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India Regulatory Services
Welcome to Satori OCS's India Regulatory and Licensing Services. Our comprehensive range of services is designed to assist you in navigating the intricate regulatory landscape of the Central Drugs Standard Control Organization (CDSCO). With our expertise and dedication to excellence, we help you ensure your products meet the stringent standards set by the Indian regulatory authorities, enabling successful market entry and operation in India. Satori OCS promises to retain openness while offering you 100 percent support for CDSCO Registration of Drugs, Pharmaceuticals, Cosmetics, Medical Devices, IVDs, Ayurvedic Medicines, Veterinary Medicines and other Healthcare products in India.
CDSCO (Central Drugs Standard Control Organization)
The CDSCO is the regulatory authority in India responsible for the regulation of and licensing for drugs, pharmaceuticals, cosmetics, medical devices, and healthcare products. It was established under the Drugs and Cosmetics Act, 1940, and functions under the Ministry of Health and Family Welfare of the Government of India. CDSCO plays a crucial role in ensuring the safety, efficacy, and quality of these products for public health and patient safety.
CDSCO's headquarter is situated in New Delhi and it maintains six zonal offices and thirteen sub-zonal offices across India. The organization's regulatory responsibilities are conducted through several departments, including the Drug Controller General of India (DCGI) and the Central Drugs Laboratory (CDL).
The CDSCO's role encompasses approving, licensing, and regulating drugs, pharmaceuticals, vaccines, cosmetics, medical devices, & other healthcare products; managing their import, manufacturing, distribution, & sale; evaluation of new drugs & medical devices; supervision of clinical trials; and post-market surveillance to ensure their safety, efficacy, and quality in accordance with the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945.
CDSCO's responsibilities extend to collaborating with national and international organizations on diverse drug regulation initiatives like pharmacovigilance, drug safety monitoring, regulatory guideline development, and capacity building for regulatory authorities. The organization also facilitates coordination with domestic and international regulatory bodies, guaranteeing conformity to global standards of safety and effectiveness for drugs and medical devices.
Key Functions of CDSCO
CDSCO is responsible for the regulation and control of the manufacture, distribution, sale, and import of drugs, pharmaceuticals, cosmetics, medical devices, and other healthcare products in India. It is also responsible for the enforcement of regulations related to the labeling, packaging, and advertising of drugs, pharmaceuticals, cosmetics, medical devices, and other healthcare products in India.
CDSCO is responsible for regulating the manufacturing, import, sale, and distribution of drugs and pharmaceuticals in India.
CDSCO oversees the registration and regulation of medical devices in India. This includes classifying medical devices based on their risk levels and ensuring their quality, safety, and performance.
CDSCO regulates cosmetics, including their import, manufacture, and sale, to ensure they meet safety standards and do not pose any harm to consumers.
CDSCO monitors the safety, efficacy, and quality of drugs & medical devices in India and takes necessary actions if adverse events or safety concerns arise during post-marketing surveillance. This involves collecting and analyzing data on adverse drug reactions.
CDSCO is responsible for approving and regulating clinical trials including protocols for new drugs and medical devices. It ensures that trials are conducted ethically and with proper scientific rigor. It reviews clinical trial data, evaluates safety and efficacy, and grants marketing approvals for new drugs.
CDSCO enforces quality control standards for pharmaceuticals, drugs, cosmetics, medical devices, and IVDs ensuring that they meet the required quality specifications.
CDSCO regulates the import and export of pharmaceuticals, drugs, cosmetics, medical devices, IVDs, and other healthcare products, making sure they comply with relevant regulations.
CDSCO grants licenses for the manufacture, sale, and distribution of pharmaceuticals, drugs, cosmetics, medical devices, IVDs, and other healthcare products and conducts inspections to ensure compliance with Good Manufacturing Practices (GMP) and other quality standards.
CDSCO provides guidance to the industry on regulatory matters, helping manufacturers, importers, and other stakeholders navigate the regulatory landscape.
CDSCO collaborates with other national and international regulatory agencies to harmonize standards and practices related to drug and healthcare product regulation.
Types of License Granted by CDSCO
The Central Drugs Standard Control Organization (CDSCO) grants various types of licenses to different entities to regulate the manufacturing, distribution, sale and import of drugs, pharmaceuticals, medical devices, cosmetics, and other healthcare products in India. This includes licenses for different categories like Allopathic, Homeopathic, and Ayurvedic medicines.
Some of the key types of licenses issued by CDSCO include:
- Formulation Manufacturing License
This license is required for the manufacturing of pharmaceutical formulations dosage forms medicines such as tablets capsules injections syrups etc.
- Bulk Drug Manufacturing License
This license is required for the manufacturing of active pharmaceutical ingredients (APIs) or bulk drugs.
- Medical Device Manufacturing License
Granted to manufacturers of medical devices to ensure quality safety and compliance with regulations.
