- Your Strategic Partner For Regulatory Compliance
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.
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.
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:
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.
MDR consultants offer free initial consultations to discuss your specific needs. This allows you to assess their expertise and get a feel for their approach. Additionally, request quotes from several consultants to compare pricing and services before making a decision.
Please feel free to talk to us if you have any questions.
We endeavour to answer within 24 hours.