High Court · 2025

WP.No.19469 of 2025In the High Court of Judicature at MadrasReserved on 02.7.2025Delivered on :07.7.2025Coram :The Honourable Mr.Justice N.ANAND VENKATESHWrit Petition No.19469 of 2025 &WMP.Nos.21757 & 21758 of 2025Micro Labs Limited,No.11, Bank Street,Kilpauk, Chennai-10....PetitionerVs1.Union Of India Rep.By Its Secretary, Ministry of Health & Family Welfare, Nirman Bhavan, New Delhi-1.2.The Drugs Controller General of India, Office of the Drugs Controller of India, Central Drugs Standards Control Organization, Government of India, ITO, FDA Bhavan, Kotla Road, New Delhi-2....RespondentsPETITION under Article 226 of The Constitution of India praying for the issuance of a Writ of Certiorarified Mandamus to call for the records of the 1st respondent pertaining to the ban on Nitrofuran 1/10 https://www.mhc.tn.gov.in/judis WP.No.19469 of 2025and its formulations, quash the impugned Notification S.O.1158 (E) dated 12.3.2025 published in the Gazette of India by the 1st respondent and consequently forbear the respondents, their men, servants and agents from interfering with the manufacture sale and distribution of the furaltadone powder for veterinary use by the petitioner in accordance with law and award costs For Petitioner : Mr.T.D.Selvan BabuFor Respondents:Mr.K.K.Muralidharan, CGSCORDERThis writ petition has been filed challenging the Notification issued by the first respondent dated 12.3.2025 published in the Gazette of India and to forbear the respondents from interfering with the manufacture, sale and distribution of furaltadone powder for veterinary use. 2. Heard the learned counsel for the petitioner and the learned Central Government Standing Counsel appearing for the respondents.2/10 https://www.mhc.tn.gov.in/judis WP.No.19469 of 20253. The case of the petitioner is as follows :(i) The petitioner company is one of the leading pharmaceutical companies in India. They manufacture pharmaceutical, medicinal, veterinary preparations, nutraceuticals, food supplements and feed supplements in their factories. They also obtained necessary product licences/approvals for several drug formulations. One such product approval was given for the veterinary drug furaltadone powder consisting of furaltadone hydrochloride. Furaltadone is one of the derivatives of the nitrofuran group of drugs and there are several other derivatives of nitrofuran, which are used in the treatment as an anti-microbial or anti-bacterial in both human and animals. (ii) The grievance of the petitioner is that all of a sudden, through the impugned Notification dated 12.3.2025, the first respondent prohibited the import, manufacture, sale and distribution of nitrofuran and its formulations for the use in food producing animal rearing system with immediate effect. (iii) The petitioner has challenged the same on the ground that the impugned Notification has been issued without any basis and without any study conducted and that the formulations, which were available in India for decades, have been stopped abruptly without 3/10 https://www.mhc.tn.gov.in/judis WP.No.19469 of 2025giving any notice and without giving an opportunity to the stakeholders. 4. The respondents filed a counter affidavit wherein they took the following stand :(i) The ban was necessitated due to repeated detection of the residues of chloramphenicol and nitrofurans in seafood exports and as a result, it adversely impacted India's export credibility. Since there is zero tolerance towards these substances in foreign countries like United States of Americal, European Union and Japan, a policy decision was taken to completely stop the import, manufacture, etc. of those substances. (ii) The selective ban has been taking place from 2002 onwards and in spite of it, there have been recurring rejections of the Indian seafood products, which prompted the need for a comprehensive ban across all animal rearing systems to align with international food safety standards. (iii) The use of chloramphenicol and nitrofurans in food producing animals poses serious health risks including anti-microbial resistance and potential carcinogenic effects. This view has been 4/10 https://www.mhc.tn.gov.in/judis WP.No.19469 of 2025endorsed by the international agencies such as the World Health Organization (WHO) & the Food and Agriculture Organization (FAO) and the national regulators of the US, European Union and Japan. In so far as the non issuance of