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

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.

Submissions

Indrajit 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 that this procedural lapse jeopardized the petitioner's defense rights and rendered a fair trial impossible.

Drawing from the precedent set in the case of T. Nagappa V. Y.R. Muralidhar (2008) 5 SCC 633, Sinha emphasized that non-compliance with the aforementioned sections undermined the petitioner's right to a fair trial. Based on these grounds, he urged the quashing of the entire criminal proceeding.

Shailesh Kumar Sinha, representing the State, argued that the mere absence of evidence related to quality complaints from the market or medical professionals doesn't exonerate the petitioner. He contended that the firm associated with the petitioner had indeed manufactured, distributed, and sold substandard drugs. The assertion was supported by the Central Drugs Laboratory, Kolkata, which declared specific batches of Tarivid I.V. not of standard quality.

Moreover, Sinha emphasized that the petitioner's control over the samples from manufacturing units renders reports from their own laboratory irrelevant. He cited instances of adverse drug reactions reported by medical institutions, such as the Rajendra Institutes of Medical Sciences, Bariatu, Ranchi, further strengthening the case against the petitioner.

He highlighted the inspections conducted by Drug Inspectors, during which samples were collected and divided as per legal requirements. Despite compliance with the procedural requirements outlined in the Drugs and Cosmetics Act, Sinha argued that the quantity of samples collected was inadequate. Nevertheless, all samples were sent for analysis to the Central Drugs Laboratory, Kolkata.

Sinha underscored the significance of adhering to the procedures outlined in the Act, emphasizing the serious nature of the allegations, particularly when they originate from government institutions. He argued that the petitioner failed to present evidence contrary to the Government Analyst Report within the stipulated time frame, as required by Sections 25(3) and 25(4) of the Act.

Furthermore, Sinha contested the petitioner's discharge petition, asserting that its pending status does not warrant the rejection of the case. He concluded that the disputed facts should be resolved through trial proceedings, emphasizing that the case should not be dismissed on the grounds presented.

Verdict

The court, in its judgment, observed that the patient's reaction was a result of using the specified medicine.

Additionally, it noted, “The medicine was also not in adequate quantity before the patient that is why at that time samples were not been divided into four parts as such compliance of Section 23(4) was not done that time, but later on at the time of inquiry Drug Inspector collected the samples from the concerned medical shops and made the compliance of Section 23 of the Drugs and Cosmetic Act.”

Based on the aforementioned facts and analysis, the court concluded that there were contested issues of fact that could only be resolved during trial, thus dismissing the petition.

Nevertheless, the court clarified, “what is discussed hereinabove is with regard to parameters of Section 482 of Cr.P.C. and if the trial will proceed that will be decided in accordance without prejudice to this order. Pending I.A., if any, stands disposed of.”