High Court: Manufacturer has right to dispute correctness of Govt Analyst Report

Hon'ble Apex court observed and held

399
Justice Court

The Jammu and Kashmir and Ladakh High Court recently ruled that a drug manufacturer has a right to dispute the correctness of the report of the government analyst within the statutory period of 28 days from the date of the receipt of the report as per the mandate of section 25 (3) of the Drugs and Cosmetics Act, 1940.

Dispute the correctness of the report of the government analy

The observation was made by a bench of Justice Rajnesh Oswal while hearing a plea in terms of which the petitioners had challenged proceedings pending against it before the court of Chief Judicial Magistrate, Jammu.

Sections 23(4), 25 (3) and 25 (4)

The petitioners challenged the said complaint primarily on the ground that the trial court, without application of mind, took cognizance against the petitioner when the substantial right of the petitioner to get the drug in question re-tested/re-analyzed by the Central Drug Laboratory Kolkata as envisaged in sections 25 (3) and 25 (4) of the Act was denied to the petitioner by the deliberate conduct of the respondents and also by its failure on its part to supply one sealed sample portion of the drug in question to the petitioner as required under section 23 (4).

The petitioner further contended that the trial court, without application of the mind, took cognizance against the petitioner in light of the fact that the present complaint was filed very shortly before the expiry of the shelf life of the drug in question, and by the time the petitioner received a summons, the drug in question had already expired.

The petitioner, as such, has lost its valuable right of getting the drug in question reanalyzed/retested from the Central Laboratory Kolkata, the counsel submitted.

Adjudicating upon the contentions raised, Justice Oswal noted that the perusal of the report of the government analyst dated 31.10.2011 reveals that the drug in question has been found to be of standard quality and the petitioner has admitted the receipt of the communication dated 18.11.2011 whereby the test report along with the sample was sent o the petitioner.

Manufacturer’s right

The petitioner had a right to dispute the correctness of the report of the government analyst within the statutory period of 28 days from the date of the receipt of the report as per the mandate of section 25 (3) of the Act and the letter dated 20.12.2011 relied upon by the petitioner was allegedly sent through courier and in the courier receipt dated 20.12.2011 relied upon by the petitioner neither the designation nor the address of the respondent No.1 is correct, as such, no reliance can be placed upon the said letter at this stage particularly when the receipt of the said letter has been denied by the respondents, the bench underscored.

Section 482 Crpc

Accordingly, Justice Oswal observed that whether the letter dated 20.12.2011 was sent to respondent No. 1 at his correct address or not and further, whether the same was received by respondent No. 1 or not, becomes a disputed question of fact and the same cannot be adjudicated by this Court while exercising jurisdiction under section 482 Crpc.

Buttressing the position of law as mandated under Sec 25(3) of the Drugs and Cosmetics Act, the bench found it worthwhile to record the observations of the supreme court in Glaxosmithkline Pharmaceuticals Ltd. v. the State of M.P., reported in (2011), where the Hon’ble Apex court observed and held:

Hon’ble Apex court observed and held

“The law permits the drug manufacturer to controvert the report by expressing his intention to adduce evidence to controvert the report within the prescribed limits of 28 days as provided under Section 25(3) of the 1940 Act.”

In view of the fact that the appellants did not express an intention to adduce evidence to controvert the analyst report within the statutory limitation period of 28 days, further delay in filing the complaint becomes immaterial.

Even otherwise, expiry date of the medicine was March 1998 i.e. only after 4 months of submission of the reply by the appellants, and they did not fulfill their burden of expressing an intention to adduce evidence in contravention of the report.”

Therefore, they cannot raise the grievance that the complaint had been lodged at a much-belated stage”

In view of the above, the court found no merit in the petition and dismissed it, leaving the petitioner free to raise the above issues before the trial court during the course of the trial.

Case Title : Symbiosis Pharmaceuticals Pvt Ltd Vs State of J&K

Citation: 2022 LiveLaw (JKL) 141

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