PLI Scheme for Bulk Drugs and Resilient Pharmaceutical Supply Chain

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.