- Cosmetic Manufacturing License
Issued to manufacturers of cosmetics, ensuring they meet safety and quality standards.
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Import License for Drugs, Medical Devices and Cosmetics
Entities that wish to import Drugs, Medical Devices, or Cosmetics need an import license issued by CDSCO, to bring these products into India. This ensures that the imported products meet quality and safety standards.
- Wholesale Drug License
Issued to wholesalers or distributors of drugs, pharmaceuticals, medical devices allowing them to distribute these products to retailers, hospitals, and other institutions.
- Retail Drug License
Granted to retailers (pharmacies) engaged in the retail sale of drugs and pharmaceuticals to consumers.
- Restricted (Restricted Area) License
This license is required for the sale of certain specialized drugs that are subject to additional restrictions.
- Cosmetic Manufacturing License
This license is necessary for the manufacturing of cosmetics, ensuring they comply with safety and quality standards.
- Cosmetic Sale (Wholesale/ Retail) License
Entities engaged in the wholesale or retail sale of cosmetics need this license.
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Standalone Medical Device License
This license is required for entities involved in the manufacturing, sale, or distribution of standalone medical devices.
- Manufacturing License for Medical Devices
This license is required for manufacturing medical devices.
- Import License for Medical Devices
Similar to drugs, medical devices being imported into India require an import license.
- Wholesale or Retail License for Medical Devices
Depending on the nature of the business, wholesalers and retailers of medical devices may need specific licenses.
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Narcotic and Psychotropic Substances Licenses
CDSCO also issues licenses related to the manufacturing, distribution, sale, and use of narcotic and psychotropic substances in accordance with the Narcotic Drugs and Psychotropic Substances Act.
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Loan License
A loan license is granted to a manufacturer to produce drugs on behalf of another manufacturer, who holds a valid manufacturing license. This type of license allows a company to manufacture drugs at premises other than its own. The company holding the manufacturing license is known as the "Loan Licensee."
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Test License
Entities can obtain a test license to carry out tests or analysis of drugs, cosmetics, or medical devices for a limited purpose, often in research or testing facility.
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Clinical Trial License
Sponsors/ entities conducting clinical trials for new drugs or medical devices must obtain this license before initiating the trials. The license has to ensure that trials are conducted ethically and according to regulatory standards.
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Bioavailability (BA) or Bioequivalence (BE) Approved Sites
Registration for sites involved in Bioavailability (BA) or Bioequivalence (BE) studies.
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Ethics Committee Registration
For the research ethics committee involved in clinical trials.
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R&D Organization
For research and development organizations engaged in pharmaceutical studies.
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Blood Bank License
Establishments that collect, process, store, and distribute blood and blood components require a license to ensure the safety and quality of these products.
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NOC (No Objection Certificate)
Sometimes, CDSCO issues NOCs for specific activities like the import or export of certain medical products.
Based on the type of product, its classification, and other regulatory considerations; the application process, the exact requirements and documentation needed for obtaining each type of license can vary and involve submitting detailed documentation, including information about the facility, personnel, quality systems, and more.
CDSCO Licensing Process
The CDSCO (Central Drugs Standard Control Organization) grants licenses for various activities related to drugs, medical devices, cosmetics, and other healthcare products. These licenses allow individuals and entities to legally engage in activities such as manufacturing, distribution, sale, and import of these products. The specific licensing requirements and procedures can vary based on the type of product and the activity you intend to undertake. Here's a general overview of the process you might need to follow to obtain a license from CDSCO
- Determine the Type of License Needed
Identify the specific type of license you require based on your business activities. This could be a manufacturing license, wholesale license, retail license, import license, or others, depending on the nature of your operations.
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Gather Documentation
Collect all the necessary documents required for the license application. These documents may include information about your company, facility details, product information, manufacturing processes, quality control procedures, and more.
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Submission of Application Form (Online/ Offline)
Prepare and submit the relevant application form along with the required documents to the CDSCO office or State Drugs Control Department. The application form for the type of license you are seeking can be obtained from the CDSCO website or the concerned State Drugs Control Department. Make sure to fill out the forms accurately and completely.
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Document Submission
Scan and upload the required documents as per the instructions provided in the online application form. Commonly required documents include company details, manufacturing premises information, product details, quality control procedures, and more.
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Application Fee Payment
Online applications require payment of application fees. CDSCO provides online payment options through secure payment gateways.
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Application Review and Document Verification
CDSCO will review your online application and the accompanying documents for completeness and accuracy. If any additional information is needed, they may contact you. This review process involves assessing your facility's compliance with Good Manufacturing Practices (GMP), product quality, safety, and other regulatory requirements.
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Communication and Updates
CDSCO might use online communication methods to notify you about the progress of your application, any additional requirements, or any clarifications needed.
