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2019 (9) TMI 9
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....d notification'), proscribing the Combikit of (i) Azithromycin; (ii) Secnidazole; and (iii) Fluconazole (hereafter referred to as 'the Combikit'). The impugned notification has been issued in exercise of powers under Section 26A of the Drugs and Cosmetics Act, 1940 (hereafter 'the Act'). It is the petitioners' case that the Combikit is not a drug or a fixed drug combination (FDC), but comprises of three separate drugs, which are administered at separate times. It is further contended that the Combikit is only a convenient package of three separate drugs in question and, therefore, the same could not have been considered as FDC. Factual background : 2. The petitioner in W.P. (C) 10220/2018 manufactures and markets the Combikit under t....
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....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 n....
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....f these infections. 2. For the syndromic management of vaginal discharge, the National Guidelines on Prevention, Management and Control of Reproductive Tract Infections and Sexually Transmitted infections (July 2014) recommend : Tab Secnidazole 2 gm orally, single dose (OR Tab, Tinidazole 500 mg orally, twice daily for 5 days OR Tab Metronidazole 400 mg, twice daily for 7 days). Plus Tab Fluconaizole 150 mg orally single dose OR local Clotrimazole 500 mg vaginal pessary once. Azithromycin is not mentioned here. The National & International Standard Treatment guidelines for the management of PID, the anti-microbial combination recommended are Cefrazone + Doxycyclino + Metronidazole and for the vaginal discharge Tinidazole + Clin....
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....nning the Combikit. Aggrieved by the same, the petitioners have preferred the present petitions. Reasons and conclusion : 12. At the outset, it will be relevant to refer to Section 26A of the Act, which reads as under :- "26A. Powers of Central Government to prohibit manufacture, etc., of drug and cosmetic in public interest. - Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that i....
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....le 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 Azithr....
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.... submitted that in view of the observations made by the sub-committee, there could be no dispute that the therapy entailing the drugs comprised in the Combikit was irrational and could not be permitted. 21. This is countered by the petitioners. 22. It is apparent that there is a controversy as to 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. However, the provisions of Section 26A of the Act cannot be pressed into service for proscribing a therapy. As noticed above, the Combikit is not a drug and, therefore, a notification under Section 26A proscribing the same is unsustainable. 23. The Combikit ....