Statutory
Audit
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Introduction to Statutory Audit
A statutory audit is a legally required review of the annual financial statements of a company to verify if they represent a true and fair view of its financial position. It is carried out by an independent, external auditor appointed by the shareholders.
Most countries have legislation mandating certain companies to compulsorily undertake annual statutory auditing. The objective is to enhance credibility, transparency and compliance in financial reporting across businesses beyond a certain scale or type.
Types of Companies Requiring Statutory Audit
While specific thresholds and criteria vary, these companies commonly require a statutory audit:
- Public Limited Companies: As they raise capital from public shareholders, statutory audit is compulsory to vet their financial statements.
- Private Limited Companies: Above certain paid up share capital or turnover/revenue thresholds, statutory audit is mandatory.
- Banks & Financial Institutions: Being public deposit takers, financial sector firms face additional audit requirements given high public interest.
- Listed Companies: Any company listed on a stock exchange must get their accounts audited as per listing regulations.
Based on level of public interest and to prevent financial malpractices, certain organisations like non-profits, hospitals, educational institutions may also need statutory audits. Companies Act usually specifies audit requirements.
Appointment & Rotation of Statutory Auditors
The first auditors of a new company get appointed by its Board of Directors. Subsequently, annual auditors are selected by a majority vote of shareholders during the Annual General Meeting (AGM).
To ensure independence between company management and auditors, laws govern:
- Mandatory auditor rotation: Same audit firm can only be appointed for a fixed, continuous period of 4 or 5 years, after which compulsory change of auditor is required.
- Partner rotation: Audit partners overseeing the company audit must be rotated every 3 years. This avoids over-familiarity with clients affecting impartiality.
Guidelines also prohibit immediate relatives of company directors/management or those with financial interests or dependencies from being appointed auditors.
Role & Duties of Statutory Auditors
As per legal provisions and auditing standards framework in a country, key responsibilities include:
- Evaluating the reliability, adequacy and effectiveness of company’s internal control systems, policies, accounting records and financial statements
- Verifying the books of account, registers, documents and transactions on a test check sample basis for authenticity
- Checking proper application of accounting standards, policies and financial reporting procedures
- Visiting company facilities for stock inspection and physical asset verification
- Obtaining management representations and confirmations as audit evidence
- Ensuring due compliance with taxation laws, company law and other regulations
The auditor collects sufficient appropriate evidence through audit techniques, scrutinizes financial records, statements and disclosures to deliver a fair audit opinion.
Audit Reporting Requirements
Upon completing the statutory audit, the auditor is required to submit an audit report typically containing:
- Title specifying it as Report of the Statutory Auditor
- Audit opinion declaring accounts as true and fair or qualified opinion highlighting inadequacies
- Basis of opinion citing auditing standards followed
- Observations, discrepancies and reservations noticed
Audit reports with qualifications regarding misstatements or non-compliance must include their impact on true and fair view of the financial position. Any major deficiencies get officially reported to shareholders as well as authorities.
An unqualified audit report signifies the audited accounts are accurate without material misstatements as per reporting framework and statutory requirements. Qualified reports can signal financial problems needing regulatory interventions. Most stakeholders rely on auditor’s statutory audit certification for critical economic decision making regarding the company.
Rights & Authority of Auditors
Statutory auditors function as vital governance and risk oversight mechanism regarding company finances. They have expansive legal rights and power to:
- Access all accounting books, policies, records, documents confidential information for audit purposes
- Inspect company’s assets, cash, inventory, facilities and operational processes
- Attend annual stock taking and physical verification procedures
- Seek information or clarifications required from directors, management and staff
- Report and notify authorities immediately regarding frauds or irregularities
- Be indemnified by company against legal costs from dutiful actions
- Receive notice of every board meeting and right to attend meetings
These privileges safeguard independence plus ability to conduct audits effectively and deliver transparent reports. Auditors send early warning signals regarding improprieties or risks before issues assume unmanageable proportions.
