The Central Drugs Standard Control Organization (CDSCO) is responsible for the approval and regulation of all kinds of drugs and medical devices that are sold or imported into India. This is the national regulatory authority for pharmaceuticals, cosmetics, medical devices, and equipment in India. Under the Drugs and Cosmetics Act CDSCO was established in 1961 for ensuring the safety and quality of specific drugs and medical devices.
CDSCO registration plays an important role in growing healthcare products as well as gives an assurance to consumers that CDSCO-certified medical devices or drugs are safe to use. The CDSCO registration process involves a few steps and may take several months to complete. This process can vary according to the type of drug or medical device.
Which Steps are involved in CDSCO registration?
Firstly, the applicant has to fill out the application form for CDSCO registration and submit it with the necessary documents. Documents must contain the required information about the product specifications, manufacturing process, quality, and safety details that have to be filled in properly and accurately.
After submission of the application form to CDSCO with defined charges, the application will be reviewed by the CDSCO and other official bodies like the Drug Controller General of India (DCGI) and the Ministry of Health and Family Welfare. The charges vary according to product which can be from a few thousand rupees to several lakhs of rupees.
After this, the CDSCO tests the products and checks every specification that is mentioned in documents about that product to ensure the safety, quality, and efficacy of the product. This verification part also includes lab testing, clinical trials, and bioequivalence studies.
If all the details and verification are found correct and accurate by the CDSCO officials then CDSCO grants approval for the product and after this product can be marketed in India. The manufacturer needs to maintain all the set of standards that are necessary for that product as per the CDSCO. This is because CDSCO continues to monitor its safety and quality through post-marketing surveillance. Inspection and testing of product samples can be done by CDSCO even after the certification of the product.
What are the benefits of CDSCO registration?
CDSCO registration for pharmaceuticals, medical devices, cosmetics, and other healthcare products has many benefits. CDSCO registration shows that products meet the necessary sets of quality standards defined by Indian regulatory authorities. This also wins the confidence and trust of the consumers and ensures that only safe and effective products enter the Indian market and protect public health from various issues.
Without CDSCO registration, companies cannot sell their products in India. For importers and distributors, CDSCO registered products simplify the import and distribution process and reduce the risk of customs issues or product seizures. Not only this, CDSCO registration also increases the credibility and trust of consumers and healthcare professionals. This registration improves the reputation of that product.
The registration process may vary according to the type of healthcare product. This process can be complex, so it is advisable to consult with a qualified consultant in India who can guide and provide proper details about this registration process. Induce India which is a BIS consultant in India can help to provide knowledge about this certification process and ensure that their products meet the Indian standards.
Induce India not only makes a proper plan for each certification but also ensures that the manufacturer gets all the benefits through that certification. Our company helps to show a path for the CDSCO registration to grow the manufacturer business and ensure the customer’s demands by fulfilling all standards. Induce India is not only helping you to achieve CDSCO certification but also clear the doubts about the certification.