The word CBD took Indian news channels by storm in September 2020. Right, wrong, ridiculous, and everything else was in the news about CBD oil. And why not? CBD comes from one of the most demonized plants of human history; Cannabis. The word Cannabis is acceptable for the TRP game. Above the stigma and misinformation lie hundreds of medicinal and industrial benefits of this plant.

Cannabidiol (CBD) is a naturally occurring chemical compound in the Cannabis plant, known for its therapeutic properties. CBD is extracted from various parts of the Cannabis plant like flowers, buds, leaves, and stems. This blog aims to identify the correct mechanism to manufacture and procure CBD oil / Cannabis-based medicines in India.

The laws and regulators

First things first, let us understand what does the law around Cannabis permits us. The Narcotic Drugs and Psychotropic Substances Act (NDPS) 1985 excluded Cannabis leaf and seeds from the definition of Cannabis (Hemp). The NDPS Act prohibits the consumption, possession, and sale of Cannabis (other than leaves and seeds); the provision of manufacturing drugs using Cannabis is defined in the NDPS act.

Three government agencies can grant a license for using Cannabis in medicine or food products.

1. Central Drugs Standard Control Organisation (CDSCO): It is India’s national regulatory body for pharmaceuticals and medical devices.

2. Ministry of AYUSH: It is the government’s arm for India’s research and development of indigenous alternative medicine systems.

3. FSSAI: It is the apex food regulatory body of India.

There are 191 poly-herbal Ayurvedic formulations that use Cannabis-leaf as an ingredient. CBD drops or products can be seen as a newer version of product formulation using Cannabis.

Various types of CBD Oil

CBD Oil can be classified into three main categories.

1. Full-spectrum CBD Oil: Full spectrum meaning the final product contains the entire range of naturally occurring chemicals present in the cannabis plant. This includes CBD, THC, other cannabinoids, terpenes, flavonoids, etc.

2. Broad-spectrum CBD Oil: Broad-spectrum contains the entire range of naturally occurring chemicals except for THC.

3. CBD Isolates: CBD-isolates contain only CBD compounded blended with any carrier oil.

Imported CBD products

In India, various types of CBD products are available, but Indian authorities regulate not everyone. The CBD products imported in India and not explicitly manufactured bore huge risks under the NDPS Act. The products whose raw material is not Cannabis leaf or seeds will be termed Cannabis as per NDPS Act. All the products in India that claim CBD Oil but are unregulated by the above three authorities are deemed illegal in India. If not approved by regulators of India, they violate the NDPS Act. Often, it is easier to procure these products that are available without a doctor’s prescription. The liabilities of these products fall on the manufacturers, sellers, and consumers. Given these products are not evaluated by any Indian authority, they may come with health hazards. These products often come with a disclaimer that the consumers are taking them at their own risk, and in case of any damage, the manufacturer is not liable.

Ministry of AYUSH-approved products

In India, most of the Cannabis-based medicines are manufactured under the Ministry of AYUSH license. These cannabis-based medicines are made using the leaf of the plant. In medicine, the entire range of naturally occurring chemical compounds is present. The raw material is sourced from a government agency responsible for the collection and distribution of the leaves. While the Ministry of AYUSH-approved products requires a valid prescription, the procurement journey is tedious. However, the Ministry of AYUSH-approved products are 100% legal and thoroughly evaluated, making them safe for consumption.