Category: Announcements

SEBI Notification

April 23, 2025April 23, 2025by valueaddedinLeave a comment

SEBI Notifications on the Position of Compliance Officer for Listed Entities

The Securities and Exchange Board of India (SEBI) has, through recent regulatory updates, significantly enhanced the role and responsibilities of the Compliance Officer within listed entities in India.

This post provides an analysis of the SEBI (Listing Obligations and Disclosure Requirements) (Third Amendment) Regulations, 2024, issued in December 2024, and the subsequent SEBI Circular dated April 1, 2025, which clarified certain aspects of these amendments. These regulatory actions highlights SEBI’s commitment to strengthening the corporate governance framework and ensuring robust compliance practices within listed entities.

The key changes mandate that the Compliance Officer must be a whole-time employee, hold a senior position not more than one level below the board of directors, and be designated as a Key Managerial Personnel (KMP). These requirements aim to empower the Compliance Officer, providing them with the necessary authority and access to effectively discharge their duties.

The April 2025 circular further clarifies the interpretation of the “level” of the Compliance Officer within the organizational structure, addressing ambiguities and ensuring consistent application of the regulations across different types of listed entities. These updates necessitate a re-evaluation of organizational structures and a greater emphasis on the strategic importance of the compliance function within listed entities.

II. SEBI (Listing Obligations and Disclosure Requirements) (Third Amendment) Regulations, 2024 (December 2024): Enhancing the Role and Position of the Compliance Officer

The SEBI (Listing Obligations and Disclosure Requirements) (Third Amendment) Regulations, 2024, were notified on December 12, 2024. This amendment, effective from the date of its publication in the Official Gazette on December 12, 2024 (with the exception of specific sub-regulations coming into force later) , signifies a determined effort by SEBI to reinforce the compliance framework within listed entities. The prompt implementation of these amendments suggests a recognition of the immediate need to elevate the stature and accountability of Compliance Officers.

A pivotal aspect of this amendment is the revision of Regulation 6(1) of the LODR Regulations, which pertains to the appointment of a qualified company secretary as the compliance officer.

A new proviso has been inserted, stipulating that the Compliance Officer must be an officer in the whole-time employment of the listed entity. This requirement effectively prohibits the appointment of part-time compliance officers or external consultants, ensuring that the individual responsible for overseeing compliance is fully integrated within the company’s operations and dedicated to this critical function. This full-time commitment is expected to foster a deeper understanding of the company’s specific compliance needs and challenges, leading to more effective implementation of compliance policies and procedures.

Furthermore, the amendment introduces a significant seniority requirement for the Compliance Officer, stating that they should not be more than one level below the board of directors. This elevation in the organizational hierarchy is intended to grant the Compliance Officer greater authority and access to the decision-making processes within the company. By positioning the Compliance Officer closer to the board, SEBI aims to ensure that compliance considerations are integrated at a higher level of management, thereby enhancing the overall culture of compliance within the listed entity. This also empowers the Compliance Officer to effectively communicate compliance-related concerns to the highest levels of management and facilitates quicker and more decisive action on compliance matters.

In a move that further ignites the importance of the Compliance Officer role, the amendment mandates their designation as a Key Managerial Personnel (KMP). The concept of KMP is well-established under the Companies Act, 2013, and includes senior management personnel who have significant influence over the functioning of the company. Designating the Compliance Officer as a KMP aligns their responsibilities and potential liabilities with those of other key decision-makers such as the Managing Director (MD), Chief Executive Officer (CEO), and Chief Financial Officer (CFO). This designation reinforces the accountability of the Compliance Officer to the stakeholders and regulatory authorities for ensuring adherence to applicable laws and regulations, thereby elevating the significance of the role within the corporate structure.

Recognizing the unique challenges faced by entities undergoing insolvency proceedings, the amendment introduces a new sub-regulation (1B) in Regulation 6. This provision specifically addresses vacancies in the office of the Compliance Officer for listed entities where a resolution plan has been approved under Section 31 of the Insolvency and Bankruptcy Code, 2016. It mandates that such vacancies must be filled within three months from the date of the resolution plan’s approval. Additionally, a proviso to this sub-regulation states that during any interim period where the Compliance Officer position is vacant, the listed entity must have at least one full-time KMP managing its day-to-day affairs. This demonstrates SEBI’s proactive approach to ensuring that a robust compliance framework is maintained even during periods of financial distress and corporate restructuring, minimizing the potential for regulatory lapses during such critical times.