notice of hearing is concerned, Section 26A of the Drugs Act does not require the issuance of any individual notices of hearing before issuing the Notification. Accordingly, the respondents sought for dismissal of this writ petition.5. This Court has carefully considered the submissions of the learned counsel on either side and perused the materials available on record and more particularly the impugned Notification.6. It will be relevant to take note of the Minutes of the 91st Meeting of the Drugs Technical Advisory Board held on 14.8.2024 when they considered the proposal to prohibit the manufacture, sale and distribution of chloramphenicol and nitrofurans. For proper appreciation, Agenda No.4 is extracted as hereunder :"Consideration of the proposal for considering prohibition on the import and manufacture of chloramphenicol and nitrofurans drug formulations for use in all food producing 5/10 https://www.mhc.tn.gov.in/judis WP.No.19469 of 2025animal system :The Board was apprised that the matter was deliberated in the 63rd meeting of DCC wherein the committee deliberated the matter and agreed with the proposal for prohibit the import, manufacture, distribution and sales of chloramphenicol and nitrofurans drugs for use in any food producing animal rearing system.DTAB deliberated the matter and agreed to prohibit the import, manufacture, distribution and sales of chloramphenicol and nitrofurans drugs for use in any food producing animal rearing system."7. Even in the reports prepared by the WHO, it has been mentioned that nitrofuran derivatives fall within the yellow category, which would indicate that it is an important anti-microbial.8. The respondents have taken into consideration the fact that the European Union countries have already prohibited such manufacture 30 years back and that there is a lot of resistance and prohibition since the residues of chloramphenicol and nitrofurans were found in the seafood exports. 6/10 https://www.mhc.tn.gov.in/judis WP.No.19469 of 20259. The learned counsel for the petitioner submitted that nitrofuran and its formulations have not been banned for human use, that they are still freely available for consumption for the treatment of urinary track infection in human and for other ailments and that they are freely available when it comes to human consumption whereas it is banned in so far as the animal use is concerned without conducting any study and without giving an opportunity to the stakeholders. 10. This Court must keep in mind that a Judge, exercising jurisdiction under Article 226 of The Constitution of India, is not an expert in this field. While such decisions are taken by the Government, they consider larger ramifications that entail when exports are made to foreign countries and when they are rejected due to the residues found in the food producing animal rearing system. The respondents have considered that there is a larger public interest involved and it also involves safeguarding India's export credibility. Hence, when a policy decision was taken in the meeting held on 14.8.2024 based on the report given by the experts and it was deliberated by the experts, this Court cannot sit over such a decision taken by the experts. 7/10 https://www.mhc.tn.gov.in/judis WP.No.19469 of 202511. On the one hand, it involves serious health risks and on the other hand, it involves the export credibility of India. Therefore, in cases of this nature, this Court should not exercise its discretion under Article 226 of The Constitution of India. Further, no mala fides are alleged against the respondents and in view of the same, this Court must necessarily conclude that the respondents have taken into account all the ramifications and have proceeded to issue the impugned Notification. This is not a fit case to exercise the writ jurisdiction.12. Accordingly, the writ petition is dismissed. No costs. Consequently, the connected WMPs are also dismissed.07.7.2025To1.Union Of India Rep.By Its Secretary, Ministry of Health & Family Welfare, Nirman Bhavan, New Delhi-1.8/10 https://www.mhc.tn.gov.in/judis WP.No.19469 of 20252.The Drugs Controller General of India, Office of the Drugs Controller of India, Central Drugs Standards Control Organization, Government of India, ITO, FDA Bhavan, Kotla Road, New Delhi-2.RS9/10 https://www.mhc.tn.gov.in/judis WP.No.19469 of 2025N.ANAND VENKATESH,JRSW.P.No.19469 of 2025 & & WMP.Nos.21757& 21758of 2025 07.7.202510/10