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Importance of Drug Regulations

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Drugs are substances specifically recognised by an official Pharmacopeia and Formulary that are approved for use to treat, diagnose, cure or prevent a disease or disorder. A medical substance induces change to the function or structure of the patient’s body.

The regulation of drugs and medicine is crucial to the health and safety of the public. Ensuring that a medicine is high quality is achieved by checking the efficacy, quality and safety of the drug. The medicines are prepared, stored, manufactured and shipped according to health and safety guidelines of professional and experienced chemists and pharmacists. The FDA (Food and Drug Administration) and other health governing authorities prohibit illegal and unethical production of drugs.

Regulation is important and followed continuously in every step and process that the drug material passes through. These steps include: raw material handling, formula applications, lot number maintenance, humidity, light and temperature control, storage, special packs for sensitive drugs, SOPs for drug movement, refrigerator usage, legal documents and records, shipping and handling, all of which are necessary for proper drug maintenance and for the safety and health of the consumer.

Regulations for drugs should be under the control of the authorities. The national government may be responsible for activating the national medical regulatory board, which is represented by medical regulatory authorities (MRAs). The regulatory bodies are responsible for the ensuring that all medicine production complies with the rules and regulations and ethical behavior guidelines outlined by the local and international bodies.

The governing body ensures that all staff, including technicians, pharmacists, chemists and labor, are qualified. Checks are made on a regular basis to ensure that quality control is observed in production departments, equipment, technical literature, and distributors, etc. For the compliance of all matters, the regulatory body, the government and the people are held accountable. Decisions made by the authorities should be clear and transparent; they should be made in compliance with the rules and regulations to ensure the prosperity of the country.

The FDA ensures that pharmaceutical companies and organizations are practicing the CGMP (Current Good Manufacturing Practices) regulations. Should the manufactured drugs not comply with the conditions and standard operating procedures, there would be a possibility of contamination and compromise to the drug’s quality, resulting in conditions that may be harmful, dangerous, or even life threatening to the patients. Drugs, especially those that are sensitive, can readily change structure and components at any stage when not maintained or handled properly.

It is for these reasons that strict regulatory plans, legal documentation and implementation must be followed. This helps to ensure that accidents in the medical world are kept to an absolute minimum.