Excipient ingredients do not alter the essential character of a drug; micronised progesterone product qualified for exemption.

A product sold as "Sugest" containing natural micronised progesterone with excipients was treated as falling within the exemption entry under Notification No. 4/2006-C.E. read with the relevant entry in Notification No. 21/2002-Cus. The presence of ordinary excipients was held not to change the essential character of the basic drug, and exemption could not be denied merely because the medicine contained constituents other than the active ingredient. The product was therefore regarded as covered by the exempted description, and the revenue objection failed.

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Issues: Whether the respondent's product, sold as "Sugest" and containing natural micronised progesterone with other excipients, was eligible for exemption under Notification No. 4/2006-C.E. read with the relevant entry in Notification No. 21/2002-Cus.

Analysis: The product was found to be sold as natural micronised progesterone tablets, and the additional ingredients were treated as excipients ordinarily used in medicines. It was held that the presence of excipients does not alter the essential character of the basic drug, and the exemption entry could not be denied merely because the medicine contained other constituents in addition to the active ingredient. The product was therefore held to fall within the exempted description in the relevant notification entry.

Conclusion: The product was entitled to exemption, and the revenue's objection was rejected.

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