Site icon Raw Law

Allahabad High Court Quashes Review of Drug License Revival for Lack of Jurisdiction — “Appellate Authority Became Functus Officio After Passing Final Order Under Rule 85(3); No Power of Review or Proof of Fraud or Misrepresentation”

Allahabad High Court Quashes Review of Drug License Revival for Lack of Jurisdiction — “Appellate Authority Became Functus Officio After Passing Final Order Under Rule 85(3); No Power of Review or Proof of Fraud or Misrepresentation”

Allahabad High Court Quashes Review of Drug License Revival for Lack of Jurisdiction — “Appellate Authority Became Functus Officio After Passing Final Order Under Rule 85(3); No Power of Review or Proof of Fraud or Misrepresentation”

Share this article

Court’s Decision

The Allahabad High Court allowed the writ petition, setting aside the order dated 4.10.2023 passed by the Appellate Authority/Special Secretary, Food, Safety and Drug Administration, U.P., which had suspended its earlier order dated 11.8.2023. The Court held that:

“Appellate authority having passed the order dated 11.8.2023 became functus officio. The moment he passed the order… his appellate power under Rule 85(3) of Rules 1945 comes to an end.”

The Court concluded that the appellate authority lacked jurisdiction to review its earlier order in the absence of any express statutory provision, and no fraud, forgery, or misrepresentation was made out to justify invoking any inherent power.


Facts

The petitioner company, engaged in manufacturing pharmaceutical drugs, held valid licences in Form 25 and Form 28 under the Drugs and Cosmetics Rules, 1945, to manufacture drugs including DOK-1 Max syrup for export. Following the deaths of 15 children in Uzbekistan allegedly linked to the consumption of the said syrup, a joint inspection by Central and State Drug Authorities was conducted between December 2022 and January 2023.

Show cause notices were issued citing the detection of Diethylene Glycol (DEG) and Ethylene Glycol (EG) beyond permissible limits in the drug samples. Based on test reports and alleged licence violations, the petitioner’s licences were cancelled on 13.3.2023 by the State Licensing Authority without allowing the mandatory 28-day period for objection under Section 25(3) of the Drugs and Cosmetics Act, 1940.

The petitioner successfully challenged the cancellation before the Appellate Authority, which on 11.8.2023 revived the licences with restrictions on manufacturing drugs containing Propylene Glycol (PG). Subsequently, a review application was filed by the Assistant Commissioner (Drugs) on 4.10.2023, and on the same day, the appellate order was suspended.


Issues

  1. Whether the Appellate Authority under Rule 85(3) of the Drugs and Cosmetics Rules, 1945 has jurisdiction to review its own order in absence of a specific statutory provision?
  2. Whether the principle of “functus officio” applied to bar such review?
  3. Whether the review was justified on grounds of fraud, misrepresentation, or concealment of material facts by the petitioner?

Petitioner’s Arguments


Respondent’s Arguments


Analysis of the Law

The Court clarified that:

The Court differentiated between a judicial/quasi-judicial act and administrative policy decisions, clarifying that functus officio applies more stringently to the former.


Precedent Analysis

The Court relied extensively on the following rulings:


Court’s Reasoning

The Court held that:

“The review order… is nothing but a personal whim of the authority concerned, who wants to review the order dated 11.8.2023… I did not find any such ingredient which comes within the definition of fraud/forgery or misrepresentation.”


Conclusion

The appellate authority under Rule 85(3) had no jurisdiction to review its own order dated 11.8.2023. The review order dated 4.10.2023 was passed without authority, without hearing, and without new material or fraud, and hence was quashed. The High Court restored the appellate order dated 11.8.2023.


Implications

This judgment underscores that:

Also Read – Delhi High Court Upholds Injunction Restraining Use of ‘KRB’ Mark for Rice and Food Grains — “Deceptively Similar to ‘KRBL’; No Perversity or Arbitrariness in Trial Court’s Discretion, Interference Unwarranted”

Exit mobile version