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

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;

“… in the light of law as explicitly explained in Ashok Kumar (supra), the present FIR could not have been registered for any offences under the D & C Act by the police, which is in the exclusive domain of Drugs Inspector. Moreover, it is noted in the Status Report that Drugs Inspector, Karnataka has already initiated investigations in the allegations of adulterated/spurious drugs, under D&C Act.”

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;

“… the Product was of Standard quality till it got dispatched from the Factory of the Petitioner, but the Particulates came in during the transit or thereafter, for which the Petitioner cannot be held responsible. … To put it concisely, adulteration has prima facie been noticed only at the premises of Respondent No.2 and not at the time of dispatch from the Manufacturing Unit of the Petitioner No.1. Also, the Product never got sold in the market. Further, the proceeding for prosecution under D&S Act has already been initiated by the Drugs Inspector, Karnataka, as per the Status Report."

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;

"It is concluded that the Police does not have any jurisdiction to register an FIR in respect of the offences under D & C Act which can be undertaken only by the competent officer under S.32 D & C Act. Therefore, the registration of FIR under the provisions of D & C Act is without jurisdiction and FIR in respect of offences under D & C Act is quashed."

"The FIR under Section 274 and 275 IPC IPC though maintainable, but in the present case the offences under have not been prima facie made out, as discussed above. Also, the FIR was registered in the year 2019, but till date even the investigations have not been completed. The limitation as per Section 468 IPC for concluding the investigations and the Chargesheet to be filed in the Court for the purpose of taking cognizance is one year. It is not expedient or in the interest of justice to let the investigations be continued in such a case which is hopelessly barred by limitation. It is in fact, an abuse of the process of law which merits a quashing."

The court held;

"The Petition is allowed and the FIR No.053/2019 under Sections 274/275 IPC and Section 13 of the D & C Act registered at PS Okhla Industrial Area is hereby, quashed. It is clarified that observations made herein are only for the purpose of aforesaid FIR and are not an expression on the merits for any other proceedings under the D & C Act or any other enactment that may have been initiated or undertaken."

To view the official order, click the link below: