Pharmaceutical Industry Archives

Industry Update – Application Process for Seeking Extension of Schedule M

March 31, 2025March 31, 2025by valueaddedinLeave a comment

Application Process for Seeking Extension of Schedule M

The Central Drugs Standard Control (CDSCO) has issued a Circular on 24th March 2025, that an online portal ONDLS has been launched for submission of application for extension of the timeline to comply with Schedule M by Small and Medium Manufacturers.

Small and Medium manufacturers with turnover of less than Rs.250 crores, can submit an application within 3 months of this notification in Form A (plan of upgradation) to the Central License Approving Authority for extension of implementation till 31st December 2025.

In this regard, CDSCO has developed an online system for submiting application through ONDLS portal.

The applicant / manufacturer seeking extension of the timeline has to register on the ONDLS portal and thereafter submit an application.

No hard copy of the application for seeking extension will be considered.

Circular of CDSCO is given below :

Source: https://statedrugs.gov.in/SFDA/ondls-login.html

Industry update – PRIP Scheme

March 9, 2025March 9, 2025by valueaddedinLeave a comment

PRIP Scheme’s
Expression of Interest (EOI)

The Department of Pharmaceuticals announces the launch of the Expression of Interest (EoI) under the Scheme for Promotion of Research & Innovation in Pharma, MedTech Sector (PRIP)

The EoI has been designed to provide you with an opportunity to co-shape India’s journey towards becoming an R&D innovation hub. All interested entities are encouraged to participate in PRIP Scheme’s Expression of Interest (EoI) process and share description of suitable projects.

Please visit the scheme’s website to access the EoI form: https://pharma-dept.gov.in/prip/

About the PRIP Scheme:

The PRIP Scheme aims to transform India into a global powerhouse for R&D in the Pharma MedTech sector. The scheme has a total outlay of ₹5,000 Cr, of which ₹4,250 Cr is focused on accelerating investments in industry-led R&D projects within six priority research areas, including: New Chemical Entities, New Biological Entities and Phyto-pharmaceuticals, Complex generics and Biosimilars, Precision Medicine, Medical Devices, Orphan Drugs and Drug Development for Antimicrobial Resistance (AMR)

For any queries about the scheme or EoI process please write to us at support-prip@pharma-dept.gov.in

Source : https://www.linkedin.com/posts/pharma-dept_innovation-healthcare-pharmaceuticals-activity-7303677221112541184-9yrW?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABYr-QBBx6RLFkUHnEgb2n9GcB2vrhm0cg

Scheme Overview

The Scheme for “Promotion of Research and Innovation in Pharma MedTech sector (PRIP)” has been launched by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India, with the goal of transforming India into a global powerhouse for R&D in the Pharma MedTech sector. The scheme has been notified vide Gazette Notification No. 199 dated 17th August 2023. The scheme has a total financial outlay of Rs. 5,000 Crores, of which Rs 4,250 Crores is focused on accelerating investments in the R&D ecosystem within the sector.

The scheme proposes funding across 6 priority areas and 3 funding categories:

Priority Areas
There are six priority research areas which will be covered by the PRIP scheme

New Chemical Entity, New Biological Entity and Phyto-pharmaceuticals
Complex generics and Biosimilars
Precision medicine (Targeted innovative therapeutics)
Medical devices
Orphan Drugs
Drug development for AMR

Key Funding Categories

R&D projects (focused on one or more of the priority areas above) need to be submitted within one of the following three funding categories:

1. B I: Funding up to 35% of total project cost or ₹125 Cr (whichever is less)

Applicants must be Pharmaceutical or MedTech companies with:
o Annual revenue ≥ Rs. 1,000 Cr (Pharma) or ≥ Rs. 250 Cr (MedTech)
o R&D expenditure of 3-5% (Pharma) or 1-3% (MedTech) of total revenue in the last five years
o Collaboration with a Government Research Institution (See Appendix II for more details)
o Projects in priority areas at any TRL 1 to 9

2. B II: Funding up to 35% of total project cost or Rs. 100 Cr (whichever is less)

Entities working on R&D projects in priority areas that are at TRL 5 or 6

3. B III: Funding up to Rs. 1 Cr per project

Startups and MSMEs working in priority areas at TRL 1 onwards to TRL 4
For more information on TRL, kindly refer to the Appendix III of the EoI document

Invitation for Expression of Interest
Department of Pharmaceuticals invites Expression of Interest (EoI) from interested entities – e.g.,
Proprietary Firm or Partnership Firm or Limited Liability Partnership (LLP), Startups or a Company /Group
of companies registered in India for project funding under the PRIP scheme.
This EoI has been designed to provide you with an opportunity to co-shape India’s journey towards
becoming an R&D innovation hub, by soliciting your inputs on:
Current R&D projects in the scheme’s priority areas for PRIP funding consideration
Challenges in execution of an R&D projects
Actions to strengthen the R&D ecosystem for Pharma and MedTech innovation in India

Download the EOI Document here

Source: https://pharma-dept.gov.in/prip/

AMD – CF schemes for Medical Device Clusters

January 17, 2024January 17, 2024by valueaddedinLeave a comment

Assistance to Medical Device Clusters for Common Facilities (AMD-CF)

The Ministry of Chemicals & Fertilizers Department of Pharmaceuticals has issued the Guidelines for the Scheme for “Assistance to Medical Device Clusters for Common Facilities (AMD-CF)” on May 9 ,2023 with a proposed financial outlay of Rs. 300 crore

