KATHMANDU, Oct 28: A Non-Governmental Bill on Medicines and Health Materials (Regulation and Control) has been registered in the House of Representatives (HoR).
Nepali Congress Member of Parliament (MP) Pradeep Paudel has mentioned that it is necessary to provide quality medicines or health materials to general public and to stop the sale and distribution of substandard medicines through the Bill to manage medicines and health materials (regulation and control) registered in the HoR a few days ago.
The bill aims to create an obligation on manufacturers to ensure that only quality medicines or health materials are sold and distributed by the pharmaceutical department to monitor the market.
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The bill proposes that a production license should be obtained before the production of medicines and health materials, and it also provides for a license to be obtained for the importation of medicines. It has been proposed that a certificate should be obtained and a pharmacy or retail sales firm should be registered when selling and distributing pharmaceuticals and health products.
Similarly, if the medicines or health materials that have come to the market for sale and distribution are of poor quality and substandard, then an arrangement has been proposed to provide only quality and quality medicines or health materials to the consumers by returning them immediately.
The bill proposes that the department of each drug or health product should conduct risk-based market surveillance. It is also proposed in the bill that medicines should be classified according to the nature of the medicine and regulations should be made accordingly. According to this Act, it is proposed that the Government of Nepal will be the plaintiff in the case of conviction.
The current Drugs Act Act has been in force since 2035 BS and has been amended various times. This Act does not cover the technical materials used during self-treatment.
It is important to protect and ensure the fundamental rights of consumers, which are provided by the Constitution of Nepal. It is said that this bill has been introduced at a time when a strong regulatory structure is deemed necessary to provide safe, quality medicines and health materials to the general public and to address the ongoing challenges in the health sector.
