Conclusive Report of Central Drugs Laboratory u/s 25(4) of Drugs and Cosmetics Act, 1940 supersedes Government Analyst’s report: Himachal Pradesh HC

himachal pradesh high court

Himachal Pradesh High Court: In a petition filed under Section 482 of the Criminal Procedure Code, 1973 (‘CrPC’) to quash the proceedings initiated against the petitioners, Rakesh Kainthla, J.*, opined that opined that it was apparent from the bare perusal of the Section 25(4) of the Drugs and Cosmetics Act, 1940 (‘the Act’), that the report of Director, Central Drugs Laboratory had been made conclusive of its contents and would supersede the report of the Government Analyst. The Court further relied on Amery Pharmaceuticals v. State of Rajasthan, (2001) 4 SCC 382, and opined that in the present case, the report of Central Drugs Laboratory, Kolkata, clearly showed that the sample was found to be conforming to the standard laid down. Since, this report was conclusive, it superseded the report of the Government Analyst and thus, it was admissible without examination of the report’s author. The Court opined that continuation of the proceedings before the Trial Court would amount to an abuse of the Court’s process and would be an exercise in futility and accordingly, quashed the proceedings initiated against the petitioner.

Background

In an instant case, it was asserted that on 15-03-2021, the Drug Inspector, drew sample of drug Azilsartan Medoxomil tablet, which was manufactured by Hetro Labs Limited (‘petitioner’). Subsequently, the drug was sent to a Government Analyst, Regional Drugs Testing Laboratory, and Chandigarh for testing and analysis, which issued a result stating that the sample did not conform to the claim as per the patent and proprietary with respect to the dissolution. Further, in compliance with Section 25 of the Act, one copy of the report was delivered to the petitioner. Thus, a complaint was filed against the petitioners before the Trial Court. However, the petitioners got their sample analysed at their own end and found that it complied with the requirement.

The petitioners filed an application under Section 25(4) of the Act for sending the sample to the Central Laboratory, Kolkata for its analysis. The Central Drugs Laboratory, Kolkata issued a report stating the drugs conformed to the manufacturer’s specification with respect to the test for dissolution. The report of the Government Analyst was superseded by the report issued by the Central Drugs Laboratory, Kolkata, therefore the petitioner filed the present petition to quash the proceedings initiated against them.

Analysis, Law, and Decision

The Court relied on Supriya Jain v. State of Haryana, (2023) 7 SCC 711; Gulam Mustafa v. State of Karnataka, 2023 SCC OnLine SC 603; CBI v. Aryan Singh, 2023 SCC OnLine SC 379 and Abhishek v. State of M.P. 2023 SCC OnLine SC 1083, and opined that power under Section 482 of the CrPC could be exercised to prevent the abuse of process or secure the ends of justice. The Court could quash the FIR if the allegations did not constitute an offence, or a case is not made out against the accused. However, it was not permissible to conduct mini-trial to arrive at such findings.

The Court further noted that as per Section 25(4) of the Act, the Director of Central Drugs Laboratory should cause the sample to be tested and such report should be conclusive evidence of the facts. The Court opined that it was apparent from the bare perusal of the Section 25(4) of the Act, that the report of Director, Central Drugs Laboratory had been made conclusive of its contents and would supersede the report of the Government Analyst. The Court further relied on Amery Pharmaceuticals v. State of Rajasthan, (2001) 4 SCC 382, and opined that in the present case, the report of Central Drugs Laboratory, Kolkata, clearly showed that the sample was found to be conforming to the standard laid down. Since, this report was conclusive, it superseded the report of the Government Analyst and thus, it was admissible without examination of the report’s author. The Court opined that continuation of the proceedings before the Trial Court would amount to an abuse of the Court’s process and would be an exercise in futility and accordingly, quashed the proceedings initiated against the petitioners.

[Hetero Labs Limited v. Union of India, Cr. MMO No. 810 of 2023, decided on 08-01-2024]

*Judgment authored by- Justice Rakesh Kainthla


Advocates who appeared in this case :

For the Petitioners: N.S Chandel, Senior Advocate with Vinod Gupta, Advocate

For the Respondent: Shashi Shirshoo, Central Government Counsel

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