Many people are not very clear about the differences between the three words' country of origin ',' generic name ', and' API ', nor are they sure what they are. So today, let's truly understand what' country of origin ',' generic name ', and' API 'are, and what are the differences between them?
As the name suggests, "original research drug" refers to a new drug with originality, which undergoes screening of thousands of compounds and rigorous clinical trials before being approved for market.
The development of this drug requires approximately 15 years and hundreds of millions of dollars in investment, so only large multinational pharmaceutical companies have the ability to develop it.
In China, "original research drugs" mainly refer to imported drugs that have already passed the patent protection period.
After the development of "original research drugs", patent protection can be applied for, with a general protection period of 20 years. After the expiration of patent protection, other companies can only produce and sell generic drugs after obtaining approval from the drug regulatory authority, otherwise it will be considered infringement.
Generic drugs "refer to drugs produced by imitating patented" original drugs ". Simply put, this is what we often refer to as' counterfeit drugs'.
According to the US FDA regulations, generic drugs must be "identical to patented drugs in terms of active ingredients, dosage, safety, efficacy, effects (including side effects), and targeted diseases". This is called 'consistency evaluation' in China.
Therefore, from the perspective of efficacy alone, "generic drugs" are not fake drugs, but genuine and good drugs. However, due to some counterfeit anti-cancer drugs from India not being registered or approved for sale in China, they are classified as black market products and therefore labeled as "fake drugs".
China, Europe, and the United States all have strict patent protection for their drugs. The Indian government has not taken any patent protection measures, but has implemented "mandatory licensing" for anti-cancer drugs. India allows direct replication of the drug regardless of whether the patent protection period has expired.
Although Indian generic drugs have been approved for market in India, they have not been registered and approved for market in China, which constitutes a black market product and clearly infringes on drug intellectual property rights.
Despite illegal activities, many patients still try every means to purchase Indian generic drugs. Due to the elimination of the lengthy research and clinical process of patented drugs, the price of generic drugs can be as low as 20% to 40% of the original drug, and some even as low as 10%.
It is worth noting that in addition to generic drugs, there are also many "fake generic drugs" in India, which are usually produced by illegal processing factories and sold to China. Therefore, when choosing Indian generic drugs, careful consideration must be given.
Raw materials are upstream products of drugs, which are compounds with certain pharmacological effects. Due to the fact that compounds cannot all have perfect physicochemical parameters, they cannot exert optimal efficacy in the complex environment of the human body. Therefore, various excipients and dosage forms need to be used to transform themselves into drugs in order to be called "drugs".
The main component of a drug is its active ingredient, while other components are collectively referred to as "excipients".
API has the same or similar active ingredients as the original drug or generic drug, but without going through the formulation process.
Strictly speaking, active pharmaceutical ingredients are not directly consumed by patients. They are not drugs, but like other chemical products, they are still just raw materials.
Many patients use raw materials due to price issues or inability to purchase original drugs domestically, which not only leads to incomplete efficacy, but also other adverse consequences due to improper medication.
Therefore, patients should also carefully consider the use of APIs.
