India Opens PLI Applications for Bulk Drug Manufacturing till December 26, 2025

Posted by Written by Archana Rao Reading Time: 4 minutes

India is intensifying its push for pharmaceutical self-reliance through expanded PLI schemes and support for bulk-drug manufacturing, with the sixth application round opening on November 26, 2025. The renewed window targets priority APIs like Meropenem and Ritonavir.

India is steadily strengthening its essential pharmaceutical manufacturing ecosystem through a combination of Production Linked Incentive (PLI) schemes and large-scale bulk-drug infrastructure initiatives. On November 26, 2025, the central government launched the sixth application round under the PLI scheme for bulk drug manufacturing, inviting companies to seek approval for eligible products.

The renewed application cycle follows the Department of Pharmaceuticals’ (DoP) decision to reopen the scheme, reflecting India’s push to expand domestic capacity for critical active pharmaceutical ingredients (APIs) and reduce reliance on imported inputs.

Fresh applications invited for domestic production of Meropenem and Ritonavir

The DoP has announced a new round of applications under the PLI Scheme for Key Starting Materials (KSMs), Drug Intermediates (DIs), and APIs. The latest round focuses specifically on two essential medicines: Meropenem, a broad-spectrum antibiotic, and Ritonavir, a key anti-retroviral drug.

Target segment

Name of eligible product

Minimum annual production capacity (in MT)

Total available production capacity (in MT)

Maximum number of applicants to be selected

Other chemical synthesis-based KSMs/DIs/APIs

Meropenem

4

16

4

Other chemical synthesis-based KSMs/DIs/APIs

Ritonavir

5

20

4

Source: Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, GoI.

The eligible applicants may apply through online mode from November 27, 2025, to December 26, 2025, through the official portal: plibulkdrugs.ifciltd.com

Detailed guidelines of the scheme and necessary corrigendum are available at pharma-dept.gov.in/schemes.

Scheme conditions and eligibility

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As per the announcement, applicants must comply with existing PLI scheme guidelines, including product-specific incentive ceilings and incentives available only until FY 2027-28 for chemical synthesis products. 

Please note that entities that previously received approval but withdrew or had approvals cancelled for non-performance are not eligible to reapply.

The DoP issued a similar notification on May 14, 2025, that opened applications for 11 bulk drug categories under the PLI Scheme for domestic manufacturing of critical KSMs, DIs, and APIs.

Target segment

Name of eligible product

Minimum annual production capacity (in MT)

Total available production capacity (in MT)

Maximum number of applicants to be selected
Key fermentation
based KSMs/Drug
Intermediates		 Erythromycin
Thiocyanate
(TIOC) 		 800  1600  2
Fermentation based
niche KSMs/drug
intermediates/APIs 		 Neomycin  80  160  2
Fermentation based
niche KSMs/drug
intermediates/APIs 		 Gentamycin  40  80  2
Fermentation based
niche KSMs/Drug
Intermediates/APIs 		 Clindamycin
base		 60  120  2
Fermentation based
niche KSMs/drug
intermediates/APIs		 Streptomycin 50  100  2
Fermentation based
niche KSMs/drug
intermediates/APIs		 Tetracycline 200  400  2
Key chemical
synthesis based
KSMs/drug
intermediates		 2-Methyl (5)
Nitro Imidazole
(2MNI)		 800  3200  4
Other chemical
synthesis based
KSMs/drug intermediates/APIs 		 Ciprofloxacin 150  600  4
Other chemical
synthesis based
KSMs/drug
intermediates/APIs		 Diclofenac sodium 175  175  1
Key chemical
synthesis based
KSMs/drug
intermediates		 Dicyandiamide
(DCDA)		 8000 24000  3
Key chemical
synthesis based
KSMs/drug
intermediates		 1,1
Cyclohexane
Diacetic Acid
(CDA)		 1500 1500 1

Source: Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, GoI.

Also Read: Eli Lilly’s Mounjaro Becomes India’s Top-Selling Drug: Market View

India’s API dependency challenge and PLI scheme progress

As per the central government estimates, India imports over 70 percent of its bulk drug requirements from China, creating massive supply chain vulnerabilities. To reduce import dependence, the PLI Scheme for Bulk Drugs was launched in FY 2020-21.

Implementation progress (as of August 2025):

  • 32 pharmaceutical firms selected for greenfield projects
  • 48 projects approved across 33 APIs/DIs/KSMs

Since FY 2022-23:

  • Cumulative sales: INR 19.62 billion (US$218.3 million)
  • Exports: INR 4.79 billion (US$53.29 million)
  • Import substitution: INR 14.83 billion (US$165 million)

Bulk drug parks

Infrastructure support for API manufacturing

In addition to offering incentives through the PLI schemes, India is simultaneously strengthening its pharmaceutical ecosystem by developing large-scale industrial infrastructure under the Scheme for Promotion of Bulk Drug Parks.

On September 1, 2022, the central government granted in-principle approval for three such parks located in Andhra Pradesh, Gujarat, and Himachal Pradesh, to support domestic API and bulk drug production.

These projects have a combined outlay of more than INR 63.06 billion (US$701.6 million), supported by up to INR 30 billion (US$333.5 million) in central government incentives.

State-level incentives for bulk drug parks

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In addition to central support, several states offer supplementary incentives to attract investment into bulk drug parks. These may include:

  • Goods and services tax (GST) reimbursement for a defined period
  • Interest subsidies on eligible loans
  • Exemptions on stamp duty and registration fees
  • Concessional power and water tariffs
  • Single-window mechanisms for faster approvals

Strengthening critical API capacity in India

The PLI Scheme for Bulk Drugs aims to create domestic capacity for critical APIs, KSMs, and drug intermediates, thereby reducing dependence on single-source imports for essential medicines.

Financial and production outcomes (as of September, 2025)

  • Scheme outlay: INR 69.40 billion
  • Investment committed: INR 43.29 billion
  • Investment achieved: INR 47.63 billion
  • 26 APIs/KSMs/DIs now have domestic production capability
  • Sales: INR 23.15 billion
  • Exports: INR 5.08 billion
  • Import savings: INR 18.07 billion

The scheme runs through FY 2029-30.

Driving high-value pharmaceuticals manufacturing 

Complementing the bulk drug initiative, the broader PLI Scheme for Pharmaceuticals aims to scale India’s capabilities in advanced and high-value pharmaceutical products. The scheme prioritizes sectors such as biopharmaceuticals, complex generics, patented and near-patent-expiry drugs, and other high-technology therapies, positioning India to move further up the global value chain.

Investment and output (as of September 2025)

  • Scheme outlay: INR 150 billion (US$1.66 billion)
  • Committed investment: INR 172.75 billion (US$1.92 billion)
  • Actual investment: INR 408.90 billion (US$4.54 billion)
  • 726 APIs/KSMs/DIs being manufactured
  • 191 products produced in India for the first time
  • Cumulative domestic sales: INR 261.23 billion (US$2.9 billion)

The scheme will continue until FY 2028-29.

Conclusion

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Through coordinated efforts across PLI schemes and bulk drug park infrastructure, India is rapidly advancing toward pharmaceutical self-reliance. The reopening of applications for critical APIs like Meropenem and Ritonavir is a strategic reinvestment in domestic capacity. Together, these initiatives are reducing import dependence, strengthening supply-chain resilience, and positioning India as a more robust and competitive player in the global pharmaceutical industry.

(US$1 = INR 89.87)

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