Atmanirbhar Pharma: India’s Push for API Independence in 2025

Introduction

Atmanirbhar Pharma is a pharmaceutical initiative launched by the Indian government to build a domestic pharmaceutical base. Indian Pharmaceuticals is often referred to as the “Pharmacy of the World” and ranks third globally, distributing affordable generic medicines to over 200 countries. 

India has received its raw materials for primary medicines from various countries, but during COVID-19, industries shut down, and there was not even enough supply of generic drugs. India recognized the need to begin preparing the Key Starting Material, final products, and active pharma ingredients in India. 

Atmanirbhar Pharma, an initiative under the Atmanirbhar Bharat umbrella, envisions making India a producer of medicines and driving a pharma revolution.

Understanding APIs and Their Role in Pharma Manufacturing

An Active Pharmaceutical Ingredient (API) is the biologically active part of a drug that produces therapeutic effects and treats the disease. Active pharma ingredients India play a vital role in ensuring that high-quality medicines reach global markets.

API manufacturers in India are considered a crucial step in pharmaceutical manufacturing and account for around 40% of total formulation expenditure, which may range from 70% to 80% for a few drugs. The production of API starts with Key Starting Material (KSM), which undergoes a multi-step chemical synthesis to form Drug Intermediates (DI) and then bulk API. 

Indian manufacturers are skilled at converting DI to API, but the production of required KSMs and DIs is primarily through fermentation-based chemical reactions. With the Atmanirbhar Pharma Initiative, India aims to become an API-independent country, taking control of the entire pharmaceutical manufacturing process.

India’s Current API Landscape and the Import Challenge

Given the economic challenges faced by API manufacturers in India, the country relies on other nations to meet its medicinal needs. The active pharma ingredients India has been majorly dependent on imports for the past two decades.

Dominant Dependency: 

● India is dependent on approximately 70% of the bulk API on a single geopolitical source, and it may vary up to 90-100% for specific, crucial KSMs and DIs. 

Price Factor: 

● Indian manufacturers found it very difficult to cope with the quantities of KSMs and DIs needed. On the other hand, import prices were lower than manufacturing prices. India has stringent rules and regulations regarding environmental well-being, which require manufacturers to use cleaner chemical reactions that are very expensive.

Merchant Operations in India: 

● The Indian government post-COVID-19 fueled the health facilities and the policies like Atmanirbhar Pharma led companies to have Captive API production, where companies produced the API in bulk in an in-house setup. 

● Merchant Operations, where the bulk API product is to be sold to different pharma companies, who use it to make the medicine. Atmanirbhar Pharma helped the manufacturers to make their own medicines without being dependent on any geopolitical source for KSMs and DIs.

Government Initiatives Driving API Independence

The Indian government launched two financial schemes under the Atmanirbhar Pharma Initiative to support the adoption of new pharmaceutical methods.

Production Linked Incentives(PLI): 

● Production Linked Incentive(PLI), launched in 2020, is a scheme that laid the base foundation of the Atmanirbhar Pharma Initiative. 

● The scheme offers financial capital for 41 identified crucial drugs, KSMs, DIs, and API manufactures in India over a particular time span. 

● With these initiatives, India can build greenfield manufacturing projects. This initiative is a stepping stone to attract even larger investors and secure the funds needed for API production in India. 

● Under the PLI scheme, authorities approved a few applicants to manufacture crucial drugs that other nations previously supplied entirely, including Penicillin G, certain DIs, and KSMs for specific antibiotics and vitamins.

Bulk Drug Parks: 

● This scheme is basically designed to create better infrastructure and the essential services like electricity, water, gas, etc. The focal point of this scheme is to develop proper, upgraded, and integrated ecosystems. 

● The purpose of this scheme is to set up 3 Mega Bulk Drug Parks in a few states by helping with the proper financial aid. 

● These parks will have the basic utilities, solvent recovery units, and the very important Common Effluent Treatment Plants. 

● These parks are necessary to follow the government guidelines regarding the high operational and environmental costs, which were a prime factor in not establishing these manufacturing units earlier. 

● These schemes are already at work producing some very crucial drugs, and we can now, in 2025 at least, decrease the import amounts for the production of medicines.

Technological Advancements in API Production in India

Over time, there have been many technological advancements in pharmaceutical manufacturing processes. A few new methodologies are replacing traditional batch-wise drug production.

Continuous Manufacturing(CM): 

● Continuous manufacturing is a non-stop flow of the product instead of producing it in small batches. 

● CM has superior quality control methods, better yield, and consistency. Along with these benefits, companies reduce plant footprints, improve safety and security, and lower invested capital. 

AI and the Transformations in API Production in India: 

● Real-time monitoring of the crucial parameters while producing the product, like temperature and pressure, etc., enabled by sensors and automation processes, is an excellent help for the Atmanirbhar Pharma initiative. 

● The quality is checked continuously, reducing the consumption of the energy resource and maintaining the Electronic Batch Records(EBRs).

Green Chemistry in API Production in India: 

● Green Chemistry is the new generation, and it is very crucial to adopt its methodologies in real-time production for the sustainable manufacture of crucial pharmaceutical drugs. 

● API manufacturers are using closed-loop solvent recovery systems to reduce waste production. 

● Use of catalysts/ biocatalysts is a recommended practice rather than using dangerous reagents. Atom Economy is a crucial point of using the Green Chemistry principles.

Opportunities and Global Impact

India will be a complete “Global Pharma Hub” once it achieves API independence.

Global Supply Chain: 

● Post-pandemic political realignments and pharmaceutical manufacturing diversification are driving countries to seek alternatives to importing all materials from other nations. 

● But now, with the help of the Atmanirbhar Pharma initiative, India can produce their supply and also be the second source hub of pharmaceutics on a global level. 

Higher-Value Produce: 

● India started the production with higher value manufacturing, producing biopharmaceuticals, high-potency APIs, complex genetics, and oncology medicines. 

● With greater revenue, we will refine the Atmanirbhar Pharma even better.

Higher Economic Effect: 

● Under the Atmanirbhar Pharma initiative, there are visible possibilities of a higher boost in the job market, increased industrial manufacturing of KSMs, India’s position as a global health provider, and the healthcare facilities are reaching higher levels.

Challenges Ahead for API Independence in 2025

We have power, skills, and funds. But we are new to the entire process from start to finish. Till now, India has dealt with different parts of the production. This approach may bring new challenges, and the sections below predict some of them: 

● India is majorly dependent on other nations for its KSMs and DIs. Now, when we produce our own, there is a risk of economic fluctuations. The budget we set for API manufacturing in India may or may not be accurate. 

● The Bulk Drug Parks need to be advanced and fault-free. This manufacturing can take time, and meeting the higher medicinal requirements in the pharmaceutical sector is essential but challenging. 

● The processes are new, so the Atmanirbhar Pharma initiative requires new talent on board. The initiative needs new and skilled engineers, chemists, and scientists.

Final Thoughts

The Atmanirbhar Pharma has a long-term vision, and the PLI and Bulk Drug Parks will work to produce critical drugs. The vision is to be less dependent on other nations for medicines by the end of 2025.

The API independence is possible with proper technological advancement, manufacturing, digitalization, and superior quality assurance, protecting our nation and its environment. 

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