ONDLS

As an MDR Consultant, my core mission is to empower you to successfully navigate the intricate landscape of India’s Medical Device Rules, 2017 (MDR 2017). A crucial element in this journey is understanding and effectively utilizing the National Single Window System (NSWS) portal.

What is the NSWS Portal?

The NSWS (www.nsws.gov.in) is a landmark initiative by the Government of India, designed as a unified digital platform for all business-related approvals and clearances. It’s an ambitious endeavor to create a “one-stop shop” for investors, aiming to simplify and accelerate the process of setting up and operating a business in India.

How Does NSWS Impact the Medical Device Industry?

For the medical device sector, the NSWS portal is transforming how regulatory approvals are sought from the Central Drugs Standard Control Organization (CDSCO). It directly addresses the complexities previously faced by manufacturers, importers, and authorized agents.

Key Contributions to Your Medical Device Business:

1. Centralized Application Process: No more juggling multiple portals or physical submissions for specific approvals! The NSWS portal now serves as the single point of entry for crucial applications under MDR 2017.
2. Mandatory for Key Applications: As of January 1, 2024, certain vital applications are exclusively processed through NSWS. These include:
• Form MD-01: Application for Certificate of Registration of a Notified Body.
• Form MD-12: License to manufacture medical devices for R&D, testing, evaluation, demonstration, or training.
• Form MD-16: License to import medical devices for R&D, testing, evaluation, demonstration, or training.
• This shift signifies the government’s commitment to a streamlined, digital-first approach.
3. Enhanced Transparency & Predictability: The portal offers real-time application tracking and provides clear guidelines, reducing ambiguity and allowing for better planning and forecasting.
4. Efficiency and Cost-Effectiveness: By digitizing and consolidating the application process, NSWS significantly cuts down on processing times and associated administrative costs, improving your operational efficiency.
5. Promoting “Ease of Doing Business”: The NSWS aligns with India’s broader vision to attract investment and foster domestic manufacturing in the medical device sector. By simplifying regulatory compliance, it creates a more favorable environment for innovation and growth.
6. Secure and Centralized Document Management: Uploading documents once and attaching them to multiple applications saves time and reduces the risk of errors.

What This Means for You (Our Client):

As your MDR Consultant, I will guide you through the NSWS portal, ensuring:

• Accurate Identification of Approvals: Utilizing the “Know Your Approvals” (KYA) module to precisely determine your compliance requirements.
• Seamless Application Submission: Assisting with the correct preparation and submission of all necessary forms (e.g., MD-01, MD-12, MD-16) and supporting documentation on the NSWS portal.
• Proactive Status Monitoring: Keeping you informed about the real-time progress of your applications.
• Resolution of Queries: Liaising with regulatory authorities through the NSWS platform for any clarifications or requests.

The NSWS portal is a pivotal tool for achieving timely and compliant medical device approvals in India. By leveraging its capabilities, we can accelerate your market entry and ensure continuous adherence to the Medical Device Rules, 2017.

Contact us today to discuss how we can integrate NSWS into your regulatory strategy for optimal results.

Authentical Source References:

• NSWS Official Website: www.nsws.gov.in (This is the most authentic source for the portal itself and its functionalities).
• CDSCO Notifications: The Central Drugs Standard Control Organization (CDSCO) frequently issues notifications regarding the transition of various medical device applications to the NSWS portal. These are available on the CDSCO website (cdsco.gov.in).
• Invest India: As a lead developer of the NSWS portal, Invest India’s resources and reports also provide authentic information.
• Medical Device Rules, 2017: The foundational regulation under which these applications are made.

By presenting this information, you demonstrate a clear understanding of the regulatory environment and how the NSWS portal directly benefits medical device companies seeking approvals in India.

Service: ONLDS

As MDR (Medical Device Rules) Consultants, we specialize in guiding businesses through the regulatory landscape of medical devices in India. However, the modern healthcare sector often demands a broader understanding of compliance, especially when operations span both medical devices and pharmaceutical products. This is where the Online National Drugs Licensing System (ONDLS) portal becomes a crucial tool.

Developed by the Centre for Development of Advanced Computing (C-DAC) in collaboration with the Central Drugs Standard Control Organization (CDSCO) and State Drug Control Authorities, ONDLS is India’s dedicated single-window digital platform for all drug-related licensing and certifications. It represents a significant step towards a more transparent, efficient, and streamlined regulatory process for the pharmaceutical industry.

