Central Drugs Standard Control Organization
CDSCO is the leading national body for setting standard protocols for Indian Pharmaceuticals, medical devices, Import and Registration of bulk drugs and finished formulations in India. Drugs Controller General is the topmost individual position with its headquartered at CDSCO, FDA Bhawan, Kotla Road, Near Bal Bhawan, New Delhi. CDSCO comes under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
Any drug or substance needs to be fully registered before being given permission to be imported into India and its manufacturing site with CDSCO. A certificate is given that allows the sale of the drugs in India with a subject to specific use or wholesale use as per the drugs.
With IndianNexus you will be given complete guidance with step by step assistance in getting the right certification
  • Getting right information about the drugs to the concerned authorities
  • Preparing a sophisticated Covering Letter that signifies the drug intent
  • Form 42 Submission with standard Drugs & Cosmetics Rules
  • Filling out the product information
  • Form procedures for Import for cosmetics in India
  • Laying the precise procedures to get the drug certified by CDSCO
  • Communicating with concerned authorities till the final approval by obtaining Registration certificate in Form 43
  • Notifying public for minor modifications if required
  • Main changes in the manufacturer with Importer/agent notification
Testing expenditures for the manufacturing lab within India or abroad are to be carried out by the applicant only. Indians drug companies are required to pay in rupees while foreign companies can pay in international currencies or dollars. Within six months of applying for the Certification with a minimum timeline is of 90 days.
After carefully consideration Free Sale Certificate/Certificate to Foreign Government/ Certificate of Marketability is offered by CDSCO that must have all the specific cosmetic information. In case of Foreign Country Power of Attorney is Issued along with Indian Embassy stamp that signifies the whole.
You can ask for a renewal of certificate 9 months before the expiry for step by step processing of the whole information and keeping things in a check.
In case of minor modifications, updating labels, packages, a simple notification is to be issued by the applicant with a suitable explanation of the changes concerned.