Industry update – Release of 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:

  1. Five key sectors for focus.
  2. Five implementation phases (e.g., acceleration phase in 2025–2026).
  3. 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.

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

Industry Update – 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

CROs Registration

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.

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.

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

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

Industry Update – Karnataka Biotechnology Policy 2024-2029 – Operational Guidelines

Karnataka has been at the forefront of biotechnology in India and is rightly known as the biotech capital of India. Over the years, the development of a strong ecosystem and modern infrastructure through a proactive policy framework enabled Karnataka to achieve sustainable development and become the flag bearer of India’s biotechnology growth. Bengaluru, Karnataka’s science capital and Asia’s fastest growing technopolis, has developed into an ideal base for the biotechnology industry.

Department Of Electronics, Information Technology and Biotechnology, Karnataka has released comprehensive operational guidelines for implementing its new Biotechnology Policy 2024-2029.

The guidelines details the executional framework for fiscal incentives and concessions designed to catalyze the state’s biotechnology sector.

The document provides essential information on:

1. Detailed eligibility criteria
2. Application processes
3. Approval mechanisms
4. Incentive structures
5. Compliance requirements

Subsidy and reimbursement amount shall be released/disbursed on seniority basis depending upon the budget allocated under the Policy by the State Government, during the respective financial year.

The Department will put in place required mechanisms that will provide for a conducive environment for application, review, approval and disbursement of these incentives.

This release marks a significant step in Karnataka’s strategic initiative to establish itself as a global biotechnology hub, with a targeted bioeconomy valuation of $100B by 2030. Organizations interested in accessing these benefits can now submit applications through the official portal.

The guidelines ensure transparency and streamlined processing for all stakeholders.

Note: Registration under Karnataka Biotechnology Policy is compulsory to avail the fiscal incentive under policy period

To Register under Karnataka BT Policy, click the link – https://lnkd.in/gVNaYcuS

To access the OPG Document, please click the link – https://lnkd.in/gNyXaurF

To apply for incentives, please click the link – https://lnkd.in/gXSqap9x

Source: https://eitbt.karnataka.gov.in/bt/public/en#

Industry Update – Legal Metrology (Packaged Commodities) Rules, 2011 with amendments

The Ministry of Consumer Affairs, Food, and Public Distribution, Department of Consumer Affairs has issued The Legal Metrology (Packaged Commodities) Rules, 2011 with all amendments up to December 24, 2024.

It outlines the regulations for pre-packaged commodities in India, ensuring that consumers receive accurate information about the products they purchase. 

The rules apply to packages intended for retail sale but exclude certain categories such as:
(a) packages of commodities containing quantity of more than 25 kilogram or 25 litre
(b) cement, fertilizer and agricultural farm produce sold in bags above 50 kilogram
(c) packaged commodities meant for industrial consumers or institutional consumers

The document includes several key amendments to the Legal Metrology (Packaged Commodities) Rules, 2011, compared to earlier versions. ​ Here are some notable amendments:

  1. Consumer Definition Update:
    • The definition of “consumer” has been updated to align with the Consumer Protection Act, 2019. ​
  2. E-commerce Provisions:
    • Definitions for “E-commerce,” “E-commerce entity,” and “marketplace-based model of e-commerce” have been added. ​
    • E-commerce entities must ensure that mandatory declarations are displayed on their digital platforms. ​
  3. Retail Sale Price (MRP):
    • The format for declaring the maximum retail price has been standardized to ensure clarity and consistency. ​
  4. Unit Sale Price:
    • The requirement to declare the unit sale price in rupees, rounded off to the nearest two decimal places, has been introduced. ​
  5. QR Code Usage:
    • For electronic products, the use of QR codes to provide additional information such as the manufacturer’s address, common or generic name, and size/dimensions has been allowed. ​
  6. Packaging Size and Weight:
    • Specific packaging sizes for various commodities have been updated or added, such as for baby food, biscuits, edible oils, and more.
  7. Exemptions:
    • New exemptions have been introduced for certain packages, such as those containing loose commodities ordered through e-commerce channels and garments sold in loose or open form at the point of sale. ​
  8. Inspection and Testing:
    • Detailed procedures for inspecting and testing packages at the premises of manufacturers, packers, and dealers have been specified, including the use of statistical methods to determine compliance. ​
  9. Penalties and Compounding of Offenses:
    • The penalties for non-compliance have been updated, including specific fines for different types of offenses. ​
    • The sum for compounding offenses has been specified, with different amounts for retailers, wholesale dealers, manufacturers, and importers. ​
  10. Registration Requirements:
    • The process for registering manufacturers, packers, and importers has been clarified, including the requirement to provide a complete address and the option to register a shorter address. ​
  11. Declaration of Quantity:
    • The rules for declaring the net quantity of commodities have been refined, including the requirement to exclude the weight of wrappers and materials other than the commodity. ​
  12. Best Before/Use by Date:
    • The requirement to declare the “best before” or “use by” date for commodities that may become unfit for human consumption after a period of time has been emphasized. ​

These amendments aim to enhance consumer protection, ensure transparency, and adapt to the evolving marketplace, including the rise of e-commerce.

The e book of  Legal Metrology (Packaged Commodities) Rules, 2011 can be downloaded from https://doca.gov.in/lm-ebook/

source: https://doca.gov.in/lm-ebook/

Industry updates: Webinar on Export of Environmental Services to Argentina and Brazil

Service Export Promotion Council (SEPC) is inviting participation from the industry in Webinar on Export of Environmental Services to Argentina and Brazil. Friday, 7-Feb- 2025 4:30PM to 6:00PM IST (8:00AM to 9:30AM BRT/ART)*

Embassy of India in Argentina and Brazil will be addressing the industry stakeholders of Environmental services sector

This exercise aims to strengthen the commercial ties between the industry members of both the countries promoting Indian exports in environmental sectors through dialogue, knowledge exchange and generation of strategic action plan for 2025-26.

