The Himachal Pradesh High Court has observed that a conclusive report of the Central Drugs Laboratory supersedes the report of the Government Analyst and is per se admissible without examination of the author.

In that context, the Bench of Justice Rakesh Kainthla held that, "the report of the Central Drugs Laboratory, Kolkata clearly shows that the sample was found to be conforming to the standard laid down, hence, the case of the prosecution that the Drug did not conform to the standard has been falsified by the report. Since this report is conclusive, it supersedes the report of Government Analyst and is per se admissible without examination of the author; therefore, the complainant’s version that the sample did not conform to the standard quality is falsified by the report. The continuation of the proceedings before the learned Trial Court will be an exercise in futility and will amount to an abuse of the process of the Court".

Senior Counsel NS Chandel appeared for the petitioners, while CSG Shashi Shirshoo appeared for the respondent.

The Drug Inspector drew a sample of Azilsartan Medoxomil tablet on 15.03.2021, manufactured by M/S Hetro Labs Limited. The sample, initially deemed non-compliant by a Government Analyst, was later independently analyzed by the petitioners, who asserted its compliance.

The Trial Court dismissed the complaint, prompting a revision before a High Court. Following a directive to the Central Drugs Laboratory, Kolkata, their report confirmed conformity to specifications.

The petitioner argued that this report superseded the previous one, rendering the complaint moot. The respondent, acknowledging the sample's standard quality as per the central laboratory, requested appropriate orders.

The High Court noted that Section 25(4) of the Drugs & Cosmetics Act provides that the Director of the Central Drugs Laboratory, Kolkota, shall cause the sample to be tested and such report shall be conclusive evidence of the facts stated therein.

With that background, it was observed that, "it is apparent from the bare perusal of the Section that the report of the Director, Central Drugs Laboratory, Kolkota, has been made conclusive of its contents and will supersede the report of the Government Analyst".

In light of the same, the petition was quashed.

Cause Title: M/S Hetero Labs Limited & others vs Union of India through Drug Inspector

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