Beyond the specific enhancements to the Compliance Officer’s role, the December 2024 amendment also included the omission of Regulation 7(3). This deletion removes the previous requirement for listed entities to submit a compliance certificate to the stock exchange, which was to be signed by both the Compliance Officer and the authorized representative of the share transfer agent. This change suggests a potential shift in regulatory focus towards placing greater reliance on the individual responsibility of the Compliance Officer and other internal mechanisms for ensuring compliance, rather than a joint external certification. It could also indicate SEBI’s move towards streamlining compliance procedures and reducing potential redundancies.

III. SEBI Circular on Clarification of Compliance Officer Position (April 2025): Defining the “Level”

Following the issuance of the December 2024 amendment, SEBI received queries from listed entities seeking clarity on the interpretation of the term “level” as used in the revised Regulation 6(1) of the LODR Regulations. To address these ambiguities and ensure consistent implementation of the new requirements, SEBI issued a circular on April 1, 2025, bearing the reference number SEBI/HO/CFD/PoD2/CIR/P/2025/47. This circular provides a crucial clarification regarding the meaning of “one-level below the board of directors.” SEBI explicitly stated that this phrase refers to a position directly below the Managing Director (MD) or Whole-time Director(s) (WTDs) who are part of the Board of Directors of the listed entity. This clarification provides much-needed certainty for listed entities, particularly those with an MD or WTD on their board, ensuring a uniform understanding of the required reporting structure for the Compliance Officer. This removes potential inconsistencies in interpretation and facilitates smoother implementation of the amended regulations.
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Recognizing the diverse organizational structures prevalent among listed entities, the circular also provides specific guidance for companies that do not have an MD or a WTD. In such cases, SEBI clarified that the Compliance Officer cannot be positioned more than one level below the Chief Executive Officer (CEO), Manager, or any other individual responsible for heading the day-to-day affairs of the listed entity. This ensures that even in the absence of a traditional MD or WTD, the Compliance Officer still occupies a sufficiently senior position within the organizational hierarchy, maintaining the intended level of authority and access. This demonstrates SEBI's pragmatic approach in tailoring the regulatory requirements to accommodate different organizational models while upholding the core objective of ensuring a senior and empowered Compliance Officer.

Furthermore, SEBI emphasized that this interpretation of the term “level” is in alignment with regulation 2(1)(o) of the LODR Regulations, which defines “key managerial personnel” by referencing section 2(51) of the Companies Act, 2013. This alignment between SEBI’s listing regulations and the broader corporate law framework in India reinforces the consistency and coherence of the regulatory landscape. By linking the seniority requirement for the Compliance Officer to the definition of KMP under the Companies Act, SEBI ensures a unified approach to identifying and positioning key managerial personnel within listed entities.

IV. Impact and Implications for Listed Entities:

The December 2024 amendment and the subsequent April 2025 circular have profound implications for listed entities in India, primarily centered around the enhanced status and responsibility of the Compliance Officer. These regulatory changes collectively elevate the Compliance Officer’s role from a primarily administrative function to a more strategic and influential position within the organization. Listed entities are now expected to empower their Compliance Officers to play a more proactive role in ensuring regulatory adherence and fostering a strong culture of compliance. This shift reflects a growing global recognition of the critical importance of compliance in mitigating risks, maintaining investor confidence, and upholding the integrity of the capital markets.

To comply with these new regulations, listed entities may need to undertake a comprehensive review and potential adjustment of their existing organizational structures. Companies where the Compliance Officer currently reports to a level of management more than one step below the board (or the MD/WTD or CEO/Manager in their absence) will need to restructure their reporting lines and responsibilities to meet the new seniority requirements. This may involve creating new reporting structures or redefining the roles and responsibilities of other senior management personnel to ensure the Compliance Officer has a direct reporting line to the appropriate authority.

