No Court Is Under Compulsion To Cause Sample Test U/S 25(4) Of Drugs And Cosmetics Act, If Requested After Long Delay: Jharkhand HC

Update: 2024-03-08 09:30 GMT

The Jharkhand High Court stated that the Court is under no compulsion to cause the sample test under Section 25(4) of the Drugs and Cosmetics Act, 1940, if the request is made after a long delay.

The bench of Justice Sanjay Kumar Dwivedi observed, “the petitioner can avail remedy indicated under sub-section 4 of Section 25 of the Act by requesting the Court to send the other portion of sample remaining in the court to be tested at the Central Drugs Laboratory. However, no Court is under compulsion to cause the said sample so tested if the request is made after a long delay. However, the discretion is conferred to the Court to decide whether the such sample should be sent to the Central Analyst Report from the report on the strength of such request.”


In the present case, the dispute is there about the sample of Ofloxacin Infusion in some batches that were alleged to have been found not of standard quality. The said samples were collected under the complaint made by the Director, Rajendra Institute of Medical Science (RIMS), Ranchi, which were examined by the Government Analyst, Kolkata and the report was annexed with the criminal complaint which was filed by the Drug Inspector.

Hence, the Petitioner-company approached the High Court under the present petition for quashing of entire criminal proceedings pending with the Chief Judicial Magistrate.

Advocate Indrajit Sinha appeared for the Petitioner and Additional Public Prosecutor Shailesh Kumar Sinha appeared for the Respondent.

As per the Petitioner, Section 23 of the Drugs & Cosmetics Act, 1940 was not followed as the counterpart of the used samples were not available with the Drug Inspector.

The company further argued that their right to request the Court to send the samples for test under Section 25(4) was not allowed to be exercised as the procedure under Sections 23 and 25 was not followed hence, no fair trial can take place.

The High Court noted that, in the present case, the petitioner had not given any evidence to adduce any evidence in contravention of the Analyst report and according to the Court, if such disputed questions of facts are there then it can be only agitated before the trial court.

For that, Court relied on the decision of Glaxosmithkline Pharmaceuticals Limited and Another Vs. State of Madhya Pradesh” reported in (2011) 13 SCC 72 where Apex Court held, “The case of the statutory authorities is that option/willingness to adduce evidence to controvert the analyst's report was not filed within the period of 28 days i.e. limitation prescribed for it. The appellants are the persons who knew the date on which the show-cause notice was received. For the reasons best known to them, they have not disclosed the said date. It is a Company which must be having Receipt and Issue Department and should have an office which may inform on what date it has received the notice, and thus, should have made the willingness to controvert the report.”

“…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.”

The High Court noted that as the medicine was not in adequate quantity before the patient, therefore, at that time samples were not divided into four parts and Section 23(4) was not complied with. However, as per the Court, later, the inquiry Drug Inspector collected the samples from the concerned medical shops and made compliance with Section 23 of the Drugs and Cosmetic Act.

The Court found that there is a disputed question of fact in the present case which can only be decided in trial.

Consequently, the petition was dismissed.

Cause Title: M/s Aventies Pharma Limited v. The State of Jharkhand

Appearance:

Appellant: Adv. Indrajit Sinha,  Adv. Akshat Hansaria, Adv. Jyoti Nayan

Respondent: A.P.P. Shailesh Kumar Sinha

Click here to read/download Judgment


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