CDSCO Online Registration

Are you a medical device manufacturer looking to sell your products in India? 

If so, you need to be aware of the regulatory process involved in getting your products approved for use in the Indian market. 

The CDSCO stands for Central drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services of the Ministry of Health and Family Welfare. Several CDSCO responsibilities are outlined in the Drugs and Cosmetics Act, ranging from approval of drugs to clinical trials, providing standards for drugs and quality checking of imported drugs.  

All-in-all CDSCO promises coordination of the activities of SDCO (State Drug Control Organisation) while providing expert advice and training in uniformity in the implementation of the Drugs and Cosmetics Act in mind. No wonder, it has to ensure smooth coordination with SDCO to undertake the operations smoothly.

A CDSCO Certificate refers to an approval granted by the regulatory authority in ensuring the efficiency and quality of Pharmaceuticals, medical devices & cosmetics. It stands as a testament to the commitment to complying with stringent regulations and adhering to the stated standards for the products. 

Under the Drug & Cosmetics Act, the arrangement of manufacture, sale & distribution of Drugs is a priority of State Authorities while Central Authorities are only responsible for permitting new drugs or clinical experiments in the country. 

With CDSCO Certificate in hand, you can rest assured that the product you are using has undergone rigorous testing, adhering to standards, and has been thoroughly evaluated for its composition, manufacturing processes, and packaging, leaving no room for compromise. Moreover, CDSCO is also a part of permitting specified categories of drugs such as blood and blood products, I. V. Fluids, and vaccines.           

Who Can Apply Under CDSCO? 

The following are the applicants that can apply under CDSCO, which are as follows- 

• Importers
• Indian agents
• Corporates
• Foreign enterprises in the Indian subsidiary

The functions of CDSCO Certification consist of the following factors- 

• Giving permits to new drugs and clinical trials
• Import Registration & Licensing
• License approval of Blood banks, LVP, Vaccine, r-DNA Products & some medical devices
• Amendment to D & C Rules
• Banning of Drugs & Cosmetics
• Grant of test license, Personal License, NOCs for export
• Testing of New Drugs

Central Drugs Standard Control Organization has 8 Divisions with Which It Deals. Following is the list of CDSCO divisions:

New Drugs

Demonstration of the safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing and marketing in the country.

The Rules 122A, 122B, 122 DAB, 122DAC, 122 DD and 122E of Drugs and Cosmetics Rules give the information, and data required for approval of clinical trials and or to import or manufacture of newly introduced drugs for marketing in the country.

New drugs as defined under Rule 122-E of Drugs and Cosmetics Rules, New drugs including bulk drug substance or Phytopharmaceutical drug which has not been used in the country to any remarkable extent under the conditions, recommended or suggested in the labelling thereof and has not been acknowledged as effective and safe by the licensing authority mentioned under rule 21 for the proposed affirmation.

A drug that has already been approved by the Concerned Authority mentioned in Rule 21 for certain affirmation, which is now proposed to be marketed with modification or new affirmation, indications, namely (storage, dosage form (quantity) and route of administration.

Drugs derived from the vaccines and Recombinant DNA (rDNA) shall be considered new drugs unless it is certified by the Licensing Authority under Rule 21. From the date of first-time approval of a new drug, it shall be considered a new drug for 4 years.

Medical Device & Diagnostics

In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act and Rules made there in 1945.

• Substances used for artificial insemination detection and incision dressings, incision bandages, incision staples, incision sutures, ligatures, blood and blood component collection bag with or without anticoagulant.
• Substances include prophylactic techniques (birth control contraceptives (condoms, I-pill, unwanted – 72), intrauterine devices, tubal rings), antiseptic and insect killers.

Drugs Import & Registration

• The import of Drugs into India is regulated under Chapter III of the Drugs & Cosmetics Act & Part IV of the Drugs & Cosmetics Rules.
• The applications for registration certificates & import licenses of drugs are processed as per the Drugs & Cosmetics Rules.

Drug includes:

• All substance that has medicinal properties and can be used internally or externally in human beings or animals and all substances which can be used for or in the detection, cure, or reduction of any disease or disorder in human beings or animals, also includes mixtures applied or sprayed on the human body to repel or distance the insects from the human body like mosquitoes.
• Such substances (other than food) are just used to alter the structure or any function of the human body or are intended to be used for the destruction of insects that cause disease in human beings or animals.

BA/BE

• Bioavailability (BA): Bioavailability may be defined as the respective amount of drug that reaches the systemic circulation and so able to have an active effect in the body.
• Bioequivalence (BE): Two drugs are said to be Bioequivalence drugs if they function the same in all intent by giving in equivalent proportions. 