The designation of the Compliance Officer as a KMP carries significant implications in terms of increased accountability and potential liabilities under the Companies Act, 2013. Compliance Officers, now recognized as key decision-makers, will be subject to the same level of scrutiny and held to the same standards as other KMPs. This necessitates that individuals appointed to this role possess the requisite expertise, experience, and integrity to effectively discharge their responsibilities. Listed entities must ensure that their Compliance Officers are equipped with the necessary resources, authority, and support to fulfill their expanded mandate.

Collectively, these changes are expected to significantly strengthen the overall compliance function within listed entities. A more empowered and senior Compliance Officer is likely to lead to the development and implementation of more robust and effective compliance programs. This proactive approach to compliance can help reduce the risk of regulatory violations, penalties, and reputational damage, ultimately contributing to better corporate governance and enhanced investor trust.

For many listed entities, the existing Company Secretary, if possessing the requisite qualifications and experience, is likely to be designated as the Compliance Officer, thus fulfilling both roles. However, the enhanced responsibilities and elevated seniority associated with the Compliance Officer role may lead to an increased workload for Company Secretaries. Companies should therefore assess the existing capacity and provide adequate support and resources to their Company Secretaries to enable them to effectively manage their expanded scope of responsibilities. This may include providing additional staff, training, or technological tools to assist in managing the increased demands of the combined role.

V. Conclusion:

The SEBI (Listing Obligations and Disclosure Requirements) (Third Amendment) Regulations, 2024, and the subsequent clarification circular issued in April 2025, represent a significant step towards strengthening the corporate governance framework for listed entities in India. By mandating that the Compliance Officer be a whole-time employee, hold a senior position not more than one level below the board, and be designated as a Key Managerial Personnel, SEBI has unequivocally emphasized the critical importance of the compliance function. The clarification provided in the April 2025 circular regarding the interpretation of the term “level” further ensures consistency and clarity in the implementation of these regulations across all listed entities. It is now incumbent upon listed entities to adapt to these regulatory updates by reviewing their organizational structures, empowering their Compliance Officers, and fostering a strong culture of compliance to ensure continued adherence to regulatory requirements and maintain the trust of their investors.

Source : SEBI Circulars
Clarification on the position of Compliance Officer in terms of regulation 6 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 – April 1, 2025

https://www.sebi.gov.in/legal/regulations/dec-2024/securities-and-exchange-board-of-india-listing-obligations-and-disclosure-requirements-third-amendment-regulations-2024_89956.html – Dec 12, 2024

Industry update – Guidelines for Common Bio Medical Waste Treatment

April 23, 2025April 23, 2025by valueaddedin1 Comment

Guidelines for Common Bio-medical Waste Treatment and Disposal Facilities

The Guidelines for Common Biomedical Waste Treatment and Disposal Facilities (CBWTFs) were introduced by the Central Pollution Control Board (CPCB) under the Ministry of Environment, Forest and Climate Change (MoEF&CC), Government of India.

These guidelines aim to ensure the safe, scientific, and environmentally sound handling of biomedical waste generated by healthcare facilities.

CBWTF stands for Common Biomedical Waste Treatment and Disposal Facility. It is a centralized facility designed to collect, treat, and dispose of biomedical waste generated from healthcare facilities (such as hospitals, clinics, laboratories, etc.) within a specific region.

As the amount of biomedical waste continues to increase—especially after the COVID-19 pandemic—the need for centralized facilities that can efficiently serve multiple healthcare units has become more urgent. They are especially important for smaller healthcare units that lack the resources to treat waste independently. By standardizing procedures and encouraging centralized treatment, these guidelines help minimize health risks, environmental pollution, and legal non-compliance.

The guidelines establish standards for site selection, infrastructure requirements, waste collection, transportation, treatment, disposal, staff safety, and legal compliance.

