CDSCO Registration Certificate

About 

Global solution paves the way for your medical devices in India. From registration to market access. Experience a hassle-free path to device registration and let our experts drive your product to market success.

Brief 

The Central Drugs Standard Control Organization (CDSCO), is the national regulatory authority in India and operates under the Ministry of Health & Family Welfare’s Directorate General of Health Services. 

The Drug and Cosmetics Act of 1940 & the accompanying rules, established in 1945, delegate various responsibilities to central and state regulators to regulate drugs and cosmetics. 

A  decentralized organizational structure, working with the drugs controller general of India DCGI.

The CDSCO laid down the standards for drugs, controlled the imported drug’s quality, coordinated the activities of the SDCO state drug control organization and facilitated expert advice with an outlook of the regularity in the enforcement of the Drugs & Cosmetics Act.

Any organization that manufactures or exports drugs & cosmetics conducts research & development activities regarding drugs, and imports drugs to examine and conducts BA Bioavailability & BE Bioequivalence studies in drugs for export purposes needs to obtain CDSCO registration through its online registration portal.

Responsible for 

CDSCO is an Indian federal agency responsible for the PAN India enforcement of the Drugs and Cosmetics Act.

CDSCO is responsible for several functions under the Drug & Cosmetics Act, including 

• drug approval, 
• clinical trial management,
• drug standards development, 
• quality control of imported drugs, and 
• coordination of state drug control organisations’ activities.

CDSCO and state regulators share responsibility for granting licenses for specific critical drugs, such as blood and blood products, IV fluids, vaccines, and sera.

Additionally, CDSCO is involved in registering medical devices, drugs, and cosmetics in India. The Indian Pharmacopoeia Commission (IPC) is planning to expand across multiple cities.

CDSCO constantly strives to bring out transparency, accountability & uniformity in its services to ensure the safety, efficacy, and quality of medical products manufactured, imported, and distributed in the country.

Purpose 

Stakeholders need to fill out an application in form 40 to CDSCO for a registration certificate and a license moreover With CDSCO authority India, for issuance of an import registration certificate for the import of drugs into India.

The purposes for which a stakeholder can register under the portal of CDSCO are as follows 

• Test license dual use NOC [ trader ] 
• Dual-use NOC trader 
• Blood bank registration 
• Cosmetics Registration 
• BA or BE-approved sites 
• Import or manufacture of drugs 
• Ethics committee registration 
• Formulation of research and development organization 
• Sponsors BA or BE and  CT 
• Export NOC [ zone ] 
• Blood product registration.

Who can apply for CDSCO Registration? 

Stakeholders who can apply for CDSCO registration in India are as follows –

• Indian agents 
• Corporates 
• Importers of medical devices / IVD / cosmetics 
• Foreign enterprises holding Indian subsidiary 
• A manufacturing unit cannot register directly on the website 
• Authorized agent of the medical devices and IVD 
• Domestic manufacturers of medical devices and IVD 
• Foreign manufacturers of medical devices and IVDs
• The Indian subsidiary of medical devices and IVD.

Categories that come under CDSCO registration 

Following are the categories for CDSCO registration 

Cosmetics 

For import into India, the cosmetics products need to be registered with the licensing authority as defined under rule 21 of drugs & cosmetic rules. the regulatory application needs to be submitted in Form 42 along with the information about the brands, products and manufacturer, product specification and testing protocol to receive the cosmetics registration certificate in Form 43.

Under the rules made thereunder, the manufacturing of cosmetics is controlled under a system of examination & licensing by the state licensing authority assigned by the concerned state government while the import of cosmetics is governed under a registration system by the authority appointed by the central government.

DCC-DTAB

The administration of the act & rules thereunder shall be done by changing the pertinent particulars of the Drugs & Cosmetics Act & rules. DCC- DTAB also organises the meeting for effective checking of the rules.

BA / BE 

Bioavailability is defined as the respective amount of drug that reaches the intrinsic circulation and so able to have an active effect in the body.

