The Allahabad High Court has quashed the order that cancelled the licence of a drug company in 2023 after around 15 children died in Samarkand, Uzbekistan due to consuming a syrup manufactured by the company. Justice Dinesh Pathak, allowing a writ petition filed by M/s Marion Biotech Private Limited, observed that he was surprised that Indian authorities are “trying to validate their proceedings” based on the judgement of the Supreme Court of the Republic of Uzbekistan.
The judge quashed an order dated October 4, 2023 passed by the reviewing authority that the drug company (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, UP and Drug Controller General of India after implementing the process of corrective and preventive action. The petitioner is a private limited company having its manufacturing unit at Noida Sector 67. A Joint Inspection Team of central and state drug authorities conducted several inspections at the factory premises of the petitioner in between and collected samples of drugs for testing and analysis. Later, they found the samples to not be of standard quality. Subsequently, the drugs licensing-cum-controlling authority in the state cancelled the licence of the petitioner by an order dated March 13, 2023.
Quashing the order, the court observed, “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”. Indian laws relating to drugs are exhaustive and self-sufficient code which does not require any validation of the judgement passed by a foreign court, the high court order said. The court added that the 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. Authorities concerned have delved deep “to examine the manufacturing process of the drugs at the factory premises of the petitioner and the quality of drug as well as legal requirement enunciated under the Act 1945 and Rules 1945,” it said.
“There is nothing convincing, as to what special the state and central authorities have found in the judgement passed by the foreign courts intending to validate their official duties performed under the Indian law. “Nothing special has been demonstrated before this 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,” the judge said. “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”, the court added in its judgment dated May 19.
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