Click here to read the Guideline document

Source: https://cpcb.nic.in/openpdffile.php?id=TGF0ZXN0RmlsZS80NDBfMTc0NDgwMDgzMl9tZWRpYXBob3RvMTA1MjUucGRm

Industry Update – Programme on Implementation of NABH 1st Edition Digital Health Standards for Hospitals

April 23, 2025April 23, 2025by valueaddedinLeave a comment

Programme on Implementation of NABH 1st Edition Digital Health Standards for Hospitals

NABH (National Accreditation Board for Hospitals and Health Care Providers) is organizing 2 days training on ” NABH 1^st Edition Digital Health Standards for Hospitals” in an online mode

Objective of the Programme: The objective of this programme is to provide guidance to healthcare providers, healthcare administrators and Healthcare IT personnel on implementation of NABH standards

The aim of the programme is to develop Internal Counsellors within the hospitals for helping them to work towards implementation of Digital Health Standards for quality and patient safety, achieving accreditation and maintaining the same.

Who Should attend: Owners of healthcare organization, CTO`s of the Hospitals, Healthcare IT personnel, HMIS and EMR product owners/employees, medical professional, nursing professional, medical administrators, para medical staff, etc. NABH encourage to keep the group a mix of professionals from diverse healthcare background.

Registration: Click the link https://portal.nabh.co/EventDetails.aspx?id=271#gsc.tab=0

Please click on “Click to Register” on the preferred batch. After you register, Login with the registered credentials, go to Education and Training, go to the programme you have registered for and “Click to Register” and pay the registration fees.

Registration fee (non-refundable & non-changeable) is Rs. 8,000/- + GST @ 18% (total Rs. 9,440/).

The fees would include Guidebook of 1^st Edition Digital Health Standards for Hospitals course material. It is a nonresidential programme.

Program Schedule : Virtual Mode
Dates – April 26-27, 2025
May 17-18,2025

Limited Seats are available and will be allotted on ‘first cum first serve’ basis

For any queries please contact:

Mr. Vikash Chaudhary
Assistant Director
National Accreditation Board for Hospitals & Healthcare Providers (NABH)
Quality Council of India
ITPI Building, 5th Floor,
4 – A, Ring Road, I P Estate,New Delhi – 110002
Tel: +91 11 42600622
Fax: +91 11 233 23 415
Email: vikash@nabh.co

Source: https://nabh.co/

Industry Update – Revision of Risk based Classification of Medical Devices – CDSCO

April 7, 2025April 7, 2025by valueaddedinLeave a comment

Revision of Risk based Classification of Medical Devices – CDSCO

Central Drugs Standard Control Organisation (CDSCO) has revisited the existing risk based classification of Medical Devices in the categories of Cardiovascular and Neurological and added new entries based on their classification as per the First Schedule (Part I) of the MDR 2017

In this regard, CDSCO has issued a notification dated 1^st April 2025, inviting all Stakeholders in the Medical Devices sector, such as Healthcare professionals, Manufacturers, Policymakers, Regulatory bodies, and other entities involved in the classification and regulation of medical devices to review the draft document and provide feedback within 30 days of publication to refine the risk-based classification framework for medical devices.

All concerned associations/stakeholders are requested to forward your comments by filling the Google form at https://forms.gle/62xF3BtXWC5pgD3TA within 30 days from the date of publication of this draft.

Click here for the List

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI2MjM=

Industry Update – Boot-camp by FABA

April 7, 2025April 7, 2025by valueaddedinLeave a comment

A month-long intensive boot-camp (8 May-4 June 2025) is organised by Federation of Asian Biotech Associations (FABA) on Foundations in MICROBIOLOGY, MOLECULAR BIOLOGY, CELL CULTURE & SOFT SKILLS

The Federation of Asian Biotech Associations (FABA) and Indian Immunologicals Limited (IIL), jointly organising a One-month program – Foundations in MICROBIOLOGY, MOLECULAR BIOLOGY, CELL CULTURE & SOFT SKILLS.

This one-month course will provide students with a strong foundation in microbiology, molecular biology, and cell culture techniques, enabling them to pursue further studies or research in these exciting fields.

About the Organisers :

The Federation of Asian Biotech Associations (FABA) is a non-profit organization established in 2004 for providing a platform for academy, industry, and government bodies. FABA has launched the FABA academy to bridge the gap between academy and industry in human resources development by providing professional development programs to science graduates (https://biofaba.org.in/).