Biological

• Biological products or biologics are medical products. Most of the biological presence on earth is made from a variety of natural sources (human, animal or microorganism). Like some medicine, some biologics are intended to treat diseases and medical conditions. Other biological products are used to prevent or diagnose diseases. 

Vaccines

• Blood and blood-derived products for transfusion and/or manufacturing into other products
• Allergenic extracts from plants, which are used for both diagnosis and treatment (for example, allergy shots)
• Human organs or cells or tissue used for transplantation (for example, tendons, ligaments and bone)
• Gene therapies
• Cellular therapies
• Blood donor test to screen for infectious agents such as HIV 

Cosmetics

According to the Drugs and Cosmetics Act, “Cosmetic” means “any article that is intentionally used, pat, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleaning, decorate, enhancing glow, or changing the appearance and includes any article intended for use as a component of cosmetic.”

Under the provisions of the Drugs and Cosmetics Act, and the Rules made there under, the manufacture of cosmetics is regulated under a system of inspection and licensing by the State Licensing Authorities appointed by the concerned State Governments while the import of cosmetics is regulated under a system of registration by the Licensing Authority appointed by the Central Government. The Drugs Controller General (India) functions as the Licensing Authority that grants the registration certificate and regulates the import of cosmetics in India under the provisions of the Drugs and Cosmetics Act, and Rules made there under.

DCC-DTAB

DTAB & DCC gives the recommendations on the matters that rose out of the administration of the Drugs and Cosmetics Act and Rules there under shall be done by amending the relevant particulars of the Drugs and Cosmetics Act and Rules there under.

DCC - DTAB also organizes the meeting for effective monitoring of the rules.

What are the Rules Governing Clinical Trials?

The main regulations as per clinical trials mention the following, which are of the utmost importance. One needs to remain vigilant enough in conforming to the same.  

• Rule 122-A: Registration for permission to import new drug
• Rule 122-B: Registration for approval to manufacture a new drug
• Rule 122-DA: Requirement of permission from DCG for the conduct of the clinical trial of a new drug;
• Rule 122 DAB: Provision for compensation during a clinical trial-related case. Provision for cancelling of the license of the applicant in case of failure to pay compensation
• Rule 122 DAC: Requirement of permission for conduct of the clinical trial which includes the requirement to follow Good Clinical Practice (GCP) guidelines, guidelines and requirements given in Schedule Y of Drugs and Cosmetics Rules. Provision for cancellation of license of applicant and investigator in case of failing to do compliance
• Rule 122 E: Definition of new drug
• Schedule Y: Detailed instruction and essential details for the procedure to conduct clinical trial and approval of the new drug
• Good Clinical Practice Guidelines: Issued by Central Drug Standard Control Organization and Directorate General of Health Services, Govt. of India.

The documents required as per CDSCO Registration are as follows-

• Identification proof
• Address proof
• A copy of the BA/BE Site Registration approved by CDSCO in the case of BA/BE Approved sites
• Undertaking by a government authority
• Manufacturing license in case of the Manufacture or import of drugs

The CDSCO Registration process consists of various steps, without which you cannot carry out procedures. Let u shift our gaze to how it can help you-

• Step 1:- Connect with Corpseed

Firstly, contact Corpseed as your one-stop solution.

• Step 2:- Assign a Dedicated Professional

Secondly, Corpseed will assign a dedicated professional to help you with the CDSCO Registration online.

• Step 3:- Filing of Applicant Registration

Thirdly, our experts will undertake the registration process and help you with the filing of the application form with necessary details, ranging from applicant name, username, password, and email id along with CIN, address, type & form of organisation with corporate address proof. Make sure, you avoid any errors and discrepancies while submitting your data to us.

• Step 4:- Confirmation of details

Once we have helped you with the submission of the application form, our experts will guide you with the confirmation of details for further verification. Sooner, the same will be shared for approval with the respective authorities.

• Step 5:- Application Status

Once you have completed and adhered to the above-mentioned procedures, an email will be sent by authorities, signifying the acceptance or rejection of your application. Where, in both cases, you will be notified via your registered email id. Now, once we are informed about its acceptance, your CDSCO Registration will be completed.

At Corpseed, our team is fuelled by an indisputable commitment to CDSCO Registration. With years of experience and an extensive knowledge base, we are the go-to experts for all your Registration needs.  So why settle for anything less than the best? Trust the passionate team at Corpseed to handle all your trademark needs. Contact us today and let us help you pave the way to a successful CDSCO Registration.