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.
