Do Ayurveda Medicine Manufacturers have to declare Ingredients and MRP on package label?

Many ayurveda drug manufacturers and marketers consider their drug formulations and ingredient combinations to be commercially sensitive and may not wish to publicly disclose complete details of ingredients and name and address of actual manufacturer on product labels. Some businesses also feel that detailed disclosures make it easier for competitors to replicate their products and reduce brand uniqueness.

Sometimes, ayurveda clinics charge patients for treatment such that medicines are provided as part of an overall consultation or therapy plan, rather than being sold as standalone retail products. In such cases, presence of MRP on the label of product supplied to the patient becomes sensitive for the ayurveda clinic.

In above scenarios and many other such cases, businesses wish to whether it is legally permissible to market such medicines without disclosing certain confidential information on the label, such as the true list of ingredients used in the preparation of the medicine, details of the manufacturer and Maximum Retail Price (“MRP”) of the product if sold in retail packs.

In this article, we will examine whether there is any legal and flexibility with ayurvedic drug manufacturers to avoid declaration of list of ingredients, name and address of actual manufacturer and MRP.

Laws governing labelling requirements of ayurvedic medicines in India

Under the existing legal framework in India, ayurvedic medicines manufactured under manufacturing license and supplied as a pre-packaged commodity are compulsorily required to carry mandatory labelling declarations prescribed under The Drugs & Cosmetics Act, 1940 (“D&C Act”), The Drugs Rules, 1945 (“Drugs Rules”) and The Legal Metrology (Packaged Commodities) Rules, 2011 (“LMPC Rules”).

Any deviation from these requirements may expose manufacturers or marketers to substantial regulatory risks. Specifically, failure to disclose mandatory particulars may result in the medicine being treated as a “misbranded drug” under the D&C Act along with criminal prosecution, monetary penalties, seizure or confiscation of stock and suspension or cancellation of manufacturing licenses.

Importantly, liability of manufacturing and selling misbranded ayurvedic medicines is not limited to the actual manufacturer alone. The marketer i.e. brand owner and other entities involved in distribution may also face regulatory action.

Is there any alternative available?

The law that governs labelling of ayurveda products does provide relaxations where medicines supplied under specific treatment-based or practitioner-led models ought not to declare list of ingredients, details of manufacturer and MRP on the label of products. However, these relaxations are very narrow in scope, and the ability of a business to use the relaxation depends on how the medicines are manufactured, packed, prescribed, and supplied to patients. The decision to change the label without ensuring compliance with requirements of claiming relaxations, or simply outsourcing manufacturing without considering regulatory intricacies, may in fact be counter productive and have severe repercussions for business and senior management, including criminal prosecution.

Therefore, before adopting any alternative approach to seek relaxation from standard labelling requirements, ayurvedic businesses should carefully evaluate their overall business and operational model and then take a conscious decision