There are two parts of a drug, the excipient and the active pharmaceutical ingredient.
While the former, excipient, is responsible for delivering the drug to the system, the active pharmaceutical ingredient is the biologically active part that is responsible for showing the effects of a drug. Active pharmaceutical ingredients, is also known as API or “bulk active”.
APIs were traditionally, literally known as “magic drug/substance”, this was derived from the Greek word “pharmakon” or “pharmakon”.
Many drugs, usually contain more than one active pharmaceutical ingredient.
The countries in which APIs are made
Initially, and till a few decades ago, pharmaceutical companies were preparing and manufacturing APIs in their country of business, but now they have started outsourcing the work, which is efficient, and cuts costs. For example, the company Dr. Reddy’s API manufacturing work has been outsourced to cut costs and save money, which can be utilized for employees, infrastructure and costly equipment.
As expected, the largest pharmaceutical companies are situated in the region of Asia, specially in India and China, although, there are a lot of them in the U.S.A. and Europe as well.
Probably the best example of outsourcing by a pharmaceutical company, is of AstraZeneca Pharmaceuticals. They had many manufacturing units in the United States of America earlier but now have only 15% of them left in the USA, as they are rigorously working on outsourcing the manufacturing process.
APIs and Regulations
An active pharmaceutical ingredient is the main component of a drug and at times, a drug can have many of them. Due to the fact that they directly affect our health and the body, poor manufacturing, or quality compromise can lead to serious health problems, illnesses and even death.
While the countries to which the manufacturing work has been outsourced to, have their own safety standards and regulations to prevent such blunders as the ones that we have mentioned above, the US has its own Food and Drugs administration organization which tests these drugs intensively, before they are allowed to be put on the shelves.
Now that the manufacturing process take place outside of the home country, the parent companies are unable to keep a track of all the processes, which can ultimately lead to manufacturing defects. Even though the outsourcing helps in cutting costs, and the money that’s been saved, can be used for research and development for preventing such defects, it’s not always enough.
The FDA of US, as we have mentioned before, runs many rigorous screenings to ensure that the quality standards are followed. If they are not, the companies can run into serious troubles and even into lawsuits which can end up haunting them till their end.
Some popular APIs
Therapy – Can prevent stomach ulcer by reducing the amount of acid released, which damages the internal coating of the body. Can also be used to treat stomach ulcers.
Side effects –
- Consumer can have an allergy to the drug.
- If the patient has kidney or liver impairment, special caution should be taken.
- The doctor should be consulted before the drug is taken.
Breastfeeding – The drug is mixed with breast milk and then released, and this can be harmful to the child.
Pregnancy – A pregnant woman should consult the doctor first before taking this drug.
- Amisulpride (Solian)
Therapy – Used for the treatment for schizophrenia and is an anti-psychotic medicine.
Side effects –
- Parkinsonism, dystonia, tremor, akathisia, are very common.
- Nausea, hyperactivity, vomiting, hypersalivation, anxiety, headache, insomnia are common.
- Benazepril (Novartis)
Therapy – Congestive heart failure, heart attack, hypertension, and can also be used for the prevention of renal (related to kidney) and retinal complications in diabetes.
Side effects –
- Chronic headache or cough, usually developed after many months of use.
- Anaphylaxis, angioedema and increase in potassium levels.
The Moral Question
In an industry where each company is competing to make more profit in any way they can, it’s a very moral question as if to what they choose to do with the power they hold, treat people, or put their health and lives at stakes for a small profit.
While the FDA of the US and other regulatory organizations have done and keep doing a tremendous job of finding culprits in the industry who compromise with manufacturing process for cutting costs, the consumers themselves need to wake up and understand the dangers of bad manufacturing.
Active pharmaceutical ingredients, which are the main content of the drugs you take, should be well-known about. This can help us in becoming better consumers, and also in waking up others about any manufacturing defects. That is what happened in case of Sun Pharmaceuticals, which we’ll cover in one of the upcoming articles of the Active Pharmaceutical Ingredients production series.