Air,food and water are the major essential things required to live on this planet,but medicines also play a vital role in human beings life because so many times ups and downs are occured related to health.If people feel unhealthy they always prefer to go to medical practitioner who prescribed different medicines related to diseases. Medicine cure diseases by correcting body dysfunction, reliving symptoms and preventing further complications.
There are the step by step process to ensure medicines are safe, effective and good quality.
- Drug Discovery: when disease identified, scientist find a biological target like enzymes then tested thousands of compounds and select one lead compund.
- Pre-clinical study: after finding lead compund,it is tested on cells and animals (in vitro and in vivo) before testing in human being to ensure their toxicity, dose range and their pharmacokinetic study (ADME)
- Clinical trials:If lead compunds result satisfactory in pre-clinical study then move to human trials in 4 different phrases. Phase I :Tested on 20-100 volunteer to check drugs safety and dosage range. Phase II :Tested on 100-300 patients to check drugs effectiveness and side effects. Phase III : Tested on 1000-3000 patients to confirm efficiency and safety in comparison with existing drug.
- Regulatory approval: All the data related to the drug submitted to regulatory authorities (FDA,CDSCO and EMA) for approval purpose.
- Drug manufacturing process: After approval from drug regulatory authority start manufacturing of drug. Large scale product carried out in GMP certified company.Drug manufacturing carried out in different dosage form like Solid, liquid, semi-solid etc depends on market requirement and nature of the drug followed by quality control test.
- Packing and distribution: After manufacturing process drug should packed in suitable packing material depends on nature of drug. Label includes manufacturing date, expiry date, direction and name of manufacture. After successful packing and labeling medicine is dispatched to market.
- Post manufacturing surveillance (Phase IV): In that phase monitor drug safety continuously even after medicine are dispatched in market by detecting rere side effects through pharmacovigilance.
Do you think these parameters can ensure whether the medicine are safe, effective and good quality?
MBH/AB