Patna High Court
Ashok Kumar AnalversusThe State of Bihar
- Decided
- Disposal
- DISPOSED
Holding
The petition is dismissed as there is no violation of the applicable rules and it is deemed a personal interest litigation.
Summary
The petitioner, Ashok Kumar Anal, filed a public interest writ seeking multiple directions for the State of Bihar and the Union of India to enforce the Medical Devices Rules, 2017 and related drug regulations, including regular inspection of medical devices, registration of sellers, appointment of a licensing authority, and the quashing of a notification appointing the State Drug Controller as the licensing authority. The respondents filed a counter‑affidavit alleging that the petition was driven by a personal agenda against the State Drug Controller. The Court examined whether there was any violation of the Medical Devices Rules, 2017 or the Drugs Rules, 1945, and whether the petition constituted genuine public interest litigation. Finding no breach of the statutory provisions and concluding that the petition was essentially a personal interest suit, the Court declined to grant any relief. Consequently, the application was disposed of without any order.
Issues considered
- Whether the State of Bihar and the Union of India have violated the Medical Devices Rules, 2017 or the Drugs Rules, 1945 by failing to appoint a licensing authority and conduct inspections.
- Whether the petition to quash Notification No. 919(15) dated 25‑10‑2024, issued under Rule 51(i) of the Drugs Rules, 1945, is maintainable.
- Whether the writ petition constitutes a genuine public interest litigation or a personal interest suit.
Legislation cited
- Drugs Rules, 1945 — s. Rule 51(i), Rule 59, Rule 64
Subjects
- Medical devices regulation
- Public interest litigation
- Licensing authority
- Drug Rules 1945
- Inspection of medical devices
- Quashing notification
- Personal interest litigation
Judgment
IN THE HIGH COURT OF JUDICATURE AT PATNA
Civil Writ Jurisdiction Case No.14945 of 2025
======================================================
Ashok Kumar Anal Son of Laxmi Prasad, Resident of Mohalla Khalasi Tola
near Petrol Pump Sampatchak, PO Gulzarbag, PS Alamganj, District Patna.
... ... Petitioner/s
Versus
1. The State of Bihar through Additional Chief Secretary, Health Department,
Govt. of Bihar, Patna.
2. The Union of India through Drug Controller, General of India, FDA
Bhawan, Kotla Road, New Delhi 110002.
3. The State Drugs Controller, Sixth Floor, Swasth Bhawan, Sheikhpura, Patna.
... ... Respondent/s
======================================================
Appearance :
For the Petitioner/s : Mr. Harshwardhan Sahay, Advocate
For the State : Mr. P.K. Shahi, Advocate General
For C.G.C. : Mr. Hariram Singh, Advocate
======================================================
CORAM: HONOURABLE THE CHIEF JUSTICE
and
HONOURABLE MR. JUSTICE ALOK KUMAR SINHA
ORAL JUDGMENT
(Per: HONOURABLE THE CHIEF JUSTICE)
Date : 09-02-2026
This writ petition in the nature of Public Interest
Litigation has been filed for following relief(s):
“(i) Respondents may be directed to make
regular inspection of medical devices which
are being sold by medical shops/Nursing
Homes/Hospitals/Pathological Laboratories.
(ii) Respondents may be directed to make
registration of Medical Shops/ Nursing
Homes/Pathological Laboratories which are
selling medical devices without any
registration.
(iii) Respondents may be directed to notify
laboratories which can test the
Patna High Court CWJC No.14945 of 2025 dt.09-02-2026
2/3
malfunctioning/Duplicate Medical Devices.
(iv) Respondents may be directed to appoint
Licensing Authority under Rule 87 (A) of
Medical Device Rule 2017 which came in
force on 30.9.2022 and has never been
appointed by State of Bihar.
(v) Respondents may be directed to make
Online Drug Licensing System (ONDLS) in
accordance with Rule 59 and Rule 64 of
Drug Rule 1945 and Bihar Drugs Control
Cadre Rule 2014.
(vi) Respondents may be directed to make
ONDLS user friendly so that the ordinary
applicants for License of Drugs can apply
and get License quickly.
(vii) To quash notification as contained in
Memo No.919 (15) dated 25.10.2024
whereby State Drugs Controller has been
Licensing Authority under Rule 51 (i) of
Drugs Rule 1945.”
2. The counter affidavit has been filed by respondent
nos. 1 and 3, in which it is stated as follows:
“(6).That it is further manifest that under the
garb of the demand for implementation of
Medical Devices Rules, 2017, petitioner
appears to have also a hidden agenda against
the In-charge State Drug Controller, Bihar,
Patna, as he has also sought for quashing the
Health Department's NotificationNo.919(15)
dated 25.10.2024(vide Annex-P/5) whereby
and whereunder Nityanand Kishloya, Deputy
Drug Controller, Drug Control
Administration(HQ), Patna has been
Patna High Court CWJC No.14945 of 2025 dt.09-02-2026
3/3
authorized under working arrangement to act
as working State Drug Controller-cum-Chief
Licensing Authority, Bihar, Patna and D.D.O.
of the Directorate of Drug Control
Administration, Bihar, Patna.”
3. In view of such averments taken, we do not find
that there is any violation of any of the provision of the rules
and it appears to be personal interest litigation and accordingly,
we are not inclined to pass any order.
4. The application stands disposed of.
(Sangam Kumar Sahoo, CJ)
(Alok Kumar Sinha, J)
guddukr/-
AFR/NAFR
CAV DATE
Uploading Date 10.02.2026
Transmission Date
Checking your session…