As Genetic Testing becomes more popular, we have been repeatedly asked to advice on the regulatory approvals necessary for Direct-2-Consumer genetic testing. Indian regulations are extremely 'light touch' and we expect regulators to get active in the next few years. Below is an overview of the legal landscape that regulates D2C.
1. CLINICAL ESTABLISHMENTS ACT, 2010
The Clinical Establishment Act, or it's state level offspring, regulates clinical establishments where genetic testing is carried out. The Act(s) provide minimum standards for provision of facilities, services, staffing and maintenance of records and reporting.
2. DRUGS AND COSMETICS ACT, 1940
The Drugs And Cosmetics Act is the primary legislation regulating the import, manufacture, distribution and sale of drugs. Any device intended for use in the diagnosis, treatment, mitigation or prevention of disease or disorder would be a drug. Depending on the additional services offered by the provider of D2C Genetic Testing, the D&C Act may apply.
3. MEDICAL DEVICE RULES, 2017
If D2C gene testing companies undertake the manufacturing of medical devices for the testing, they would have to adhere to the rules, including registration and getting a license for manufacturing the devices.
4. PRE-NATAL DIAGNOSTIC TECHNIQUES (REGULATION AND PREVENTION OF MISUSE) AMENDMENT ACT, 2002
This act regulates pre-natal diagnosis, including genetic testing and determination of the sex of the foetus. Genetic testing facilities are allowed to carry out genetic testing to determine: chromosomal abnormalities; genetic metabolic diseases; haemoglobinopathies; sex-linked genetic diseases or congenital anomalies. However, genetic testing solely for the purposes of sex determination is prohibited.
5. ICMR GUIDELINES, 2017
The Guidelines mention certain best practices that may be adopted for genetic testing such as written consent for pre-symptomatic testing, for children appropriate consent along with parental consent must be obtained.
6. DRUGS AND MAGICAL REMEDIES (OBJECTIONABLE ADVERTISMENTS) ACT, 1940
Any medicine used in the diagnosis, cure, mitigation, treatment or prevention of disease which affects or influences any organic function of the body would fall under this act. Any article intended for use as a component of any medicine would also be a drug, courts have interpreted 'any article' to mean any article that will have curative or remedial effects for the ailments sought to be cured.
There is also no explicit restriction on advertisement of any genetic testing or diagnostic centre or wellness check-up tests. Online advertisements on an e-commerce website are also currently unregulated. Many companies market such D2C genetic tests as wellness tests on their websites.
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