Active Pharmaceutical Ingredients(apis) - A Comprehensive Guide

What are Active Pharmaceutical Ingredients?

Active pharmaceutical ingredient or API, also known as drug substance, is a term you often hear in business news. Therefore, it is important to understand the meaning of this term and the production of APIs in India for the India business segment of the IAS exam.

An active ingredient is a component of a biologically active drug or insecticide. Similar terms drug and bulk active ingredient are also used in medicine, although the term active ingredient is sometimes used for natural products.

An active pharmaceutical ingredient (API) is the part of a drug that provides an intended health benefit. APIs are made from raw materials with specific strengths and chemical concentrations. Some drugs such as Combination therapy, have multiple APIs that work in different ways or treat different symptoms.

Active Pharmaceutical Ingredients (APIs)

An active pharmaceutical ingredient is an active ingredient contained in a drug.

• It is the part of the drug that produces the intended therapeutic effect.
• For example, in pain relievers, the active ingredient relieves pain. Acetaminophen is the active ingredient of the over-the-counter drug Crocin.
• A medicinal product contains only the required amount of drug substance since a small amount of drug substance is required to be effective.
• Some medicines contain multiple APIs to treat different conditions.
• APIs are the most important raw materials in the manufacture of pharmaceuticals.

Components of Drugs

All medicines contain two parts:

1. APIs
2. Excipients – These are chemically inert substances that help deliver API into the system. Examples: lactose, mineral oil, etc.

Intermediates are chemical substances in the process from raw materials to active ingredients. Many intermediates can be made before the final active ingredient is made.

Where Are APIs Made? 

While many pharmaceutical companies are based in the US and UK, most API manufacturers are based overseas.

Outside the United States, the largest are in Asia, particularly India and China, according to the FDA.

How are APIs made?

API makers first develop their compounds in the lab. The manufacturing department then uses large reactors to produce large quantities of the active ingredient. Purity is then checked before being sold to pharmaceutical manufacturers. “If the purity of the active ingredient is not high, it will not be able to pass the strict quality standards.

Manufacture of APIs

India has a thriving pharmaceutical industry and is one of the world's leading suppliers of generic drugs. What has worked for Indian companies is their ability to reverse engineer drug formulas and manufacture cheaper medicines to create markets both globally and domestically.

India is also one of the countries with the lowest manufacturing costs in the world.

Indian companies are known for manufacturing generic drugs and active ingredients. Dr. Reddy's Laboratories is one of the world’s leading manufacturers of APIs.

• In 2019, India's pharmaceutical exports were valued at US $19.14 billion. Indian companies are major suppliers of pharmaceuticals around the world but are now increasingly dependent on importing active ingredients from China.
• In the early 90s, China relied on her APIs, but cheaper products allowed the Chinese to capture the domestic API market.
• Because of this, Indian manufacturers are gradually stopping the production of APIs.
• China's Hubei province is the center of the API manufacturing industry.
• About 68% of India's API demand is currently met by Chinese imports.
• During the COVID-19 pandemic, India's ability to meet global drug demand has been hampered by its inability to import APIs from China.

Strength of APIs 

Manufacturers use specific criteria to determine the API strength of each drug. The FDA requires that generic drugs be tested for equivalence to ensure they have the same potency as the branded version.

Manufacturers are required by the FDA to demonstrate the efficacy of their products under laboratory conditions and in real patients.

Conclusion:

The government has developed a new program to encourage mass production of medicines in India so that imports of raw materials can be reduced. Schemes are described in the next section.

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