Background:
The Drugs and Cosmetics Act, 1940 was enacted to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India. The Act aims to ensure the safety, efficacy, and quality of drugs and cosmetics, preventing substandard, adulterated, or misbranded products from reaching consumers. It also sets standards for labeling, packaging, and advertisement of drugs and cosmetics to protect public health.
Applicability:
The provisions of this Act shall be in addition to, and not in derogation of, the Dangerous Drugs Act, 1930 (2 of 1930), and any other law for the time being in force. This act shall be applicable to the importers, manufacturer, distributers and sellers of drugs and cosmetics in India
Compliance requirements under the Act
Display in the prescribed manner on the label or container thereof the true formula or list of active ingredients contained in it together with the quantities thereof.
Display in the prescribed manner on the label or container thereof the true formula or list of active ingredients contained in it together with the quantities thereof.
License holder for manufacture/ import/ sale/ distribute drugs or cosmetics shall keep and maintain required records, registers and other documents as prescribed in the rules.
Every person holding a licence to manufacture or import or sale or distribute drugs or cosmetics shall keep and maintain such records, registers and other documents as may be prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Act.
Penalties & Punishments
On contravention of Section 18A and 18B: Imprisonment for a term which may extend to one year or with fine which shall not be less than twenty thousand rupees or with both
On Contravention of Section 18(a) (iii): Imprisonment for a term which may extend to three years and with fine which shall not be less than fifty thousand rupees or three times to value of the cosmetics confiscated, whichever is more
Conclusion
The Drugs and Cosmetics Act, 1940 provides a comprehensive legal framework to regulate the pharmaceutical and cosmetic industry in India. Compliance ensures public safety, maintains product standards, and prevents the circulation of harmful or misleading products. Adherence to the Act is mandatory, and violations may lead to legal actions, including fines, imprisonment, or cancellation of licenses.
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