Understanding the Data requirement

Understanding the data and documentary requirements is daunting task. Coupled this with compleitng regulatory approvals in an efficient and timely manner can be challegning for even experienced professionals.The cosmetic division of CDSCO has defined a clear checklist of documents that need to be furnished for request of registration certificate of imported cosmetics

Documents required to Submit a Online application on SUGAM from Legal Manufacturer or Brand holder is as below:

1. Power of attorney OR Letter of Authorisation as per the Prescribed format by CDCSO must be either apostilled in country of origin or Attested by Indian embassy
2. Free sale certificate in English version stating that the products intended to be imported in india are Freely sold in country of origin duly issued of attested by a Chamber of Commerce  of Health authorities of the Origin country duly apostilled in country of origin or Attested by Indian embassy
3. A copy of GMP or Manufacturing License or ISO Certificate in English version of the actual manufacturer duly apostilled in country of origin or Attested by Indian embassy
4. Original artwork or Labels for all the products 
5. Ingredient list or List of ingredients in the nomenclature of standard reference along with percentage contained in the cosmetic duly signed by competent authorized person with stamp from the manufacturer
6. Specification and testing method for testing of cosmetics duly signed by competent authorized person with stamp from the manufacturer
7. Non Animal testing declaration stating that the products Imported in India are not tested on animal on or after 12.11.2014
8. Test reports for Mercury, Lead or Arsenic or Declaration for Heavy Metal such as Mercury, lead and Arsenic along with a Declaration stating that the products are free from Hexachlorophene content.

Documents required to Submit a Online application on SUGAM from  Authorized Agent or Indian Importer are as below:

1. Covering Letter to CDSCO on letter head of Importer duly signed and stamped with annexures being submitted along with Form 42
2. Form 42 is being System Generated from SUGAM portal, when the entire application is uploaded and it details Legal and actual manufacturing sites along with Indian importer details along with product details 
3. Proof of payment of requisite fee:  Fees has to be paid online from SUGAM Portal for Each category USD 2000 and USD 50 per variant 
4. Schedule D III  as per Prescribed format by CDSCO 

Preparing regulatory documents is a time consuming and meticulous exercise. As an importer or brand owner, one is already engrossed in various business aspects prior to the launch of a brand in India. If a mistake is made, it can lead to a complete delay in the business plan, overheads, financial planning issues as well as supply chain disruption. 

NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of methods in between the madness.