November 02, 2025

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Police Have No Jurisdiction to Register FIR Under Drugs & Cosmetics Act: Delhi HC

New Delhi:The Delhi High Court has quashed an FIR against Revacure Lifesciences LLP and its partners, who were accused by Bhardwaj India of supplying defective Docetaxel injection 20 mg vials allegedly containing glass particles. The FIR, registered in 2019 under Sections 274/275 IPC and Section 13 of the Drugs and Cosmetics Act, 1940, was declared without jurisdiction as only a Drug Inspector is empowered to initiate prosecution under the Act. The ruling was delivered by Justice Neena Bansal Krishna on September 23, 2025, who observed that the FIR under the Drugs and Cosmetics Act, 1940, was without jurisdiction since only a Drug Inspector can initiate prosecution under Section 32 of the Act. The dispute began when Bhardwaj India alleged that Docetaxel injection 20 mg vials manufactured at Revacure’s Jabalpur facility under a loan licence arrangement were defective, with broken glass and visible foreign particles. The complainant accused Revacure and its partners of manufacturing substandard medicines that could endanger patients. Acting on this complaint, a Metropolitan Magistrate ordered the registration of FIR No. 53/2019 under Sections 274/275 IPC and Section 13 of the Drugs and Cosmetics Act at Okhla Industrial Area police station. Revacure argued that it only provided its manufacturing facility under a loan licence agreement, while the responsibility for product quality lay with Bhardwaj India, the license holder. The petitioners contended that the drugs were tested and cleared at their unit and that the alleged contamination occurred after delivery at the complainant’s premises. They further claimed that the FIR was an abuse of process, as offences under the Drugs and Cosmetics Act could only be pursued by a Drug Inspector, not the police. Bhardwaj India countered that Revacure was solely responsible for the quality of the drugs as per agreements, technical staff records, and statutory provisions. It maintained that test reports from the Karnataka Drug Control Department had declared the drugs as “not of standard quality.” The company alleged that Revacure had failed to uphold manufacturing standards and supplied substandard medicines despite receiving full payment. Justice Krishna noted that under Section 32 of the Drugs and Cosmetics Act, only designated authorities such as Drug Inspectors or gazetted officers can institute prosecutions, not the police. Thus, the FIR under the Drugs and Cosmetics Act was invalid. Regarding IPC offences, the court observed that Section 275 IPC (sale of adulterated drugs) was not applicable as no drugs were sold in the market, while Section 274 IPC (adulteration) was also not made out since control samples taken from Revacure’s premises were found to meet prescribed standards. The alleged contamination was detected only after delivery to Bhardwaj India. It noted; Further, the Court observed that the particles found in the product were certainly absent at the time of dispatch from the Petitioners’ factory. It noted; Subsequently, the High Court quashed FIR No. 053/2019, holding that both the Drugs and Cosmetics Act charges and IPC charges lacked merit. It also noted that the case was hopelessly barred by limitation, with the FIR registered in 2019 and no chargesheet filed within the statutory period. The court concluded that continuing the proceedings would amount to an abuse of process. It observed; The court held; To view the official order, click the link below:

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