J&K HC Quashes Case Against Pharma Company

(MENAFN- Kashmir Observer) Srinagar- Seeking re-analysis of drug sample before expiry of a valuable statutory right, the High Court of J&K and Ladakh has quashed criminal proceedings against a pharmaceutical company.

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A bench of Justice Wasim Sadiq Nargal passed the judgment in a petition filed by Maxmed Life Sciences Pvt. Ltd., its director and another accused against proceedings arising from a complaint under Sections 18(a)(i) read with 27(d) of the Drugs and Cosmetics Act, 1940.

The case related to a drug marketed as“Amzone”, Batch No. MLI-386, manufactured in December 2013 and having an expiry date of November 2015. The sample was lifted on January 16, 2014 from Chest and Disease Hospital, Bakshi Nagar, Jammu.

The Government Analyst, Jammu, in a report dated February 11, 2014, declared the sample“Not of Standard Quality” after it“failed” the prescribed particulate matter test.

The petitioners were subsequently informed about the analyst's report and, within the statutory period, communicated their intention to controvert the report and seek re-analysis of the sample. Their communication referred to testing at an NABL-accredited laboratory.

The prosecution contended that the petitioners had not specifically requested testing by the Central Drugs Laboratory (CDL), which is the statutory authority whose report is conclusive under the Drugs and Cosmetics Act.

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The Court, however, rejected the contention that the reference to an NABL-accredited laboratory amounted to abandonment of the petitioners' statutory right.

The Court examined Section 25 of the Drugs and Cosmetics Act, particularly sub-sections (3) and (4), and held that once an accused communicates within the prescribed period an intention to controvert the Government Analyst's report, the statutory mechanism for securing a conclusive analysis by the Central Drugs Laboratory has to be given meaningful effect.

The Court observed that the use of the word“may” in Section 25(4), in the circumstances of the case, could not be construed as conferring an unfettered discretion to defeat the statutory safeguard available to the accused.

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Holding that the petitioners had been deprived of their valuable statutory right to have the drug sample tested by the Central Drugs Laboratory before the expiry of its shelf life, the Court quashed the criminal proceedings arising from the complaint.

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