Consequences of Non-Compliance
If a company fails to appoint an auditor or its audit reveals misstatements deliberately ignored without corrective action, then penalties applicable as per law include:
- Imprisonment up to 1 year plus fines on officers and company in default
- Disqualification of current directors from future appointments
- Deactivating operations by revoking license and registration
- Prohibit raising fresh capital from market
- Legal prosecution by regulators against company directors
Thus through financial inspection and verification mechanisms, statutory audits enhance stakeholders’ trust, regulatory compliance and ethical growth across industries. The deterrence effects also enable proactive prevention of corporate frauds or failures.
Feel free to reach out if you have any questions or require further assistance.
Call NowConclusion
In summary, mandatory annual statutory audits by authorized independent auditors ensure companies credibly meet reporting standards and governance norms vital for market confidence. Backed by legal authority for full access and transparency, statutory audits ensure accountability and stability in the corporate finance system.
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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 method in between the madness.
cosmetic regulatory services
frequently asked questions
Through years of experience, NKG experts have ironed out an efficient, step by step process starting from the basics of understanding a client’s requirements through to providing an exhaustive overview of the regulatory obligations concerning the products. Once a regulatory pathway is identified, NKG experts handhold the client through each step of the process concluding to receipt of licenses and approvals.
Does animal or pets shampoos attract COS-2
As per Section 3(aaa) of Drugs and Cosmetics Act, 1940 “Cosmetic” means “any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and includes any article intended for use as a component of cosmetic.” Form 43 is required for registration of imported cosmetics. Therefore, as per definition of cosmetics , Form 43 is not applicable for pet or animal shampoos.
What are the Labelling guidelines as per CDCSO
For cosmetic products, strict enforcement of compliance to various provisions of labelling is rountily being done during the processing of regulatory dossiers before grant of approval, at Indian Customs during the customs clearance priocedures and in the online – offline marketplaces by the CDSCO enforcement teams. Use this link to get detailed answer on labelling guidelines as per Drugs & Cosmetics Act for cosmetics.
Can POA be attested in India
Preparing regulatory documents is a time consuming and costly affair. It requires close and clear communication with external stakeholders such as overseas regulatory teams and attestation agencies across the world. Power of Attorney is a non-negotiable document required during the cosmetic registration process. As explained in our blog (attach link here), Power of Attorney has to be attested before submission to the CDSCO India. Attestation of POA can take anywhere between 2 to 4 weeks. NKG provides attestation of this document locally in India at a competitive cost and very efficient timeline of a few days. By delegating the attestation of POA in India to NKG, overseas brands and Indian Importers reduce the burden on the regulatory team overseas as well as save a lot of time by attesting in India.
As per the checklist of documents issued by CDSCO, POA attested by a First Class Magistrate is acceptable to CDSCO for processing of application and grant of approval. NKG provides assistance in getting the Power of Attorney attested by First Class Magistrate in India to its clients as and when required.
What is the difference between Power of Attorney (POA) and Letter of Authorisation (LOA)?
Imported cosmetics can be imported in India in two bread ways. Case one is where import of cosmetics is for a Brand owned by an Overseas Brand Holder/Manufacturer. Case two is one the Brand Holder is a company incorporated in India and such a company is getting its cosmetics products manufactured in an overseas location and importing such a cosmetic product in India. In case one, POA document is used as authoirsation given by an overseas brand holder to an Indian Importer to register the products with CDSCO on behalf of the overseas brand holder. In case two, instead of POA, the document LOA is used where the the Indian Entity owning the brand authorises an overseas manufacturer to manufacture the product in their country on its behalf.
What are the mandatory details to be listed on POA/LOA document.
- Power of attorney has to be issued by Legal Manufacturer on its letter head signed and stamped
- Should list an exhaustive product list as per categorization.
- There should be Complete correlation in product names – descriptions – pack sizes in ml or gms as per Artworks of products
- Should be Co-Jointly signed by Both Indian importer and Overseas Legal Manufacturer
- Validity of Power of attorney should be mentioned as 3 years minimum,since registration is valid for 3 Years
- Read our blog Imported Cosmetics: Step by Step Process to a Regulatory Dossier
Is it mandatory to mention Percentages on Ingredients or can it be avoided due to confidentiality
Yes, as per clause 2(a) of Schedule D (III) of Drugs and Cosmetics Rules, 1945,
name(s) of ingredients in the nomenclature of standard references, along with percentage contained in the cosmetics is required to be submitted.