Bioequivalence means that two drugs are said to be BE  drugs if they function the same in all intent by providing equivalent proportions.

Import and registration of drugs 

The import of equipment into India is governed under Chapter 3 of the act and Part 4 of the rules. the application for registration and import license of drugs are processed as per the drugs & cosmetics rules.

New drugs 

Under rules 122 – E  of drugs & cosmetics rules, new drugs comprising bulk drug substances or phytopharmaceutical drugs which have not been used in India to any remarkable extent under the conditions, suggested in the labelling thereof & have not been recognised as safe & effective by the authority mentioned under the rules 21 of the concerned affirmation.

Medical devices and diagnostics 

Biological products 

Vaccines 

Vital necessary documents required for online CDSCO registration 

Following are some vital necessary papers that should be submitted during CDSCO registration 

• Identity proof of the applicant 
• Address proof of the applicant 
• Upload the copy of BE or BA site registration as issued by CDSCO 
• Undertaking allotted by a government authority.
• Wholesale license or manufacturing license in case of manufacture or  either import of blood product registration or drugs or test license registration

Register a medical device import license 

• Device specification 
• Manufacturing process details 
• Clinical trial data 
• Labelling and packaging 
• Device master file DMF 
• Power of attorney 
• Free sale certificate 
• GMP certificate 
• Declaration of conformity.

CDSCO registration process 

For new drug approval 

The CDSCO registration process can be complex and involves several steps as follows 

• Submission of an application
• Review of the application
• Inspection of the manufacturing facility 
• Clinical trials 
• Approval 
• Post-marketing surveillance 

For Medical device 

• Pre-submission process 
• Classification of medical devices 
• Documentation 
• Review of documentation 
• Inspection 
• Testing 
• Approval 
• Post-marketing surveillance 

Benefits of registering medical devices with the CDSCO 

Registering medical devices with the central drugs standard control organization CDSCO offers several benefits for manufacturers, importers and distributors as follows 

• Legal compliance 
• Market access 
• Quality assurance 
• Competitive advantage 
• Increased revenue
• Risk management  

Authorization for manufacturer 

The authorization by a manufacturer to his agent in India shall be documented by a power of attorney executed and authenticated either in India before a first-class magistrate, or in the country of origin before such an equivalent authority, the certificate of which is attested by the Indian embassy of the said country, and the original of the same shall be furnished along with the application for a registration certificate. Apostille’s power of attorney from Hague Convention member countries is also acceptable. the authorized agent will be responsible for the manufacturer’s business activity in India.

Issuance of license 

An application shall be made to the licensing authority in form 40 either by the manufacturer himself, having a valid wholesale license, for the sale or distribution of drugs or by his authorized agent in India either having a valid license to the manufacturer for the sale of a drug or having a valid wholesale license for sale or distribution of drugs.

A  duly attested/notarized in India and valid copy of the wholesale license for the sale or distribution of drugs under drugs and cosmetics 

Rules in the form of 20 B & 21 B or its renewal in form 21 C issued to the manufacturer subsidiary office/representative of the parent company or its agent by the state licensing authority in India. if the agent is a manufacturer, a duly attested/notarized in India and valid copy of the manufacturing license issued by the state licensing authority.   

Document required 

• Information on the drugs to be imported 
• Manufacturer information like address and contact details 
• Original challan and the details of the challan 
• Form 40 
• Schedule D document as provided by the drug manufacturer 
• Power of attorney issued by the manufacturer 
• Copy of wholesale license of applicant 
• Copy of authorization letter of applicant 
• Power of attorney issued by the manufacturer 
• An undertaking shall be submitted by the proprietor of the firm in case of a proprietorship firm case of a private limited company by the board of directors.

Criteria to be fulfilled by the manufacturer 

Power of attorney should be co-jointly signed and stamped by the manufacturer and the Indian agent indicating the name & designation of the authorized signatories along with the name and address of the firm.

It should list the names of all proposed drugs if possible along with their specific indication or intended use. Furthermore, the name of the proposed drug should correlate with those mentioned in form 40, a free sale certificate or certificate of pharmaceutical product [ COPP] as per the WHO- GMP certification scheme.

