Prosecution Of Crimes Involving Illegal Genetic Testing Services
🔷 I. INTRODUCTION
Illegal genetic testing services refer to the offering or conducting of DNA or genetic tests without requisite authorization, in violation of privacy, ethical, or statutory restrictions. These acts can involve:
Unlicensed laboratories conducting genetic tests.
Unauthorized collection or analysis of human genetic material.
Illegal disclosure of genetic data.
Violation of national regulations such as the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act, 1994 (India), Genetic Information Nondiscrimination Act, 2008 (GINA) (U.S.), or Data Protection Laws (EU and others).
Prosecution in such cases typically involves charges under:
Criminal statutes (e.g., cheating, fraud, illegal medical practice, data theft).
Biotechnology or medical regulation laws.
Privacy and data protection laws.
🔷 II. LEGAL FRAMEWORK IN INDIA
Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 (PCPNDT Act):
Prohibits use of genetic testing for sex selection or determining the sex of a fetus.
Mandates registration for genetic clinics, laboratories, and counseling centers.
Section 22: Prohibits advertisement relating to pre-natal determination of sex.
Offenses are cognizable, non-bailable, and non-compoundable.
Indian Penal Code (IPC):
Section 420 (Cheating): When clinics deceive patients or misuse samples.
Section 468 (Forgery for purpose of cheating) and Section 471 (Using forged documents).
Section 269/270 (Negligent acts likely to spread infection) may apply in unsanitary testing.
Information Technology Act, 2000:
Sections 43A and 72A protect against misuse of sensitive personal data, including genetic information.
Biomedical Waste Management Rules and Medical Council Regulations also govern proper use and disposal of biological samples.
🔷 III. DETAILED CASE LAWS
1. Voluntary Health Association of Punjab v. Union of India (2013) 4 SCC 1 (Supreme Court of India)
Facts:
The petitioner NGO highlighted rampant misuse of prenatal diagnostic techniques by clinics conducting illegal genetic tests for sex determination. The Supreme Court examined the implementation failure of the PCPNDT Act.
Held:
The Court directed strict enforcement of the PCPNDT Act, including suspension and prosecution of errant clinics and doctors.
It emphasized that illegal genetic testing for sex determination is a criminal offense, not merely a regulatory violation.
Directed creation of a national database of registered genetic laboratories.
Significance:
This case became the cornerstone for criminal prosecution of unregistered or illegal genetic testing centers in India.
2. State of Maharashtra v. Dr. Dinesh Sharma & Ors. (2015 Bombay High Court)
Facts:
A doctor conducted genetic testing for determining fetal sex using ultrasound and blood samples without proper authorization. Evidence showed false records and unregistered machines.
Held:
The Court upheld prosecution under Sections 23 and 25 of the PCPNDT Act, and IPC 420 and 468.
It stated that even possession of unregistered ultrasound or genetic testing equipment creates a presumption of illegal intent.
Conviction upheld with imprisonment and fine.
Significance:
This case clarified that lack of license itself is a sufficient ground for criminal prosecution, even before proof of actual testing.
3. United States v. GeneDx Laboratories (2018, Federal Court, Maryland)
Facts:
GeneDx, a U.S.-based genetic testing company, was prosecuted for billing fraud and violation of GINA (Genetic Information Nondiscrimination Act). They were accused of conducting tests without informed consent and disclosing patient genetic data to insurers.
Held:
The company settled for penalties exceeding $10 million.
The Court held that unauthorized testing and sharing of genetic data amounts to criminal misuse of health information and violation of federal privacy statutes.
Significance:
Established that data misuse in genetic testing is not only a civil wrong but also a federal offense when linked to fraud or unauthorized disclosure.
4. State of Tamil Nadu v. Dr. Manimegalai (2017 Madras High Court)
Facts:
The accused operated a small diagnostic center and offered “genetic abnormality tests” without any registration under the PCPNDT Act or relevant medical council approvals.
Held:
The Court held that conducting genetic tests without authorization is prima facie evidence of a criminal act under the Act.
The defense plea that it was “for research purposes” was rejected because no ethical clearance or registration existed.
Significance:
Set a precedent that “research” cannot be used as a defense for conducting unlicensed genetic tests.
5. People v. BGI Genomics Co. Ltd. (2021, Beijing Intermediate People’s Court, China)
Facts:
BGI, a major genetic company, was accused of conducting unapproved prenatal genetic testing and exporting genetic data without state approval, violating Chinese Biosecurity Law.
Held:
Company executives were held criminally liable.
The Court found that genetic data is a matter of national security and personal privacy, and unauthorized cross-border transfer is a serious criminal act.
Significance:
The case reflects international recognition of genetic data as sensitive personal information, supporting strong criminal penalties for illegal testing or export of genetic data.
🔷 IV. ANALYSIS AND CONCLUSION
| Aspect | Legal Position | Illustrative Case |
|---|---|---|
| Unregistered testing centers | Criminal offense under PCPNDT Act | State of Maharashtra v. Dr. Dinesh Sharma |
| Sex determination testing | Punishable with imprisonment and cancellation of license | Voluntary Health Association v. UOI |
| Data misuse or fraud | Violates privacy and data laws | U.S. v. GeneDx |
| Unauthorized “research” | Not a valid defense; still punishable | State of Tamil Nadu v. Dr. Manimegalai |
| Cross-border genetic data transfer | National security and privacy breach | People v. BGI Genomics Co. |
Conclusion:
Prosecution of crimes involving illegal genetic testing services operates at the intersection of criminal law, medical ethics, and data privacy. Courts across jurisdictions consistently uphold strict liability, emphasizing:
Unauthorized genetic testing is a punishable offense, irrespective of motive.
Possession or advertisement of testing equipment without license creates a presumption of illegality.
Disclosure or misuse of genetic information attracts both civil and criminal penalties.
Internationally, genetic privacy is treated as a human rights issue, increasing criminal accountability for violations.
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