Are drug claims allowed to be mentioned on Cosmetics labels (Labels containing phrases that may appear to attract the definition of the drug. E.g. affects the structure or any function of the human body, Treatment of any disease/disorder, Drug Facts, Dermatologist recommended etc.)
No, Cosmetic and Drug are defined separately under Section 3 in Drugs and Cosmetics
Act, 1940. Products having drug claim do not come under the definition of cosmetic as per the Act and therefore cannot be considered for registration as cosmetic.
Which is the Regulatory Authority that governs the regulations of Import of Cosmetics in India?
Cosmetics Imported into India are regulated under Drugs & Cosmetics Act 1940 by CDSCO New Delhi, India under the Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India. CDSCO is the National Regulatory Authority (NRA) of India.
What is the difference between COS-1 and COS-2?
An Application for registration of import of cosmetics is submitted in Form 42. COnsequently, if after processing of application , the licensing authority is satisfied with the regulatory dossier submitted in Form 42, then licensing authority may grant approval of such an application in Form 43
When was the fees from USD 250 per category increased to USD 2000 per category of products and USD 50 per product variant and where is the notification of the same?
From April 2013 till December 2018, the government fee for cosmetic registration was USD 250 or equivalent Indian Rupees per category of products.
However, Vide Notification No.GSR 1193(E)dated 12th December 2018, the Indian Government has notified the increase in the fees as enclosed.
What is the meaning of variants for government fees?
Variants are those variations in products like colors, shades, flavours, fragrances or other inherent characteristics apart from the base formulation only. Different sizes of products need registration but are not considered as variant for the purpose of payment of government variant fee.
Whether each kit or Palettes having multiple colors or products attract a government fee of USD 50 once or USD 50 times the number of shades.
If a unit pack (Kit, Palettes etc.) containing different colors, shades, flavours,
fragrances or other inherent characteristics apart from the base formulation which is sold as a single unit pack in retail, then it will be considered as a single variant.
What is the difference between Fresh file, Endorsement file and renewal file?
A “Fresh application” for registration of imported cosmetics in Form 42 has to be made in case when the brand is being registered by an Importing Entity for the first time.
An “Endorsement Application” in Form 42 is submitted when an applicant has already been granted a “Fresh Registration Certificate in Form 43. Endorsement application could be for new products, variants, sizes or manufacturing sites.
Renewal Application: A “Fresh“ registration certificate and all corresponding “Endorsement” Certificates under such a registration certificate are valid for a period 3 years from the date of issuance of such “Fresh “ Registration certificate unless suspended or cancelled.In order to keep continuing imports under a valid registration certificate issued by CDSCO, an overseas brand holder and importer need to submit an application for re-registration or renewal of such registration certificate well in time. If license is not renewed before the date of expiration, then it stands cancelled.
Is the validity of endorsement 3 years from approval date or of fresh RC?
Yes, as per Rule 129 D, Validity of Registration certificate in Form 43 is 3 Years from the issue date.
Does FSC is required to be submitted for all variants of a product
Yes,Free sale certificate for all variants needs to be submitted.
Whether Registration Certificate is required for import of Cosmetic products in bulk for repackaging for 100% export to other countries?
No.Cosmetic products which are imported into India as bulk for repackaging for 100% export to other countries will not require registration certificate. In such cases the importer has to obtain necessary permission from CDSCO HQ. Importer must give written undertaking that these products are not released for domestic sale.
Is a registration certificate required for importing small quantities of Cosmetic products for R&D purposes like packaging trials, consumer studies, shelf life studies and transport studies?
No.For Import of cosmetics for R&D purposes like packaging trials, consumer studies, shelf life studies and transport studies, registration certificate is not required. In such cases the importer has to obtain necessary permission from CDSCO HQ. Importer must give written undertaking that these products are not released for domestic
Does CDSCO grant license to manufacture cosmetics in India?
