Only Drug Inspectors Can Initiate Prosecution Under Drugs Act; Police FIR Without Authority is Null: Delhi High Court Quashes FIR in Alleged Adulterated Drug Case

FIR by Police under Drugs and Cosmetics Act beyond jurisdiction — “Only officers under Section 32 D&C Act can prosecute, police have no role to play”: Delhi High Court, in a detailed and significant judgment delivered by Justice Neena Bansal Krishna, allowed a petition to quash FIR No. 053/2019 registered under Sections 274/275 IPC and Section 13 of the Drugs and Cosmetics Act, 1940, holding that the registration of FIR by the police under the D&C Act was without jurisdiction. The Court ruled that only specified authorities under Section 32 of the D&C Act, such as Drug Inspectors or authorised officers, have the power to initiate prosecution, and not the police.

The judgment, in the case of Revacure Lifesciences LLP & Ors. vs. State Govt. of NCT of Delhi & Ors., also found that no prima facie IPC offence of drug adulteration was made out, and that the continuation of the investigation was barred by limitation, terming the proceedings an abuse of process of law. Accordingly, the FIR was quashed in its entirety.

Commercial Dispute Given Criminal Colour – Complaint filed to defame and extort under garb of criminal proceedings

The petition before the High Court arose from a commercial dispute between the petitioner pharmaceutical manufacturer (Revacure Lifesciences LLP) and the complainant (M/s Bhardwaj India Pvt. Ltd., Respondent No. 2), which had entered into a Loan Licence Agreement to use the petitioner’s manufacturing facilities for drug production. Allegations were made that drugs supplied by the petitioner contained glass particles and were substandard, leading to the filing of a criminal complaint under Section 156(3) CrPC, which was allowed by the Magistrate and resulted in FIR registration.

However, the Court noted that the relationship between the parties was purely contractual and civil in nature, involving commercial terms such as advance payments, facility sharing, and quality assurance protocols. The Court observed that “allegations arose from failure of Respondent No. 2 to sell drugs in market”, and that there was an arbitration award which found no fault on part of the petitioner, further observing that tampering was likely done by the complainant himself.

“The dispute is essentially of a civil nature which has been given a cloak of criminal allegations. The facts do not disclose any criminal offence,” the Court noted, relying on R.K. Vijayasarathy vs. Sudha Seetharaman [(2019) 16 SCC 739].

FIR under Drugs & Cosmetics Act Quashed – “Only Drug Inspector can initiate prosecution under Section 32, not police”

Addressing the legality of the FIR registered for offences under the Drugs and Cosmetics Act, particularly Section 13, the Court emphasised that Section 32 of the Act restricts the initiation of prosecution only to specific categories:

“No prosecution under this Chapter shall be instituted except by – (a) an Inspector; or (b) a gazetted officer… or (c) the person aggrieved…”, the Court quoted Section 32 D&C Act, adding that “a police officer is not authorised to register an FIR under the Act or investigate such offences.”

The Court relied on the Supreme Court decision in Ashok Kumar Sharma vs. Union of India, Crl. Appeal No. 200/2020:

“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 Cr.P.C.”

In light of this, the Court categorically held that: “The FIR for the offences under the D & C Act is hereby quashed with liberty to the Drugs Inspector to proceed as per the provisions of the Act.”

IPC Offences Also Quashed – “No prima facie evidence of adulteration or sale of substandard drugs”

Although offences under Sections 274 and 275 IPC (adulteration and sale of adulterated drugs) can be investigated by the police, the Court held that no ingredients of these offences were made out.

“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,” the Court held.

It further found that no adulteration was proven to have occurred at the petitioner’s manufacturing unit. The Joint Inspection Report dated 20.08.2018 by the Central Drugs Standard Control Organisation (CDSCO) and M.P. Drug Inspector found:

“...the joint investigation team is of the opinion that the firm by and large complies with the provisions of Schedule M-GMP of the Drugs and Cosmetics Rules, 1945... the control sample did not contain any glass pieces or foreign particles.”

In contrast, particles were found only in samples lifted from the complainant’s premises after delivery. The Court concluded:

“Whatever the particles that may have been found in the Product, they were definitely not present till the Product got dispatched from the factory of Petitioners.”

Loan Licencee Is Manufacturer in Law – “Responsibility for drug quality rests with licensee, not the facility provider”

Referring to Rules 69A and 75A of the Drugs and Cosmetics Rules, 1945, and Schedule M, the Court explained the legal framework of Loan Licensing, under which the licensee—not the factory owner—is the manufacturer and responsible for drug quality.

The Court cited Indica Laboratories Pvt. Ltd. vs. Union of India, 1991 (32) ECC 15, holding: “Loan licensees who get their medicines manufactured in a third-party factory are deemed the manufacturers in law and are responsible for the quality of drugs.”

The Court reinforced that the petitioner (Revacure) was only providing infrastructure and had no role in product testing, release, or marketing. The responsibility for compliance with Schedule M-GMP standards, raw material procurement, and testing lay solely with Respondent No. 2, the loan licensee.

FIR Also Barred by Limitation – “No chargesheet for six years; continuation is abuse of process”

Finally, the Court ruled that even if the IPC offences were to be considered, the FIR could not survive due to being barred by limitation.

“The FIR was registered in 2019 for offences punishable with up to six months’ imprisonment. As per Section 468 Cr.P.C., the limitation for taking cognizance is one year,” the Court held, adding, “investigations have not concluded for six years without any justification.”

Citing abuse of process, the Court invoked Section 482 Cr.P.C. to quash the FIR entirely: “It is not expedient or in the interest of justice to let the investigation continue. It is in fact, an abuse of the process of law which merits a quashing.”

The Court, therefore, quashed FIR No. 053/2019 registered at P.S. Okhla Industrial Area under Sections 274/275 IPC and Section 13 of the D&C Act.

“The FIR is hereby quashed. Observations made herein are only for the purpose of the FIR proceedings and not on the merits of any other statutory action under the D&C Act or other laws.”

Date of Decision: September 23, 2025