Jharkhand HC Declines Aventis Pharma's Plea To Quash Criminal Proceedings Over Ofloxacin Tablet Samples Allegedly Not Upto Standard Quality Requirements

The Jharkhand High Court has rejected the plea of Aventis Pharma, a global healthcare company, seeking to dismiss the entire criminal proceedings related to a complaint filed under section 27(d) of the Drug and Cosmetics Act, 1940. The complaint arose from a dispute regarding samples of Ofloxacin Infusion taken from three different batches.The samples were collected following a complaint from the Director of Rajendra Institute of Medical Science (RIMS), Ranchi, and were subsequently investigated by the Government Analyst in Kolkata.Justice Sanjay Kumar Dwivedi, presiding over the case, dismissed the plea noting that the petitioner failed to provide any evidence contradicting the Analyst report. Placing reliance on the Apex Court's judgement in Glaxosmithkline Pharmaceuticals Limited and Another Vs. State of Madhya Pradesh (2011), he emphasized, “As discussed hereinabove, it appears that the petitioner has not given any evidence to adduce any evidence in contravention of Analyst report and if such disputed questions of facts are there in the light of judgment of the Hon'ble Supreme Court in the case of Glaxosmithkline Pharmaceuticals Limited (supra) that can be only agitated before the trial court. Further, 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 such sample should be sent to the Central Analyst Report from the report on the strength of such request,” Justice Dwivedi added.The case stemmed from a complaint filed based on Test Reports forwarded by the Drugs Inspector in Ranchi, indicating that samples of Ofloxacin Infusion from Batch No. 237007, 236015, and 236019, manufactured by the petitioner-company, did not meet the standard quality requirements.There was a dispute concerning the sample of Ofloxacin Infusion from Batch No. 237007, 236015, and 236019. These samples were collected following a complaint from the Director of Rajendra Institute of Medical Science (RIMS), Ranchi. The complaint was investigated by the Government Analyst in Kolkata.A Complaint Case was filed, alleging that the Drugs Inspector in Ranchi, under Letter No. 3/6 dated March 8, 2008, forwarded copies of Test Reports from the Government Analyst at the Central Drug Laboratory in Kolkata. These reports claimed that samples of Ofloxacin Infusion from Batch No. 237007, 236015, and 236019, manufactured by the petitioner-company, were not of standard quality.SubmissionsIndrajit Sinha, the counsel representing the petitioner, asserted that the petitioner maintains regional offices in Delhi, Mumbai, Chennai, Kolkata, Hyderabad, and Lucknow. The petitioner obtained wholesale licenses on August 28th, 2001, in Form-20B and 21B to sell drugs wholesale in Jharkhand.He further stated that the petitioner-company manufactures 130 products under various licenses, including Tarivid, I.V, 100 ml. Tarivid is an anti-infective infusion administered intravenously, containing Ofloxacin as the active ingredient. This product is typically packaged in 100 ml glass bottles or vials, containing 200 mg of Ofloxacin, sealed with aluminium and dark green flip-off seals, and provided with pre-printed cartons with plastic hangers and package inserts.Sinha elaborated that the petitioner-company has been manufacturing Tarivid I.V. 100 ml since 1998, initially at its plant in Mulund, Mumbai, and later shifting production to an external manufacturing site at M/s. Wintac Ltd. Bangalore, under a loan license arrangement as per the relevant regulations.He emphasized that there have been no reported failures or quality complaints regarding this product in the past. Sinha argued that the complaint lodged by the Drugs Inspector lacked procedural adherence to the Drugs and Cosmetics Act, 1940.Sinha mentioned that the petitioner informed the Drugs Inspector, through a letter dated March 14, 2008, that control samples from three batches were tested internally and found to be within permissible quality limits. The petitioner contested the findings of the Government Analyst's report based on this information.He further pointed out that the Drug Inspector, Ranchi, had only taken one vial from each batch for testing, and thus, did not follow the procedures outlined in Section 23 of the Drugs & Cosmetics Act, 1940. Sinha argued that the Drug Inspector failed to comply with several provisions of the Act, including not tendering fair prices for the samples, not providing receipts in the prescribed format, and not properly handling and marking the samples.Moreover, Sinha contended that the petitioner's right to challenge the findings was hindered due to the non-supply of samples, as mandated by Section 25(4) of the Act. He argued...

Jharkhand HC Declines Aventis Pharma's Plea To Quash Criminal Proceedings Over Ofloxacin Tablet Samples Allegedly Not Upto Standard Quality Requirements

Bhavya Singh

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