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Inspection
Depending on the type of license, CDSCO might conduct an inspection of your manufacturing or business premises to verify compliance with regulations. Inspection could be coordinated through an online platform or through correspondence.
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Approval and License Issuance
Once your application is reviewed and your facility is found to be compliant, CDSCO will approve your application and will issue the license through an online platform or provide instructions for collecting the physical license. The license will specify the activities you are authorized to carry out along with any conditions to be fulfilled.
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Renewal and Updates
Licenses issued by CDSCO typically have a validity period, after which they need to be renewed. Make sure to keep track of your license's expiration date and initiate the renewal process in a timely manner. CDSCO offers online renewal options, allowing you to update your license for continued compliance.
Our Comprehensive Range of Services
At Satori OCS, we specialize in making technical compliance certifications effortless and convenient for your business. Our wide array of services covers various domains, helping you ensure compliance with the necessary regulations and enabling your successful operations. Explore the diverse services we offer:
- Retail Drug License
If you're planning to start a retail business for drug sales in India, a Retail Drug License is mandatory under the Drugs and Cosmetics Act, 1940. Our experts guide you through the licensing process, helping you ensure in meeting the regulatory requirements.
- Wholesale Drug License
For wholesale drug sales, a Wholesale Drug License is essential. We assist in obtaining this license, helping you ensure adherence to regulatory norms for wholesale drug trade.
- Bulk Drug (API) Manufacturing License
Manufacturers of Active Pharmaceutical Ingredients (API) or Bulk Drugs need a Manufacturing License from the Drug Controlling Authority. We facilitate the application process, helping you navigate the regulatory framework.
- Formulation Manufacturing License
This license is required for the manufacturing of pharmaceutical formulations/ dosage forms/ medicines such as tablets, capsules, injections, syrups, etc. We assist in obtaining this license, helping you ensure adherence to regulatory norms.
- Drug Import License
Our professionals help you ensure compliance with CDSCO regulations for drugs import, safeguarding the intended population and sellers from legal implications.
- Medical Device Manufacturing License
Our services encompass the process of obtaining a medical device manufacturing License from the CDSCO. We guide you through the regulatory landscape to ensure compliance.
- Medical Device Import License
If you're importing medical devices into India, our experts help you obtain the necessary import license from the CDSCO, ensuring compliance with Indian regulations.
- In Vitro Diagnostic (IVD) Device Manufacturing License
We assist manufacturers in obtaining the license required to manufacture In Vitro Diagnostic Devices, ensuring compliance with State Licensing Authority and CDSCO regulations.
- In Vitro Diagnostic (IVD) Device Import License
Importing In Vitro Diagnostic Devices into India requires compliance with the Drugs and Cosmetics Act and Rule. We guide you through the import licensing process.
- Wholesale or Retail License for Medical & IVD Devices
Depending on the nature of the business, wholesalers and retailers of medical & IVD devices may need specific licenses. We assist in obtaining these licenses, ensuring adherence to regulatory norms as per CDSCO regulations.
- Cosmetic Import License
If you're importing cosmetics, we facilitate the process of obtaining the Import License from CDSCO, adhering to strategic product plans and testing.
- Cosmetic Manufacturing License
This license is necessary for the manufacturing of cosmetics, ensuring they comply with safety and quality standards. We guide you through the regulatory landscape to ensure compliance.
- Cosmetic Sale (Wholesale/ Retail) License
Entities engaged in the wholesale or retail sale of cosmetics need this license. We guide you in obtaining these Licenses from CDSCO.
- Drug Export NOC
Our experts assist in obtaining a NOC for the export of drugs outside India, authorized by the CDSCO.
- Drug Import NOC
For drug imports, a NOC from CDSCO is mandatory. We facilitate the process of obtaining this certificate.
- Dual-Use NOC (Trader)
Dual-Use NOC is essential for trading products that have both medical and industrial applications. We assist in obtaining a Dual-Use NOC to ensure compliance with relevant regulations.
At Satori OCS, we streamline the CDSCO Registration process, making it efficient and hassle-free. Our team of experts offers unparalleled guidance, transparent fees, and timely responses, ensuring your journey to obtaining CDSCO licenses is smooth and compliant. Contact us today to embark on a seamless CDSCO Registration journey.
FAQs
Q1. How are pharmaceuticals classified and registered in India?
Pharmaceuticals are classified into various categories, and registration is based on the type of drug, its risk level, and intended use. Registration with CDSCO is typically required for marketing and distribution.
Q2. What are the labeling and packaging requirements for pharmaceutical products in India?
Pharmaceutical products in India must have compliant labeling and packaging, including information such as drug composition, dosage instructions, expiry date, and safety warnings.
Q3. Which regulatory body is responsible for pharmaceutical licensing in India?
The regulatory body responsible for pharmaceutical licensing in India is the Central Drugs Standard Control Organization (CDSCO).
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