Adding preservatives to ayurvedic medicine will change the classification of medicine

by Arjun Singh

The recent decision by the CESTAT, Ahmedabad in the case of Lyka Labs Limited v. C.C.E. & S.T.-SURAT-II has provided clarity on the classification of ayurvedic medicaments. The CESTAT set aside the order passed by the Adjudicating Authority and held that the addition of non-active ingredients such as preservatives does not change the classification of the product if the active ingredients are ayurvedic.

In this case, M/s. Lyka Labs Limited manufactured Sensur Rubefacient and Herbyl Skin ointment. The company argued that these products are manufactured using ayurvedic ingredients specified in Ayurveda Grantha and are sold as ayurvedic medicine. The Appellant also pointed out that the Drug Authority has given them a license to sell these products as ayurvedic medicine.

The issue before the CESTAT was whether the inclusion of preservatives in ayurvedic medicaments would result in a change in classification.

The CESTAT, taking into consideration various judgments of the Supreme Court, outlined the criteria for classifying a product as an ayurvedic medicament. Firstly, the medicament should be manufactured using ayurvedic ingredients specified in Ayurvedic Grantha or Ayurveda authoritative books. Secondly, the product should be sold as ayurvedic medicine in the trade parlance.

In this case, although some of the ingredients were non-ayurvedic, they were non-active ingredients such as preservatives, excipients, binding agents, carriers, or fillers. The CESTAT concluded that even though these non-active ingredients were not ayurvedic, if the active ingredients were ayurvedic, the medicament can still be classified as an ayurvedic medicament.

Based on these observations, the CESTAT set aside the order and remanded the matter to the adjudicating authority for passing a fresh order, considering the Supreme Court judgments and the criteria outlined by the CESTAT.

This decision provides clarity on the classification of ayurvedic medicaments and emphasizes the importance of the active ingredients in determining the classification. Non-active ingredients that are not ayurvedic do not change the classification as long as the active ingredients are ayurvedic.

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