6 March 2018

The real price paid by a patient is when an ailment goes untreated due to application of substandard medicines. Recent studies even suggest that substandard medicines might be the cause of the spread of drug resistant diseases in Pakistan. The sole emphasis of our policy makers on reducing the cost of drugs is a popular one. Nevertheless, in the process they ignore the most important aspect of treating an ailment that is the quality of the medicine i.e. its effectiveness. Some drugs without proper manufacturing and distribution processes might even be more harmful than beneficial.

Around the world Good Manufacturing Practices (GMP), Good Packaging Practices (GPP) and Good Distribution Practices (GDP) are followed to make high quality medicines. It requires huge investments in high quality plant and machinery. Also establishing a supply chain network, so that the drug maintains its efficacy when it reaches the patient. For instance, if the particular conditions are required such as temperature, humidity, air purity during manufacturing or distribution, any deviation would reduce the efficacy of the medicine and render it ineffective for treatment. Hence, companies invest in expensive HVAC systems to control environment inside the manufacturing facility.  

International standards require that Safety, Health and Environment of the workers in the manufacturing facilities in particular and the society in general have to be considered. This means that manufacturing facilities are designed to incorporate preventive safety features and in case of emergencies, proper structures and equipment should be in place as to minimize the damage and avoid any major disaster.  For instance, water and other discharged from the manufacturing facility is treated before being drained and any harmful contaminants are incinerated at high temperatures to safeguard the environment. Some of the pharmaceutical companies who have been granted licenses without stringent checks as they do not comply with international standards and are endangering the lives of people and polluting the environment.

The initiative of Drug Regulatory Authority of Pakistan (DRAP) of issuing barcoding rules for curbing counterfeit and spurious drugs was welcomed by the industry. However, medicines manufactured in licensed facilities that are substandard would go undetected.    

Another aspect of quality includes the level and types of impurities a raw material has that is used to manufacture a drug. Low quality and cheaper alternatives are not only sometimes ineffective but might have harmful side effects due to such impurities. Before procurement, raw materials are tested for impurities and the harmful effects they have. Higher quality materials are expensive but are essential safeguard against harmful side effects of impurities that might be in cheaper and low quality alternatives. Many generic medicines use low cost raw materials for cost saving purposes.

One of the biggest issue with the Pakistani pharmaceutical sector is that generic drugs can be registered without bioequivalence tests and there is no limit on number of generics registered against a patented molecule. A bioequivalence of a generic medicine is that after the patient takes the generic medicine, the amount of medicine in the bloodstream is measured. If the levels of the medicine in the bloodstream are the same as the levels found when the brand name medicine is used, the generic medicine will work the same.

The issue of cheaper generic medicine is based on the premise of measurable and enforceable assurance about quality through bioequivalence tests and other globally mandated parameters. The so called generic medicine are also sold with a brand name – the only difference being that these brand names are not widely promoted or publicized.

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