this purpose, AYUSH drugs can be sold without any license under the Drugs and Cosmetics Act. This is because the definition of AYUSH drugs is exclusive from that of generic drugs under the law. Further, their production and supply chains are also regulated under distinct provisions. Let’s have a closer look at the legal framework.
Definition of AYUSH Drugs and Generic Drugs under the Drugs and Cosmetics Act
This is separate from the definition of generic drugs mentioned in Section 3 (b) of the Act which includes all pharmaceuticals, cosmetics, and devices intended to be used in the diagnosis, treatment, mitigation, or prevention of diseases in humans and animals. The fact that AYUSH drugs are excluded from the definition of generic drugs, implies that their regulatory frameworks are also different.
Regulatory Framework of AYUSH Drugs - Chapter IV A of Drugs and Cosmetics Act
Chapter IV of the Drugs and Cosmetics Act regulates the manufacture, sale, and distribution of drugs and cosmetics, in general. It mandates the requirement of separate licenses for manufacturing, retail, and wholesale activities. However, Section 33A clearly states that none of the chapter’s provisions apply to AYUSH Drugs, which are further regulated under Chapter IV A.
Chapter IV A contains distinct rules for the manufacturing, sale, and distribution of drugs under sections 33EEB and 33EEC. According to Section 33EEC, no individual, either directly or through a representative,
- shall manufacture for sale or distribution:
- Any Ayurvedic, Siddha, or Unani drug that is misbranded, adulterated, or spurious;
- Any patent or proprietary medicine unless the label or container prominently displays the accurate list of all ingredients contained within it;
- Any Ayurvedic, Siddha, or Unani drug that violates any provision of this Chapter or any rule established under it.
- sell, stock, exhibit, or offer for sale or distribution any Ayurvedic, Siddha, or Unani drug that has been manufactured in contravention of any provision of this Act or any associated rule.
- Manufacturing of any Ayurvedic, Siddha, or Unani drug for sale or distribution is only permitted under a manufacturing license/loan license and by the conditions of a license issued for this purpose by the designated authority.
Note here that no license has been prescribed for the sale of AYUSH drugs explicitly. This condition was further supported by a press release dated 10 March 2015 in respect of the information provided by Minister of State, AYUSH(IC), Shri Shripad Yesso Naik in his written reply to a question in Rajya Sabha.
Exceptions to Section 33EEC:
The section does not apply to Vedas and Hakims who manufacture Ayurvedic, Siddha, or Unani drugs for the use of their patients. Additionally, manufacturing small quantities of any Ayurvedic, Siddha, or Unani drug for examination, test, or analysis is exempted, subject to prescribed conditions. Patent or proprietary medicines within the Ayurvedic system refer to formulations that exclusively contain ingredients listed in the formulae outlined in the authoritative books of Ayurveda specified in the First Schedule of the Drugs and Cosmetics Act. However, this category excludes medicines administered via parenteral routes.
Certification Provides for AYUSH Drugs
The provision for Good Manufacturing Practices (GMP) Certification of AYUSH drugs is mentioned in Section 152 of the Drugs and Cosmetics Act. The State licensing authorities supervise the process according to Rule 155-B of the Drugs and Cosmetics Rule, 1945. Additionally, WHO guidelines for certification of pharmaceutical products also apply to AYUSH drugs. It is overseen by the Office of Drugs Controller General of India. Besides these institutional certifications, AYUSH medicines are also applicable for a voluntary certification implemented by the Quality Council of India.
The regulatory framework for AYUSH drugs favour their promotion as traditional medicine. This is reflected in their exclusive definition, distinct regulatory framework, and reduced licensing requirements under the Drugs and Cosmetics Act. However, their efficiency is put to the test through various national, international, and voluntary certifications under Institutions like the State Government, Drugs Controller General, and Quality Council of India.
FAQs
Q1: What are AYUSH drugs?
AYUSH stands for Ayurveda, Unani, Siddha, and Homeopathy medicines. These are the traditional forms of medicines used in India for the treatment of human as well as animal diseases. Their composition contains natural ingredients and lacks any chemical compounds.
Q2: Are AYUSH drugs considered as modern medicine?
No. The Drugs and Cosmetics Act defines AYUSH medicines distinctly based on their exclusive formulae and composition. They are not classified as modern medicines.
Q3: Do I need a License to manufacture AYUSH medicines?
Yes. You either need a manufacturing license or a loan license to manufacture AYUSH medicines. While a manufacturing license is granted to entities having their manufacturing facilities, a loan license is given to entities manufacturing the drugs at the facility of a third-party licensed manufacturer. There are exceptions to this rule. Vaidyas and Hakims who produce these drugs for use on their patients do not need any license. Also, the same applies if the drugs are being produced for testing purposes.
Q4: Do I need a retail or wholesale license for my AYUSH drug store?
No. Selling AYUSH drugs does not require any license.
Q5: How can I certify my AYUSH products?
AYUSH products can apply for voluntary certification by QCI, or government certification by state licensing authorities.