About AMD-CF Scheme

AMD-CF Scheme aims to strengthen the existing and new medical device clusters by providing financial assistance for setting up new testing laboratories for medical devices ensuring quality and sustainable growth for the sector

The Scheme further intends to support Central or State Government/s or Institutions or Organization to establish or strengthen the Testing Laboratories for Medical Devices to meet the needs arising due to roll out of the licensing regime of the MDR, 2017 and ensuring availability of more testing facilities for evaluation of Medical Devices on behalf of the manufacturers, as mandated under MDR, 2017 or as per the amendment thereon, from time to time

The Scheme would be implemented in a Public Private Partnership (PPP) mode through one time grant-in-aid for creation of infrastructure and common facilities. A Special Purpose Vehicles (SPVs) will be set up for this purpose. The SPVs will have a minimum of 3 pharma units (including Bulk Drug and Medical Device Units) as its shareholders. There shall be a minimum of five medical device manufacturing units as members of SPV.

The SPV should have representatives from cluster members, financial institutions, state and central government and R&D organisations and the individual manufacturing unit cannot hold more than 40 per cent in the SPV. The Medical Devices enterprises shall hold at least 51 per cent equity of the SPV

The outcomes of the Scheme will be reviewed after 2 years from the date of its initiation.

SIDBI has been appointed as Project Management Agency (PMA) for implementation of Scheme.

Components / Sub schemes of AMD – CF Scheme

There are two components / sub schemes to this AMD – CF scheme :

1. Assistance for Common Facilities (CF) : To strengthen the medical device clusters’ capacity for their sustained growth by creating Common Infrastructure Facilities.
2. Assistance for Testing Facilities (TF) : To strengthen availability of more Medical Device Testing Laboratories in order to boost manufacturing of quality medical devices

Financial outlay of the Schemes :

The sub-schemes are designed to set up 12 common facilities and 12 testing laboratories, under which the common facilities will be supported with a financial assistance of Rs. 240 crore for the common facilities and Rs. 60 crore for the testing facilities

Tenure of the Scheme :

The tenure of the Scheme is from Financial Year 2023-24 to Financial Year 2026-27.

Incentives Under this Scheme :

For Common Infrastructure Facilities (CIF) for the Medical Device (MD) clusters: the limit of support will be 70% of the approved project cost or Rs. 20 cr., whichever is less, as per the approval of SSC (Scheme Steering Committee). In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 20 Crore per Cluster or 90% of the project cost of the CIF, whichever is less

For Testing Facilities (TF) of Medical Device (MD) products,the limit of support will be 70% of the approved Testing Facilities project cost or Rs. 5 cr., whichever is less, as per the approval of SSC.

In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 5 Crore per Cluster or 90% of the project cost of the CIF, whichever is less.

Any expenditure above the prescribed limit shall be borne by the elected applicant

Benefits of the Sub Schemes are :

i. Improvement in quality standards of medical devices
ii. Improvement in regulatory compliance specified for medical device
iii.Increased availability of trained personnel for Medical Devices clusters
iv.Increased competitiveness of Medical Devices units in cluster
v. Reduction in the manufacturing cost of Medical Devices

Notice for Invitation of Applications:

The Department has now invited applications from eligible applicants under the Scheme AMDCF.

The eligible applicants may apply through online mode only. The link is https://amdcf.udyamimitra.in/.

The detailed guidelines of the Scheme is available at https://pharmaceuticals.gov.in/schemes.

The last date for filing of the application is 10.02.2024.

Click here to read the AMD-CF Guidelines

BSI Launch Event: Antimicrobial Resistance (AMR) certification

June 22, 2023June 22, 2023by valueaddedinLeave a comment

BSI Antimicrobial Resistance (AMR) Certification – Launch event on Monday, 26th June 2023 between 15:00 hrs – 16:30hrs (IST)

According to the World Health Organization, antimicrobial resistance (AMR) has been declared a top 10 global public health threat and is expected to get worse unless action is taken. It threatens to undermine the basis of modern medicine by rendering the antibiotics used to treat and prevent infections ineffective.

Resistance can come from many sources – BSI is working with the pharmaceutical industry to focus on the evolution of responsible manufacturing of antibiotics. Manufacturing waste from the production of antibiotics may contribute to the development of AMR in the environment unless emissions from waste streams are effectively controlled

BSI, in collaboration with the AMR Industry Alliance, will launch an industry antibiotic manufacturing certification scheme on 26 June 2023

This independent and impartial certification program is perfectly situated to serve as a mechanism for antibiotic manufacturers to demonstrate evolving best practice and compliance to the Antibiotic Manufacturing Standard. While government regulators have a role to play in promoting responsible manufacturing, the industry has shown its willingness to self-regulate by developing this manufacturing standard and independent certification scheme.

Companies including Centrient, Roche, Pfizer, Teva, Viatris, and Sandoz were participants in the pilot program and have helped provide technical expertise to shape the certification program.

Provide independent third-party assurance that your organization is minimizing the risk of waste emissions from manufacturing
Prove that the industry can self-regulate the antimicrobial resistance topic through certification and external third-party independent assessments
Differentiate yourselves in healthcare systems tenders by showing your antibiotic products are independently certified by a trusted organization with a recognizable Mark of Trust

Who should attend?