The appellate authority under the Drugs and Cosmetics Act lacks jurisdiction to review its own order without statutory provision, becoming functus officio after a final decision.

JUDGMENT :

Dinesh Pathak, J.

1. Heard Sri V.P. Srivastava (Senior Advocate) assisted by Sri Veerendra Singh and Neeja Srivastava, learned counsel for the petitioner and Sri Manish Goyal (Senior Advocate), learned Additional Advocate General, assisted by Sri A.K. Goyal, learned Additional Chief Standing Counsel for the State respondents Nos. 1 to 5 as well as Sri Shashi Prakash Singh (Senior Advocate), Additional Solicitor General of India, assisted by Sri R.P.S. Chauhan, learned counsel for respondents No. 6.

2. Petitioner is aggrieved with the order dated 4.10.2023 (Annexure no.16) passed by the Appellate Authority/Special Secretary Food, Safety and Drug Administration, State of U.P. (respondent no.2), whereby review application dated 4.10.2023 moved on behalf of the Assistant Commissioner (Drugs) has been allowed and previous order dated 11.8.2023 passed in Appeal No.1005 of 2023 under Rule 85(3) of The Drugs and Cosmetics Rules, 1945 (in brevity 'Rules 1945') has been suspended, and the manufacturing company (petitioner) has been directed to produce the certified copies of the orders passed by different courts of Republic of Uzbekistan and submit a compliance report to the Drug Licensing-Cum-Controlling Authority of Uttar Pradesh and Drug Controller General of India after enforcing the process of Corrective and Preventive Action (CAPA).

3. Facts culled out from the record are that petitioner is a private limited company having its manufacturing unit at B-48-49, Sector 67, District Gautam Budh Nagar. He has been granted drugs license in Form 25 and Form 28 under the provisions of Rules 1945 to manufacture the drug both for indigenous and foreign sales. In pursuant to the license issued by the competent authority, he has been permitted to manufacture tablets, capsules and syrups with various active ingredients. Present writ petition relates to the manufacturing of DOK-1, Max tablets and Syrups having active pharmaceutical ingredients of Paracetamol BP 500 mg, Guaifenesin BP 200 mg and Phenylethrine Hydrochloride BP 10 mg. By letter dated 29.9.2022 (Annexure no.3), he has been 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 have conducted several inspections at the factory premises of the petitioner between 27.12.2022 to 12.1.2023 and collected samples of drugs for the purposes of testing and analysis. Subsequently, show cause notice dated 30.12.2022 has been issued to the petitioner, under Rule 85(2) of Rules 1945, as to why his drugs license (Form 25 and Form 28) should not be cancelled/suspended because of violation of the license conditions as enunciated under Rule 74 and 78 of the Rules 1945. Petitioner has filed his reply dated 13.1.2023. However, in the meantime, samples collected by the Joint Inspection Team has been sent for testing and analysis, and its report has been communicated to the petitioner by subsequent notice dated 3.3.2023 (Annexure No.7) and 4.3.2023 (Annexure No.8) with an observation that as per test reports dated 1.3.2023 and 14.1.2023 respectively sent by Government Analyst, Regional Drugs Testing Laboratory (RDTL), Chandigarh, samples are found "Not of Standard Quality" for the reasons that samples contains DI Ethylene Glycol (DEG) and Ethylene Glycol (EG) more than required standard.

4. Drugs Licensing-Cum-Controling Authority U.P. has cancelled the drugs licence o