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48 projects approved to ensure uninterrupted supply of critical APIs

New Delhi: Under the Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical Key Starting Materials (KSMs) / Drug Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs) in India, 48 projects have been approved.
This information was disclosed by the Union Minister of State for Chemicals and Fertilizers Smt Anupriya Patel in Rajya Sabha in a written reply to a question.
The scheme aims to avoid disruption in supply of critical active pharmaceutical ingredients (APIs) used to make critical drugs for which there are no alternatives by reducing supply disruption risk due to excessive dependence on single source. Products notified and approved under the scheme prior to commencement of production under the PLI scheme were primarily imported.
As of December 2024, against an investment commitment of Rs 3,938.5 crore over the period of six years, investment of Rs 4,254 crore has already been made under the scheme. As a result of the scheme, cumulative sales of Rs 1,556 crore have been reported over the period from the beginning of the scheme till December 2024, including exports of Rs 412 crore, thereby avoiding imports worth Rs 1,144 crore and creating domestic manufacturing capacity for 25 identified KSMs/DIs/APIs.
The 48 projects approved include products such as Penicillin G, Clavulanic Acid, Rifampicin, Betamethasone, Diclofenac sodium, Levofloxacin, Meropenem, and Aspirin. Firms such as Hetero Drugs, Granules India, Lyfius Pharma, Orchid Bio‑Pharma, and MSN Life Sciences are among the approved beneficiaries
Number of measures were taken to enhance awareness and encourage participation in the scheme at the time of the launch of the scheme and various rounds of invitation of applications under it, including the following:
- Conducting of webinars and stakeholder consultation meetings with industry associations and potential applicants;
- Issuing of press releases, detailed guidelines, clarifications in the form of frequently asked questions (FAQs) and answers thereto and scheme notifications on official websites;
- Regular outreach through social media campaigns;
- Provision of dedicated helpdesk support and query resolution mechanisms through the scheme portal; and
- Issue of press releases and hosting of the same on government websites.
Details regarding applicants/beneficiaries under the PLI Scheme for promotion of domestic manufacturing of critical KSMs/DIs/APIs in India
S. No. | Name of the applicant | Approved product |
Lyfius Pharma Pvt. Ltd. | Penicillin G | |
Karnataka Antibiotics and Pharmaceuticals Ltd. | 7 ACA | |
Kinvan Pvt. Ltd. | Clavulanic Acid | |
Orchid Bio-Pharma Ltd. | 7 ACA | |
Macleods Pharmaceutical Ltd. | Rifampicin | |
Natural Biogenex Pvt. Ltd. | Betamethasone | |
Natural Biogenex Pvt. Ltd. | Dexamethasone | |
Natural Biogenex Pvt. Ltd. | Prednisolone | |
SymbiotecPharmalab Pvt. Ltd. | Prednisolone | |
Emmennar Pharma Pvt. Ltd. | 1,1 Cyclohexane Diacetic Acid (CDA) | |
Granules India Ltd. | Dicyandiamide (DCDA) | |
Hindys Lab Pvt. Ltd. | 1,1 Cyclohexane Diacetic Acid (CDA) | |
Meghmani LLP | Para Amino Phenol | |
Sadhana Nitro Chem Ltd. | Para Amino Phenol | |
Alta Laboratories Ltd. | Aspirin | |
Amoli Organics Pvt. Ltd. | Diclofenac sodium | |
Anasia Lab Pvt. Ltd. | Losartan | |
Anasia Lab Pvt. Ltd. | Olmesartan | |
Andhra Organics Ltd. | Olmesartan | |
Andhra Organics Ltd. | Sulfadiazine | |
Andhra Organics Ltd. | Telmisartan | |
Aviran Pharmachem Pvt. Ltd. | Artesunate | |
Centrient Pharmaceuticals India Pvt. Ltd. | Atorvastatin | |
Dasami Lab Pvt. Ltd. | Carbamazepine | |
Dasami Lab Pvt. Ltd. | Oxcarbazepine | |
Global Pharma Healthcare Pvt. Ltd. | Ofloxacin | |
Globela Industries Pvt. Ltd | Norfloxacin | |
Globela Industries Pvt. Ltd | Ofloxacin | |
Hazelo Lab Pvt. Ltd. | Vitamin B6 | |
Hetero Drugs Ltd. | Carbidopa | |
Hetero Drugs Ltd. | Levodopa | |
Hetero Drugs Ltd. | Levofloxacin | |
Hetero Drugs Ltd. | Oxcarbazepine | |
Hindys Lab Pvt. Ltd. | Acyclovir | |
Honour Lab Ltd. | Levetiracetam | |
Honour Lab Ltd. | Lopinavir | |
Honour Lab Ltd. | Valsartan | |
Honour Lab Ltd. | Vitamin B6 | |
K. P. Manish Global Ingredients Pvt. Ltd. | Artesunate | |
Kreative Actives Pvt. Ltd. | Diclofenac sodium | |
Lifetech Sciences | Ritonavir | |
MSN Life Sciences Pvt. Ltd. | Levofloxacin | |
Rajasthan Antibiotics Ltd. | Meropenem | |
RMC Performance Chemicals Pvt. Ltd. | Aspirin | |
Sudarshan Pharma Industries Ltd. | Vitamin B1 | |
Sudarshan Pharma Industries Ltd. | Vitamin B6 | |
Vital Laboratories Pvt. Ltd. | Levofloxacin | |
Vital Laboratories Pvt. Ltd. | Ofloxacin |
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751