In India manufacturing, importing, selling and distribution of drugs are regulated under the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetic Rules 1945. At present, bulk drugs and finished formulations are regulated under the Act. Any substance falling within the Act must be registered under CDSCO Registration before importing any medical product in India. Under this Act, manufacturing sites must also be registered under CDSCO (Central Drugs Standard Control Organization) to import drugs. A CDSCO License is mandatory for importing or selling medical devices in India. Manufacturers dealing with Medical devices must obtain the CDSCO registration.
The Drugs & Cosmetics Act, of 1940 has delegated various responsibilities to central & state regulation of drugs & cosmetics. It authorises consistent implementation of the provisions to ensure the safety, and well-being of the patients. CDSCO is continuously bringing new updates to ensure transparency, uniformity and accountability in the standard and quality of the medical products imported, manufactured, and sold in India.
WHO Mandated to Obtain CDSCO Registration?
Below are the applicants dealing with medical devices who must apply for CDSCO registration online:
- Importers
- Manufacturers
- Indian Agents
- Distributors
- Corporates
- Foreign Enterprises holding Indian Subsidiary
Benefits of obtaining CDSCO Registration
CDSCO License acts as a legal support for the drug business. It increases the reliability and trust of the customers. Here are some of the benefits why a drug business needs CDSCO registration for its medical product/device or cosmetics product:
- Wider Opportunity: To enhance the brand image and attract a wider opportunity in nationals and international market.
- Legal Benefit: CDSCO License has legal benefits by avoiding government notices, penalties, etc. By complying to the regulatory norms you can seamlessly manufacture, sell and distribute medical devices in India.
- Safety: To ensure the safety, security and quality of the medical products that reduce the legal and penal risks
List of Documents required to obtain CDSCO Registration
- ID Proof and address proof along with your photograph
- Original Challan that has proper details
- Documents provided by Schedule D(I) by the drug manufacturer
- Documents provided by Schedule D(II) of drug(s) manufacturer
- Form 40
- Power of Attorney issued by the manufacturer
- Copy of Authorization letter of Applicant
- Copy of the Whole Sale License of the applicant
- In the case of a proprietorship firm, an Undertaking shall be submitted by the proprietor firm and in the case of a Private limited Company, an Undertaking shall be submitted by the Board of Directors.
Our Role in Obtaining a CDSCO License
- Assist in obtaining a CDSCO registration
- Help in preparing documentation and application process
- Cordinating with the CDSCO department on approval process
- Assist in end-to-end CDSCO compliance process
- Help in testing process of medical devices