Case Background
The case concerns a proprietorship firm engaged in manufacturing medicines at Salimpur Ahra, Patna. The firm held a valid manufacturing licence, bearing Licence No. 985/92 in Form 25, issued by the State Drug Controller under the Drugs and Cosmetics Act, 1940 and the Rules framed under it. The licence covered drugs other than those listed in Schedules C, C(1) and X of the Act.
According to the petitioner, the factory was shut down from 18.12.2012 due to the long illness of the proprietor’s wife, financial problems, and disconnection of electricity supply. Because of this closure, all employees are said to have left their jobs and joined other employers.
Despite the shutdown, on 09.08.2013 at about 7:00 a.m., three officials described as Drug Inspectors, arrayed as respondent nos. 3, 4 and 5, visited and inspected the factory premises. At that time, one Ravi Kumar was alone inside, allegedly cleaning the premises, which he used to do once a week since the factory was closed.
The petitioner’s case is that Ravi Kumar informed the respondents that the proprietor was out of town and that no manufacturing had taken place for about six months. However, the three officials proceeded to inspect the premises, prepared an inspection report dated 09.08.2013 and sealed the factory.
A copy of this inspection report was handed over to the landlord of the premises, Sri Ravindra Kumar Sinha. When the proprietor returned to Patna, the landlord gave him the copy of the report.
Subsequently, the State Drug Controller issued a notice dated 10.10.2013, which, as per the record, the petitioner received on 19.11.2013. The petitioner responded by a reply dated 25.11.2013, sent by speed post, narrating the above circumstances and requesting that the factory be unsealed. A reminder was then sent on 09.04.2014. Further representations requesting unsealing were also addressed by the petitioner on 27.03.2015 and 01.04.2015.
As no relief came from the authorities, the firm approached the Patna High Court in Civil Writ Jurisdiction Case No. 6393 of 2015. The petitioner asked the Court to direct unsealing of the premises and to quash the inspection report dated 09.08.2013, terming both the inspection and sealing as illegal and without authority under the Drugs and Cosmetics Act, 1940.
What the Court Examined and Decided
The main dispute before the Patna High Court was whether the three respondents, described as Drug Inspectors, were legally competent under the Drugs and Cosmetics Act, 1940 to inspect the petitioner’s factory and issue the inspection report dated 09.08.2013, and whether consequent sealing of the premises was lawful.
The petitioner’s counsel focused on the definition and appointment of “Inspector” under the Act. Section 3(e) of the Act defines “Inspector” as a person appointed by the Central Government or the State Government under Section 21 (for drugs and cosmetics other than Ayurvedic, Siddha or Unani) or under Section 33G (for Ayurvedic, Siddha or Unani drugs). In this case, the dispute related to allopathic drug manufacturing, so Section 21 was directly in issue.
Section 21(1) of the Act provides that the Central Government or a State Government may, by notification in the Official Gazette, appoint qualified persons to be Inspectors for specified areas. Thus, for any person to act as Drug Inspector under this law, his or her appointment must be notified in the Official Gazette, and the notification must also specify the area of jurisdiction.
The petitioner argued that respondent nos. 3, 4 and 5, although claiming to be Drug Inspectors for Patna-3, Patna-11 and Patna-16 respectively, had not been appointed as Inspectors by any notification of the Central or State Government published in the Official Gazette. Therefore, according to the petitioner, they were not “Inspectors” under Section 3(e) read with Section 21 and had no authority to enter the premises, conduct inspection, search and seizure, or seal the factory.
The petitioner further contended that the Drugs and Cosmetics Act, 1940 does not contain any provision specifically authorising sealing of premises by Drug Inspectors. On this basis also, the sealing of the factory was claimed to be illegal and beyond the powers conferred by the Act.
On 17.12.2024, the Patna High Court recorded a specific contention of the petitioner that the counter affidavit filed by the State did not show that respondent nos. 3 to 5 were competent authorities under Section 21 of the Act. In response, the State filed a supplementary counter affidavit.
In this supplementary counter, the State asserted that respondent nos. 3, 4 and 5 were competent authorities to conduct inspection and investigation under Sections 21 and 22 of the Act. It was stated that:
- Respondent no. 3 (Indrakant Kumar) and respondent no. 4 (Yeshwant Kumar Jha), along with others, were appointed as Drug Inspectors (Allopathic system) by Health Department’s Notification No. 1208 (15) dated 20.07.2011, with respondent no. 3 at Serial No. 10 and respondent no. 4 at Serial No. 2.
- Respondent no. 5 (Chunendra Mahto) and others were appointed as Drug Inspectors (Allopathic system) by Health Department’s Notification No. 02 (15) dated 05.01.2004, with respondent no. 5 at Serial No. 11.
