Isabella Mariam

The High Court of Delhi Single Bench of Justice Neena Bansal Krishna quashed an FIR registered under Sections 274 and 275 of the IPC and Section 13 of the Drugs and Cosmetics Act, 1940, concerning alleged adulteration of the cancer drug Docetaxel. The Court noted that under Section 32 of the Act, the authority to initiate prosecution lies with a designated Drugs Inspector, and the police lacked jurisdiction to file the FIR. It further recorded that the drug batch met quality standards at the time of dispatch and that any contamination appeared to have occurred subsequently, absolving the manufacturer of liability.

The dispute arose when M/s Bhardwaj India Private Limited, the complainant, alleged that Revacure Lifesciences LLP and its partners had supplied defective medicines, specifically Docetaxel injections containing broken glass and visible foreign particles. The allegations stated that the defective products posed risks to patient safety.

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The petitioners contended that Revacure had only provided its facility to the complainant under a Loan Licence Agreement dated 2012 and 2013, and the responsibility for quality, strength, and purity of the product rested entirely with the licensee, M/s Bhardwaj India Pvt. Ltd. According to the petitioners, the arrangement was akin to that of landlord and tenant, where Revacure only received payments for use of its facilities. They argued that the complainant’s director, Bhupendra Mohan Bhardwaj, had maliciously contaminated the drugs to create false grounds for prosecution. Further, they relied on inspection reports by the Central Drugs Standard Control Organization (CDSCO) and FDA, Madhya Pradesh, which found the manufacturing unit compliant with Schedule M-GMP provisions and that control samples from the factory were of standard quality.

The complainant countered that the petitioners had concealed critical agreements, including a Technical Agreement (2017), a Supply Agreement (2018), and a General Agreement (2018), which explicitly placed responsibility for manufacturing and quality control on Revacure’s staff. It was further argued that test reports by the Karnataka Drug Control Department declared the products “Not of Standard Quality,” establishing liability.

The State’s status report noted that while joint inspections found compliance at Revacure’s factory, later testing of samples drawn in Bengaluru revealed presence of foreign particles. Investigation continued under the FIR until challenged by the petitioners under Section 482 Cr.P.C. for quashing.

The Court considered whether offences under the Drugs and Cosmetics Act could form the basis of FIR registration by the police. Referring to Section 32 of the Act, it recorded: “The police officer cannot prosecute offenders in regard to such offences. Only the persons mentioned in Section 32 are entitled to do the same… a police officer cannot register an FIR under Section 154 Cr.P.C. in regard to cognizable offences under Chapter IV of the Act and he cannot investigate such offences under the provisions of Cr.P.C.” The Court relied on the Supreme Court’s judgement in Union of India vs. Ashok Kumar Sharma.

It was further noted: “Therefore, 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.” The Court clarified that since Drug Inspector, Karnataka had already initiated proceedings, continuation of FIR was unwarranted.

On IPC offences, the Court observed Section 32(3) of the D&C Act, noting: “Nothing contained in this Chapter shall be deemed to prevent any person from being prosecuted under any other law for any act or omission which constitutes an offence against this Chapter… thereby implying that the FIR for IPC offences shall sustain itself and investigations therein shall be continued by the Police.”

However, with respect to Section 275 IPC (sale of adulterated drugs), the Court stated: “In the present case, the complaint was about manufacturing of drugs and not of sale. There is not an iota of word that these adulterated drugs were ever sold in any market. Therefore, offence under Section 275 IPC is not disclosed from the averments made in the Complaint and the same is liable to be quashed.”

Regarding Section 274 IPC (adulteration of drugs), the Court noted the Loan Licence arrangement and referred to statutory provisions and prior precedent. It observed: “It becomes clear that a loan licensee being a manufacturer will certainly have to be held to be in sole authority over the quality of the drugs manufactured under its supervision.” Further, the Court relied on inspection reports and arbitration findings to record: “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.”

The Court concluded: “There is prima facie no offence under Section 274 IPC made out against the Petitioners even if all the averments made in the Complaint are admitted.”

On the question of limitation under Section 468 Cr.P.C., the Court stated: “The FIR was registered on 14.02.2019 under Sections 274/275 IPC which are punishable for maximum sentence of six months and/or fine. As per Section 468 Cr.P.C., limitation for taking cognizance on the Chargesheet for the said offences is one year.” It recorded that despite six years since registration, no investigation was concluded, rendering continuation of proceedings “not expedient or in the interest of justice.”

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The Court issued its final directive stating: “From the aforesaid discussion, 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.”

“Secondly, the FIR under Section 274 and 275 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.”

It clarified that its observations were confined to the FIR proceedings and not binding on any other proceedings under the D&C Act or other enactments.

Advocates Representing the Parties

For the Petitioners: Mr. Aditya Singh Deshwal and Mr. Daksh Sharma, Advocates
For the Respondents: Mr. Utkarsh, APP for the State; Mr. Biswajit Swain and Mr. Akhil Ganga, Advocates.

Case Title: Revacure Lifesciences LLP & Ors. vs. State Govt. of NCT Delhi & Ors.
Neutral Citation: 2025: DHC:8558
Case Number: CRL.M.C. 2085/2021
Bench: Justice Neena Bansal Krishna