New Delhi : The production linked incentive (PLI) scheme for promotion of domestic manufacturing of bulk drugs has seen setting up of 21 projects including capacities for manufacturing of over 25,000 MT of para aminophenol and around 4500 MT of 1,1 cyclohexane diacetic acid (CDA) in the country, till the end of December, 2022.
According to data from the DoP, capacities for 21 bulk drug facilities from various companies have been set up as on December 30, 2022. The projects were commissioned with an actual investment exceeding the total committed investments, said the Department of Pharmaceuticals (DoP).
This includes Meghmani LLP’s facility to manufacture para amino phenol, the raw material for drugs including paracetamol, with installed capacity of 13,500 MT; Sadhna Nitro Chem Ltd’s facility for para aminophenol with installed capacity of 12,000 MT; Hindys Labs Pvt Ltd’ s 3000 MT facility for 1,1 cyclohexane diacetic acid (CDA), an ingredient for anti-depressant gabapentin; and Emmennar Pharma’s CDA facility with a capacity of 1,500 MT.
The other facilities set up under the PLI include Centreient Pharmaceuticals India’s atorvastatin (installed capacity of 180 MT); Andhra Organics Ltd’s sulfadiazine (360 MT); Hetero Drugs Ltd’s oxcarbazepine (195 MT), levofloxacin (230 MT), carbidopa (16 MT), and levodopa (40 MT); Dasami Lab’s cabamazepine (260 MT), and oxcarbazepine (195 MT); Honour Lab’s lopinavir (49 MT), valsartan (300 MT), and levetiracetam (840 MT); Hindys Lab’s acyclovir (525 MT); Globela Industries’ norfloxacin (60 MT), and ofloxacin (100 MT); Anasia Lab’s losartan (400 MT), and olmesartan (75 MT); and Hazelo Lab’s vitamin B6 (70 MT) plants.
The Department has recently said that under the PLI for promotion of domestic manufacturing of critical key starting materials (KSMs)/drug intermediates (DIs)/active pharmaceutical ingredients (APIs), a total of 21 project has been commissioned with actual investment of Rs. 890.82 crore as against total committed investment of Rs. 843.79 crore.
In its year end review, the Department said that the Scheme was approved with the objective of attaining self-reliance and reducing import dependence in critical KSMs/DIs/APIs. The scheme will boost domestic manufacturing of identified KSMs, DIs and APIs by attracting large investments in the sector and thereby reduce India’s import dependence in critical APIs. The tenure of the sub-scheme is from financial year 2020-21 to 2029-30, with the total financial outlay of Rs. 6,940 crore.
The financial incentive under the sub-scheme is provided on sales of 41 identified products categorized into four target segments. Total 249 applications were received in four rounds. In this, 51 applicants have been approved with committed investment of Rs. 4,138.41 crore against which investment of Rs. 1,707 crore has already been incurred. These 51 projects are expected to generate an employment of around 10,598 persons. The works on these projects have already generated employment of 1,907 persons up to September, 2022, it added.
The PLI scheme for bulk drugs has also seen some of the major challenges including that there was a lack of interest from the industry to take up manufacturing projects for bulk drugs using fermentation processes. The Department has tweaked some of the criteria and moved some projects from the fermentation process, in order to make it more viable.