Active ingredients are responsible for the beneficial health effects of drugs individuals consume. In pharmaceutical drugs, the active ingredient is known as the active pharmaceutical ingredient (API), like acetaminophen in pain relief tablets. In biological drugs, the active ingredient is a bulk process intermediate (BPI), such as insulin in insulin pen cartridges used by people with diabetes.

Active Pharmaceutical Ingredients covers a significant part of the Science & Technology subject of the General Studies Paper-3 syllabus and current events of national importance in UPSC prelims.

In this article, we will learn about Active Pharmaceutical Ingredients (API) and other associated details that the candidate can find helpful in all upcoming examinations and the UPSC CSE Exam. Candidates can also enrol in our UPSC Online Coaching program and get the best guidance for Science and Technology subjects.

What is Active Pharmaceutical Ingredient?

Active Pharmaceutical Ingredients (APIs) are vital in drugs, providing relief and treating specific health issues. APIs are distinct from raw materials, as raw materials serve as chemical compounds for API manufacturing. Each medicine contains two main elements: API and Excipient, where the Excipient aids in delivering the medicine to the targeted system. The Food and Drug Administration (FDA) closely monitors APIs' strength in drugs.TEVA leads API production, followed by other companies like Cipla, Ranbaxy, and Sun Pharma.

Examples of APIs

APIs significantly impact the body; for example, Paracetamol is the API in Crocin, providing relief for fever and body aches. Despite high manufacturing costs and stringent regulations, APIs present an attractive opportunity due to lifestyle changes and increasing disease causes. East Asia has emerged as the primary API manufacturer, fueled by growing healthcare expenditure and increased Research and Development in this field.

Major Components of Drug

There are two main components of a drug.

• Active Pharmaceutical Ingredients – It creates the desired impact on the human body. Aspirin, diphenhydramine, Humira, Remicade, Rituxan, etc., are some examples of API
• Excipients are the other components that help the API to reach the system. These are inactive compounds in medicine or drugs such as lactose and determine factors such as taste, colour, consistency, etc., of the medicine.

• Manufacture of Active Pharmaceutical Ingredients

  The manufacture of active pharmaceutical ingredients (APIs) is a complex process. It involves many steps, including:

  • Synthesis: The API is synthesized from raw materials using chemical reactions. The synthesis process is carefully controlled to ensure the purity and quality of the API.
  • Purification: The API is purified to remove any impurities. This is typically done using a variety of techniques. This includes crystallization, filtration, and chromatography.
  • Drying: The API is dried to remove any moisture. This is important to prevent the API from degrading.
  • Packaging: The API is packed in a way that protects it from moisture, light, and other contaminants.

  • TIFAC Report on Active Pharmaceutical Ingredients

    TIFAC stands for Technology Information Forecasting and Assessment Council. It is an autonomous organization under the Department of Science & Technology, Government of India. 

    In 2020, TIFAC released a report titled "Active Pharmaceutical Ingredients- Status, Issues, Technology Readiness and Challenges". The report highlights the importance of APIs in the pharmaceutical industry. It highlights the need for India to become self-sufficient in API production. 

    It also identifies some of the key challenges facing the Indian API industry, such as:

    • India invests very little in R&D for API development. This has led to a situation where India is dependent on imports for a significant portion of its API needs.
    • Many API manufacturers in India use outdated technology. This makes it difficult for them to compete with global players.
    • The Indian regulatory framework for API manufacturing is complex and time-consuming. This discourages new investment in the sector.

    The report also makes many recommendations for addressing these challenges. These recommendations include:

    • The government and industry should increase investment in R&D for API development. This will help India to develop new APIs and reduce its dependence on imports.
    • API manufacturers should upgrade their technology to remain competitive. The government can provide incentives to manufacturers to invest in new technology.

    • Source of Active Pharmaceutical Ingredients

      Active Pharmaceutical Ingredients (APIs) can be sourced from a variety of sources, including:

      • Organic synthesis: This is the most common method for producing APIs. Organic synthesis involves the chemical transformation of raw materials into APIs.
      • Natural products: Some APIs are derived from natural sources. This includes plants, animals, or microorganisms. Natural products are often extracted from these sources and then purified.
      • Recombinant DNA technology: This technology can be used to produce APIs that are difficult or impossible to produce using other methods. This involves the insertion of DNA from one organism into another organism to produce a desired protein.The government should simplify the regulatory framework for API manufacturing. This will make it easier for new entrants to enter the market and for existing manufacturers to expand their operations.

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      • Types of Active Pharmaceutical Ingredients

        Active Pharmaceutical Ingredients (APIs) can be broadly classified into two types:

        Synthetic APIs

        These are APIs that are chemically synthesized in a laboratory. Synthetic APIs are the most common type of API, and they are used in a wide range of medications. Examples of synthetic APIs include ibuprofen, paracetamol, and aspirin.

        Natural APIs

        These are APIs that are derived from natural sources, such as plants or animals. Natural APIs are less common than synthetic APIs, but they are used in many important medications, such as insulin and penicillin. Examples of natural APIs include morphine, codeine, and quinine.

      Regulation of Active Pharmaceutical Ingredients

      Many Countries around the globe, including India, are facing a rising issue of Drug Counterfeiting. India’s Growing population and the deadly impact of Covid 19 Pandemic have left the pharmaceutical industry in distress. With the increase in demand for drugs, there is a significant delay in the supply of the drugs, effectively making way for the counterfeiting of drugs.