Indian Immunologicals Limited (IIL): Indian Immunologicals Ltd (IIL) is the market leader in veterinary and human biologicals in India. It manufactures over 150+ products. IIL operates one of the largest plants in the world for veterinary vaccines. IIL has adequate infrastructure and cold chain distribution capability to reach out to various parts of India and world market.

Why choose this program?

Comprehensive curriculum covering microbiology, molecular biology, and cell culture
Hands-on laboratory experience with cutting-edge techniques and equipment
Career development through professional soft skills training
Expert instruction from experienced faculty members
Industry-relevant skills that enhance employability
Networking opportunities with professionals in the field

What you’ll learn:

Technical Skills:

Microbial culture techniques and analysis
DNA isolation, PCR, and gel electrophoresis
Cell culture maintenance and advanced applications
Laboratory safety and aseptic techniques
Experimental design and data analysis

Professional Skills:

Scientific literature searching and evaluation
Laboratory notebook maintenance
Career development strategies
Personal branding and CV building
Using AI tools for scientific research

Faculties to Program

Project Head: Dr. M V Jagannadham is a distinguished scientist with a Ph.D. in Life Sciences from Jawaharlal Nehru University, New Delhi. He served as Chief Scientist at CCMB, Hyderabad, visiting professor, University of Hyderabad and currently scientific committee member of FSSAI, New Delhi, specializing in mass spectrometry, protein chemistry and proteomics.

Industry experts will share practical insights and cutting-edge applications in biotechnology, providing participants with valuable industry perspectives and networking opportunities.

Experienced faculty members with expertise in microbiology, molecular biology, and cell culture.

Program Fee:

Students (Undergraduates/Graduates/Postgraduates) – Rs. 10,000

Faculties/Ph.Ds and Postdocs -Rs. 15,000

Industry Professionals- Rs. 20,000

Application Deadline: 1st May 2025

Course Period : 8th May to 4th June 2025

Since the experiments are hands-on, seats are limited to only 20. Apply early to secure your spot in this careerenhancing program.

How to Apply

Registration Fee Payment

Bank Details:

Name of the account: Federation of Asian Biotech Associations
Bank Name & Branch: Indian Overseas Bank / Rajbhavan Road
Account number: 118001000010387
Account type: Savings Bank
IFSC Code: IOBA0001180
Bank Address: R.V.S. Kamala Castle, Raj Bhavan Road, Somajiguda, Hyderabad 500082

Please upload a screenshot of your payment:

Selection Process

• Selection Criteria:
Participants will be selected based on:
– Academic/professional background relevance
– Statement of purpose submitted in this application
– Order of registration (for equally qualified candidates)
– Institutional diversity (to ensure representation across organizations)

• Notification Timeline:
All applicants will be notified about their selection status by May 1, 2025.

• Refund Policy:
If you are not selected for the program, your full registration fee will be automatically refunded to your original payment method within 5 business days of notification.

Early registration is appreciated as applications are reviewed on a rolling basis.

For any questions regarding the selection process, please contact
Dr. T.N.G. Sharma at info@biofaba.org.in or +91 7989957263.

Contact Information

Federation Of Asian Biotech Associations (FABA)
Agri Biotech Foundation Campus,
Rajendra Nagar, Hyderabad
Dr. T N G Sharma, Senior Manager
Email: info@biofaba.org.in
Ph: +91 7989957263

Dr. Jagadeesh Gandla Chief Operating Officer
Email: coo@biofaba.org.in
Ph: +918074648547

Click here for Brochure

Source: https://biofaba.org.in/

Industry update – Release of India Bioeconomy Report 2025

April 7, 2025April 7, 2025by valueaddedinLeave a comment

India Bioeconomy Report 2025

Union Minister of Government of India has released the “India Bioeconomy Report 2025” (IBER 2025) at the BIRAC Foundation Day ceremony at the National Media Centre

During the meeting the following informations were shared on India’s Bio Economy Growth :

India’s bioeconomy has grown from $10 billion in 2014 to $165.7 billion in 2024, marking a 16-fold increase. This growth is attributed to the government’s commitment to fostering biotechnology as a key economic pillar.

