GAHC030001042025 IN THE GAUHATI HIGH COURT (HIGH COURT OF ASSAM, NAGALAND, MIZORAM & ARUNACHAL PRADESH)

CRIMINAL PETITION NO.03 OF 2025

1. Shri Sanjeev Kumar Bhatia S/o Shri K.L. Bhatia R/o House No.562, Section-2 Pannchkula, PO: Panchkula Section-8, Dist- Panchkula Haryana- 134109.

2. Sri Virender Miglani S/o Vir Bhan Miglani R/o C-87, Sangam Apartment Sector-9, Rohini Rohini Sector-7, North West Delhi, Delhi-110085.

3. Smt. Sharda Rani Bhatia D/o Bhagwan Dass Bhatia R/o BC-7, Miyanwali Nagar Paschim Vihar, New Delhi Delhi-110087

4. Shri Manish Kumar S/o Ishwar Chand R/o H-76, Third Floor Shivaji Park, Punjabi Bagh, West Delhi, Delhi-110026

5. Shri Pramod Sethi S/o Tirath Ram Sethi R/o C-38, Shivaji Park Punjabi Bagh, West Delhi Delhi-110026

6. Shri Krishan Lal Bhatia S/o Ram Chand Bhatia R/o BC-7 AB Mianwali Nagar Paschim Vihar, New Delhi Delhi- 110087

7. Shri Mohan Singh S/o Khajan Singh R/o 496, Krishna Colony, Ward N.13, Naraingarh (219), Ambala, Haryana- 134203

8. Shri Radhe Shyam S/o Nolaram, R/o Tehsil Nawa, Lamba, Nagaur, Rajasthan, 341519 Petitioners …….

-Versus-

The Union of India represented by Shri Abu Hanif Imran Choudhury, Drugs Inspector, Office of the Assistant Drugs Controller (India), Central Drugs Standard Control Organization (C.D.S.C.O) Sub Zone Guwahati, RDTL Campus, Six Mile, Panjabari Road Guwahati- 781022. …….Respondent – B E F O R E –

HON’BLE MR. JUSTICE KAUSHIK GOSWAMI For the Petitioner(s) :Mr. Joseph Lalchhanhima, Advocate. For the Respondent(s) :Mr. S. K. Medhi, learned CGC for the respondents.

Date of Hearing : 19.05.2026.

Date of Judgment : 19.05.2026 J UDGMENT & O RDER (ORAL Heard Mr. Joseph Lalchhanhima, learned counsel appearing for the petitioners. Also heard Mr. S. K. Medhi, learned CGC appearing for all the respondents.

2. This petition under Section 528 of the Bharatiya Nagarik Suraksha Sanhita, 2023 has been instituted seeking quashing of Criminal Complaint No. 119 of 2023 pending before the Court of the learned Judicial Magistrate First Class, Aizawl District, Aizawl, Mizoram, together with the order dated 02.06.2023 whereby cognizance was taken and summons were issued against the petitioners in connection with alleged offences under the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the “Act of

1940”).

3. The petitioners before this Court are arrayed as accused Nos. 2 to 9 in the complaint proceedings. Accused No. 1 is M/s Algen Healthcare Limited, a pharmaceutical manufacturing company holding licenses under the Act of

1940.

4. The prosecution case, in brief, is that on 10.11.2021, the concerned Drugs Inspector drew samples of Primaquine Tablets IP, Batch No. AHT-2768, manufactured by accused No. 1 company, from the Central Medical Store, Zemabawk, Aizawl, Mizoram, in exercise of statutory powers under Section 23 of the Act of 1940.

5. One portion of the sample was forwarded to the Government Analyst, Regional Drugs Testing Laboratory, Guwahati, for analysis. The Government Analyst, by report dated 28.04.2022, declared the subject sample to be “Not of Standard Quality”, recording that the sample did not conform to the Indian Pharmacopoeia standard with respect to dissolution and assay for Primaquine.

6. Following receipt of the analyst’s report, statutory communications were issued to the concerned authorities and the manufacturer. The manufacturer furnished certain materials including internal test records, batch documentation, invoices, and recall-related correspondence. A joint investigation thereafter came to be conducted by the regulatory authorities.

7. The investigation report records certain deficiencies concerning manufacturing processes and quality control protocols, including absence of process validation, absence of stability studies, deficiencies in analytical documentation, incomplete manufacturing records, insufficiency of retained samples, and other procedural lapses allegedly noticed during inspection

8. Thereafter, sanction was obtained from the competent authority, followin