No.Cosmetics Manufactured in India are regulated by State Licensing Authorities (SLA) across all States/UT of India respectively. Under the Drugs & Cosmetics Act 1940, Licenses and registrations regarding manufacturing of Cosmetics, Renewal of manufacturing licenses of cosmetic products have been granted by the Respective SLAs since decades.
Who issues the manufacturing license for cosmetics in India?
State Licensing Authority or SLA of each State/UT respectively.
My cosmetic products contain Petrolatum as an ingredient, what should I do?
Various subjective declarations such as Information regarding refining history of petrolatum if petrolatums is used as an ingredient in any of the product need to be submitted to CDSCO. Contact NKG team to seek assistance on your regulatory needs.
Does CDSCO accepts products which have any cells or tissues derived from Human cells?
No, Ingredients derived from Human cells or tissues are banned from use in Cosmetics in India. For more information Read our Imported Cosmetics: Step by Step Process to a Regulatory Dossier
Where and how does the fees for registration has to be paid?
Government fee for registration of application of cosmetics and/or other products regulated under Drugs & Cosmetics Act have to be paid through online payment made by logging into the SUGAM account of an applicant on the CDSCO portal.
What is a Free sale certificate and what must it mention?
Free Sale certificate is a document issued by a brand holder giving evidence that goods, such as food items, cosmetics, biologicals, or medical devices, are legally sold or distributed freely without restriction, and approved by the regulatory authority of the country of origin. An overseas Brand holder/ Manufacturer has to procure a Certificate of Free Sale for the products that are expected to be imported into India.
NKG Insight:
– FSC can be procured EITHER by the Legal Manufacturer OR the Actual manufacture in their respective countries.
– FSC can be issued by either the Chamber of Commerce or Ministry of Health.
– FSC canbe duly apostilled or attested by the Indian embassy.
– Product names on POA/FSC Must be identical and request you to use enclosed FSC List for the issuance of FSC.
– FSC must mention that products are FREELY SOLD In the country of Origin
To know more about Imported Cosmetics: Step by Step Process to a Regulatory Dossier
Does CDSCO Grant approval for claims such as Antibacterial or Acne or Blemish or anti inflammatory?
No. Cosmetic and Drug are defined separately under Section 3 in Drugs and Cosmetics
Act, 1940. Products having drug claim do not come under the definition of cosmetic as per the Act and therefore cannot be considered for registration as cosmetic.
What are the acceptable standards for hydroquinone for cosmetics products?
As per BIS, Under Cosmetics,Hydroquinone is allowed to be used ONLY in the application ofArtificial Nail systems. The Manximum allowed concentration in the finished product is 0.02% after mixing for use.
Does Room fresheners attract cosmetics registration?
As per Section 3(aaa) of Drugs and Cosmetics Act, 1940 “Cosmetic” means “any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and includes any article intended for use as a component of cosmetic.” Form 43 is required for registration of imported cosmetics. Therefore, as per definition of cosmetics , Form 43 is not applicable for room freshners.
Does Eye lashes and eyelash glue attract registration?
Eye Lash Glue is a considered as a cosmetic product and does require cosmetic registration in Form 43 under Drugs & Cosmetics Act 1940.
Is the government fees of USD 50 per variant for each size of product as well?
Variants are those variations in products like colors, shades, flavours, fragrances or other inherent characteristics apart from the base formulation only. Different sizes of products need registration but are not considered as variant for the purpose of payment of government variant fee.
How many products can i apply in one time on SUGAM portal?
An applicant can apply upto a maximum of 500 independant products on the portal of CDSCO. However, at the same time, each product can technically have multiple variants within itself.
ON which website is the COS-1 application for registration of imported cosmetics submitted?
An application for registration of imported cosmetics is submitted on
https://cdscoonline.gov.in/CDSCO/homepage
What is the official notified timeline for CDSCO to grant approval?