The names and addresses of the manufacturer as well as the Indian agent stated in the power of attorney should correlate with the form 40. multiple sites are in tabular form. It should be valid for the period of said registration certificate. it implies that a fresh POA is to be submitted at the time of the revalidation of RC. 

Standard of drug 

The second schedule of the act prescribes standards to be complied with by imported drugs and by drugs manufactured for sale / stocked or exhibited for sale or distributed in the country. if the drug is in IP must meet the standards of identity, purity and strength otherwise USP, BP or EP.

Testing of drugs 

In case of registration of bulk active pharmaceutical ingredient drugs, the consecutive three batches are asked to be submitted to the designated laboratory for testing for which a fee is to be paid by the applicant to the laboratory as per their norms.

The applicant should enclose adequate samples for reanalysis purposes from each of three consecutive batches along with specification, method of analyses, COA tested in their laboratory, impurity standards, markers compounds reference standards along its COA wherever applicable.

Free sale certificate/certificate to foreign government/certificate of marketability 

Free sale certificate or certificate to a foreign government for each drug issued by the national drug regulatory authority of the country of origin. free sale certificate should state that the proposed drug is freely sold in the country of origin and can be legally exported.

GMP certificate

Duly apostilled by the Indian embassy in the country of origin and a valid copy of the GMP certificate of WHO guideline or certificate of pharmaceutical product COPP as per WHO GMP certification scheme/product registration certificate issued by NRA and or proof of DMF approval by NRA and / CEP [ EDQM certificate] for each drug issued by the national drug regulatory authority of the country of origin.

Market authorization certificate or manufacturing license 

Manufacturing license in respect of applied drugs issued by the national drug regulatory authority of the country of origin. Free sale certificates of other countries if available is also be submitted .

Product registration certificate 

Duly apostilled by the Indian embassy in the country of origin and a valid copy of the product registration certificate wherever applicable in respect of the foreign manufacturing sites.

Validity of registration and undertaking required for registration 

At the time of application for renewal of registration or re-registration, the application is to be made 9 months before the expiry of the registration certificate. in addition to regulatory documentary compliance like form 40 POA, GMP, COPP, registration certificate, DMF, and license.

Undertaking required 

• Undertakings by the manufacturer or his authorized agent in India in respect of any administrative action taken due to adverse reaction market withdrawal, regulatory restrictions or cancellation of authorization, and not of standards quality report of any drug about the registration certificate declared by the regulatory authority of the country of origin or by any regulatory authority of any other country, where the drug is marketed/sold or distributed.
• Undertaking by the manufacturer or his authorized agent in India in respect of any change in the manufacturing process or packaging or in labelling in testing or the documentation of any of the drugs about this registration certificate.
• Undertaking by the manufacturer or his authorized agent in India in respect of any change in the constitution of the firm including the name or address of the registered office/factory premises operating under this registration certificate 
• Details of drugs imported in India during the last three years 
• Submission of original RC issued.

Document required for import of drug 

The following documents are required to be submitted in the following manner and order for the issue of the import license in form 10 of the drugs for import into India.

Covering letter 

The covering letter is an important part of the application and should specify the intent of the application.The covering letter should be duly signed and stamped by the authorized signatory, indicating the name & designation of the authorized signatory along with the name and address of the firm.

Authorization letter 

Authorization letter issued by the company secretary of the Indian agent firm revealing the name & designation of the person authorized to sign.

legal documents such as form 8 and Form 9 on behalf of the firm should be submitted when the application for an import license is submitted.

Form 8 

A duly filled application for a license to import drugs excluding those specified in Schedule 10 to the Drugs and Cosmetic Rules 1945 as per the proforma prescribed in the Drugs & Cosmetics Rules, duly signed & stamped by the Indian agent along with name & designation of the authorized signatory.

