In CDSCO matters, CliniExperts guidance matters
Central Drugs Standard Control Organization (CDSCO) Registration & Approval
CDSCO is India’s federal agency responsible for the pan-India enforcement of the Drugs and Cosmetics Act. Operating under the Ministry of Health & Family Welfare, the agency imposes end-to-end compliance of this Act. The primary aim is to ensure the quality, safety, and effectiveness of healthcare products before and after they are in the market. With over 13 years of expertise, CliniExperts is now India's top name for all things related to CDSCO compliance.
Over 850+ companies choose CliniExperts because we make sure they follow the CDSCO guidelines perfectly.
Understanding CDSCO And The Drugs And Cosmetics Act
It is India’s central drug authority, entrusted with the primary duty of enforcement of the Drugs and Cosmetics Act 1940, and Rules 1945. It has offices spread across India and a decentralized organizational structure, working with the Drugs Controller General of India (DCGI). The Zonal level operations play a crucial role in the overall functioning of the authority across the entire geography of India.
CDSCO's vision and mission propagate promotion and protection of citizens' health and well-being.
CDSCO works to keep a constant watch on the safety, effectiveness, and quality of drugs, cosmetics, and medical devices. This is all part of commitment to build an ethical healthcare system with a strong focus on quality.
CDSCO’s functional responsibilities integrate entire pre- and post-market product lifecycles. These involve tests, evaluation, approval, licensing, and continuous market-centric monitoring. The key steps include clinical trials, ensuring drug standards, evaluating new drugs, granting approvals, issuing licenses, and maintaining quality control for imported drugs and raw materials. CDSCO's responsibilities cover drugs, biologicals, cosmetics, medical devices, veterinary products, and Ayush products.
Product Categories Associated
Drug
This is CDSCO's most extensive area of operation, where it manages the entire process of drug approvals, imports, and post-market activities. It also involves coordinating, following up, and supervising state authorities in these matters. Visit this page to know more.
Medical devices
CDSCO regulates the registration and sale of these devices, with the DCGI overseeing the entire process cycles. CliniExperts has an entire section to explain this process at this page.
Cosmetics
CDSCO manages the production of cosmetic products through its state-level authorities, while it regulates imported products through the central authority. Visit CliniExperts’ page to know more.
Biologicals
Biological products, such as vaccines and allergenic extracts, are important for human health. Before they are deemed safe and effective, they have to go through rigorous quality checks. To better understand how all of this works, visit the page here.
Types of registrations handled
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Fresh Registration (Cos-2) |
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Permission for new cosmetic |
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Product Compliance |
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Authorised agent support - Cosmetic |
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Test License for Manufacturer |
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Authorised agent support - Drug |
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Registration |
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Import License (Form 10) |
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Authorised agent support - Biological |
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Import license for predicate Medical Device (Form MD 14, 15) |
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New Medical Device permission (Form MD 26, 27) |
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Test License to import Medical Device (Form MD 16, 17) |
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Authorized Agent Support - Medical Device |
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Import License of Predicate In Vitro Diagnostics (Form MD 14, 15) |
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Test license to import In Vitro Diagnostics (Form MD 16, 17) |
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Authorized Agent Support |
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Registration Number for Non-Notified Medical Devices |
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Clarification regarding Medical Devices from CDSCO (NOC) |
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Clarification letter / NOC from CDSCO for In- Vitro Diagnostics |
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SUGAM Registration- MD/ IVD |
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Permission to conduct clinical investigation (Form MD-22, 23) |
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Permission to Manufacture Class C & D Medical Devices (Form MD 7, 9) |
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Test license to Manufacture Medical Devices (Form MD 12, 13) |
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Free Sale Certificate from CDSCO for regulated Medical Devices |
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Label Compliance - Medical Device |
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Post Approval Change- Major/ Minor |
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Permission for Loan License to Manufacture Class C & D Medical Devices (Form MD 8, 10) |
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Test license to import In Vitro Diagnostics (Form MD 16, 17) |
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Test license to manufacture In Vitro Diagnostics (Form MD 12, 13) |
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Permission to Manufacture Class C & D In- Vitro Diagnostics(Form MD 7, 9 |
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Permission for Loan License to Manufacture Class A & B In- Vitro Diagnostics (Form MD 4, 6) |
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Permission for Loan License to Manufacture Class C & D In- Vitro Diagnostics (Form MD 8, 10) |
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Free Sale Certificate from CDSCO for regulated In- Vitro Diagnostics |
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Label Compliance - IVD |
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Registration Number for Non-Notified In Vitro Diagnostic |
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Permission to conduct Clinical Performance Evaluation (Form MD 24, 25) |
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Permission to Manufacture Class A & B In Vitro Diagnostics (Form MD 3, 5) |
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Post Approval Changes - Drug |
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Post Approval Changes - Cosmetic |
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Test License for Importer |
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Cosmetic Manufacturing License (Form COS-8) |
Why CliniExperts?
We've embraced our founder's simple but powerful philosophy, and it has become the cornerstone of our corporate values. Today, we're recognized not only for our knowledge and experience but also for our commitment to doing what's right. We've proudly assisted more than 850 clients in the complex CDSCO field, always maintaining balance between excellence and integrity.
Testimonials
The Brand That Promises To Turn, Your Business Around!
Atomy India Pvt ltd
We have been associated with CliniExperts for about a year now for our food products related services for FSSAI compliances and licenses from CliniExperts and are completely satisfied with their performance. Quick turnaround time in responding to queries, meticulous planning in completing the task, alongside the extensive knowledge of the regulations of the entire team is highly appreciable and marks the professionalism and quality driven ethics of the organization. We highly recommend their services as we believe it is best in the industry so far.
Rajeev Rattava
Finance Manager
Morepen Laboratories Ltd.
The team at CliniExperts is proficient in the subject matter and provide prompt services . We are satisfied with our engagement and would recommend their services.
Anubhav Suri
Business Head
Proficon Medisol Pvt. Ltd.
We have been professionally associated with Cliniexperts for more than 5 years now. They have smoothly sailed us all these years in different projects & this has been possible because of the knowledge & dedication cliniexpert team has in their portfolio. All the best Cliniexpert. Keep going.
Ajitesh Trehan
Director
Unity Enterprises
We appointed Cliniexperts for our Cosmetic registration project for one of our critical products for which we received the registration certificate much before the timelines committed by the company. The entire project was handled efficiently with sheer professionalism and in our comfort zone . We are very happy with the overall working experience with CliniExperts and will highly recommend their services to everyone.
Faiyaz
Founder, Unity Enterprises
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