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Home / IAS Preparation / Bulk Drug Park

Bulk Drug Parks - Selection of Bulk Drug Parks, Aims, Objectives, Significance And More

Last Updated on Sep 06, 2023
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Bulk Drug Parks are specialized industrial zones dedicated to manufacturing bulk drugs or active pharmaceutical ingredients (APIs). These parks are designed to provide a conducive environment to attract pharmaceutical companies. These parks help promote the domestic production of essential drugs. The Central government of India has granted 'in principle' approval for three bulk drug parks. These are located in Gujarat, Himachal Pradesh, and Andhra Pradesh. These parks aim to ensure a steady availability of essential drug components. 

In this article, we shall discuss information on the meaning, significance, and other facts about the bulk drug parks in India given below.

This is an important topic for the upcoming UPSC Exams, and aspirants should understand the importance, benefits, and other facts about the bulk drug parks in India. This topic is important for General Studies Paper 1 of the UPSC prelims exam and General Studies Paper 2 and GS Paper 3 of the Main examination.

Latest News about the Bulk Drug Park
  • The Department of Pharmaceuticals has established a high-level committee to track the development of bulk drug parks in three states. Mansukh Mandaviya, Union Minister of Chemical and Fertilizer, is in charge of the high-level committee. Minister of State Bhagwanth Khuba is vice chairman, and other top officials, including business experts, are also members.
  • In October 2022, the Prime Minister of India laid the foundation stone of the bulk drug park in Una, Himachal Pradesh. It is expected to generate investment of roughly Rs. 10,000 crores and employ more than 20,000 people. It will also have a positive effect on the local economy.
  • The first bulk drug park in India was set up in Jambusar of Bharuch district, Gujarat.

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What is Bulk Drug Park?

A Bulk Drug Park is a place where bulk drugs or APIs (Active Pharmaceutical Ingredients) are manufactured in huge quantities. These drugs are used in the manufacture of medicines. Bulk Drug Parks are set up by the government to promote the manufacturing of bulk drugs in India.

Controlling Ministry

The Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals) will be the controlling ministry for the Scheme for promoting bulk drug parks. The concerned State Government would set up a State Implementing Agency (SIA), a legal entity, to carry out the scheme. The day-to-day operation of bulk drug parks shall be under the control of the SIA.

Selection of Bulk Drug Parks

13 States submitted proposals under the scheme for promoting bulk drug parks. To evaluate the proposals, the Department of Pharmaceuticals was advised by an advisory committee under the CEO of NITI Aayog.

As per the proposals submitted by the States, three states got ‘in-principle approval from the Centre to establish bulk drug parks. Bulk drug parks will be set up in the following States:

  • In 1402.44 acres of land at Tehsil Haroli, District Una, Himachal Pradesh
  • 2015.02 acres of land at Tehsil Jambusar, District Bharuch, Gujarat and
  • 2000.45 acres of land at K.P. Puram & Kodhada of Thondagi Mandal of East Godavari District, Andhra Pradesh.

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What is Bulk Drug?

An Active Pharmaceutical Ingredient (API), often known as a bulk drug, is the vital component of a medicine that gives it the desired therapeutic effect or causes the intended pharmacological activity. For instance: One common bulk drug that serves to treat pain is paracetamol. It is combined with binding agents or solvents to produce the paracetamol tablet (the finished product).

What is Active Pharmaceutical Ingredient (API)?

An active Pharmaceutical Ingredient (API) is a biologically active component in pharmaceutical drugs that produce the intended therapeutic effect. They are the key chemical substances responsible for the pharmacological activity of the medication. APIs are typically synthesized through chemical processes or derived from natural sources. They undergo rigorous testing and must meet specific quality standards before they can be used to produce pharmaceutical formulations.

Types of APIs

There are several types of APIs:

  • Synthetic APIs are chemically synthesized in laboratories.
  • Biotechnological APIs, also known as biologics, are derived from living organisms.
  • Semi-synthetic APIs are a combination of natural and synthetic components.
  • Plant-based APIs are derived from plants and their extracts.
  • Marine-based APIs are derived from marine organisms.
  • Radiopharmaceutical APIs are radioactive substances used in nuclear medicine.

Key Starting Material (KSM)

Key Starting Material (KSM) refers to a crucial raw material used in an active pharmaceutical ingredient's synthesis or manufacturing process (API). KSMs are the foundational components that undergo chemical transformations and reactions to yield the desired API. They play a pivotal role in producing APIs, serving as the starting point or precursor for the synthesis pathway. The quality and purity of KSMs are of utmost importance to ensure the integrity and efficacy of the final API. KSMs are typically carefully selected and subjected to rigorous quality control measures to meet the pharmaceutical industry's specific requirements and regulatory standards.

Drug Intermediate (DI)

A Drug Intermediate (DI) is a chemical compound produced and used during a pharmaceutical drug's synthesis or manufacturing process. DIs are intermediate compounds formed as part of a series of reactions and transformations that ultimately produce the final Active Pharmaceutical Ingredient (API). These intermediates have specific chemical structures and properties that make them suitable for further modifications and conversions to obtain the desired API.

