Why Regulation of Drugs is required?

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Why Regulation of Drugs is required?

A Drug is a specific substance recognized and located by an official Pharmacopeia and Formulary, and used for cure, treatment, diagnose and prevention of disorder or disease.

Drug is a substance (excluding food) that that exert changes about structure and any function of the body.

Regulation of Drugs and medicine is very important for the safety and health of public. Regulation is done by checking the quality, efficacy and safety. Medicines are manufactured, prepared, stored and distributed under guidance of professional and experienced Pharmacists and chemists. On the other hand, illegal and unethical manufacturing of drugs is prohibited by the special authorities like FDA and such others.

Regulation of medicines is a very important and continuous process that needs to be followed from the use of raw material, authentic formulas applied, step by step look after of drugs being manufactured from one point to another, batch number maintenance, temperature , humidity and light control, storage of medicine in special packs, storage under standard conditions, use of SOPs for movement of drugs that come under room temperature, Air conditioned and Refrigerator area, use of legal documents for maintaining the batch numbers, temperature, movement from one city or country to another and all those conditions that are must for the health of people and maintenance of drugs.

This is very much important to regulate the drugs under control of official authorities. For this purpose national governments are responsible to make active the national medicines regulatory authorities represented as MRAs. These regulatory authorities are responsible for the strict compliance of regulatory matters of medicines according to legal national and international rules and regulations and the ethical behavior. These authorities will ensure the required staff like pharmacists, technicians, labor and chemists etc. There will be confirmed and checked on regular basis about the right working of Quality control department of manufacturers and distributors, the proper equipment, technical literature and information. For compliance of all these matters the Regulatory authorities must be accountable and both the governments and people. The decision making process of these authorities should be clear and transparent under the rules and regulations and for the prosperity of the society, country and health.

FDA confirms and makes sure that whether the Pharmaceutical manufacturing companies and organizations are fulfilling the current Good manufacturing practices (CGMP) regulations. If the drugs are not manufactured under strict conditions and environment of standard operating procedures, then it means the drugs may become poison at any stage. When there will be this condition there will be very dangerous results for the patients and people. There also may arise very severe side effects about human body and there may be life threats. Reason for this is that the drugs are very specific and sensitive substances that can change their nature, chemistry and structure at any stage if they are not handled or maintained properly.

This is a major reason for making the strict regulatory plans, implementation and legal documentation. So when the regulatory matters are followed there will be very low chances of any misshape or accident in the medicine world.

References

www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm ...

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm

http://www.who.int/medicines/areas/quality_safety/regulation_legislation/en/

About the Author

Anjum Rehman's picture
Author: Anjum Rehman

I am an experienced Pharmacist and MBA.

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