As per Rule 129C of Drugs and Cosmetics Rules, 1945, if the application is complete in
all respects and information specified in Schedule D III is in order, the licensing authority
shall, within six months from the date of receipt of an application, issue such Registration
Certificate, and in exceptional circumstances and for reasons to be recorded in writing, the Registration Certificate may be issued within such extended period, not exceeding three months, as the licensing authority may deem fit. However, CDSCO targeted timeline for processing of applications is 90 days as per Circular dated 30.05.2014.
How does the product categorisation work and how can i define which product falls in which category?
Read our blog Imported Cosmetics – What is a Cosmetic, Product Categorization & Government Fees.
Is the registration certificate transferable?
No, registration certificate in Form 43 is non-transferable/cannot be transferred to anyone.
What types of analysis and specifications of products is required by CDSCO?
Certificate of Analysis:
The Certificate of Analysis of all products have to be submitted to the Cosmetic division of CDSCO as part of regulatory dossier accompanying application for registration of cosmetics.
Cosmetic Products have to comply with the specifications prescribed under Schedule S and Schedule Q or any other standard of quality and safety of CDSCO & BIS from time to time . No cosmetic shall be imported unless it complies with the specifications prescribed under Schedule S and Schedule Q or any other standards of quality and safety applicable to it, and other provisions under the rules.
Schedule S:
Finished products specific standards as per Bureau of Indian Standards. The following cosmetics in finished form shall conform to the Indian Standards specifications laid down from time to time by BIS (+30) Skin Powders. / Skin Powder for infants./ Tooth Powder./ Toothpaste./ Skin Creams. / Hair Oils. /Shampoo, Soap-based. / Shampoo, Synthetic-Detergent based. / Hair Creams. / Oxidation hair dyes, Liquid. / Cologne./ Nail Polish (Nail Enamel). / After Shave Lotion. / Pomades and Brilliantines. / Depilatories Chemical. / Shaving Creams. / Cosmetic Pencils. / Lipstick. / Toilet Soap. / Liquid Toilet Soap./ Baby Toilet Soap. / Shaving Soap. / Transparent Toilet Soap./ Lipsalve / Powder Hair Dye / Bindi (Liquid). / Kum Kum Powder / Henna Powder …etc.
Read our blog: Imported Cosmetics: Step by Step Process to a Regulatory Dossier
I have changes in ingredients of some products, do I need to reapply?
Yes, change in ingredients artworks or specifications post registration require to be notified to CDSCO.There are times where post grant of valid registration certificate, the registered products undergo some change with respect to the formulation of the product, specification of the product or artworks. These are considered as cases of Minor changes but still require some regulatory actions in order to keep the products under compliance with the approved standards or specifications set in Drugs & Cosmetics Act and by Bureau of Indian Standards.
Such changes are required to be mandatorily “NOTIFIED” to CDSCO.
NKG experts work closely with its clients in understanding the the nature of such changes that may happen from time to time and follow a simple and efficient process of submission of “Notifications of change in registered product post registration” to CDSCO so that the products of the clients are always in compliance with the various rules and regulations.
There are changes in design and color of the artwork do i need to re apply?
Yes, read question number 42 above.
Is import of samples allowed without registration.
No, Import of samples are not allowed without registration.
How many samples does CDSCO require for registration approval?
CDSCO does not usually ask for samples of products during the process of registration. If in case samples are required, it will be decided on a case by case basis and communicated in writing by CDSCO to the applicant.
I have a product with size 60 ml or 30 gms, do i need to mention ingredients on labels?
Ingredients are mandatory to be listed for sizes more than 60 ml or 30 gms.
Read our blog Labelling Guidelines for Cosmetics as per Drugs & Cosmetics Act for a completed understanding of label compliance.
What are the mandatory declarations to be made for cautions and instructons for Para-Phenylenediamine or other Dyes, Colours and Pigments
Read our blog Labelling Guidelines for Cosmetics as per Drugs & Cosmetics Act for a complete checklist of labels of cosmetic products.
What is the allowed limit for Formaldehyde as per BIS to be used in cosmetics in India?
As per BIS, IS 4704 Part 2 Annex A, many substances have been identified which must NOT form part of a cosmetic preparation in India. Formaldehyde is banned to be used in cosmetic products as per this list.
