Topic
The Drugs and Cosmetics Act regulates the manufacture, sale, and import of drugs and cosmetics in India, with strict compliance requirements enforced by the CDSCO and state authorities.
Duty free shops cannot claim automatic exemption from regulatory laws merely operating beyond the customs barrier, Bombay High Court held. It affirmed that drugs and cosmetics remain under regulatory control despite customs barrier fiscal exemptions.
The Jharkhand High Court granted anticipatory bail to a medical officer whose duties did not include blood collection or transfusion, holding that under BNS Section 438, the mere gravity of HIV transmission charges cannot override the accused’s minimal, non-operational role. This sets a critical precedent for healthcare professionals facing vicarious liability in systemic failures, reinforcing that bail must be assessed by individual culpability, not collective blame.
The Karnataka High Court held that a pharmaceutical supplier’s blacklisting for supplying non-standard quality drugs under a government tender clause is valid even if the Drug Inspectorate failed to follow statutory procedures, as long as the supplier received a specific show-cause notice and opportunity to respond in writing. This reinforces that contractual enforcement in public procurement can proceed independently of administrative lapses, setting a critical precedent for tendering authorities and drug manufacturers alike.
The Himachal Pradesh High Court has ruled that a Managing Director cannot be held vicariously liable under the Drugs and Cosmetics Act solely based on their corporate position - prosecution must allege specific, concrete involvement in day-to-day operations. This sets a critical precedent for corporate officers facing criminal liability in regulatory offences, reinforcing that designation alone is insufficient to establish mens rea.
Directors cannot be held criminally liable under Section 34 of the Drugs and Cosmetics Act merely for their position; the prosecution must specifically aver their active role in operational control. The Himachal Pradesh High Court quashed proceedings against directors, reinforcing that vicarious liability demands concrete evidence of involvement beyond directorship.
Bombay High Court quashes prosecution under Section 27(d) of the Drugs and Cosmetics Act, 1940, holding that inordinate delay in sample testing and failure to transmit a sample portion to the manufacturer violates mandatory procedural safeguards under Rule 45, rendering the prosecution untenable.
The J&K High Court quashed a drug prosecution for failing to provide the manufacturer with a sealed sample portion under Section 23(4)(iii) of the Drugs and Cosmetics Act, ruling that procedural non-compliance violates statutory rights and amounts to abuse of process. The judgment underscores that adherence to sampling protocols is a non-negotiable prerequisite for valid prosecution under the Act.
The Bombay High Court has ruled that importing cosmetics without a CDSCO license renders them prohibited goods under Section 2(33) of the Customs Act, even if intended solely for re-export. Warehousing facilities cannot circumvent statutory regulatory requirements, and seizure or confiscation under Section 111 is lawful - a critical warning to importers and logistics operators relying on warehousing as a regulatory loophole.
The Punjab & Haryana High Court ruled that anticipatory bail cannot be denied merely because the case involves serious offences under the Drugs and Cosmetics Act if the prosecution relies solely on documentary evidence. The court held that custodial interrogation is unwarranted without specific grounds, reinforcing that arrest is not automatic even in non-bailable offences.
Bombay High Court holds partners liable for drug quality violations under Section 34 Companies Act when firm fails to contest lab report; clarifies burden under Section 25.
Supreme Court holds that failure to maintain Schedule-M/U records under Drugs and Cosmetics Act attracts prosecution under Section 27(d), not merely Section 18-B, clarifying jurisdiction and limitation.
Madhya Pradesh High Court denies bail to drug wholesaler linked to 26 child deaths from DEG-contaminated cough syrup, emphasizing public health harm and evidence tampering.
Bombay High Court holds that only Drug Inspectors may prosecute offences under Chapter-IV of the Drugs and Cosmetics Act, 1940; police FIRs are legally invalid.