What is CDSCO Registration under The Drugs & Cosmetics Act, 1940?
Indian health care and pharma industry is one of the fastest-growing industries in the world. Sanctions are provided to safety, quality, and efficacy of drugs, as well as medical devices. CDSCO registration under The Drugs & Cosmetics Act, 1940 is one such example. Everything you would like to know about CDSCO registration with special emphasis on cdsco medical devices, cdsco license, cdsco import license, and drug and device approval process is listed below.
What is CDSCO
CDSCO, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India drug regulator. CDSCO licenses and approves drug and medical device in India. CDSCO makes cdsco approved drug and cdsco approved medical device quality of standard safety and efficacy.
The Legal Framework: The Drugs & Cosmetics Act, 1940
Drugs & Cosmetics Act, 1940, and regulations made under it (i.e., Medical Devices Rules, 2017) is legislation through which CDSCO regulation and medicine and medical devices registration is conducted in India. The legislation provides for regulation of production, import, distribution, and sale of medicine and cosmetics so that fake or sub-standard ones are not being supplied to Indian consumers.
What is CDSCO Registration?
CDSCO registration is a permit that is mandatory for certain medical devices and medicines prior to producing the product, importing the product, or marketing the product in India. CDSCO registration is the procedure in which the technical documents, safety documents, and clinical trial documents (if applicable) are filled with CDSCO. CDSCO issues cdsco license to the product after checking the product.
CDSCO Registration of Medical Devices
As per cdsco medical device guidelines, government has categorized the medical devices into four classes, i.e., A (low risk), B (low-moderate risk), C (moderate-high risk), and D (high risk). Approval and registration will be according to the risk class.
Major Steps of CDSCO Registration of Medical Devices:
- Find Classification: Check whether the product falls under cdsco regulation definition of a medical device.
- Indian Authorised Agent Appointment: Foreign company is required to appoint an Indian agent.
- Documentation preparation: Device master files, clinical evidence, test reports, and compliance certificates.
- Application for CDSCO License: Sugam portal submission.
- Approval: Once the product is approved, the product becomes a part of cdsco approved medical devices list.
Importing Medical Devices: CDSCO Import License
If you are a foreign manufacturer or an importer, you would need a cdsco import license. It allows relevant foreign companies to market certain cdsco medical devices in India.
Documents required for CDSCO Import License are:
- ISO 13485 certificate
- Free Sale Certificate of the exporting country
- Device Master File (DMF)
- Plant Master File (PMF)
- Power of Attorney with appointment ofoffer Authorized Indian Agent
Once the product is launched, it is put in cdsco approved medical devices list, and thus the product can be imported and sold in India.
CDSCO Approval of New Drugs
New drugs which are making a fresh entry in India's market must be CDSCO approved, particularly if it cannot be located anywhere in India's market. It requires more regulatory testing and clinical trials.
What is a New Drug?
- "New drug" means, under CDSCO
- New chemical entities (NCEs)
- New fixed combinations
- New dosage forms
- New routes of administration
Procedure of Approval of New Drug:
- Submit Clinical Trial Data: As per Good Clinical Practices (GCP) and ICMR guidelines.
- File Application: Online filing of Form CT-21 or CT-22 on CDSCO portal.
- Regulatory Review: Data are in process by SEC.
- Granting of Approval: The drug is listed in cdsco approved drug list on approval of the drug.
CDSCO Approval Required
CDSCO clearance isn't a norm—a stamp of safety and efficacy. Whatever cdsco cleared new medicine or cdsco cleared medical devices are, cdsco cleared makes it more authentic and reliable in the Indian market and international market.
Advantages are:
- True marketing in India
- Improved customer confidence
- Public tenders and institutional business
- Free export clearances in some cases
- CDSCO Guidelines Navigating
Learn cdsco guidelines of medicine and drug devices for successful drug approval and product registration. They provide guidelines on labeling, testing, documentation, and post-market surveillance.
CDSCO Approved List of Drug and Medical Devices
CDSCO periodically updates its cdso approved list of medical devices and cdso approved list of drugs. It is a ready reckoner to drug companies, medical device companies, doctors, and importers.
How to reach them
- Visit the official website of CDSCO
- Click on "Drugs" or "Medical Devices"
- Observe the cdsco approved medicines and approved cdsco medicines list
It contains all the data of recently cdsco-approved drugs, which can be of market research significance as well as for the monitoring of competition.
Final Thoughts
CDSCO registration is not a choice—it is a must for every pharma or medical device company that is willing to sell or enter India. If you need a cdsco license, if you need a cdsco import license, or if you need a product which falls under the category of cdsco approved medical devices, then The Drugs & Cosmetics Act, 1940 and cdsco medical device guidelines compliance is the master plan which takes precedence over the others.
CDSCO strict infrastructure by itself, though, makes good product and quality accessible to release to, and be used by, Indian patients. CDSCO registration complexity, from drug approvals to cdsco medical device procedures, expertise makes the companies not only follow up but even a committed step to one of the world's biggest health care markets.
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