While our core expertise lies with medical devices, we understand that many clients require drug licenses for diversified portfolios, specific distribution models, or ancillary healthcare products. Our role is to simplify these parallel regulatory pathways, ensuring your comprehensive compliance.

Wholesale & Retail Drug Licenses: Your Essential Checklist via ONDLS

Whether your business involves the bulk distribution (Wholesale) or direct-to-consumer sales (Retail) of pharmaceutical products, obtaining the correct drug license is a non-negotiable legal requirement. These licenses are critically governed by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, safeguarding public health and maintaining product integrity across the supply chain.

The application process for both Wholesale Drug Licenses (WDL) and Retail Drug Licenses (RDL) is primarily conducted online through the ONDLS portal. To assist you, we’ve compiled a precise checklist of required documents, reflecting the latest departmental expectations for a smooth application:

1. Firm’s Legal Foundation: * Constitutional Documents: Your Partnership Deed, or Memorandum of Association (MOA) and Articles of Association (AOA), reflecting the legal structure of your business. * Stakeholder List: A comprehensive list of all Partners or Directors on your company letterhead. * Changes in Directorship: Any relevant forms documenting changes in Directors, if applicable. * Partnership/Dissolution Deed: If a partnership firm, a notarized deed on a ₹1000/- stamp paper.

2. Key Declarations (Affidavits): * Applicant’s Affidavit: A sworn statement from the Proprietor, Partner, or Director confirming compliance and other legal undertakings. * Personnel Affidavit: An affidavit from the Registered Pharmacist (for RDL) or Competent Person (for WDL), confirming their full-time engagement and supervisory role.

3. Identity & Address Verification: * For Proprietor/Partner/Director: Mandatory Aadhar Card, along with proof of both permanent and present addresses (e.g., Ration Card, Voter ID). * For Registered Pharmacist/Competent Person: Aadhar Card, permanent and present address proofs. Crucially, if living in rented accommodation, a Rent Agreement with Police Verification is required.

4. Professional Qualifications & Experience: * For Proprietor/Partner/Director: At least a Matriculation (10th) certificate and six recent passport-sized photographs with your name. * For Registered Pharmacist/Competent Person: * Academic credentials: 10th (Matriculation), 12th (10+2) certificates, and relevant marksheets (e.g., Diploma/Degree, B.Pharmacy Final Year). * Valid Pharmacy Council Registration: Up-to-date registration certificate from the relevant State Pharmacy Council (e.g., Haryana State Pharmacy Council), with validity proof. * Recent Photographs: Six passport-sized photographs, clearly displaying their Name and Pharmacy Council Registration Number. * Employment History: Last three years’ working statements or resignation letter from previous employment.

5. Operational Premises & Facility Documentation: * Authorization (for Companies): Board of Resolution or Power of Attorney in favor of a responsible director to apply on behalf of the firm. * Temperature Control Proof: Purchase receipt for your refrigerator. * Premises Occupancy: Rent Agreement along with the latest Rent Receipt (if rented) and the Commercial Electricity Bill for the premises. * Premises Layout: A clear A-4 size Blue Print of the premises. * Photographic Evidence: * A postcard-sized photograph of the exterior of your premises. * Photographs clearly showing signboards of adjoining shops on both sides for location context. * Internal photographs that fully showcase the complete drug storage area. * Surveillance System: The purchase bill for a CCTV Camera system for premises surveillance. This is increasingly a key requirement for many State Drug Control Authorities to ensure security and monitoring.

Our Expertise: Streamlining Your Drug License Application

Even with a primary focus on medical device compliance, our team offers comprehensive support to navigate these crucial drug licensing processes through ONDLS. We provide:

• Precise Document Management: Guiding you through each item on this detailed checklist, ensuring all documents are meticulously prepared, correctly formatted, and ready for online submission, minimizing rejections.
• ONDLS Portal Expertise: Seamless assistance with online registration, accurate form selection (e.g., Form 19, 20, 20B, 21, 21B, 20C, 20D, 20F, 20G), and efficient uploading of your complete application.
• Inspection Readiness: Expert advice on setting up your premises to meet all regulatory standards, including optimal placement of essential equipment (AC, refrigerator, CCTV), and ensuring your qualified personnel are prepared.
• Proactive Regulatory Liaison: We act as your point of contact with State Drug Control Authorities, handling queries, addressing potential discrepancies, and diligently tracking your application’s progress from submission to successful license issuance.

By partnering with us, you ensure your wholesale or retail drug distribution operations are not only legally compliant but also efficiently integrated into your broader healthcare business strategy.