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2019 (9) TMI 9 - HC - Indian LawsSeeking approval for manufacturing the Combikit as an FDC - therapy entailing the drugs comprised in the Combikit - whether there is any therapeutic justification for comprising the three drugs which are included in the Combikit. And, there may be good reasons not to prescribe such therapy. - Notification [No. S.O. 4429(E)] - powers under Section 26A of the Drugs and Cosmetics Act, 1940 HELD THAT:- A plain reading of Section 26A of the Act indicates that the Central Government is empowered to regulate, restrict or prohibit the manufacture, sale or distribution of any such drug or cosmetic, that is, (a) likely to involve any risk to human beings or animals, or (b) a drug which does not have the therapeutic value claimed or purported to be claimed for or contains ingredients, and in such quantity for which there is no therapeutic justification, and (c) where it is necessary to do so in public interest - In the present case, there can be no dispute that the Combikit is not a drug. The Combikit comprises of three different types of tablets : (i) One Tablet of Fluconazole 150 mg; (ii) one Tablet of Azithromycin 1 gm; and (iii) two tablets of Secnidazole 1 gm tablet. The four tablets are packaged in a single strip and sold as the Combikit. The petitioner is licensed to manufacture each of the said formulations. The Combikit cannot be sold except on a medical prescription prescribing all the three drugs, which are packed in a single strip. Plainly, if that therapy is irrational for the indication, the necessary action would have to be taken against the medical practitioner prescribing the said therapy, however recourse to Section 26A of the Act is unavailable to prohibit prescription of a therapy. The issue relates to packaging of the three separate drugs in one single package. The said issue may also be addressed in the context of the regulations relating to packaging of drugs, if any. However, the powers under Section 26A of the Act cannot be exercised to proscribe packaging of drugs in any particular manner. The impugned notification is, accordingly, set aside - Appeal allowed - decided in favor of appellant.
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