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DoP releases updated list of applications approved under PLI scheme for bulk drugs
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Gireesh Babu, New Delhi
August 10 , 2022
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The Department of Pharmaceuticals (DoP) has released an updated list of 45 approvals it has issued to various companies 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).
Of these, 10 applications are for fermentation based KSM, DI and APIs, in which in the target segment I for key bulk drugs were approved against application by Aurobindo Pharma through Lyfius Pharma Pvt Ltd for penicillin G, Karnataka Antibiotics and Pharmaceuticals Ltd and Orchid Bio-Pharma Ltd for 7-ACA and Kinvan Pvt Ltd for clavulanic acid.
The other six under the Target Segment II for Fermentation based niche bulk drugs, approvals were awarded to Natural Biogenex Pvt Ltd for betamethasone, dexamethasone and prednisolone, Symbiotec Pharmalab Pvt Ltd for prednisolone, Macleods Pharmaceutical Ltd for rifampicin and Karnataka Antibiotics and Pharmaceuticals Ltd for clindamycin Base.
In the Target Segment III for Key Chemical Synthesis based KSMs/drug intermediates, approvals were given to six companies - Emmennar Pharma Pvt Ltd, Hindus Lab Pvt Ltd, and Alkimia Pharma-Chem Pvt Ltd for 1,1 cyclohexane diacetic acid (CDA), Meghamani LLP and Sadhana Nitro Chem Ltd for para amino phenol, and Granules India Ltd for dicyandiamide (DCDA).
Under the Target Segment IV for other chemical synthesis based KSMs/DIs and APIs, approvals were issued for Rajasthan Antibiotics Ltd for Morepenem, Centrient Pharmaceuticals for atorvastatin, Anasia Lab Pvt Ltd and Andhra Organics Ltd for olmesartan, RMC Performance Chemicals and Alta Laboratories for aspirin, Lifetech Sciences for ritonavir, Honour Lan for lopinavir, Hindys Lab Pvt Ltd for acyclovir, Dasani Lab Pvt Ltd for carbamazepine and oxcarbazepine, Hetero Drugs for oxcarbazepine, Hazels Lab Pvt Ltd, Sudarshan Pharma Industries and Honour Lab Ltd for vitamin B6, Honour Lab Ltd for valsartan, Anasia Lab for losartan, Hetero Drugs, MSN Life Sciences and Vital Laboratories for levofloxacin, Vital Laboratories, Global Pharma Healthcare Ltd and Globela Industries Pvt Ltd for ofloxacin, Kreative Actives, Amoli Organics and Vapi Care Pharma for diclofenac sodium.
The rest of the approvals under the same target segment were issued to Hetero Drugs for carbidopa and levodopa, Andhra Organics for Sulfadiazine, Sreepathi Pharmaceuticals for ciprofloxacin, Andhra Organics for telmisartan, Honour Lab for levetiracetam, Globela Industries Pvt Ltd for norfloxacin and African Pharmachem and K P Manish Global Ingredients for artesunate.
It may be noted that the ministry has recently modified the PLI scheme for bulk drugs, moving one of the fermentation based products to chemical synthesis based products. The department has moved the manufacturing of vitamin B1 from fermentation based products to chemical synthesis route.
Based on this, now there would be nine fermentation based products with a total outlay of Rs. 900 crore instead of 10 products with an outlay of Rs. 1,000 crore. Simultaneously, now there will be 24 chemical synthesis based products with a total outlay of Rs. 1,480 crore, as against 23 products with an outlay of Rs. 1,380 crore according to the original guidelines issued on October 29, 2020.
“As per the decision taken, the 10 per cent incentive rate shall be applicable as applicable for APIs produced through chemical synthesis and the incentive ceiling for vitamin B1 will remain the same as per original guidelines,” said a corrigendum for the guidelines issued by the DoP.
Under the fermentation based products, the rate of incentive for vitamin B1 was at 20 per cent from FY 2023-24 to FY 2026-27, 15 per cent on FY 2027-28 and five per cent in the year FY 2028-29. Now, the rate of incentive under the chemical synthesis products will be 10 per cent flat from FY 2023-24 to FY 2027-28.
The maximum incentive per annum under the fermentation based products was Rs. 20 crore from FY 2023-24 to FY 2026-27, which will come down to Rs. 15 crore in FY 2027-28 and Rs. 5 crore in FY 2028. Under the chemical synthesis route, this will be Rs. 20 crore from FY 2023-24 to FY 2027-28.
Similarly, under the fermentation based route, the maximum incentive for each selected applicant per annum was Rs. 10 crore from FY 2023-24 to FY 2026-27, Rs. 7.5 crore for FY 2027-28 and Rs. 2.5 crore for FY 2028-29. Now, this has been changed to Rs. 10 crore from FY 2023-24 to FY 2027-28, according to the corrigendum. For the fresh applications invited, the year FY 2022-23 will be considered as the installation year.
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