Topics covered :

a.Investment opportunities in Brazil for Indian Environmental consultants.
b.Any specific challenge in exporting to Brazil.
c.Any specific competence of Indian workforce required to compete in Brazil.
d.Suggest international fairs, expos, or virtual platforms for participation in Brazil.

Program highlights :


▪Valuable insights into emerging opportunities and challenges in Environmental sector.
▪Opportunity to interact with distinguished speakers from the Embassies of both the countries.

This event is set to be a platform for the exchange of ideas and the development of cooperation strategies in this sector, consolidating India’s role as a strategic partner in Their economic sphere.

Program Date & Time

Date: February 7th, 2025
Time: 4:30 PM – 6:00 PM (IST) | Platform: Online

Registration :

Click the link below for Registration
https://docs.google.com/forms/d/e/1FAIpQLSePLIyR4RkvS4eaq7F4QclQtumFhsvwUT98mkB8aUfIng8hBA/viewform?usp=mail_form_link

For more Details, please contact

Mr. Deepak Kumar Verma 8178262474 verma.deepak@servicesepc.org
Ms. Manisha Gosain 9810796729 manisha.gosain@servicesepc.org

Source: https://www.servicesepc.org/upload/Forthcoming_Event/Circular%20Environmental%20Services%20Webinar_9619.pdf

Industry Update – Guidance Document

Indian Council of Medical Research (ICMR) in coordination with Central Drugs Standard Control Organisation (CDSCO) has published a Guidance Document on Validation of Rapid Diagnostics for Pathogen Identification and Antimicrobial Susceptibility Testing (AST)

This document provides guidance for innovators and testing laboratories on validating diagnostics for pathogen identification and antimicrobial susceptibility testing.

It outlines a systematic framework to evaluate diagnostic performance, focusing on precision, accuracy, reproducibility, and the ability to detect target pathogens or their genetic materials (e.g., DNA, RNA, toxins, or antigens).

It also includes methods for antimicrobial susceptibility testing and prepares developers for the validation process by detailing evidence requirements and regulatory approval pathways.

Prepared by the AMR Coordination Unit of ICMR, this third draft incorporates expert feedback and inputs from the Central Drugs Standard Control Organization (CDSCO).

The document is designed to evolve with advancements in technology and methodologies, ensuring reliable diagnostics for clinical decision-making.

Source: https://www.icmr.gov.in/icmrobject/uploads/Guidelines/1736941384_guidancedocument_amrdiagnostics_revised.pdf

Industry Updates : Import of refurbished medical devices are not allowed – CDSCO

Central Drugs Standard Control Organisation (CDSCO) regulates Quality, Safety and Performance of the Medical Devices under Drugs and Cosmetics Act, 1940 and Medical Devices Rules 2017.


To control the second-hand / unregulated medical devices in the country, recently CDSCO has issued a letter to the Principal Commissioner of Customs, New Delhi, clarifying that No separate license is issued for import of refurbished medical devices in the country. Following points are covered in the communication

  1. All the Medical Devices are regulated under Medical Devices Rules 2017
  2. However, there is no specific provision for regulation of refurbished medical devices under the said Medical Devices Rules 2017         
  3. Hence no license is issued for import of such devices and it cannot be imported in the country under Medical Devices Rules 2017 for sale and distribution.

Industry Update – DPDP Rules 2025 – Draft

The Ministry of Electronics and Information Technology (MeitY) has released the draft ‘Digital Personal Data Protection Rules,2025’.

The draft rules along with a explanatory note of the rules in plain and simple language to facilitate ease of understanding are available on Ministry’s website at www.meity.gov.in/data-protection-framework.

The feedback/comments on the draft rules in a rule wise manner may be submitted by 18th February 2025 on MyGov portal at the link : https://innovateindia.mygov.in/dpdp-rules-2025/

Source: https://www.meity.gov.in/writereaddata/files/259889.pdf

Industry Update – Standard IVD Evalution protocols

Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly issued the Draft Standard IVD Evaluation Protocols

The document outlines the need for standardized evaluation protocols for IVDs as mandated by the Medical Devices Rules 2017. These protocols are essential to ensure the quality and performance of diagnostic kits used in India

Several specific performance evaluation protocols have been drafted, including those for:

a. Chikungunya IgM ELISA
b. Dengue NS1 RDT and ELISA
c. Zika virus real-time PCR , among others

The document includes detailed guidelines for evaluating various IVDs, emphasizing:

i. Study design and ethical considerations
ii.Requirements for evaluation sites and laboratory standards
iii.Procedures for conducting diagnostic accuracy studies
iv.Acceptance criteria for sensitivity and specificity of tests.

This initiative by ICMR and CDSCO aims to enhance the reliability of diagnostic testing in India through structured evaluation processes, ensuring that manufacturers adhere to high standards of quality in their products. Stakeholder engagement is critical to refining these protocols before their final adoption.

Stakeholders are invited to provide comments on these protocols until February 15, 2025.

Comments should be submitted via email before 15th February 2025, at ivdevaluation@gmail.com as per the specified format given in the notification

Source: https://www.icmr.gov.in/icmrobject/uploads/WhatsNew/1735801120_advt_ivd_document.pdf