Published On : Mon, Jul 8th, 2024
By Nagpur Today Nagpur News

HC quashes FDA case against Directors of Reklim Pharma Co in Nagpur

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Nagpur: Citing procedural lapses and legal insufficiencies in the complaint filed by the Food & Drug Administration (FDA), Justice G A Sanap at the Nagpur Bench of the Bombay High Court has ordered the quashing of a criminal case against directors and a pharmaceutical company in Nagpur.

The petitioners, Swapnil Mane and Snehal Mane, Directors of M/s Reklim Pharmaceuticals Private Limited, along with the company itself, challenged their implication in a case under Section 27(d) of the Drugs and Cosmetics Act, 1940. The case was registered on the complaint of Monica Vinod Dhawad, a Drugs Inspector, about the quality of ReklimoLB Tablets distributed by the company.

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The court’s decision underlined several critical deficiencies in the prosecution’s case. Firstly, it noted that the complaint failed to specify how the accused directors were directly responsible for the alleged offenses, a crucial requirement under Section 34 of the Drugs and Cosmetics Act, 1940.

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Justice Sanap stressed that merely holding positions as directors was inadequate to establish liability without evidence of their direct involvement in the company’s affairs. Secondly, the court addressed the procedural error regarding the analysis of the drug sample. It pointed out that the analysis, conducted over a year after the sample’s collection, violated Rule 45 of the Drugs Rules, 1945, which mandates completion of analysis within sixty days. This delay undermined the integrity of the report and compromised the accused’s right to a fair trial.

In light of these findings, Justice Sanap concluded that the prosecution had failed to meet the legal standards required for continuing the case against the petitioners. As a result, the court quashed the trial pending against three accused at the Adhoc District Judge-4 and Additional Sessions Judge, Nagpur.

Adv V R Borkar represented the petitioners while APP Suraj Hulke for the respondent/State.