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TMI Blog2019 (9) TMI 9X X X X Extracts X X X X X X X X Extracts X X X X ..... e 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. - W.P. (C) Nos. 10220 & 12107 of 2018 with C.M. Appln. Nos. 39861 & 46974 of 2018 - - - Dated:- 18-2-2019 - Vibhu Bakhru, J ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ations dated 10-3-2016, prohibiting the manufacture, sale and distribution of 344 FDCs. The said 344 notifications also included the impugned notification, whereby the Central Government prohibited the manufacture, sale and distribution of the Combikit. 6. The impugned notification was challenged by the petitioners before this Court on several grounds including that the same had been issued without consultation with the Drugs Technical Advisory Board (DTAB). According to the petitioners, such consultation was mandatory and the failure on the part of the Central Government to do so had rendered the said notifications invalid. 7. The said petitions were considered along with a batch of petitions, which were disposed of by a common judgment dated 1-12-2016, whereby the impugned notification, along with other notifications, was set aside. Aggrieved by the said decision, the respondents preferred appeals and transfer petitions before the Supreme Court. The said petitions were disposed of by the common judgment in Union of India v. Pfizer Limited and Ors. - (2018) 2 SCC 39. The Supreme Court did not accept the view expressed by this Court that consultation with the DTAB ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... bination with Ceftriaxone. 3. The combination of the three drugs in the treatment of indications mentioned by the company is not recommended by standard therapeutic guidelines. The combikit of Fluconazole tablet, Azithromycin tablet and Omidazole tablet was already considered as irrational by DTAB under the 294 FDCs category. - The above combikit is similar in nature and hence should be considered is the same category as already considered as irrational by DTAB. There is no convincing scientific/clinical evidence/justification for the combikit. 10. In view of the aforesaid observations, the Sub-Committee recommended prohibiting the Combikit in question. The recommendations made by the Sub-Committee are set out below : - There is no therapeutic justification for this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26A of Drugs and Cosmetics Act, 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibiti ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... here can be little doubt that the Combikit cannot be classified as a drug. It is also not a FDC. 16. It is also relevant to note that the petitioner had applied to the Drugs Comptroller General of India (DCGI) for an approval for manufacturing the Combikit as an FDC. The petitioner has produced a letter dated 7-6-1999 issued by the Drugs Comptroller General of India, rejecting the petitioner's application by stating that the Combikit is not a FDC and the petitioner was required to obtain a separate licence for manufacturing the drugs. The contents of the said letter are reproduced below :- To, M/s. Lyka Labs Limited 77, Nehru Road, Vile Parle (B) Mumbai-400099. Dated, the 7 JUN 1999 Sub :- Combination kit containing Azithromycin 250 Capsules + (4 capsules) + Fluconazole Tablets 150 mg (1 Tablets) + Secnidazole Tablets-1 gm (2 Tablets). Ref :- Your letter dated 11-1-99. Dear Sirs, Combi-Kit containing Azithromycin 250 mg (Four Capsules) + Fluconazole 150 mg. (one tablet) + Secnidazole 1 mg (2 tablet) for the syndromic management of vaginal discharge is not a fixed dose combination and ea ..... X X X X Extracts X X X X X X X X Extracts X X X X
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