The ঔষধ ও কসমেটিকস্ আইন, ২০২৩ (Drug and Cosmetics Act, 2023) is a newly enacted law in Bangladesh that aims to regulate the manufacture, import, export, buying and selling, stocking, storage, display, distribution, and quality control of drugs and cosmetics. This law repeals the previous Drugs Act, 1940, and the Drugs (Control) Ordinance, 1982, in an effort to create a more up-to-date and comprehensive legal framework for the pharmaceutical and cosmetics industries.
ঔষধ আইন ২০২৩
Here's a breakdown of some key aspects of the ঔষধ আইন ২০২৩:
**উদ্দেশ্য (Objectives):**
* To regulate the production, import, export, sale, storage, display, distribution, and quality of drugs and cosmetics.
* To prevent criminal activities related to drugs and cosmetics.
* To ensure the availability of safe, effective, and quality medicines.
* To protect public health and animal health.
**গুরুত্বপূর্ণ দিক (Key Features):**
* **Scope:** The law covers a wide range of products, including allopathic, Ayurvedic, Unani, herbal, homeopathic, and biochemic medicines, as well as medical devices, dietary supplements, and cosmetics.
* **Directorate General of Drug Administration (DGDA):** The DGDA is designated as the central authority responsible for overseeing both drugs and cosmetics, including issuing licenses, regulating production, and controlling quality.
* **Licensing:** The Act outlines the requirements for various licenses related to manufacturing, selling, stocking, distributing, importing, and exporting drugs and cosmetics. It also specifies the need for Good Manufacturing Practice (GMP) guidelines.
* **Registration and Marketing Authorization:** Provisions are made for the registration of drugs and cosmetics and the issuance of marketing authorization certificates. Drug registration licenses and marketing authorization licenses are valid for five years and are renewable. Drug production licenses are valid for two years and renewable.
* **Quality Control:** The establishment of the National Drug Control Laboratory and Drug Testing Laboratories across Bangladesh is mandated for quality control purposes.
* **Prohibitions:** The law prohibits the sale, import, and export of substandard, misbranded, counterfeit, and adulterated drugs without a license.
* **Qualified Personnel:** The presence and supervision of qualified persons are required in the manufacturing process and sale of drugs.
* **Inspection and Penalties:** The Act outlines the appointment and powers of drug inspectors and specifies offenses and penalties for non-compliance.
* **Clinical Trials and Pharmacovigilance:** The law includes provisions for clinical trials, pharmacovigilance (monitoring drug safety), and vaccines.
**Where to find the official text (কোথায় পাওয়া যাবে):**
You can find the official Bengali text of the ঔষধ ও কসমেটিকস্ আইন, ২০২৩ on the website of the Directorate General of Drug Administration (DGDA): [http://www.dgdagov.info/index.php/laws-and-policies/3674-drug-and-cosmetics-act-2023/file](https://www.google.com/search?q=http://www.dgdagov.info/index.php/laws-and-policies/3674-drug-and-cosmetics-act-2023/file)
An English translation is also available from various sources, including:
* Asia Actual: [https://asiaactual.com/wp-content/uploads/2023/10/Bangladesh-Drug-and-Cosmetics-Act-2023-English.pdf](https://asiaactual.com/wp-content/uploads/2023/10/Bangladesh-Drug-and-Cosmetics-Act-2023-English.pdf)
* Pharma DRA: [https://pharmadra.net/bangladesh-drug-and-cosmetics-act-2023-english/](https://pharmadra.net/bangladesh-drug-and-cosmetics-act-2023-english/)
* Laws of Bangladesh: [http://bdlaws.minlaw.gov.bd/act-details-1447.html](http://bdlaws.minlaw.gov.bd/act-details-1447.html)
This new law represents a significant step towards modernizing the regulatory framework for drugs and cosmetics in Bangladesh, aiming to ensure quality and safety for both consumers and the industry.
The ঔষধ ও কসমেটিকস্ আইন, ২০২৩ (Drug and Cosmetics Act, 2023) is a newly enacted law in Bangladesh that repeals the Drugs Act, 1940 and the Drugs (Control) Ordinance, 1982. This comprehensive legislation aims to regulate the manufacture, import, export, buying and selling, stocking, storage, display, distribution, and quality control of drugs and cosmetics in the country.
Here's a breakdown of some key aspects of this law:
**Objectives:**
* To ensure the quality and safety of drugs and cosmetics.
* To prevent the manufacture, import, and sale of substandard, misbranded, counterfeit, and adulterated drugs and cosmetics.
* To regulate the licensing of establishments involved in the production, sale, import, and export of drugs and cosmetics.
* To control the registration and marketing authorization of drugs and cosmetics.
* To prevent criminal activities related to drugs and cosmetics.
* To align with international standards, such as the World Health Organization's Good Manufacturing Practices (GMP).
**Key Features:**
* **Unified Regulatory Authority:** The Directorate General of Drug Administration (DGDA) is now the sole authority responsible for overseeing both drugs and cosmetics. Previously, the Bangladesh Standards and Testing Institution (BSTI) had authority over cosmetics.
* **Licensing:** The Act mandates licenses for various activities, including:
* Manufacturing, selling, stocking, distributing, and displaying drugs for sale.
* Producing, distributing, importing, or exporting cosmetics.
* Importing raw materials and packaging materials for drugs.
* Expanding existing drug manufacturing businesses or establishing new production lines.
* **Registration and Marketing Authorization:** All drugs and cosmetics must be registered with the DGDA before they can be manufactured, imported, distributed, or sold.
* **Quality Control:** Manufacturers are required to adhere to the WHO's Good Practices and Good Manufacturing Practice guidelines in all aspects of drug and cosmetic production, quality control, distribution, supply, and storage. The Act also establishes the National Drug Control Laboratory for quality testing.
* **Prohibitions:** The law prohibits the sale of substandard, misbranded, counterfeit, and adulterated drugs and cosmetics. It also restricts the import and export of drugs without a valid license.
* **Qualified Personnel:** The presence and supervision of qualified personnel are mandatory during the manufacturing process and the sale of drugs.
* **Inspections:** The licensing authority has the power to inspect the premises of drug and cosmetic manufacturers.
* **Offenses and Penalties:** The Act outlines various offenses related to drugs and cosmetics and specifies the corresponding penalties for violations.
* **Clinical Trials and Pharmacovigilance:** The law includes provisions for regulating clinical trials, pharmacovigilance (monitoring drug safety), and vaccines.
**Where to find the official text (PDF):**
You can find the official Bengali text of the ঔষধ ও কসমেটিকস্ আইন, ২০২৩ on the website of the Directorate General of Drug Administration (DGDA): [http://dgdagov.info/index.php/laws-and-policies/3674-drug-and-cosmetics-act-2023/file](http://dgdagov.info/index.php/laws-and-policies/3674-drug-and-cosmetics-act-2023/file)
An English translation is also available on the Asia Actual website: [https://asiaactual.com/wp-content/uploads/2023/10/Bangladesh-Drug-and-Cosmetics-Act-2023-English.pdf](https://asiaactual.com/wp-content/uploads/2023/10/Bangladesh-Drug-and-Cosmetics-Act-2023-English.pdf) and the Pharma DRA website: [https://pharmadra.net/bangladesh-drug-and-cosmetics-act-2023-english/](https://pharmadra.net/bangladesh-drug-and-cosmetics-act-2023-english/)
This new law represents a significant step towards modernizing the regulatory framework for drugs and cosmetics in Bangladesh, aiming to ensure public health and safety.
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