What is the allowed percentage of Salicylic acid as per BIS as Cosmetics and if i have a product with more than Allowed limit how can i register it?
Allowed Percentage of Salicylic Acid is 2% as a Cosmetics. In case the content of Salicylic acid is more than 2% than it cannot be registered as cosmetics.
Whether import of Cosmetic is regulated in India?
Yes, import of cosmetic is regulated in India under the provisions of the Drugs &
Cosmetic Act, 1940 & Rules, 1945 vide Gazette notification G.S.R 426(E).
What is the purpose of regulating import of cosmetics in India?
Import of cosmetics in India needs to be regulated to ensure quality of cosmetics being
imported into India and safety of consumers using these cosmetics.
Where can we get a copy of the Gazette notification G.S.R 426 (E)?
The copy of the Gazette notification G.S.R 426 (E) is available under Cosmetics Section on CDSCO website.
Where can we get a copy of the Drugs & Cosmetics Act, 1940 & Rules, 1945?
The copy of the Drugs & Cosmetics Act, 1940 & Rules, 1945 is available on CDSCO website.
Whether all imported cosmetic products are regulated in India?
Yes. All imported cosmetic products covered under definition of cosmetic are regulated
under the provision of Drugs and Cosmetics Act, 1940 and Rules, 1945.
Which is the contact information of the Regulatory Authority that governs the regulations of Import of Cosmetics in India?
Drugs Controller General (India),
Central Drugs Standard Control Organization (CDSCO) HQ,
Directorate General of Health Services,
Ministry of Health and Family Welfare, Government of India,
FDA Bhawan, ITO, Kotla Road,
New Delhi -110002
Phone: 91-11- 23236965 / 23236975,
Fax: 91-11-23236973,
E-mail:- dci@nic.in.
Which division of CDSCO (HQ) is responsible for registration of Cosmetics for import
in India?
Cosmetics Division, Central Drugs Standard Control Organization (CDSCO) HQ,
Directorate General of Health Services,
Ministry of Health and Family Welfare,
Government of India,
FDA Bhawan, ITO, Kotla Road,
New Delhi -110002
What are the requirements for import of Cosmetics in India?
For the import of Cosmetics into India, the imported cosmetic products and
manufacturing site are to be registered with Central Drugs Standards Control Organization by
submitting an application in Form 42 to obtain Registration Certificate in Form 43.
What is COS-1?
Form 42 is an application for grant of a Registration Certificate for Import of cosmetics
into India under the Drugs and Cosmetics Rules, 1945.
What is COS-2?
Form 43 is a Registration certificate to be issued for Import of cosmetics into India
under the Drugs and Cosmetics Rules, 1945.
Who can import Cosmetics into India?
The Manufacturer himself/The Authorized Agent of the Manufacturer/The Subsidiary of
the Manufacturer/any other importer can be an applicant for issuance of Registration
Certificate for import of cosmetics into India.
To whom shall the application be submitted for Registration of Cosmetics for import
into India?
The applications for grant of Registration Certificate for import of Cosmetic products shall be submitted to the
Drugs Controller General (India),
Central Drugs Standard Control Organization (CDSCO) HQ,
Directorate General of Health Services,
Ministry of Health and Family Welfare, Government of India,
FDA Bhawan, ITO, Kotla Road,
New Delhi -110002.
What is the procedure to obtain the “Registration Certificate” in COS-2 for import of cosmetics into India?
Procedure to obtain “Registration Certificate” in COS-2 is available under Cosmetics
Section on CDSCO website.
What are the documents required for issuance of Registration Certificate in COS-2?
Documents required for issuance of Registration Certificate in COS-2 are available
under Cosmetics Section on CDSCO website. (Detailed information is available under the
guidance document on CDSCO website.)
What is the fee required for registration of cosmetics for import in India?
A fee of Two Thousand US dollars or its equivalent in Indian rupees per category of
cosmetic and a fee of Fifty US dollars for each variant shall be paid along with application in
Form 42. (As per G.S.R.1193(E) dated 12 December, 2018)
Under which categories, cosmetics are required to be classified while applying for
Registration Certificate?