- By departmental letter no. 75 dated 12.08.2013, nine Drug Inspectors/Licensing Authorities, including respondent nos. 3 to 5, were authorised to conduct inspection of the petitioner’s firm.
The Court heard both sides: the petitioner’s counsel and the counsel for the State. The petitioner relied on a reported judgment: 1999 CRI.L.J. 4449 (State of Maharashtra v. R.A. Chandawarkar and others), specifically paragraphs 40, 41 and 42. These paragraphs, reproduced in the Patna High Court judgment, emphasise that:
- The post of Drug Inspector is a vital public post impacting public health, with powers to take samples, seize drugs and prosecute for adulterated or sub-standard drugs.
- Section 21 clearly requires appointment by notification in the Official Gazette, and the notification must specify the area in which the Drug Inspector can operate.
- Publication in the Official Gazette is not discretionary; it is mandatory for a valid appointment.
- In the Chandawarkar case, in absence of an Official Gazette notification, the concerned officer could not be treated as a Drug Inspector for the relevant area, and his actions in seizing samples and prosecuting were held unauthorised.
After considering the facts and legal position, the Patna High Court recorded an important development: both parties informed the Court that the premises in question had already been unsealed by the respondent authorities. This meant that the immediate relief of unsealing had, in practice, been granted outside the Court.
However, a crucial issue still remained: the legality of the inspection report dated 09.08.2013. The Court, referring to the Chandawarkar judgment and the legal requirement of proper appointment by Official Gazette notification, noted that it appeared respondent nos. 3 to 5 were not competent authorities to conduct the investigation in the case at hand.
Against this backdrop, the Patna High Court concluded that the inspection report, prepared by these respondents on 09.08.2013, was not sustainable. Accordingly, the Court quashed the inspection report.
Since the premises had already been unsealed and the inspection report was quashed, the Court held that nothing further remained to be decided in the writ petition. The writ petition was allowed, and any interlocutory applications were disposed of.
Why This Judgment Matters
This judgment is significant for medicine manufacturers and other firms regulated under the Drugs and Cosmetics Act, 1940, especially in Bihar. It underlines that inspections and actions affecting a factory cannot be carried out by any official casually claiming to be a Drug Inspector.
The Patna High Court reinforced that Drug Inspectors must be duly appointed through a notification in the Official Gazette under Section 21, and their area of jurisdiction must be clearly specified. If such legal requirements are not met, inspections, seizure and related actions like reports can be challenged as illegal.
For small businesses, the case also shows that when premises are sealed or inspected by officials who lack proper legal authority, courts can intervene and set aside those actions. Even when practical relief like unsealing has already occurred, courts can still quash illegal reports that might otherwise be used later against the firm.
The judgment further highlights that powers under regulatory statutes must be exercised strictly as per law. Where the statute does not expressly provide for an extreme measure like sealing premises, authorities must act cautiously and within their legal limits.
Legal Issues and Answers
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Issue: Were respondent nos. 3, 4 and 5 legally competent Drug Inspectors under Section 21 of the Drugs and Cosmetics Act, 1940 to inspect the petitioner’s factory and issue the inspection report dated 09.08.2013?
Answer: The Court held that, in view of the legal position reflected in the Chandawarkar judgment, respondent nos. 3 to 5 were not competent authorities to conduct the investigation in this case, and consequently the inspection report was liable to be quashed. -
Issue: What is the effect of the fact that the factory premises had already been unsealed by the authorities during the pendency of the writ petition?
Answer: Since the premises were already unsealed, the Court found that nothing further remained to be decided regarding unsealing, and confined its operative relief to quashing the inspection report.
Cases Cited by the Court
- 1999 CRI.L.J. 4449, State of Maharashtra v. R.A. Chandawarkar and others (paragraphs 40, 41 and 42 relied upon to interpret Section 21 of the Drugs and Cosmetics Act, 1940).
Case Details
Case Number: Civil Writ Jurisdiction Case No. 6393 of 2015
Case Title: M/s Naya Dawakhana (MFG.) Co. v. The State of Bihar & Ors.
Citation: 2025 (2) PLJR 874
Coram: Hon’ble Justice Smt. G. Anupama Chakravarthy
Advocates:
- For the petitioner: Mr. Ramesh Kumar Agrawal
- For the respondents: Mr. Uma Shankar, GP-4
Date of Judgment: 05.05.2025
Nature of the Case: Writ petition (Civil) challenging legality of drug inspection, sealing of factory premises, and seeking quashing of inspection report under the Drugs and Cosmetics Act, 1940.
Link to Judgment: Click here to read the full judgment of the Patna High Court
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