Introduction to Cannabis
Medicinal cannabis is increasingly recognised for its potential to alleviate symptoms of a variety of medical conditions, such as chronic pain and anxiety, providing an alternative to traditional pharmaceuticals. Ayurveda, for example, has more than 260 formulations based on the cannabis plant.
In India, the production, possession, sale, and consumption of cannabis is prohibited except for medical, industrial, or scientific purposes under the Narcotic Drugs and Psychotropic Substances Act, 1985, and rules framed/orders issues in it (NDPS Act). As the NDPS Act does not include the seeds and leaves of the cannabis (hemp) plant, bhaang and similar derivatives made from its leaves fall outside the purview of the Act. However, cannabis, like other narcotics, may also be regulated under state-specific legislation and accordingly, its use may be prohibited or restricted depending on the jurisdiction.
Use of cannabis in ayurveda
The Drugs and Cosmetics Act, 1940 (D&C Act), is the primary legislation in India that deals with the development, manufacture, and sale of drugs. Cannabis and its derivatives are recognised as ingredients in drugs under the “Ayurvedic, Siddha, or Unani” category, a special classification of traditional medicine systems. While the state drug authorities under the D&C Act may grant licenses for manufacturing ayurvedic drugs containing cannabis, the restrictions imposed by the central and state narcotic legislation to prohibit the production and sale of cannabis-containing products may hinder the supply of raw material, research, and development activities, etc. Accordingly, the production, innovation, and distribution of ayurvedic products containing cannabis (or its derivatives) may currently seem like an uphill battle for industry stakeholders.
Introduction of central clearance
The Ministry of Ayush, in April 2024, had constituted a committee to address the growing instances of the illegal sale of ayurvedic drugs containing bhang. After deliberation, the committee recommended that the Central Government retain the power to permit the manufacture of bhanga, keeping in mind public health at large. Accordingly, on August 7, 2024, the Ministry of Ayush, released an order to streamline the regulatory framework of granting approvals (“Order”) for the manufacture of ayurvedic drugs containing Bhanga/Ganja/Charas/Bhang (except seeds) and Ahipena/Abini/Afiyun (except seeds).
In terms of the Order, the state drug licensing authorities must provide details of existing manufacturers of ayurvedic drugs containing Bhanga/Ganja/Charas/Bhang (except seeds) and Ahipena/Abini/Afiyun (except seeds) to the Ministry of Ayush. This requirement would also apply to the pending applications for approvals to manufacture such drugs. Interestingly, manufacturers seeking to produce ayurvedic drugs containing the aforementioned ingredients must first obtain clearance from the Ministry of Ayush before receiving approvals from state licensing authorities.
Implications for the Industry and Stakeholders
The revised framework set out by the Ministry of Ayush is a welcome step for all industry stakeholders, and the additional supervision stems from the intention of bringing uniformity of standards across the country. The requirement for state authorities to disclose data vis-à-vis existing and pending approvals will help in the creation of a dynamic database, facilitating increased monitoring and surveillance of licensees.
The additional obligation for state authorities to seek clearance from the central authority may improve the vigilance of ayurvedic drug manufacturers and ensure that they maintain continuous compliance with the prescribed standards and licensing conditions. This order also marks the commencement of the Indian government’s efforts to create a more cohesive and structured Ayurvedic regulatory framework, while simultaneously advancing the development and distribution of such medicines.