Cosmetics are categorized as per Column (3) of Guidelines on Registration of Import of
Cosmetics.
How the fees shall be paid for registration of cosmetics for import in India?
As per the circular no. CDSCO/IT/2018-(37) dated 09.01.2019 of this directorate and
subsequent letter of even number dated 15.02.2019, the fees shall be paid through Bharatkosh
only, from 28.02.2019 onwards. The fee shall be paid through Bharatkosh gateway under
Head of Account “0210041040000-00-1” Import and Registration and the acknowledgement
receipt shall be submitted along with the application for registration of cosmetics.
How to register additional product(s) in the already granted/valid RegistrationCertificate in COS-2?
Importer has to apply for endorsement to the existing Registration Certificate along with
the requisite documents except fees if the category is already registered and provided that the
additional product(s) are being manufactured at the same manufacturing site. If additional
category needs to be added, fees of 2000 USD per category needs to be paid.
What is the duration/validity of Endorsement issued under Registration Certificate for
additional products?
Duration/validity of Endorsement will be same as of the Registration Certificate under
which Endorsement has been issued.
Who can issue a free sale certificate for Imported Cosmetic products?
Free sale certificate can be issued by the National Regulatory Authority which in
Original or authenticated (notarized/apostilled/attested by Indian Embassy) from Country of
origin is required to be submitted. In case if it is not issued by National Regulatory Authority
from the country of origin then from other competent Associations/ organizations duly
authenticated from the Indian embassy of the country of origin needs to be submitted.
Or in case if free sale certificate is authenticated either from chamber of commerce and
apostilled or from notary public and apostilled, then it may be accepted.
Is it required to submit free sale certificate for all variants of the imported Cosmetic
products?
Yes. Free sale certificate for all variants needs to be submitted.
What changes on granted Registration Certificate require an applicant to make a fresh
registration?
The following changes require a FRESH registration – Any change with respect to
manufacturer (legal/principal) like change in constitution, change in address, change in name
etc. Any change with respect to importer/ Indian Agent like change in constitution, change in
address, etc.
What is change in the constitution?
Change in the constitution of a “licencee” means in relation to,-
(i) a firm, a change from proprietorship to partnership including Limited Liability Partnership
or vice versa;
(ii) a company –
(A) its conversion from a private to a public company, or from a public to a private company;
or
(B) any change in the ownership of shares of more than fifty per cent. of the voting capital in the body corporate or in case of a body corporate not having a share capital, any change in its membership; and where the managing agent, being a body corporate is a subsidiary of another body corporate, includes a change in the constitution of that other body corporate within the meaning of this clause.
What are the changes which do not require fresh registration and only notification or
amendment may be obtained?
Change in product composition, change in the method of testing, minor change in
manufacturing process not affecting the final product specifications, updating in labels and
packaging (provided proper justification should be provided for the above changes).
Any changes in name and/or address of Indian agent/ Importer/ legal and/or actual
manufacturer or change in constitution after issue of Registration Certificate are required to
be communicated to the Licensing Authority?
Yes, the manufacturer or his authorized agent in India shall inform the licensing
authority immediately in writing in the event of any change in the constitution of the firm and
/ or address of the registered office / factory premises operating under this Registration
Certificate. Where any such change in the constitution of the firm and/or address takes place,
the current Registration Certificate shall be deemed to be valid for a maximum period of
three months from the date on which the change has taken place unless, in the meantime, a
fresh Registration Certificate has been taken from the licensing authority in the name of the
firm with the changed constitution of the firm and/or changed address of the registered office
or factory premises (as per condition no.4 of Form 43).
Whether acquisition/merger of one company by another company is considered as
change in constitution of the company?
Yes and Indian agent/ Importer shall inform the licensing authority immediately in
writing and shall submit fresh application as per as per condition no.4 of Form 43.
Whether original labels are required to be submitted to CDSCO at the time of
application for registration of Cosmetics?
