Helen Frankenthaler Foundation

PLP

PLI's Renewed Drive for APIs to Offset Chinese Dominance

PLI's Renewed Drive for APIs to Offset Chinese Dominance

According to Industry experts at the event, the government has extended the deadline for applications to manufacture Active Pharmaceutical Ingredients (APIs) under the Production Linked Incentive (PLI) scheme after the Standard Operating Procedures it offered failed to elicit the desired response. The capital of India, New Delhi, has become highly vulnerable to supply chain disruptions, including recurrent lockdowns in China, which is the world's largest manufacturer and exporter of APIs due to its dominance in this industry.

According to the government, the PLI scheme's goal is to strengthen India's manufacturing capabilities by boosting investment and production in the pharmaceutical industry and promoting product diversification into high-value commodities. It also intends to build champions out of India who has the potential to grow on a global scale using leading-edge technology and thereby penetrate the value chains.

A Parliamentary panel recently recommended to the central government to launch the Research Linked Incentive (RLI) Scheme in line with the Production Linked Incentive (PLI) Scheme, which was launched some time ago to promote domestic production of active pharmaceutical ingredients. The panel emphasized the need to promote Research and Development (R&D) and innovation in India's pharmaceutical and medical device sectors. The PLI scheme will undoubtedly help increase the domestic production of 53 bulk pharmaceuticals, for which India is heavily dependent on imports, as well as Key Starting Materials (KSMs), Drug Intermediates (DIs), and APIs.

List of Applicants Approved under Production Linked Incentive Scheme for Promotion of Domestic Manufacturing of Critical Key Starting Materials (KSMs)/ Drug Intermediates (DIs)/ Active Pharmaceutical Ingredients (APIs) in India:

S.No.Name of the ApplicantName of the Eligible Product
Target Segment I–Key Fermentation Based KSMs/Drug Intermediates
1M/s Aurobindo Pharma Limited (Through Lyfius Pharma Pvt.Ltd.)Penicillin G
2M/s Karnataka Antibiotics&Pharmaceuticals Ltd.7 –ACA
3Orchid Bio-Pharma Limited
4M/s Kinvan Pvt.Ltd.Clavulanic Acid
Target Segment II–Fermentation Based Niche KSMs/Drug Intermediates/APIs
1M/s Natural Biogenex Private LimitedBetamethasone
2M/s Natural Biogenex Private LimitedDexamethasone
3M/s Natural Biogenex Private LimitedPrednisolone
4M/s Symbiotec Pharmalab Private Limited
5M/s Macleods Pharmaceutical LimitedRifampicin
6Karnataka Antibiotics and Pharmaceuticals LimitedClindamycin Base
Target Segment III–Key Chemical Synthesis Based KSMs/Drug Intermediates
1M/s Emmennar Pharma Private Limited1,1 Cyclohexane Diacetic Acid(CDA)
2M/s Hindys Lab Private Limited
3M/s Alkimia Pharma-Chem Pvt.Ltd.(APCPL)
4M/s Meghmani LLPPara amino phenol
5M/s Sadhana Nitro Chem Limited
6Granules India LimitedDicyandiamide(DCDA)
Target Segment IV – Other Chemical Synthesis Based KSMs/Drug Intermediates/APIs
1M/s Rajasthan Antibiotics LimitedMeropenem
2M/s Centrient Pharmaceuticals India Private LimitedAtorvastatin
3M/s Anasia Lab Private LimitedOlmesartan
4M/s Andhra Organics Limited
5M/s RMC Performance Chemicals Private LimitedAspirin
6M/s Alta Laboratories Limited (ALL)
7M/s Lifetech SciencesRitonavir
8M/s Honour Lab LimitedLopinavir
9M/s Hindys Lab Private LimitedAcyclovir
10M/s Dasami Lab Private LimitedCarbamazepine
11M/s Dasami Lab Private LimitedOxcarbazepine
12M/s Hetero Drugs Limited
13M/s Hazelo Lab Private LimitedVitamin B6
14M/s Sudarshan Pharma Industries Ltd.(SPIL)
15M/s Honour Lab Ltd.(HLL)
16M/s Honour Lab LimitedValsartan
17M/s Anasia Lab Pvt LtdLosartan
18M/s Hetero Drugs Ltd.Levofloxacin
19M/s MSN Life Sciences Pvt.Ltd.
20M/s Vital Laboratories Pvt.Ltd.
21M/s Vital Laboratories Pvt.Ltd.Ofloxacin
22M/s Global Pharma Healthcare Pvt Ltd
23M/s Globela Industries Pvt. Ltd.(GIPL)
24M/s Kreative Actives Pvt LtdDiclofenac Sodium
25M/s Amoli Organics Pvt Ltd
26M/s Vapi Care Pharma Private Ltd
27M/s Hetero Drugs Ltd.Carbidopa
28M/s Hetero Drugs Ltd.Levodopa
29M/s Andhra Organics LtdSulfadiazine
30M/s Sreepathi Pharmaceuticals Ltd.Ciprofloxacin
31M/s Andhra Organics LtdTelmisartan
32M/s Honour Lab LimitedLevetiracetam
33M/s Globela Industries Pvt. Limited (GIPL)Norfloxacin
34M/s Aviran Pharmachem Private Limited (APPL)Artesunate
35M/s K P Manish Global Ingredients Pvt. Ltd. (KPMGIPL)

To lessen reliance on China, the Department of Pharmaceuticals launched three PLI schemes: medical devices (Rs.3,420 cr), pharmaceuticals (Rs.15,000 cr), and bulk medications (Rs.6,940 cr). The government's subsidies, according to the experts, were insufficient to draw the investment needed to start large-scale manufacturing. Around 14 projects totaling Rs.612 crores have been launched in the area of bulk pharmaceuticals. The government is offering incentive rates of 20% for the first year, 15% for the fifth year, and 5% for the sixth year.

According to trade analysts, India used to produce all the APIs it needed on its own, but the closure of those manufacturing facilities was caused by cheaper alternatives from China. After COVID-19 and the Russia-Ukraine War, many nations realized the impact of their over-reliance on China for essential commodities like semiconductors and APIs.

According to ChemAnalyst, Chinese active ingredients are 20% to 30% less expensive than Indian ones, and incentives of up to 20% under PLI might help close the gap.