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DoP extends timeline for submission of applications under PLI scheme for KSMs, APIs & medical devices

Gireesh Babu, New Delhi
Wednesday, July 28, 2021, 08:00 Hrs  [IST]

The Department of Pharmaceuticals (DoP) has extended the timeline for submission of applications under the production linked incentive scheme for promotion of domestic manufacturing of critical key starting materials (KSMs) or drug intermediates and active pharmaceutical ingredients (API) and medical devices, till August 31, 2021.

The decision to extend the timeline for the PLI for promotion of KSM and APIs, along with the PLI scheme for promoting domestic manufacturing of medical devices, was announced by the department through a notice issued on July 27. The eligible applicants may apply online only, it added.

According to an earlier notice issued on April 30, 2021, the last date of receipt of complete applications for these categories was fixed as July 28, 2021.

On Tuesday, the department has also invited applications to produce Ofloxacin, the fluoroquinolone antibiotic to treat bacterial infections, under the PLI scheme for promotion of domestic manufacturing of critical KSMs/drug intermediates and APIs. The minimum annual production capacity as per scheme guidelines is 100 MT, and one applicant will be selected for the incentive as per the scheme.

The last date of submission of online applications for the product is August 31, 2021.

Earlier this month, the Department extended the deadline for submission of application for the production linked incentive (PLI) scheme for pharmaceuticals to August 15, 2021.

In April, 2021, the ministry of chemicals and fertilisers has accorded 16 applicants under the scheme, who will set up 16 plants with a total committed investment of Rs. 348.70 crore and generate an employment of around 3,042. Commercial production of these plants are projected to commence from April 1, 2023.

The applications approved include that of Honour Lab Ltd to produce Valsartan and Levetiracetam, Anasia Lab (Losartan), Hetero Drugs Ltd (Levofloxacin, Carbidopa and Levodopa), Chemex Global, and Surya Life Sciences Ltd (Levofloxacin), Andhra Organics Ltd (Sulfadiazine), Sreepathi Pharmaceuticals (Ciprofloxacin, Ofloxacin), Global Pharma Healthcare Pvt Ltd (Ofloxacin), Andhra Organics Ltd (Telmisartan), and Kreative Actives Pvt Ltd, Amoli Organics and Vapi Care Pharma (Diclofenac Sodium).

On April 30, 2021, the Department invited applications to produce Neomycin, Gentamycin, Clindamycin base, Tetracycline, Streptomycin, Vitamin B1, Dicyandiamide (DCDA), Norfloxacin, Artesunate, Aspirin, Vitamin B6. On June 14, it added Cyclohexane Diacetic Acid (CDA) and Artesunate to the list of applications invited for setting up manufacturing facilities. On July 2, it also called for applications from those who are interested to set up facilities for Erythromycin Thiocyanate (TIOC).

The Department of Pharmaceuticals had launched a PLI scheme for promotion of their domestic manufacturing by setting up greenfield plants with minimum domestic value addition in four different Target Segments (in two fermentation based - at least 90% and in the two chemical synthesis based – at least 70%) for 41 products with a total outlay of Rs. 6,940 crore for the period 2020-21 to 2029-30.


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