The bioeconomy now contributes 4.25% to India’s GDP, comparable to major economies like the US and China

The number of biotech startups has surged from 50 to over 10,075, showcasing a thriving ecosystem.

Government has recently approved BIO-E3 Policy i.e Biotechnology for Economy, Employment, and Environment—which aims to accelerate research, innovation, and entrepreneurship in the sector. Assam is the first state to adopt this framework. Under this policy, initiatives such as Bio-AI Hubs, Bio foundries, and bio-enabler hubs will be set up to integrate advanced technologies with biomanufacturing.

Government has initiated BioSaarthi, a pioneering global mentorship initiative aimed at nurturing biotech startups. Designed as a six-month cohort, BioSaarthi will facilitate structured mentor-mentee engagements, offering personalized guidance to emerging entrepreneurs in the biotech sector. This initiative will strengthen India’s biotech ecosystem by fostering innovation, enhancing industry-academia collaboration, and positioning Indian startups for global success. The initiative would engage overseas experts, particularly from Indian diaspora as international mentors who would volunteer to give back to the society

The Key highlights of the India BioEconomy Report (IBER) 2025 :

Sector Growth

India’s bioeconomy grew by 9.8% in 2024, reaching $165.7 billion, contributing 4.25% to the national GDP, aligning with global leaders like the US (5%) and China (4%)
The sector is on track to achieve $300 billion by 2030 and $1 trillion by 2047, with required compound annual growth rates (CAGR) of 10.6% (2024–2030) and 7.5% (2030–2047)

Segment Contributions

BioIndustrial led with a 47.2% share, followed by BioPharma at 35.2%
Maharashtra emerged as the top contributing state, followed by Karnataka and Telangana

Startup Ecosystem

India now has over 10,075 biotech startups, supported by initiatives like Bio-Nests, which provide incubation facilities
Plans include expanding incubation spaces to 2 million square feet and establishing a $3 billion Biotech Venture Fund by 2028

Policy Recommendations

The report outlines strategies across five key sectors: BioPharma, BioAgri, BioIndustrial, TechMed, and startups:

Launching a National Bio-fortification Mission.
Establishing biomanufacturing consortia and incentivizing academic-industry collaborations.
Strengthening the Ayushman Bharat Digital Mission to enhance healthcare delivery

Strategic Roadmap

The “5-5-5 Model” emphasizes:

Five key sectors for focus.
Five implementation phases (e.g., acceleration phase in 2025–2026).
Five core enablers: policy reforms, skilled workforce, shared infrastructure, partnerships, and global promotion

Frontier Technologies

Five transformative technologies identified for disproportionate growth include:

Cell & Gene Therapy.
Synthetic Biology.
AI + Biology integration.
Precision Agriculture.
Biomanufacturing

Regional Clusters

Specialized regional clusters are being developed:

Bengaluru-Mysore-Mangalore for BioPharma and Digital Health.
Hyderabad for vaccines and biosimilars.
Pune-Mumbai for industrial biotechnology

The IBER 2025 underscores India’s potential to become a global leader in biotechnology through coordinated efforts in policy-making, infrastructure development, and innovation promotion.

Click here to read the full report of IBER 2025

Source: https://pib.gov.in/PressReleasePage.aspx?PRID=2113745

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/

CROs Registration

March 9, 2025March 10, 2025by valueaddedinLeave a comment

Launching of registration of Clinical Research Organisation applications through SUGAM Portal

The Ministry of Health and Family Welfare has published G.S.R. 581(E) dated 19th September 2024, wherein registration of Clinical Research Organisation (CRO) has been made mandatory with effective from 1st day of April, 2025.

In this regard, the online registration of Clinical Research Organisation (CRO) is now functional on SUGAM portal (www.cdscoonline.gov.in). Applications for registration shall be submitted through SUGAM portal only along with the prescribed checklist of documents for the registration.

Click here to download Notification

Health Ministry notified Rules to register CROs under NDCTR (New Drugs and Clinical Trials Rules), 2019 and amendment to the Rules was introduced in September 2024 notifying the Chapter on CROs with related requirements to the Registration of CROs in the country. These amended rules shall come into force on and from the 1st day of April, 2025.

