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Importance of Drug Regulations

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7 June 2016 No comments

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

The regulation of drugs and medicine is crucial to the health and safety of the public. Regulations may be done via checking the efficacy, quality and safety of the drug. The meds are prepared, stored, manufactured and shipped according to health and safety guidelines of professional and experienced chemists and pharmacists. The FDA and other health governing authorities prohibit illegal and unethical production of drugs.

Regulation is important and followed continuously in every step or process that the drug material passes through. This starts from the 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 to all those other conditions that are necessary for the safety and health of the people as well as for proper drug maintenance.

Regulations of the drugs should be only under the control of the authorities. National government may be responsible to activate the national med regulatory board, which is represented as MRAs. The regulatory bodies are responsible for the compliance of matters regarding medicinal purposes according to the rules and regulations as well as ethical behavior concerning the local and international body. The governing body ensures that required staffs are qualified like technicians, pharmacists, chemists and labor, etc. There would be a check and balance on a regular basis to ensure that quality control is observed in departments, equipment, technical literature, and distributors, etc. For the compliance of all the matters, the regulatory body, the government and the people are held accountable. Decisions done by the authorities should be clear and transparent and 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 or 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 or compromise to the drug’s quality resulting to conditions that may be dangerous or harmful to the patients and may even be life threatening as well. Drugs, especially those that are sensitive can readily change structure and components at any stage when not maintained or handled properly.

This is the very reason as to why strict regulatory plans, legal documentation and implementation are followed to ensure low chances of accidents in the medical world.