While original labels are required however applicants may submit copy of original label
incorporating all details as per Part XV of Drugs and Cosmetics Rules, 1945.
Can the importers of registered Cosmetic products incorporate India-specific
requirements on labels after/post landing in India at customs warehouse or place approved by
the Licensing Authority?
Yes, importers of registered Cosmetic products are currently allowed to incorporate
India specific requirements like name and address of importer, import Registration Certificate
Number on imported Cosmetic products post landing in India at customs warehouse or place
approved by the CDSCO prior to release into the market.
If applicant has applied for Registration Certificate and still not issued but in between
there is the change has happened in the constitution of either Manufacturer or Indian Agent,
address of the manufacturer whether fresh fees is required for product registration?
No. The applicant has to submit the Fresh application excluding
fee.
What is the time limit for submission of Query Response?
There is no time limit for submission of Query Response as per the provision of Drugs
and Cosmetics Act, 1940 and Rules, 1945, however, it should be reasonable and justifiable.
Whether cosmetics tested on animals in country of origin are allowed for import in
India?
No, cosmetics that are tested on animals are not allowed for import in India.
Which standards to comply for cosmetic products?
No cosmetic shall be imported unless it complies with the specifications prescribed
under Schedule S and Schedule Q or any other standards of quality and safety, applicable to
it, and other provisions under the Drugs and Cosmetics Rules, 1945. In case the cosmetic is
not included under Schedule S, it shall meet with specifications under the rules and standards
applicable to it in the country of origin.
Is Certificate of Analysis necessary for grant of registration certificate?
No, it is not necessary. However, manufacturer may submit this document in place of
product specification
Whether percentage composition of cosmetics products is required for registration?
Yes, as per clause 2(a) of Schedule D (III) of Drugs and Cosmetics Rules, 1945,
name(s) of ingredients in the nomenclature of standard references, along with percentage
contained in the cosmetics is required to be submitted.
Whether details of principal manufacturer and actual manufacturer are required on the
labels of imported cosmetic?
As per earlier Guidelines on Registration of Import of Cosmetics, the Label should also
bear the name and address of the manufacturer and name of the country where the product
has been manufactured. If the product has not been manufactured in a factory owned by the
manufacturer, the name and address of the actual manufacturer should be printed on the label.
Further, for very small size container where the address of the manufacturer cannot be given,
the name of the manufacturer and his principal place of manufacture shall be given along
with pin code
Whether breakdown of perfume/parfum/fragrance in composition of cosmetic product is
required?
As per IS 4707 (Part 2):2017, the presence of the substance must be indicated in the list
of ingredients when its concentration exceeds.- a) 0.001% in leave on products b) 0.01% in
rinse off products. Besides that some fragrance ingredients are mentioned in ANNEX-A (list
of substances which must not form part of the composition of the cosmetic products)
However, firm may submit undertaking from the manufacturer stating that the
perfume/parfum/fragrance compositions are free from banned fragrance ingredients and
complying to IS 4707 (Part 2):2017.
How can I apply for post approval change in the already issued Registration Certificatein COS-2?
Firm can apply online on SUGAM portal of CDSCO w.r.t. the post approval change in
their already issued Registration Certificate.
What are the post approval changes for which firm can apply online on SUGAM portal
of CDSCO?
Firm can apply online for the below mentioned post approval changes in their already
issued Registration Certificate:-
i. Change of the Indian Agent in Registration Certificate (with constitution
change)
ii. Change of Name of legal/principal manufacturer in Registration Certificate
(without constitution change)
iii. Change of address of legal/principal manufacturer in Registration Certificate
(Location Change)
iv. Change of address of legal/principal manufacturer in Registration Certificate
(No Location Change)
What is the meaning of “Brand “ in case of Registration of Imported Cosmetics?
A “Brand” for the purpose of registration of imported cosmetics will mean each category of cosmetic products as mentioned in Column 3 of the list enclosed in the “Guidelines to Registration of Imported Cosmetics” issued by CDSCO.
Such category of products will include all variants of a product such as shades, flavours,variants, colour, or different pack sizes of packaged content in such products.