Wednesday, 8 April 2015

How many levels of cGMP do we have?

The Pharmaceutical Industry is regulated because the government is answerable to its citizens in case of health issues. Current Good Manufacturing Practices, cGMP for short, is a regulatory tool that prescribes certain code of conduct for manufacturers of healthcare products. Upon inspection and satisfactory compliance with prescribed norms, a manufacturer is allowed to manufacture and sell his products in the market which falls under the jurisdiction of the government.

However, even a cursory look at the practices adopted by manufacturers in the country reveals multiplicity of standards. This would make one wonder if human life is equal or graded on several platforms.

The most obvious platform is Purchasing Power, which in common parlance would translate to affordability. If I can afford it, I will buy a product of a reputed organization even if it is priced way ahead of some of the similar products. This is best exemplified by the tea that we drink as a national drink. Tea is available at a road-side stall, in a Grade II restaurant, in branded franchise outlets and in Five-Star establishments. The price can vary from Rupees 3 to Rupees 300. What is the customer paying for? Obviously the quality of ingredients, manufacturing environment (read kitchen), ambiance, cleanliness of equipment for making and serving, cleanliness of the individuals involved in the process. You can easily visualize the manufacturing and service at the roadside stall. One would expect a superior condition in the higher establishments.

Coming back to healthcare products, the matter is a little more sensitive. The person consuming these products does not do so by choice but because he is prescribed to do so because of certain diseased condition. Quite obviously, he is in a weakened state of health and one would expect a safe quality of product reaching such an individual. 

If this is the case, then all products manufactured in the country should be uniformly acceptable to the world. Herein lies the glitch. We have manufacturers qualified to market products in the developed countries typified by the USA, European and the Japanese markets. This means that those manufacturers who are not qualified are automatically disallowed. This raises the question of equality of human beings. Are Indian citizens lesser human beings than those in the developed worlds that they are given products from companies not qualified by the drug regulating agencies of the developed world?

Then we have what is popularly known as qualification by the World Health Organization (WHO). But companies qualified by the WHO are not permitted to sell their products in the developed market because they are not qualified by the regulators of the developed world. This raises a question about the validity of a WHO certificate. Is the World Health Organization not recognized by the countries of the so called developed world? Then the WHO should be renamed as UWHO which would stand for Under-developed World Health Organization. But this again raises the question of equality of human beings. Are the people of the Africa and Asian continent (except Japan) lesser humans or should we say lesser quality humans?

Then we have different countries sending their regulators to inspect and certify Indian establishments. This is a clear indication that there is no uniformity in the world about standards of healthcare products or there is no trust in the WHO certification even by regulators of under-developed countries. This can be perhaps understood because each government of every country would like to show its citizens that they are doing their bit in buying products after due qualification.

But if we talk of the Indian context, then within the same government we have varying tolerances. Every State has its own Food and Drug Administration (FDA) and the qualification criteria followed by one State need not necessarily meet the qualification criteria of another. Some States are more lenient in the interpretation of the Law while some States have other considerations in looking the other way.While Schedule M is compulsory all over India, companies in some States observe it cursorily and others observe it more stringently. 

Coming to one State for example, we will also find multiplicity of standards. We have MNCs, Indian MNCs, Medium Scale and Small Scale manufacturers occupying a piece of the lucrative healthcare pie. Each one has a certificate for manufacturing and selling. Some have properly designed and constructed factories. The small scale manufacturer is housed in an Industrial gala and has manipulated, twisted, bent and stretched the law in an attempt to qualify for a licence. One can understand the need for low cost products to cater to all strata of society. What one fails to understand is that a human body and its organs do not recognize costs. They recognize quality. The compromise is so huge that one wonders if cGMP for the poor class, the lower middle class, the upper middle class, the rich class and the super rich class can be different. The next question naturally would relate to the type of heart or lungs or liver or pancreas each category possesses. Would like a medical opinion on the gradation of the human organs based on economic classification of our society.

Now consider this! If you are consuming products orally, you have some natural protection of your digestive tract which filters away rubbish. Imagine what must be happening when you take intravenous injections that by-pass the defense mechanism of the body and enters the blood directly. You are literally at the mercy of the condition of manufacture of the small scale establishment.

Also, the pay scales being so diversely different, the kind of qualification, knowledge and experience in the lesser establishment would leave a lot to be desired. Some of the staff are not conversant with English and all the laws and guidelines are written in English. So, we now have a heady cocktail of
the industrial gala, the matchbox factory, the medium-scale unit, the Indian ownership unit, the Indian MNC and the foreign MNC and their various levels of cGMP. Within a company we can have an export quality product for the developed countries, an export quality product for the WHO qualified countries, a product for the high end local market qualified by the Indian regulator, a product manufactured in a small-scale unit on contract manufacturing basis for the lower end market and finally some other manufacturing standard for the government hospitals. Who loses? Obviously the citizen who opts for the relatively "cheaper" product. All, of course, qualified by the elected government! 

Think about it!!!

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