Section 26A cannot be used to ban a therapy regimen or separately packaged drugs; the notification was set aside.

Section 26A of the Drugs and Cosmetics Act permits regulation or prohibition only of a drug or cosmetic where the statutory conditions are met. A combikit made up of three separately manufactured, separately batch-numbered and separately labelled tablets, intended to be taken at different times, could not be treated as a single drug or fixed-dose combination. The provision did not authorise prohibition of a therapy regimen or of the packaging of separate drugs in that form. The Delhi HC therefore held the notification unsustainable under Section 26A and set it aside.

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Issues: Whether the impugned notification issued under Section 26A of the Drugs and Cosmetics Act, 1940 could validly prohibit a combikit consisting of three separately licensed drugs packed together and administered at different times.

Analysis: Section 26A empowers the Central Government to regulate, restrict or prohibit manufacture, sale or distribution of a drug or cosmetic only where the statutory conditions are satisfied. The combikit in question consisted of three separate tablets, each separately manufactured, separately batch-numbered, separately labelled, and intended to be taken at different times. On that basis, it could not be treated as a single drug or as a fixed dose combination. The controversy, at its highest, concerned the therapeutic propriety of the prescription regimen and the manner of packaging. Section 26A does not authorise the prohibition of a therapy or the packaging of separately manufactured drugs in a particular form.

Conclusion: The notification was unsustainable under Section 26A and was set aside.

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