There is more to it than just manufacturing a healthcare product and securing a buyer for it to be introduced into the Indian market. A product can be sold in India only after getting regulatory approval, registration, licence or permission from the Central Drugs Standard Control Organisation, depending on the product category.
CDSCO is the drug regulatory authority of India and also regulates several other regulated healthcare goods. It has an online system called SUGAM which offers various regulatory applications such as drugs, medical devices, cosmetics, test licences and more.
However, it is important to keep in mind that it does not mean that all healthcare products have CDSCO Approval in India. The regulatory pathway to be followed depends on the product, its intended use, whether it has been manufactured or imported, and under which Indian regulation the product must be regulated.
What is CDSCO Approval in India?
CDSCO approval shall cover the general regulatory approvals, registrations, licenses and authorisations for which CDSCO is responsible in respect of such products and activities falling under its jurisdiction.
CDSCO stands for the Directorate General of Health Services from the Ministry of Health & Family Welfare of the Government of India and is the National Regulatory Authority of India.
The types of approvals will vary based on the type of product that will be regulated and can be either drugs, medical devices, diagnostics or cosmetics.
For example, the CDSCO SUGAM portal provides separate roles and forms for activities such as cosmetics registration and the import of drugs, medical devices and test licences.
It is therefore important to identify the correct category under which the regulation will be applied before preparing an application.
Why Are CDSCO Approvals Important for Businesses?
The main objective of CDSCO regulation is to ensure that products under its regulatory jurisdiction comply with the relevant requirements for quality, safety, and performance.
Regulatory approval or licence is important for businesses to ensure lawful market access and to avoid issues that may arise from employing the incorrect registration pathway.
CDSCO compliance is particularly important for companies planning to:
- Allow importation of regulated products into India.
- Produce products that must be regulated centrally.
- Introduce novel drugs and regulated health products.
- Market medical devices and diagnostics where applicable.
- Bring in cosmetics to be registered.
- Perform activities that require CDSCO permission/licensing.
The exact obligation will vary depending on the product and relevant regulations; companies are advised to review regulations before commercial launch.
Who Needs CDSCO Approval in India?
Different businesses may be subject to different requirements under the CDSCO depending on the type of their business, product, and activity.
- Indian Manufacturers
Depending on the product and regulatory regime, the manufacturers of the products falling within the jurisdiction of the CDSCO may require a license or approval issued at the central or state level.
- Importers
Importation of the regulated drugs, medical devices, cosmetics, or other regulated products into India may require relevant CDSCO registration, an import licence or permission.
- Foreign Manufacturers
If they wish to sell regulated products in India, foreign companies will be required to follow the relevant Indian regulatory procedure and, where necessary, through an authorised representative or agent in India.
- Pharmaceutical & Healthcare Companies
The requirements of the CDSCO may be different for a company engaged in drugs, medical devices, diagnostics, clinical research, biologicals and related regulated activities depending on their specific activity.
The CDSCO online portal details the various roles of the applicants, such as importers, Indian agents, foreign companies with Indian subsidiaries, corporate applicants, etc
Which Products Come Under CDSCO?
CDSCO has regulatory duties in various categories of products in healthcare, and the requirements applicable to the products vary from category to category.
These can include:
- Drugs and pharmaceuticals
- New drugs
- Medical devices
- In vitro diagnostic devices
- Cosmetics
- Biological products and vaccines
- Products and activities associated with Clinical Trials
- Conduct tests and some research activities.
Before assuming that all medical devices follow the same regulatory classification and licensing pathway, businesses should first identify the regulatory classification of the device and pinpoint the pathway that is relevant to it.
When Is CDSCO Approval Required?
The general guideline is to seek CDSCO approval or regulatory permission before conducting the regulated activity for which the permission is sought.
This is dependent on the product and activity.
An importer might be required to ensure the product is compliant with regulations before importation and sale of a regulated product. The appropriate manufacturing licence or permission may have to be acquired before commercial manufacturing by a manufacturer.
It is therefore necessary for businesses introducing a new product to start assessing regulatory issues at product-planning time, not when the product is about to go on sale.
Early assessment is used to identify:
- The applicability of CDSCO approval or not.
- Which regulatory category does the product fall under?
- Which application or licence is required
- Whether testing or evaluation is needed
- What documents have to be created?
- Whether an Indian representative or agent is required
Where Can Businesses Apply for CDSCO Approval in India?
The CDSCO regulatory applications are made through the SUGAM online portal.
On the official CDSCO portal, the applicants can register their application and apply for various regulatory activities. It also offers facilities for tracking applications and answering queries submitted during the application review process.
