Quality control and pharma industry
RECENTLY there have been reports about deaths in Lahore caused by consumption of poor quality drugs. I would like to emphasise that quality control is the mainstay of the pharmaceutical industry. It requires that drugs must be marketed as safe and therapeutically active form prepared under strict compliance of good manufacturing and laboratory practices and active formulations whose performance is consistent and predictable.
Essentially, quality control means checking and directing the degree of excellence of processes and products. In my opinion this can be achieved, inter alia, by clear concept of spurious, counterfeit and substandard drug profile of raw materials, followed by ingredients and excipients.
Spurious raw material is one whose chemical structure might be altered. Medicines prepared from such raw material are false and devoid of their expected therapeutical activity. Consider the example of paracetamol. Its chemical name is N-acetyl-para-aminophenol. It indicates that its active part resides in para position on the chemical structure (hence, commercially called paracetamol).
If it resides on ortho or meta position, its therapeutical activity will either be lost or become minimum. Such as this, if taken, might prove to be hazardous. This mistake might occur due to unscrupulous raw material manufacturing industrial process.
This example of pracetamol should serve for all the pharmaceutical raw materials.
Counterfeit medicines imitate like genuine ones but in actuality are not. They look so similar to a genuine product that the health professionals are deceived easily. They are always illegal. They may not contain even required quantities of active ingredients and mislabelled too, to deceive the people. They create fake version of branded, generic and over the counter
Substandard drugs do not follow approved good manufacturing and laboratory practices which are regulated by the FDA.
They range from random mixture of harmful and toxic substances. They can result in treatment failure or even death. They fall below established standard and do not comply with pharmacopoeial tests. Hence called substandard drugs.
Spurious, counterfeit, as well as substandard, drugs may also result in not following good manufacturing and laboratory practices as approved by the FDA. Hence they may also contain dangerous contaminants, prepared in unsanitary and unsafe conditions using unsafe methods.
Colours and flavours from the scientific point of view should not be used at all. They may also render drugs ineffective and alter mechanism of their action in the body. Although the FDA allows their use in appropriate quantities, the fact is that there is no metabolism of colour and flavour in the body. Hence they may render the medicines ineffective.
The paradigm that can be eluded from the above-mentioned reasons of drug tragedies are that the quality control departments are negligent. They very seldom bother to go through two important tests such as related substances and impurities given at the end of every raw material test in the pharmacopoeias. The reason is that they are difficult and at times require experienced synthetic bio-organic chemists.
If these two tests are also performed with high fidelity, the spurious and counterfeit drugs can be discerned and distinguished vividly, and tragedies can be averted. Nevertheless, selling and marketing of expired drugs cannot be ruled out from the scene.
DR M. QUDRAT-E-KHUDA