Marion Biotech: Allahabad High Court Slams UP Drug Authority Over Action Tied to Uzbekistan Child Deaths

The Allahabad High Court has set aside a review order that had suspended the drug manufacturing license of Marion Biotech Pvt. Ltd., the Noida-based pharmaceutical company linked to the deaths of 15 children in Uzbekistan.

The company had approached the high court challenging a review order dated October 4, 2023, passed by the Appellate Authority (Special Secretary, Food Safety & Drug Administration, UP), which had suspended an earlier appellate order dated August 11, 2023. The August order had partially restored Marion’s manufacturing license, barring only products containing Propylene Glycol—a solvent found to contain toxic Diethylene Glycol (DEG) and Ethylene Glycol (EG).

The bench of Justice Dinesh Pathak observed that the appellate authority became functus officio after passing its August 11 order under Rule 85(3) of the Drugs and Cosmetics Rules, 1945.

Court held that there is no power of review granted either in the parent Act (Drugs and Cosmetics Act, 1940) or the Rules. As such, the October 4 review decision was without jurisdiction and liable to be quashed.

The dispute began after Uzbek authorities reported child deaths due to contaminated Dok-1 Max Syrup manufactured by Marion. Following this, a joint inspection by Indian central and state drug regulators revealed multiple violations at Marion’s manufacturing facility in Noida, including quality lapses and unhygienic conditions. Based on lab reports and inspections, the UP Drug Authority cancelled Marion’s licenses in March 2023 without affording the 28-day objection period prescribed by law.

The company successfully appealed this cancellation in August, with the appellate authority restoring its license for all products except those using Propylene Glycol. However, in October, the same authority—acting on a review plea filed by the Assistant Commissioner (Drugs)—reversed its own decision, citing alleged misrepresentations about the findings of Uzbekistan’s courts and pending foreign litigation.

The high court, however, found that all relevant materials, including the foreign court orders and lab reports, had been available at the time of the appellate hearing in August. There was, therefore, no new evidence or fraud to justify the invocation of any inherent review power. Moreover, the review order had been passed ex parte, without giving Marion a hearing, court noted. 

It emphasized that review powers cannot be exercised unless expressly granted by law and highlighted the risks of undermining the finality of decisions. Citing multiple Supreme Court precedents, it reaffirmed that a quasi-judicial authority becomes powerless to modify its own decision once passed, absent statutory backing.

Case Title: Ms Marion Biotech Private Limited vs. State Of Up And 5 Others