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Reason Behind the Promotion of Bulk Drug Parks by the Indian Government

The Indian government's scheme to promote Bulk Drug Parks has several reasons behind it:

  • Reduce dependence on imported Active Pharmaceutical Ingredients (APIs).
  • Enhance self-sufficiency in pharmaceutical manufacturing.
  • Strengthen the domestic pharmaceutical industry.
  • Ensure a consistent and reliable supply of essential drugs.
  • Boost drug security and reduce vulnerability to supply chain disruptions.
  • Create employment opportunities in the pharmaceutical sector.
  • Promote innovation and collaboration in the industry.
  • Facilitate cost-effective production through shared facilities and economies of scale.
  • Promote the export of pharmaceutical products and contribute to the country's economy.
  • Improve the availability and affordability of medicines for the population.

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Aims and Objectives of Bulk Drug Parks

The aims and objectives for setting up bulk drug parks in India are given below:

  • These parks will offer common infrastructural facilities in one location, developing a robust ecosystem for India’s bulk drug manufacturing.
  • To reduce the manufacturing cost of bulk drugs by creating world-class common infrastructure facilities.
  • To increase the competitiveness of the domestic manufacturing of bulk drugs and decrease import dependence
  • To establish a dominant position in the global market by providing easy access to standard testing and infrastructure facilities
  • To assist the industry in achieving environmental standards at a lower cost by using innovative approaches of the common waste management system and using the benefits brought about by resource optimization and economies of scale.

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Significance of Bulk Drug Parks

The significance of establishing bulk drug parks is given below:

  • This will make India self-reliant in APIs and drug intermediates and minimize India’s dependence on imports.
  • Give a fillip to indigenous manufacturing of crucial raw materials for medicines and increase the competitiveness of the domestic bulk drug industry.
  • Will bring down the cost of manufacturing bulk drugs
  • Help in the production of quality raw materials.
  • Increase the competitiveness of the domestic bulk drug industry.
  • Provide quality and affordable medical care to people.
  • Lead to more investment and employ people.
  • Ensure a continuous supply of high-quality bulk drugs and boost India’s ability to scale up its production in an emergency.

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Key Facts and Figures about Bulk Drug Parks

Important facts related to the bulk drug parks and the scheme for the promotion of bulk drug parks are given below in the table below:

Bulk Drug Parks: Key Facts and Figures for UPSC

1

What is a bulk drug park?

As per the scheme, a bulk drug park is a defined contiguous parcel of land with common infrastructural facilities for the sole purpose of manufacturing APIs, DIs, or KSMs.

2

What is the purpose of setting up a bulk drug park?

The common infrastructure facilities created under the scheme will help reduce the manufacturing cost of bulk drugs and also enhance the competitiveness of the domestic industry. It will help India become self-reliant and less dependent on the import of bulk drugs.

3

Which Ministry and Department implement the Scheme for the promotion of bulk drug parks?

The Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers

4

What is the Scheme for the promotion of bulk drug parks?
  • This is a Central Sector Scheme with a total financial outlay of Rs. 3000 Crore.

5

When was the scheme for the promotion of bulk drug parks launched?

The scheme was approved by the Government of India on March 20, 2020.

6

What is the maximum limit of financial assistance given by the central government to states to set up bulk drug parks?

The proposed bulk drug park in Gujarat and Andhra Pradesh would get financial support equal to 70% of the project’s cost for common infrastructure facilities. Himachal Pradesh would receive financial support equal to 90% of the project cost because it is a hilly state. The most that can be provided under the scheme for one bulk drug park is Rs. 1000 crores.

7

What is the rank of the Indian pharmaceutical industry by volume?

The pharmaceutical industry in India ranks third in the world in terms of volume. In the fiscal year 2021–2022, India exported pharmaceuticals worth Rs. 1,75,040 crore, comprising bulk drugs and drug intermediates.

8

Is India a producer of Active Pharma Ingredients (API) or bulk drugs in the world?

One of the world’s top producers of active pharmaceutical ingredients (API) or bulk drugs is India. In the fiscal year 2021–2022, India exported bulk drugs/drug intermediates worth Rs. 33,320 crores. However, in 2021-22, bulk drugs accounted for over 60 percent of total pharmaceutical imports.

10

What are the examples of APIs?

The APIs include:

  • Cephalosporins
  • steroids,
  • inorganic salt
  • proton pump inhibitors
  • Analgesics
  • Antipyretics
  • Anti-inflammatory drugs like paracetamol, diclofenac sodium, aceclofenac, ibuprofen etc

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Conclusion

Implementing the bulk drug park promotion scheme will help India become self-sufficient in APIs and drug intermediates in the long run. It will lower the cost of bulk drugs and make healthcare more affordable. The establishment of bulk drug parks that produce quality raw materials per industry standards will help grow the Indian pharmaceutical industry in India.

Download the PDF on Bulk Drug Parks notes for UPSC Exam here.

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Bulk Drug Park FAQs

The first bulk drug park in India was set up in Jambusar of Bharuch district, Gujarat. The foundation stone for the second bulk drug park was inaugurated at Haroli in Una district, Himachal Pradesh.

The aim of establishing bulk drug parks in India is to make India self-reliant in the sourcing of pharmaceutical raw materials. The scheme will help in import substitution.

3 Till September 1, 2022, ‘in-principle’ approval has been given to the proposals of three States, that is, Gujarat, Himachal Pradesh, and Andhra Pradesh under the Scheme for “Promotion of Bulk Drug Parks”.

Bulk drugs are often known as Active Pharmaceutical Ingredients (APIs). These are vital components of a drug that give it the desired therapeutic effect or cause the intended pharmacological activity, whereas Key Starting Material (KSM) is the primary raw material or the key chemical that undergoes reactions to form an API.

The Scheme for the Promotion of Bulk Drug Parks is implemented by the Ministry of Chemicals and Fertilizers.
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