No Misrepresentation Or Fraud: Allahabad High Court Allows Drug Company’s Plea Against License Cancellation Over Syrup Deaths Of Children In Uzbekistan
The Allahabad High Court said that there is nothing convincing, as to what special the State and Central authorities have found in the Judgment passed by the foreign Courts intending to validate their official duties performed under the Indian law.
Justice Dinesh Pathak, Allahabad High Court
The Allahabad High Court has allowed the Writ Petition of a company namely Marion Biotech Private Limited against cancellation of its license due to deaths of children on consuming a syrup in Uzbekistan.
The said Petition challenged the Order of the Appellate Authority/Special Secretary Food, Safety and Drug Administration, whereby Review Application of the Assistant Commissioner (Drugs) was allowed.
A Single Bench of Justice Dinesh Pathak observed, “Remedy available in the hands of the authorities concerned cannot be permitted to be misused in such a cavalier manner, sans proper application of mind, to bolster the revisit/review of the previous order. Excess use of DEG and EG in the drug in question manufactured by the petitioner has properly been evaluated by the appellate authority while passing the judgement, therefore, on the same ground, review of previous order is not justifiable. Even, there is no misrepresentation or fraud at the part of petitioner in placing the orders passed by different courts of Republic of Uzbekistan.”
The Bench said that there is nothing convincing, as to what special the State and Central authorities have found in the Judgment passed by the foreign Courts intending to validate their official duties performed under the Indian law.
Senior Advocate V.P. Srivastava, Advocates Veerendra Singh, and Neeja Srivastava appeared for the Petitioner while Additional Solicitor General (ASG) Shashi Prakash Singh, Additional Advocate General (AAG) Manish Goyal, Additional Chief Standing Counsel (ACSC) A.K. Goyal, and Advocate R.P.S. Chauhan appeared for the Respondents.
Case Background
The Petitioner company was granted drugs license to manufacture the drug both for indigenous and foreign sales. Thereafter, it was permitted to manufacture tablets, capsules, and syrups with various active ingredients. It was permitted to manufacture additional drug item (quantity based) only for the purposes of export. On the information received from the authorities concerned qua death of 15 children in Samarkand, Republic of Uzbekistan owing to consumption of DOK-1 Max Syrup, the Joint Inspection Team of Central and State Drug Authorities conducted several inspections at the factory premises of the Petitioner and collected samples of drugs for testing and analysis. Subsequently, a show-cause notice (SCN) was issued to the Petitioner, as to why its drugs license should not be cancelled/suspended because of violation of the license conditions as enunciated under the relevant Rules. The Petitioner filed its reply, however, in the meantime, samples collected by the Joint Inspection Team were sent for testing and its report was then communicated to the Petitioner.
As per the reports, samples were found “Not of Standard Quality” for the reasons that samples contain DI Ethylene Glycol (DEG) and Ethylene Glycol (EG) more than required standard. Resultantly, the Drugs Licensing-Cum-Controlling Authority, U.P. cancelled the Petitioner’s drugs license, aggrieved by which it filed an Appeal. The Appellate Authority partly allowed the same and revived the drugs license except the manufacturing of drugs wherein Propylene Glycol (P.G.) were permitted to be used. Later, the Drug Administration filed a Review Application, which was allowed with a direction that the Petitioner shall produce the certified copies of the Orders passed by different Courts of Uzbekistan and submit a report to the Drugs Licensing and Controlling Authority, U.P. and Drug Controller General of India after implementing the process of Corrective and Preventive Action (CAPA). Being aggrieved, the Petitioner approached the High Court.
Reasoning
The High Court in the above context of the case, noted, “Assuming arguendo that petitioner has not furnished the correct copy of the order passed by the Supreme Court of the Republic of Uzbekistan, it hardly affects the merits of the appeal which was arising out of the proceeding under the Act 1940 and Rule 1945. I am surprised to see that Indian authorities are trying to validate their proceedings conducted under the Indian law on the basis of judgment passed by the Supreme Court of the Republic of Uzbekistan. Unfortunately, nothing has been pointed out by the contesting respondents as to what procedural flaw has been committed by the Indian authorities while exercising their power under the Act 1940 and Rules 1945 or what fraud or forgery has been committed by the petitioner upon the appellate authority in a proceeding conducted under the Indian law i.e. Act 1940 and Rules 1945.”
The Court further remarked that Indian laws relating to drugs are exhaustive and self-sufficient code which does not require any validation of the Judgment passed by foreign Courts.
“Premises of the petitioner's factory has been inspected more than once and the samples collected from the factory has been examined by the Government Analyst, as per provisions enunciated in the Act 1940 and Rules 1945. Concerned authorities have delve in deep to examine the manufacturing process of the drugs at the factory premises of the petitioner and the quality of drug, as well, as per legal requirement enunciated under the Act 1945 and Rules 1945”, it added.
The Court said that nothing special has been demonstrated before the High Court in the Orders passed by different Courts of Republic of Uzbekistan except certain observations with regard to the quality of drugs, which have been found unfit for use, and the said observation was subsequently modified to certain extent.
“How this observation bearing upon the merits of the judgement dated 11.8.2023 passed by the appellate authority, has not satisfactory been explained before this court. … I am of the considered view that despite the availability of remedy of review/recall to the authorities concerned, under certain conditions, as permitted under several judicial pronouncements, no case is made out by the respondents to maintain their review application against the order dated 11.8.2023 passed by the appellate authority, who became functus officio after final decision on the appeal”, it also observed.
The Court concluded that no case of fraud, forgery, or misrepresentation has been made out to bolster the Order under challenge and the Order impugned is illegal, unwarranted under law and without jurisdiction.
“Existence of such order would prejudice to the right and interest of the petitioner and amounts to miscarriage of justice to him”, it added.
Accordingly, the High Court allowed the Writ Petition and quashed the impugned Order.
Cause Title- Marion Biotech Private Limited v. State of UP and 5 Others (Neutral Citation: 2025:AHC:86264)
