What is a CDSCO Manufacturing License?
CDSCO Manufacturing License refers to a license issued by the Central Drugs Standard Control Organization (CDSCO) in India, which is responsible for regulating the manufacture, distribution, and import of drugs and medical devices in the country.
The CDSCO Manufacturing License is required for companies or individuals engaged in the manufacturing of drugs or medical devices in India. This license ensures that the manufacturing facilities and processes meet the required standards of quality, safety, and efficacy.
To obtain the CDSCO Manufacturing License, the applicant must submit an application along with the required documents and fees to the CDSCO. The application is then reviewed by the CDSCO officials, and if all the requirements are met, the license is issued.
The CDSCO Manufacturing License is a crucial requirement for any company or individual involved in the manufacturing of drugs or medical devices in India, as it ensures compliance with the regulatory requirements and helps to ensure the safety and efficacy of the products manufactured.
Why CDSCO Manufacturing License is required?
- The CDSCO Manufacturing License ensures that the manufacturing of drugs and medical devices in India is conducted in compliance with regulatory standards and guidelines.
- It helps to maintain the quality, safety, and efficacy of the drugs and medical devices produced in India.
- The license ensures that manufacturing facilities and processes meet the required standards and guidelines for good manufacturing practices (GMP).
- It helps to regulate the market by preventing the manufacturing and distribution of substandard or counterfeit drugs and medical devices.
- The license ensures that manufacturing companies have the necessary resources, equipment, and personnel to produce quality products.
- It protects the health of the public by ensuring that only safe and effective drugs and medical devices are available in the market.
- The license is a legal requirement for companies or individuals involved in the manufacturing of drugs or medical devices in India.
Who can get a CDSCO Manufacturing License?
Pharmaceutical industry
Medical device industry
Biotech industry
Ayurvedic, Unani, Siddha and Homeopathic (AYUSH) medicine industry
Vaccine industry
Blood bank and blood product industry
Contract research organizations (CROs)
Cosmetics Manufacturers
Document Required for CDSCO Manufacturing License
Click Here & Check Document Check ListRole of Shamkris and Process of CDSCO Manufacturing License
Shamkris adopts a results-oriented approach to compliance with mandatory licence requirements in the organization. A simple and guidance methodology help organisation to achieve licence in a timely manner and cost-effective. Shamkris support 100% in advisory, Guidance, Compliance with respect to license requirements to obtain approval.
The License process described below:
- Advisory for the document required
- Preparation of documents as per application & list of documents.
- Application File
- Inspection by the department if required
- Liason department
- Yearly Compliance if Applicable
- Renewal when due
Who can issue CDSCO Manufacturing License?
A CDSCO Manufacturing License is a legal authorization issued by the Central Drugs Standard Control Organization (CDSCO) in India. It allows entities to manufacture pharmaceuticals, medical devices, cosmetics, or other regulated products in compliance with Indian regulatory standards.
Entities involved in the manufacturing of pharmaceuticals, medical devices, cosmetics, or other regulated products in India must obtain a relevant CDSCO Manufacturing License.
There are various types of CDSCO Manufacturing Licenses, including Formulation Manufacturing License, Bulk Drug Manufacturing License, Cosmetics Manufacturing License, and Medical Device Manufacturing License.
To apply for a CDSCO Manufacturing License, you need to submit an application to the relevant State Drug Licensing Authority or the Central Licensing Authority, along with the required documents, fees, and facility information.
The processing time can vary, but it typically takes several months, as the authorities conduct inspections and verify compliance with regulatory standards.
Eligibility criteria may vary depending on the type of license, but generally, entities must have adequate infrastructure, qualified personnel, and comply with Good Manufacturing Practices (GMP) standards.
Yes, CDSCO Manufacturing Licenses must be renewed periodically. The renewal process involves demonstrating continued compliance with regulatory requirements.