The requisite fee for the import of the drug 

As prescribed in the Drugs & Cosmetics Act&  Rules Rs 1000 for 1 proposed drug and Rs 100 for each additional drug to be imported may be submitted at notified branches of Bank of Baroda under the head account – 0210 – medical and public health, 04 – public health, 104 – fees and fines adjustable to pay and account officer, DGHS, New Delhi in the form of a treasury challan perform for treasury challan.

A fee of one thousand and five hundred US dollars shall be paid along with the application inform 40 as registration fee for his premises meant for manufacturing of drugs for import into and use in India.

A fee of one thousand US dollars shall be paid along with the application in form 40 for the registration of a single drug meant for import into and use in India and an additional fee at the rate of one thousand US dollars for each additional drug.

License for import of drug 

If an endorsement to an existing license is required, then stakeholders need to fill out Form 10 license along with its endorsements should be furnished along with the application.

Form 9 issued by a foreign manufacturer will be sent for verification to the Indian agent is responsible for the business activities of the foreign manufacturer in the country in all respects.

Renewal or re-registration for import of drug 

At the time of application for renewal of registration or re-registration, the application is to be made 3 months before the expiry of the import license. in addition, regulatory documentary compliance like form 8, form 9, copy of registration certificate, and license copy is to be submitted Moreover following are to be submitted 

• Details of drugs imported in India during the last three years 
• Details of sampling of drugs in India and results thereof 
• Submission of original import license issued.

The undertaking required for a registration certificate

Information and undertaking required to be submitted by the manufacturer or his authorized agent with the application for a registration certificate. the format shall be properly filled in for each application in Form 40.

Particulars of the manufacturer and manufacturing premises  

• Name and address of the manufacturing premises to be registered 
• Name and address of the proprietor/partner/directors. 
• Name and address of the authorized agent in India, responsible for the business of the manufacturer.
• A brief profile of the manufacturer’s business activity in domestic as well as global markets.
• A copy of the plant master file 
• A copy of the plant registration/approval certificate issued by the Ministry of Health / national regulatory authority of the foreign country concerned 
• A brief profile of the manufacturer’s research activity.

Particulars of the manufactured drugs 

• Names of drugs to be registered meant for import into and use in India 
• A copy of the approved list showing the bulk drugs/formulations/ special products are permitted for manufacturing/marketing in the country of origin
• A copy of goods manufacturing practice GMP certificate, as per WHO- GMP guidelines, or certificate of pharmaceutical products CPP issued by the national regulatory authority of the foreign country concerning the bulk drugs or formulation or special products, meant for import into India.
• The domestic prices of the drugs are to be registered in India, in the currency of the country of origin.

Bulk drug or special product  

The information must be submitted by the manufacturer or his authorized agent with the application form for the registration of a bulk drug/formulation / special product for its import into India.

Issue of certificate 

Free sale certificate and certificate of pharmaceutical products [ CPP] as per the WHO GMP certification scheme issued by the national regulatory authority of the country of origin.

Product registration certificate issued by NRA or proof of DMF approval by NRA and CEP EDQM certificate 

Free sale approval is issued by the regulatory authorities of other major countries.

Batch test reports / certificates of five consecutive production batches in details of the medicinal product are to be submitted for every site of the manufacturing premises.

Criteria bulk drug importers need to be fulfilled

The bulk drug requires three samples of medicinal product/drug and outlet packing is to be submitted with batch certificates. additional samples as well as reference substances with batch certificates including date of manufacture, shelf life, and storage condition of reference substance may be required both during the registration procedure and during the validity of the registration decision.

Clinical documentation 

A new drug as defined under rule 122 – E of the drugs and cosmetics rules, 1945 is required to be permitted separately by the licensing authority under rule 122A of the said rules before its registration. such a new drug requires a summary and clinical documentation, along with permission under 122- A of the said rules for its registration certificate.

