An administrative order of debarment predicated on a laboratory test report is violative of natural justice if the report is not supplied to the aggrieved party, as it effectively denies the statutory right to controvert such evidence under Section 25(3) of the Drugs and Cosmetics Act, 1940.

O R D E R

% 06.01.2026

1. This petition is directed against the impugned order of debarment dated 11.08.2025, passed by the Office of the Director General Armed Forces Medical Services (DGAFMS), New Delhi. The petitioner claims to be a WHO-GMP and CDSCO-certified pharmaceutical manufacturer of international repute and is engaged, inter alia, in the supply of life-saving infusions to the Armed Forces over 36 countries worldwide.

2. The instant petition relates to the product Compound Sodium Lactate injection I.P. and specifically to batch no.DCSL3021 in favour of the petitioner’s authorized distributor through Shri Sai Agencies. The total quantity ordered was 10,000 units, which was duly supplied through two batches i.e., Batch No. DCSL3020 (4,150 units) and Batch No. DCSL3021 (5,850 units).

3. It is the case of the petitioner that there was no quality complaint or any issue ever raised by the respondents at any point of time. However, the respondents, by way of the impugned order, have debarred the petitioner without affording a full opportunity of hearing.

4. Mr. M. Sufian Siddiqui, learned counsel appearing for the petitioner has submitted that the impugned order clearly refers to a ‘lab test report’, and a copy of which has not been supplied to the petitioner. He contends that the show cause notice and the petitioner’s reply to the same were meaningless, in absence of a copy of the report having been supplied to the petitioner.

5. Learned counsel has also referred various decisions of the Court, however, reference thereto may not be necessary for the nature of the directions which the Court proposes to be issued.

6. Dr. B. Ramswamy, learned counsel appearing for the respondents, strongly opposes the aforesaid submissions and has relied upon the averments made in the counter affidavit filed by the respondents. He has specifically taken the Court through paragraph Nos.42 to 45, 46 to 47 and 51 to 54. According to him, a copy of the test report by the Central Drugs Laboratory, Kolkata has not been supplied.

7. Dr. Ramswamy submits that the Supreme Court, in the case of Amery Pharmaceuticals and Ors. v. State of Rajasthan ,¹2001 4 SC 382 has unequivocally held that there is no necessity to supply the test report and hence, in the instant case, the authorities have made it clear that in case the petitioner so desires, it may take recourse to the exercise under Section 25(3) of the Drugs and Cosmetics Act, 1940 [‘Act’] post decision. He also submits that a show cause notice was issued, and the petitioner’s reply was considered. Further, the representation of the petitioner was made before the meeting of the Department. According to him, the impugned order is justified and does not call for any inference.

8. I have considered the submissions made by learned counsel appearing for the parties and have perused the record.

9. A reading of the impugned order dated 11.08.2025 would indicate that the show cause notice was issued to the petitioner on 03.07.2025 and the response thereto was received. It is, thereafter, that the meeting was conducted on 04.08.2025 at the Office of DGAFMS, New Delhi.

10. The plea of the petitioner appears not to have been accepted by the competent authority. However, the petitioner has been advised to take up the matter for retesting as per Section 25 of the Act, if the petitioner is not in agreement with the result of the first test report.

11. The impugned order further states that, awaiting the report or the steps to be taken by the petitione