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PLI's Renewed Drive for APIs to Offset Chinese Dominance

PLI's Renewed Drive for APIs to Offset Chinese Dominance

PLI's Renewed Drive for APIs to Offset Chinese Dominance

  • 17-Nov-2022 12:14 PM
  • Journalist: Robert Hume

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 Applicant

Name of the Eligible Product

Target Segment I Key Fermentation Based KSMs/Drug Intermediates

1

M/s        Aurobindo          Pharma         Limited

(Through Lyfius Pharma Pvt. Ltd.)

Penicillin G

2

M/s          Karnataka           Antibiotics            & Pharmaceuticals Ltd.

 

7 – ACA

3

Orchid Bio-Pharma Limited

4

M/s Kinvan Pvt. Ltd.

Clavulanic Acid

Target Segment II Fermentation Based Niche KSMs/Drug Intermediates/APIs

 

1

 

M/s Natural Biogenex Private Limited

 

Betamethasone

2

M/s Natural Biogenex Private Limited

Dexamethasone

3

M/s Natural Biogenex Private Limited

 

Prednisolone

4

M/s      Symbiotec        Pharmalab        Private Limited

5

M/s Macleods Pharmaceutical Limited

Rifampicin

6

Karnataka                 Antibiotics                  and

Pharmaceuticals Limited

Clindamycin Base

Target Segment III Key Chemical Synthesis Based KSMs/Drug Intermediates

1

M/s        Emmennar          Pharma         Private Limited

 

1,1 Cyclohexane Diacetic Acid (CDA)

2

M/s Hindys Lab Private Limited

3

M/s      Alkimia         Pharma-Chem        Pvt. Ltd. (APCPL)

 

4

M/s Meghmani LLP

Para amino phenol

5

M/s Sadhana Nitro Chem Limited

6

Granules India Limited

Dicyandiamide (DCDA)

Target Segment IV – Other Chemical Synthesis Based KSMs/Drug Intermediates/APIs

1

M/s Rajasthan Antibiotics Limited

Meropenem

2

M/s Centrient Pharmaceuticals India

Private Limited

Atorvastatin

3

M/s Anasia Lab Private Limited

Olmesartan

4

M/s Andhra Organics Limited

5

M/s RMC Performance Chemicals

Private Limited

 

Aspirin

6

M/s Alta Laboratories Limited

(ALL)

7

M/s Lifetech Sciences

Ritonavir

8

M/s Honour Lab Limited

Lopinavir

9

M/s Hindys Lab Private Limited

Acyclovir

10

M/s Dasami Lab Private Limited

Carbamazepine

 

11

M/s Dasami Lab Private Limited

 

Oxcarbazepine

12

M/s Hetero Drugs Limited

13

M/s Hazelo Lab Private Limited

 

Vitamin B6

14

M/s     Sudarshan         Pharma       Industries

Ltd. (SPIL)

15

M/s Honour Lab Ltd. (HLL)

16

M/s Honour Lab Limited

Valsartan

17

M/s Anasia Lab Pvt Ltd

Losartan

18

M/s Hetero Drugs Ltd.

 

Levofloxacin

19

M/s MSN Life Sciences Pvt. Ltd.

20

M/s Vital Laboratories Pvt. Ltd.

21

M/s Vital Laboratories Pvt. Ltd.

 

 

Ofloxacin

22

M/s Global Pharma Healthcare Pvt Ltd

 

23

M/s Globela          Industries         Pvt.       Ltd. (GIPL)

24

M/s Kreative Actives Pvt Ltd

Diclofenac Sodium

25

M/s Amoli Organics Pvt Ltd

 

26

M/s Vapi Care Pharma Private Ltd

 

27

M/s Hetero Drugs Ltd.

Carbidopa

28

M/s Hetero Drugs Ltd.

Levodopa

29

M/s Andhra Organics Ltd

Sulfadiazine

30

M/s Sreepathi Pharmaceuticals Ltd.

Ciprofloxacin

31

M/s Andhra Organics Ltd

Telmisartan

32

M/s Honour Lab Limited

Levetiracetam

 

33

M/s Globela Industries Pvt. Limited

(GIPL)

Norfloxacin

 

34

M/s Aviran Pharmachem Private

Limited (APPL)

 

Artesunate

 

35

M/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.

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