Condition Stakeholders need to fulfill to get the registration certificate 

• No drug shall be registered unless it has a free sale approval in the country of origin or other major countries 
• The manufacturer or his authorised agent in India shall comply with the conditions of the import license issued under the Drugs and Cosmetics Rules 1945.
• The manufacturer or his authorized agent in India shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, market withdrawal, regulatory restrictions, or cancellation of authorization and not of the standard quality report of any drug of this registration certificate declared by the regulatory authority of the country of origin or by any regulatory authority of any other country where the drug is marketed/sold or distributed.
• The manufacturer or his authorized agent in India shall inform the licensing authority within 30 days in writing in the event of any change in the manufacturing process packaging labelling or testing or the documentation of any of the drugs about this registration certificate.

Recommendation for import and registration of bulk drugs and finished formulation

Import license 

An application for an import license shall be made to the licensing authority in form 8 for drugs excluding those specified in Schedule 10 and in form 8-A  for drugs specified in Schedule 10 either by the manufacturer himself having a valid wholesale license for sale or distribution of drugs under these rules or by the manufacturer’s agent in India either having a valid license under the rules to manufacture for sale of a drug or having a valid wholesale license for sale or distribution of drugs under these rules and shall be accompained by a license fee of one thousand rupees for a single drug and an additional fee at the rate of one hundred rupees for each additional drug and by an undertaking in form 9 duly signed by or on behalf of the manufacturer.

Subsequent application made by the same importer for import license for drugs manufactured by the same manufacturer, the fee to accompany each application shall be one hundred rupees for each drug.

Any application for an import license in form 8 or form 8 -A as the case may be shall be accompanied by a copy of the registration certificate issued in form 41 under rule 27 – A.

Provided that in case of emergencies the licensing authority may with the approval of the central government, issue an import license in form 10 or 10 – A  as the case may be without the issuance of a registration certificate under rule 27 – A.

Registration certificate 

An application for the issue of a registration certificate shall be made to the licensing authority in form 40, either by the manufacturer himself, having a valid wholesale license for the sale or distribution of drugs under these rules or by his authorized agent in India, either having a valid license under the rules to manufacture for sale of a drug or having a valid wholesale license for sale or distribution of drugs under these rules and shall be accompanied by the fee specified in sub-rule [ 3] and the information and undertaking specified in schedule D – 1 and D -2 duly signed by or on behalf of the manufacturer.

The authorization by a manufacturer to his agent in India shall be documented by a power of attorney executed and authenticated either in India before a first-class magistrate or in the country of origin.

Before such an equivalent authority, the certificate of which is attested by the Indian embassy of the said country, and the original of the same shall be furnished along with the application for registration certificate.

Registration certificate for import of drugs manufactured by one manufacturer 

A single application may be made as addressed by single registration drugs and cosmetic rules 1945.

Certificate in form 41 may be issued in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer.

• Provided that the drug or classes of drugs are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit.
• Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs, a separate registration certificate shall be required concerning the drugs manufactured by each such factory. 

The CDSCO certificate serves as proof that the manufacturer has met all the requirements and standards for the manufacture, sale and distribution of drugs or medical devices in India. this includes requirements related to product quality, safety and efficacy as well as adherence to the regulatory framework set out in the Drugs and Cosmetics Act of 1940 and the rules and regulations made under this act.

A grant of registration certificate 

On receipt of an application for a registration certificate in the form and manner specified in rule 24 – A, the licensing authority shall on being satisfied, that, if granted, the conditions of the registration certificate will be observed, issue a registration certificate in from 41.

Provided further that if the application is complete in all respects and information specified in schedules D -1 and D – 2  are in order, the licensing authority shall within nine months from the date of receipt of an application, issue such registration certificate and in exceptional circumstances the registration certificate may be issued within such extended period, not exceeding three months as the licensing authority may deem fit.

Duration of registration certificate 

A registration certificate, unless, it is sooner suspended or cancelled, shall be for three years from the date of its issue. provided that if the application for the latest 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. 

Suspension of registration certificate 

If the manufacturer fails to comply with any of the conditions of the registration certificate, the licensing authority may after showing cause why such an order should not be passed and stating the reasons therefore suspend or cancel the registration certificate for such period as it thinks fit either wholly or in respect of some of the substance to which it relates.