ACTIVE PHARMACEUTICAL INGREDIENTS (API)

ACTIVE PHARMACEUTICAL INGREDIENTS (API)

TOPIC: Science & Tech

Context- The Production-Linked Incentive (PLI) scheme in pharmaceutical sector is to reduce import dependence on active pharmaceutical ingredients (APIs), drug intermediates (DIs) and key starting materials (KSMs).

Concept-

Active Pharmaceutical Ingredients (APIs)

• Active Pharmaceutical Ingredients are the active ingredients contained in a medicine.
• It is that part of the medicine that produces the intended therapeutic effects.
• For example, in a painkiller, the active ingredient relieves pain. In the OTC drug Crocin, the API is paracetamol.
• Only a small amount of the API is required to produce the effect and so the medicine contains only the required amount of the API.
• Some drugs contain multiple APIs to treat varied symptoms.
• API is the most important raw material in the production of medicines.
• Components of Drugs: All drugs contain two parts:
  1. API
  2. Excipient – These are chemically inactive substances that help deliver the API to the system. Eg. lactose, mineral oil, etc.

Key Starting Materials:

• Raw material refers to chemical compounds that are used as a base to make an API.
• An API starting material (or) Key Starting Material is a raw material, intermediate or an API that is used in the production of an API.
• It is incorporated as a significant structural fragment into the structure of the API.

Production Linked Incentive (PLI) Scheme:

• The scheme expected to give a fillip to the domestic drug manufacturing industry is the PLI Scheme.
• This scheme aims to promote the domestic manufacturing of, apart from APIs, drug intermediates and key starting materials (KSMs).
• In this scheme, financial incentives will be provided to eligible manufacturers of identified 53 critical bulk drugs on their incremental sales over the base year (2019-20) for a period of 6 years.
• The scheme will be implemented through a Project Management Agency (PMA) to be nominated by the Department of Pharmaceuticals.