Active Pharmaceutical Ingredients (APIs)

Active Pharmaceutical Ingredients (APIs)

News: India’s Union Health Minister, has stated that the country has initiated the domestic production of 38 active pharmaceutical ingredients (APIs) in the past 1.5 years.

Instruction – Keep a look on the term “Key Starting materials” in the image.

Background:
• The achievement has been facilitated through the production-linked incentive (PLI) scheme for the pharmaceutical sector.
• India’s dependence on a single country for the import of 95% of these APIs was reevaluated after the 2017 border standoff with China at Doklam. The move towards self-reliance in producing active pharmaceutical components is seen as a strategic shift to reduce dependency on a single source for critical medical supplies.

What are APIs?
• Active Pharmaceutical Ingredients (APIs), also known as bulk pharmaceuticals or drug substances, are the biologically active components of pharmaceutical drugs that produce a therapeutic effect in the body.
• These are the chemical compounds responsible for the intended physiological or pharmacological action of a medication.
• APIs can be derived from various sources including i) Chemical Synthesis ii) Biotechnology iii) Natural Resources
• Once the API is synthesized or extracted, it's typically formulated into various dosage forms like tablets, capsules, injections, creams, or liquids for patient use.

What are the benefits of being self-reliant on API production?
• Being self-reliant reduces the vulnerability to supply chain disruptions. For example, trade restrictions, Geo-political tensions.
• Consistent supply of essential medicines even during crisis periods.
• Domestic production allows for stricter quality control and adherence to international regulatory standards.
• Having a strong domestic API production capability fosters innovation and research within the pharmaceutical sector. It can lead to the development of new treatment options, therapeutic approaches, and advancements in drug delivery systems.
• More jobs, economic growth, better access and affordability of medicines and ensure global competitiveness.
• Examples of API’s produced in India – Ibuprofen, Metformin, Omeprazole, Ranitidine, Glibenclamide, Paracetamol.