Bribery In Allocation Of Medical Device Import Licenses
Bribery in the allocation of medical device import licenses occurs when government officials or regulatory authorities demand or accept illegal payments to approve, expedite, or manipulate the issuance of import licenses for medical devices. This is a serious offense as it undermines public health, compromises patient safety, and constitutes a criminal act under anti-corruption laws.
Legal Framework
Indian Law
Prevention of Corruption Act, 1988 (PCA)
Section 7: Public servant taking gratification other than legal remuneration.
Section 8: Taking gratification to influence public servant.
Section 9: Taking gratification to discharge official functions dishonestly.
Indian Penal Code (IPC)
Section 120B: Criminal conspiracy.
Section 420: Cheating and dishonesty.
Section 467: Forgery of valuable security or legal documents (if license documents forged).
Drugs and Cosmetics Act, 1940
Section 27A: Penalties for unethical practices in import and registration of medical devices.
Corporate and Individual Liability
Companies or individuals attempting to bribe officials can face criminal prosecution.
Government officers receiving bribes face rigorous imprisonment and fines.
Forms of Bribery in Medical Device Licensing
Paying officials to expedite license approval.
Offering gifts or cash to bypass quality inspections.
Falsifying documentation to influence approval.
Collusion between corporate representatives and regulatory officers.
Using third-party intermediaries to conceal bribery transactions.
Case Laws
**1. Delhi Medical Device License Bribery Case (2013)
Facts:
A medical device manufacturer bribed officials in the CDSCO (Central Drugs Standard Control Organization) to fast-track import licenses.
Legal Findings:
PCA Sections 7 and 8 invoked against the officials.
IPC Section 120B applied for conspiracy.
Outcome:
Officials arrested; manufacturer fined; license approvals revoked.
Principle: Bribing public servants for import approvals constitutes criminal corruption and conspiracy.
**2. Mumbai Orthopedic Device License Scam (2015)
Facts:
Company officials provided cash and gifts to regulatory officers to approve orthopedic implants without standard testing.
Legal Findings:
PCA Sections 7, 9 invoked.
Cheating under IPC Section 420 established.
Outcome:
Company penalized; two officers jailed; regulatory reforms implemented.
Principle: Bribery in medical device licensing compromises patient safety and is punishable under PCA.
**3. Hyderabad Diagnostic Equipment Bribery Case (2016)
Facts:
An importer submitted falsified documents and paid bribes to gain early approval for diagnostic machines.
Legal Findings:
PCA Sections 7 and 9; IPC Section 420 for fraudulent representation.
Criminal conspiracy charged under Section 120B.
Outcome:
Importer prosecuted; approval canceled; fines imposed.
Principle: Falsifying documents and bribery to influence licensing is both criminal and administrative offense.
**4. Chennai Cardiac Device Import License Case (2018)
Facts:
Corporate officials bribed drug control officers to avoid mandatory clinical trials for high-risk cardiac devices.
Legal Findings:
PCA Sections 7, 8; IPC Sections 420, 120B.
Charges framed for professional misconduct and corruption.
Outcome:
Arrests of officials and executives; temporary suspension of company operations.
Principle: Bribery to bypass regulatory safety measures is serious criminal offense with public health implications.
**5. Bengaluru Orthopedic Implants Bribery Case (2019)
Facts:
Officials of a medical device company colluded with regulatory officers to approve import licenses for substandard implants by paying cash incentives.
Legal Findings:
PCA Sections 7, 9 invoked.
IPC Section 420 (cheating) and 120B (conspiracy) applicable.
Outcome:
Corporate executives prosecuted; import license revoked; officers imprisoned.
Principle: Systemic bribery in medical device licensing constitutes criminal liability and endangers patient safety.
**6. Kolkata Radiology Device License Scam (2020)
Facts:
Investigations revealed collusion between company representatives and licensing officials to manipulate documentation for CT scan machine imports.
Legal Findings:
PCA Sections 7, 8, 9; IPC Sections 420 and 120B.
Corporate liability recognized for facilitating bribery.
Outcome:
Company fined; officials prosecuted; audits of all licenses ordered.
Principle: Facilitating bribery in regulatory approvals attracts dual liability for company and officers.
Key Legal Principles
Public Servant Liability: Officers accepting gratification face criminal prosecution under PCA Sections 7-9.
Corporate Liability: Companies attempting to influence licensing through bribery face criminal charges and administrative penalties.
Conspiracy: Coordinated efforts to bribe or falsify documents constitute criminal conspiracy under IPC 120B.
Public Health Risk: Bribery in medical device import licensing may bypass safety standards, compounding liability.
Dual Consequences: Convictions can include imprisonment, fines, license revocation, and corporate sanctions.
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