      • To tackle the problem of Counterfeiting, the Government of India has issued an API traceability regulation that keeps systematic monitoring of the requirements of Active Pharmaceutical Ingredients, known as a track and trace system.
      • As per the API Traceability Report, each drug supplied In India should come up with a Quick Response (QR) code containing vital information on its label at each level of packaging. Name of the API
      • Unique product identification code
      • Brand name (if any)
      • Batch number
      • Manufacturing license number
      • Name and address of the manufacturer
      • Batch size
      • Date of expiry or retesting
      • Serial shipping container code
      • Date of Manufacturing
      • Special storage conditions required (if any)

      API track and trace system is a massive step towards regulating API and building a sustainable supply chain. Once Implemented, It will fill the gaps and create a robust Pharmaceutical supply chain without any fake or low-quality products.

      Active Pharmaceutical Ingredients and Schemes Approved

      Recently, two schemes have been approved by the Union cabinet related to Active Pharmaceutical Ingredients: Promotion of Bulk Drug Parks and Production Linked Incentives (PLI).

      Who is the largest producer of API?

      To date, China is the leading producer as well as exporter of APIs in the world by volume.

      

      Source: FDA USA

      Who is the leading supplier of API to India?

      The leading Supplier of API in India is Teva Pharmaceuticals, an Israel-based Pharmaceutical company with others like Pzifer, Dr. Reddy’s, Novartis, and Sonali. Each pharmaceutical company specializes in different APIs along with generic medicines as well.

      What is the difference between API and formulation?

      Active Pharmaceutical Ingredients are the ingredients that make up the drug. In contrast, Formulation refers to the process in which different chemical components, including the active ingredients, are mixed in the ratios as required by specified drugs.

      Active Ingredient 

      Active ingredients are substances in a drug responsible for beneficial health effects to the consumer. The active ingredient in a drug is called the Active Pharmaceutical Ingredient.

      Promotion of Bulk Drug Parks

      Center Plans to Promote 3 Bulk Drug Parks in promotion with the states Gujarat, Andhra Pradesh and Himachal Pradesh. Some Details Related to the Schemes are under

      • Grant In Aid of 1000 crore per bulk park is allotted by the Government of India
      • 3000 Crore is allotted for this project for 5 years
      • Facilities like Solvent recovery plant, Distillation plant, and Power and steam units will be there in the park
      • State Implementing Agencies will implement this scheme

      It is expected that with a successful implementation of this project, the total cost of raw materials exported to India will decrease, and affordable health care will be provided to the citizens. Moreover, the Continuous supply of drugs and heavy dependency on other countries will be reduced. It will give a significant boost to India’s aim of Atmnirbhar Bharat.

      Production Linked Incentives

      The Scheme shall extend an incentive of 4% to 6% on the goods manufactured in India. It aims to increase the domestic manufacturing of APIs and other pharmaceutical intermediaries. Some details of the Scheme are as under.

      • Financial incentives will be given to eligible 53 bulk life-saving drugs on an incremental basis for a period of 6 years over the base year of 2019-2020
      • India’s Import dependency on critical drugs will drop significantly.
      • An Estimated sales of 46000 crores will increase with additional employment generation over 8 years.
      • The implementing agency will be a Project Management Agency nominated by the Department of Pharmaceuticals.

      Strengthening of the Pharmaceutical Industry Scheme

      The Ministry of Chemical and Fertiliser has recently released the Strengthening of Pharmaceutical Industry Scheme for FY 21-22 to FY 25-26 with an outlay of 500 cr. Some of the key points are :

      • Financial assistance will be provided for Pharma Clusters for the creation of common facilities.
      • Interest subvention or capital subsidies will be provided to SMEs and MSMEs to meet national and international regulatory standards.
      • Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) to facilitate MSMEs in the Pharma sector to perform better
      • Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS) for the growth and development of Pharmaceutical and Medical Devices Sectors through study and survey reports, awareness programs, creation of databases, and promotion of industry. Knowledge and awareness about the Pharmaceutical and MedTech Industry will be promoted under its sub-scheme.

      Does India Import API from China?

      India is the third largest Pharma market in the world by volume and the largest in generic medicines. Still, India is heavily dependent on China for the Import of API as far as 70 %, and in cases of life-saving drugs, it is dependent on as much as 90%.

      Has China Increased the Price Of API? Why?

      With Coronavirus causing disruptions all over the world and China being no exception, disruption of Chinese markets and prices going over the roof is seen in every field. A significant rise in packaging, freight, and raw materials has taken a toll on the prices of raw materials and led to a significant rise in Active Pharmaceutical ingredients to a range of 25- 100 %. India is heavily dependent on China for APIs and is also impacted by such a significant rise in the price of APIs.

    Concluding Remarks

    An Active Pharmaceutical Ingredient or An API causes the necessary impact on the human body and provides relief; strict rules and regulations must be followed to minimize the risk to life. India is the 3rd largest Pharmaceutical industry in terms of volume, just behind China and Italy, but still is very dependent on API imports. With strict regulations and following the recommendations given by the report of TIFAC, the demand and supply gap can be minimized along with solving issues such as counterfeiting and low-quality product.