2019 (9) TMI 9 - HC - Indian Laws

Seeking 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.

Summary

Issues:
Challenge to notification proscribing a Combikit under Section 26A of the Drugs and Cosmetics Act, 1940.

Analysis:
The petitioners challenged a notification proscribing a Combikit comprising Azithromycin, Secnidazole, and Fluconazole under Section 26A of the Drugs and Cosmetics Act, 1940. They argued that the Combikit is not a fixed drug combination (FDC) but a convenient package of three separate drugs administered at different times. The Central Government, based on recommendations from expert committees, including the Kokate Committee, issued the impugned notification along with 344 others. The petitioners contended that the notification was invalid as it lacked consultation with the Drugs Technical Advisory Board (DTAB). The Supreme Court, in a previous judgment, clarified that consultation with DTAB was not mandatory for such notifications but remanded the matter for further deliberation.

The DTAB recommended the constitution of a Sub-Committee to review FDCs, including the Combikit. After due process, the Sub-Committee recommended prohibiting the Combikit due to lack of therapeutic justification and potential risks. The Central Government accepted the recommendation and issued the impugned notification. The petitioners challenged this decision, arguing that the Combikit was not a drug or FDC, as each component was separately administered at different times. They also highlighted a previous rejection of their FDC application by the Drugs Comptroller General of India.

The Court analyzed Section 26A of the Act, which empowers the Central Government to regulate drugs likely to pose risks or lack therapeutic value. It noted that the Combikit was not a drug or FDC, as each tablet was separately packaged, administered at different times, and had distinct batch numbers and expiry dates. The Court also referenced the previous rejection of the FDC application by the Drugs Comptroller General. It concluded that the Combikit did not fall under the purview of Section 26A, as it was not a drug and the notification was unsustainable. The Court emphasized that if the therapy was irrational, action should be taken against the prescribing medical practitioner rather than proscribing the Combikit under Section 26A.

In summary, the Court set aside the impugned notification, stating that Section 26A was not applicable to the Combikit. The judgment highlighted the distinction between a drug and a convenient package of separate medications, emphasizing that powers under Section 26A could not be used to proscribe packaging or therapy. The decision underscored the need for therapeutic justification and regulatory compliance in drug-related matters.