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In India, Central Drugs Standard Control Organisation (CDSCO) wields regulations for pharmaceuticals and medical devices. The Central Drug Authority, or CDSCO, carries out the duties entrusted to it by the Act on behalf of the Central Government. Additionally, it coordinates the work of State Drug Control Organizations and offers them expert guidance.
CDSCO registration is an essential process that ensures the safety and efficacy of medical devices and pharmaceuticals in India. It is mandatory for all manufacturers, importers, and marketers to obtain this registration from the Central Drugs Standard Control Organization before launching their products in the market. At Law Samadhan, we understand the importance of CDSCO registration and provide expert guidance to our clients throughout the process.
Under the Pharmaceuticals and Cosmetics Act, 1940 ("Act") and the Drugs and Cosmetics Rules, 1945 ("Rules"), CDSCO is in charge of
1. Licensing new drugs and conduct of clinical trials in India
2. Ensure consistency in the application of the Act and Rules
3. Establishes standards for drugs
4. Safeguards patients' rights, safety, and well-being
5. Monitors the quality of manufactured, imported and distributed medicines and cosmetics
Under the Drugs and Cosmetics Act, 1940, the CDSCO Registration is a prerequisite for –
1. Importers
2. Indian Agents
3. Foreign Enterprises holding Indian Subsidiary
4. Corporates
The above-mentioned applicants can register themselves on CDSCO online portal. However, a manufacturing facility cannot register on the website directly. A corporation must create login information for the manufacturing facility to access the site.
CDSCO issues registration for following purposes:
1. BA/BE Approved Sites
2. Blood Bank Registration
3. Blood Product Registration
4. Cosmetics Registration
5. Dual Use NOC (Trader)
6. Export NOC (Zone)
7. Ethics Committee Registration
8. Formulation R&D Organisation
9. Import or Manufacture of drugs
10. Sponsors (BA
11. Test License
1. Protection from Malpractice:
Cosmetic products are quite "chemically enhanced" in nature by their very nature. Additionally, a lot of it is based on materials and chemicals that are dangerous to people.
2. Safeguarding Animal Rights:
The guidelines require to carefully undertaking animal testing and providing adequate rehabilitation facilities.
3. Quality Check of Foreign Import:
The demand for foreign cosmetics has increased; thus adequate guidelines are required to keep a quality check on imported goods.
A Registration Certificate shall be for a period of three years from the date of its issue unless it is suspended or cancelled before expiry. Provided that if the application for a fresh Registration Certificate is made nine months before the expiry of the existing certificate, the current Registration Certificate shall be deemed to continue in force until orders are passed on the application.
The authority gives an opportunity to show cause why the order for suspension/cancellation should not be passed.
Post which if the manufacturer fails to comply with any of the conditions of the Registration Certificate:
By an order in writing stating the reasons, the licensing authority may suspend or cancel the Registration Certificate for a period it finds fit, either wholly or in respect of some of the substances to which it relates.
A person, who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government.
Post this, the Central Government will conduct enquiry into the matter as it considers necessary and after give the appellant an opportunity for representing his views in the matter, pass such orders in relation thereto as it thinks fit.
• Id proof of the applicant;
• address proof of the applicant;
• Copy of bioavailability (BA) or bioequivalence (BE) site registrations issued by CDSCO for BA or BE approved sites registration;
• Undertaking given by a government authority;
• Wholesale license or manufacturing license for manufacturing or import of blood product registration or drugs or test license registration.
The CDSCO registration process can take several months to complete. The exact time frame will depend on the complexity of the application and the availability of the relevant authorities.
Yes, CDSCO registration can be done for imported products. However, the importer or Indian Agent of the foreign manufacturer will have to take the responsibility of compliance of the imported products with the Indian drug regulations.
Yes, there is a need for re-registration for already registered products. The companies are required to submit re-registration application every five years after the date of first registration or date of last re-registration.
You can check the CDSCO's online database of registered products to see if a product is registered. The database is searchable by product name or registration number. Additionally, registered products will have a unique barcode and a registration number printed on the packaging.
Yes, CDSCO registration is required for all medical devices intended for use in India. This includes devices such as diagnostic equipment, surgical instruments, and implantable devices.
Yes, a third-party agency can assist with CDSCO registration. These agencies can help companies navigate the registration process, prepare the necessary documentation, and conduct the required inspections.
Yes, there is a difference in the registration process for new and existing products. New products will require more extensive documentation and testing, while existing products will require less.
No, CDSCO registration is not required for all types of drugs. For example, drugs that are unregistered in India but are registered in other countries may be allowed to be imported under certain conditions.