Why in the News?
- The Production Linked Incentive (PLI) Scheme for Bulk Drugs is supporting domestic manufacturing of Key Starting Materials (KSMs), Drug Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs).
- Five greenfield projects have commissioned facilities for critical pharmaceutical inputs, reducing import dependence and strengthening supply-chain resilience.
Key Highlights
- Five greenfield projects commissioned under the Bulk Drugs PLI Scheme.
- Focus areas include:
- Antibiotic ingredients
- Cardiovascular medicine APIs
- Paracetamol starting materials
- Supports import substitution, domestic value addition, employment generation and backward integration.
Penicillin G – Andhra Pradesh
- Company: Lyfius Pharma Pvt. Ltd., subsidiary of Aurobindo Pharma Ltd.
- Location: Kakinada SEZ, Andhra Pradesh.
- Investment: ₹2,270.05 crore
- Capacity: 15,000 MT/year
- Direct jobs: 2,353
- Domestic value addition: More than 90%
- Penicillin G is a fermentation-based KSM.
- Used to produce 6-APA, which is used in antibiotics such as amoxicillin and ampicillin.
- Domestic Penicillin G manufacturing restored after about three decades.
Clavulanic Acid – Himachal Pradesh
- Company: Kinvan Private Limited, DPB Group.
- Location: Nalagarh, Himachal Pradesh.
- Investment: ₹504.68 crore
- Capacity: 400 MT/year
- Direct jobs: 465
- India’s first fermentation-based manufacturing facility for Potassium Clavulanate.
- Clavulanic Acid is a β-lactamase inhibitor.
- Combined with penicillin-group antibiotics such as amoxicillin to improve effectiveness against resistant bacteria.
Sulfadiazine, Telmisartan and Olmesartan – Andhra Pradesh
- Company: Andhra Organics Limited (AOL), subsidiary of Virchow Laboratories Ltd.
- Location: Pydibhimavaram, Srikakulam district, Andhra Pradesh.
- Investment: ₹151.47 crore
- Direct employment: 221
- Manufacturing technology developed in-house.
- Sulfadiazine imports declined by about 73% compared with the FY 2019-20 baseline since domestic supplies began in 2022.
- Telmisartan and Olmesartan are APIs used in medicines for hypertension.
Para Amino Phenol – Gujarat
- Company: Meghmani LLP.
- Location: Dahej, Gujarat.
- Investment: ₹60.46 crore
- Capacity: 13,500 MT/year
- PAP is a critical starting material for Paracetamol.
- Facility provides domestic capacity for a material that was earlier largely imported.
- Supports backward integration in Paracetamol manufacturing.
- Cumulative production: ₹687 crore.
Atorvastatin API – Punjab
- Company: Centrient Pharmaceuticals India Pvt. Ltd.
- Location: Nawanshahr, Punjab.
- Investment: ₹161.13 crore
- Capacity: 206 MT/year
- Domestic value addition: More than 80%
- Atorvastatin is a widely prescribed cardiovascular medicine used to lower cholesterol and reduce cardiovascular risk.
- Cumulative production: ₹432 crore.
Prelims Quick Revision
- PLI Bulk Drugs Scheme supports domestic production of KSMs, DIs and APIs.
- Penicillin G: Kakinada, Andhra Pradesh; 15,000 MT/year.
- Potassium Clavulanate: Nalagarh, Himachal Pradesh; 400 MT/year.
- PAP: Dahej, Gujarat; 13,500 MT/year; starting material for Paracetamol.
- Atorvastatin API: Nawanshahr, Punjab; 206 MT/year.
- Sulfadiazine imports: declined by about 73% against the FY 2019-20 baseline.
- Penicillin G is a fermentation-based KSM and is used to produce 6-APA.
- Clavulanic Acid is a β-lactamase inhibitor used with penicillin-group antibiotics.
UPSC Prelims Trap
- API vs KSM: API is the active pharmaceutical ingredient in a medicine, whereas KSM is a starting input used in pharmaceutical manufacturing.
- PAP vs Paracetamol: PAP is a starting material for Paracetamol, not Paracetamol itself.
- Clavulanic Acid: It is a β-lactamase inhibitor, not a penicillin-group antibiotic.
- Penicillin G: It is a fermentation-based KSM and is used in producing intermediates such as 6-APA.