The New Drugs and Clinical Trials (Amendment) Rules, 2024, notified on September 19, defines CROs as “the sponsor or a body, commercial or academic or of other category, owned by an individual or an organisation having status of legal entity by whatsoever name called, to which the sponsor may, delegate or transfer in writing, some or all of the tasks, duties or obligations regarding clinical trial or bioavailability or bioequivalence study.”

Amendment in NDCTR on CROs stipulates that no clinical research organisation shall conduct any clinical trial or bioavailability or bioequivalence study of new drug or investigational new drug in human subjects without registration granted by the Central Licencing Authority (CLA) under these rules.

Newly inducted Chapter VA addresses the following :

Registration of Clinical Research Organisation
Application for Registration of Clinical Research Organisation
Grant of registration to Clinical Research Organisation
Validity period and renewal of registration of Clinical Research Organisation
Inspection of Clinical Research Organisation registered with Central Licencing Authority.
Suspension or cancellation of registration of Clinical Research Organisation

Subsequent to this MoHFW has issued a notification of 4th Feb 2025 launching mandatory registration of CROs and applications for the same through Sugam Portal of CDSCO.

Sharing the notifications issued by MoHfW here for references :

Ministry of Health and Family Welfare has published G.S.R. 581(E) dated 19th September 2024 – New Drugs and Clinical Trials (Amendment) Rules (NDCTAR), 2024.

NDCTAR 2024 Notification

STUDY ON CRO SECTOR IN INDIA CONDUCTED BY DEPARTMENT OF PHARMACEUTICALS MINISTRY OF CHEMICALS & FERTILIZERS GOVERNMENT OF INDIA AUGUST, 2023

Department of Pharmaceuticals has released a report of Clinical Research Organisations in the country in 2023 based on a study conducted.

The Pharmaceutical global contract outsourcing market has been picking up after the covid pandemic. During the years between 2022-30, the global contract research outsourcing market is expected to grow @ CAGR of 7 % and reach USD 90.4 Billion by 2030. Out of this about USD 61.2 Billion will be contributed only by the outsourcing done in the domain of clinical development. The CRO sector in India has been growing @ CAGR of 10.75 % and will reach USD 2.5 Billion by the year Hence, it is imperative to identify the emerging opportunities for the Indian CRO sector beforehand, draft and implement strategies which will help in promoting the Indian CRO business.

Under the PMPDS Scheme, the Department of Pharmaceutical, Government of India took an initiative to conduct an independent study on the CRO sector/ market in India to identify and understand the real issues faced by CROs operating in India and work out a proposed roadmap to resolve those issues and make the necessary policy revisions.

Report has detailed information on :

RESEARCH FRAMEWORK
Business Trends in CRO industry
MARKET DYNAMICS
INDIAN CRO MARKET, BY END USER
INDIA CROs CATEGORIZATION, BY SERVICE TYPE
CROs CATEGORIZATION BY THERAPEUTIC AREA
CROs CATEGORIZATION BY LOCATION
CROs CATEGORIZATION BY SIZE
PROFILES OF SOME PROMISING CROs OPERATING IN INDIA
INSIGHTS & RECOMMENDATION

Click here to download the report

Source https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI1Njk=

Industry Update – Sustainability in Healthcare by ISQua Education

February 14, 2025March 6, 2025by valueaddedinLeave a comment

ISQua Education – Sustainability in Healthcare

ISQua Education was created in order to foster a global community of learning and improvement in healthcare quality and safety.

ISQua has partnered with the International Hospital Federation’s Geneva Sustainability Centre and The Centre for Sustainable Healthcare to offer a new introductory course on sustainability in healthcare.

This 6-module course, available with any ISQua Fellowship subscription, explores the healthcare sector’s role in climate change, sustainable quality improvement, and practical steps to reduce waste.

Learn from global case studies and gain tools to drive change within your organization.

Bonus: The first 100 Fellows to complete the course get a free 3-month subscription to GSC’s Carbon Emissions Learning Lab.