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India: The Regulatory Highs And Lows Of Launching Medicinal Hemp Products


In this article, we unpack the regulatory compliances that a medical hemp product must meet.

Introduction

In our last post1 we talked about history, science and the regulator’s position on cannabis. In this article on cannabis regulation, we explain how you can grow, sell, and market your hemp products.

Most hemp can be legally grown, processed, and sold, but only for scientific, medicinal purposes.2 or for food or industrial purposes3. For the purposes of this article, we will only discuss the medical route to doing business. Before you begin, here are a few things you should know to better understand the next section:

1. Applicable law: The Narcotic Drugs and Psychotropic Substances Act of 19852 (NDPS), the Drugs and Cosmetics Act of 1940 (DCA), excise laws and state laws specific to cannabis apply.

2. The regulator: The respective state excise department is responsible for issuing licenses for the cultivation, possession and use of cannabis. From the point of view of medical use, it is the ministry of AYUSH. And the Food Safety and Standards Authority of India (FSSAI) for food-related use cases.

3. Red flags: Recreational use of the plant is prohibited by law. Also, using without proper permission and in some cases selling without a prescription can also get you in trouble.

4. Quantity matters: Regulations prescribe the “strength” of your hemp (i.e. THC and CBD levels) – whether for cultivation or manufacturing. Discover our Last post, for what CBD and THC mean, and what they do.

The checklist

The table summarizes the compliance and requirements a company must meet to start their medicinal hemp business.

Other general e-commerce, telemedicine and consumer protection laws will also apply. But these laws do not impose any particular obligations on hemp companies.

Where do we go from here?
Policy makers have a lot to consider. The current regime is blinded by the societal stigma attached to cannabis that undermines the ability of companies to market their products. This would require involving stakeholders such as healthcare practitioners, researchers and scientists, hemp companies, among others. In addition, the harmonization of compliances and the establishment of a regulatory environment that facilitates the conduct of business are necessary. As the central government seeks to overhaul the DCA itself13it brings no clarity to the regulation of cannabis.

On the other hand, states like Tamil Nadu recognizexiv increasing demand for hemp and its value-added products. The state government is considering legalizing the cultivation of hemp for industrial and medical purposes and has requested the Tamil Nadu University of Agriculture to submit a feasibility report to that effect.

Finally, with the industry seeing so many new players emerge, we need to learn from nations that have a much more mature landscape. look Hasan Minhaj details the nuances of what the cannabis industry in the United States is facing.

Footnotes

1 https://www.ikigailaw.com/hemp-gets-recognition-as-food-but-food-comes-with-its-own-set-of-indigestible-regulatory-challenges/

2 https://www.firstpost.com/health/medicinal-cannabis-what-it-is-its-legal-status-in-india-and-everything-you-need-to-know-10354991.html

3 https://inc42.com/resources/indian-hemp-industry-understanding-the-legal-challenges-and-market-opportunities/

4 Section 8 of the NDPS

5 https://hemptoday.net/second-indian-state-frees-hemp/

6 https://www.thehindubusinessline.com/economy/agri-business/cannabis-cultivation-is-now-legal-in-uttarakhand/article24381601.ece

7 See for example: https://deoria.nic.in/past-notices/tenders/

8 https://timesofindia.indiatimes.com/city/bareilly/state-excise-department-allocates-1490-retail-outlets-of-liquor-bhang/articleshow/90427466.cms

9 Section 3 (h) of the ICA

ten https://www.ayush.gov.in/docs/guideline-drug-development.pdf

11 DAC Form 24D

12 Section 10 of the ICA

13 Drugs and Cosmetics Bill https://main.mohfw.gov.in/sites/default/files/Drugs%2C%20Medical%20Devices%20and%20Cosmetics%20Bill.pdf

14 https://www.newindianexpress.com/states/tamil-nadu/2022/jun/16/talks-under-way-to-make-hemp-cultivation-legal-in-tamil-nadu-2466090.html

The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.



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