All of the following are required to complete the applicant registration process: An authorised signatory or responsible person must complete the registration process, verify the registered email address and submit the required documentation. CDSCO also mentions the conditions of self-attestation and the document requirements for uploaded documents.
However, using SUGAM does not mean that every product follows the same online procedure. The applicable forms, documents, fees, and review requirements vary depending on the regulatory activity that is selected. Also get to know more information about CDSCO Medical Device License in India.
How to Get CDSCO Approval in India?
Businesses can go through the following steps to approach the procedure, although it will differ from product to product.
Step 1: Product Classification
Using CDSCO definitions, determine if the product is a medication, medical device, cosmetic, or diagnostic.
Step 2: Application Submission
The relevant CDSCO registration fees must be paid in addition to setting up and submitting the online application via the CDSCO portal.
Step 3: Documentation Review
CDSCO scrutinises the technical, clinical, and quality documents.
Step 4: Inspection (If Applicable)
Inspectors may go to a production site to see how the site is following GMP.
Step 5: Grant of Approval
CDSCO will offer the CDSCO certification in Delhi NCR, the CDSCO registration certificate, or the CDSCO licence if the review is successful.
Product Compliance Services UMSPCS is your partner during the various phases of the CDSCO approval process, making sure that everything is precise and compliant with the rules.
What Documents Are Required for CDSCO Approval in India?
No standard set of documents for all CDSCO applications. Requirements vary from product to regulatory path.
Typical documents are the following:
- Application (in CDSCO format)
- Drug Master File or Device Master File (DMF)
- Certificate of Free Sale
- GMP or ISO 13485 Certifications
- Clinical assessment or performance information
- IFU and product labelling
- Attorney’s Power (for importers)
- Manufacturing license
- Receipt for charge payment for CDSCO enrolment
UMSPCS regulatory specialists. Ltd is constantly dedicated to creating flawless documentation that satisfies CDSCO requirements, reducing the likelihood of delays and rejections.
- Fees for CDSCO Registration
- The cost of CDSCO registration depends on:
- Product category
- Classification of risks
- Status: domestic or imported
Read more also: CDSCO Cosmetic License in India
How Can UMSPCS Help With CDSCO Approvals in India?
One of the common difficulties faced by businesses while applying for CDSCO is when they are not sure about the classification of their product, applicable forms, technical documents or regulatory procedures.
The services provided by UMSPCS include:
- Product suitability evaluation
- Determining the regulatory path
- Preparing documentation
- SUGAM portal application assistance
- Technical document review
- Assistance with application filing
- Assisting in query and deficiency responses
- Regulatory follow-up
- Post-approval compliance
Our team helps manufacturers, importers and organisations get clarity about CDSCO requirements. At UMSPCS, we make every effort to support you throughout the certification process. In the last 6 years, we have successfully completed more than 600 certificates.
Conclusion
The process of CDSCO approvals in India is not a single approval process. The requirement applies to product category, intended activity, manufacturing/import arrangement, and relevant Indian regulations.
The first step for businesses to take is then to determine the proper regulatory process to go through before applying. After determining which is applicable, the business can make the necessary documents, apply, and answer any regulatory questions during the review process.
Manufacturers and importers can work towards CDSCO compliance more quickly and prevent needless delays by organising and recording the regulatory process.
Do you require assistance with CDSCO certification?
Businesses may find the approval process to be extremely challenging due to its complexity and length. You will receive complete assistance from our organization, UMSPCS, in completing the CDSCO registration and licensing procedure.
Read more also: Why the ISI Mark Matters on Furniture: Standards and Safety
FAQs
- What does CDSCO approval in India mean?
The term ‘CDSCO approval’ broadly means the relevant regulatory licence, registration, permission or authorisation received or obtained under CDSCO’s regulatory framework.
- Do all healthcare products require the approval of the CDSCO in India?
No. This requirement is subject to the product category and the regulatory requirements in India.
- Can CDSCO applications be submitted online in India?
Yes. The SUGAM online portal is used for many regulatory activities of CDSCO.
- Who may need CDSCO approval in india?
It is noted that in different cases of activity and product, manufacturers, importers, foreign companies, etc. may require applicable CDSCO approval/licence.
- Are the documents the same for every CDSCO application in India?
No: Documentation is dependent upon product category and regulatory avenue.
- What can UMSPCS do for the approval by CDSCO in India?
UMSPCS provides support for regulatory evaluation and documentation, SUGAM application, handling queries, and providing end-to-end CDSCO compliance assistance.
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