What is an active pharmaceutical ingredient and why is it essential in the manufacture of drugs?

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The COVID-19 pandemic has caused panic among global pharmaceutical manufacturers as API supply has been cut off from China, the world’s largest producer

Active pharmaceutical ingredients. News 18

Active Pharmaceutical Ingredients or APIs are essential to the pharmaceutical industry. According to pharmaceutical company Biocon, an API means “the biologically active component of a drug product (tablet, capsule, cream, injectable) that produces the intended effects”.

It is one of the two main ingredients in drugs, the other being an excipient. APIs are essential for the manufacture of drugs. The COVID-19 pandemic has caused panic among global pharmaceutical manufacturers as API supply has been cut off from China, the world’s largest producer.

Since then, the world has been concerned about over-reliance on China when it comes to API manufacturing. So here is a handy explainer on what APIs do and why they are vital for the pharmaceutical industries:

What do APIs do?
API is the biologically active component that guarantees the effectiveness of a drug. It is different from excipients, a chemically inactive substance that actually delivers the effect of the API.

API manufacturers first acquire the relevant raw materials. Compounds go through a multitude of processes before becoming APIs. After rigorous quality checks, these ingredients are then supplied to pharmaceutical manufacturers who use them to manufacture drugs.

Importance:
APIs are vital for pharmaceutical companies. The COVID-19 pandemic has made the world realize how easily global supply chains can be disrupted. The lockdown in China and the resulting supply shocks have forced many countries to consider their pharmaceutical supply chains.

India, which is already the world’s third largest producer of pharmaceuticals by volume, was one of them. According to a 2020 article in The Conversation, the country relied on China for around 70% of its API supply. For some well-known drugs such as ibuprofen, amoxicillin and paracetamol, the country was almost entirely dependent on China for API supply.

The government has made efforts to reduce its dependence on China and promote domestic production of APIs. The Center had announced Rs. 15,000 crore performance-linked incentive scheme for pharmaceutical companies.

According to a PTI report from March this year, 35 APIs imported earlier are being manufactured in India under the Center’s production-related program for the pharmaceutical company.

Additionally, the government has given approval “in principle” to set up three bulk drug parks, one in Gujarat, one in Andhra Pradesh and one in Himachal Pradesh.

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