Drugs & Cosmetics Act | Failed Dissolution Test When Active Content Is Within Limit Is Minor Defect, Does Not Warrant Prosecution: Rajasthan HC

Finding various procedural lapses, the Rajasthan High Court quashed a 2017 complaint under the Drugs and Cosmetics Act highlighting that the case was filed when a drug sample had purportedly failed the dissolution test even though the same had an active ingredient which was within the standard limits. In doing so the court observed that as per the prescribed guidelines and Supreme Court's decisions, such a defect was a "minor defect" for which prosecution is impermissible. It was observed that a delayed dissolution did not render the drug useless as it merely implied a slower release of the active content without affecting its efficacy.Among other lapses the court noted that the Drugs Control Officer had failed to comply with the statutory requirement under Section 25(3) which mandates sending a portion of the sample to the manufacturer for reanalysis in case of a disputed report. Justice Farjand Ali in his order said: "Additionally, the Government Analyst's report itself indicates that the drug in question failed the dissolution test but had an active ingredient within the standard limits. The Guidelines issued by the Central Government under Section 33-P of the 1940 Act classify such defects as minor, which do not warrant prosecution under Section 27(b)(i). The Hon'ble Supreme Court in Laborate Pharmaceuticals India Ltd. v. State of Tamil Nadu, (2018) 15 SCC 93, has held that where minor defects are noted, initiation of prosecution is impermissible". The court further observed that in the present case the drug's active pharmaceutical ingredient (API) was found to be within the prescribed standards, and the only deviation was in the dissolution rate. Emphasizing that a delayed dissolution did not render the drug spurious but merely implied a slower release of the active content which still remains effective, the court said that therapeutic efficacy of the drug is not entirely negated by such a delay. “Dissolution rates can be influenced by several factors, including the quality of excipients, manufacturing processes, temperature control, and climatic conditions during production and storage. The presence of the correct active ingredient in the specified quantity is the primary factor in determining a drug's standard quality. If the core content of the drug remains intact and effective, classifying it as substandard, spurious, or useless would be legally and scientifically untenable,” it added. The court said that the prosecution's "mechanical approach" in filing the complaint, without considering the nature of the defect and its actual impact on drug efficacy, substantiated the petitioners' contention that the "proceedings are an abuse of the process of law”.BackgroundThe Court was hearing a bunch of petitions moved by certain pharmaceutical companies and their officials, seeking quashing of a complaint filed against them pursuant to an inspection conducted in 2012. During the inspection, sample of a drug was collected and sent for analysis. The government analysis in 2013 declared the sample to be not of standard quality due to non-conformity with the dissolution test. Subsequently, after tracing back the distribution chain of the drug, complaints were filed against multiple companies and their directors.FindingsSample not sent to manufacturer for reanalysis After hearing the contentions and perusing the record, the Court observed that there were “glaring procedural lapses, which vitiated the very foundation of the prosecution”. Among other procedural lapses, the court observed that the Drugs Control Office failed to comply with the statutory requirement under Section 25(3) of the Act that mandated sending a portion of the sample to the manufacturer for reanalysis in case of a disputed report. Referring to Supreme Court decision, the court said: “Hon'ble Supreme Court in Medicamen Biotech Ltd. v. Rubina Bose, (2008) 7 SCC 196, categorically held that non-compliance with this statutory mandate vitiates the entire prosecution. In the present case, despite procedural irregularities and non-adherence to mandatory requirements, the complaint was filed and cognizance was taken, which is a serious lapse on the part of the prosecution,”.Petitioners appointed as non executive directors not incharge at the time of alleged offence Furthermore, the Court referred that the principle of vicarious liability provided under Section 34 of the Act, fastened liability only upon those individuals who were in-charge of the conduct of the business at the time of the alleged offence. This criteria of active participation of the directors was not established by the prosecution in the instant matter."In the present case, the petitioners, who were appointed as Additional Directors (Non-Executive) much after the relevant period, cannot be saddled with criminal liability merely by virtue of their designation," the court said. Complaint filed after expiry of drug The Court...

Drugs & Cosmetics Act | Failed Dissolution Test When Active Content Is Within Limit Is Minor Defect, Does Not Warrant Prosecution: Rajasthan HC

Nupur Agrawal

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