The Central Drug Standard Control Organization is the Indian Regulatory Body that governs all the rules and regulations for the approval of new drugs, manufacturing, Import, Export, Marketing, or distribution. The CDSCO approval is essential for manufacturers, healthcare professionals, and consumers because it ensures that the drug is of standard quality, safe, and effective for use.
For a better understanding of CDSCO-approved drugs, you can take the help of experts for regulatory and legal compliance.
About CDSCO-Approved Drugs
CDSCO approved drugs are pharmaceuticals that have undergone various evaluation parameters like preclinical and clinical studies to measure the drug’s quality, safety, and efficacy. After the approval from CDSCO, the drug is granted permission for marketing, sale, or distribution in India
How to check if a Drug is CDSCO Approved?
The various ways to check if a drug is CDSCO approved are discussed below:
- Access the CDSCO Website: The CDSCO website is the primary source for information about drug approvals. Here you can search for details about any drug.
- Visit the SUGAM: The SUGAM portal is an online platform for CDSCO approval used for applying for any type of license and this will provide all the details about approved drugs also
- Search in the notifications and publication section on the CDSCO website: CDSCO regularly use updated notifications in detail about new drug approval under the publication section
- Download from CDSCO Website: CDSCO provides a list of approved drugs in PDF or Excel sheet, you can download it from there easily.
- Offline method: You can get the list of CDSCO approved drugs by contacting CDSCO or the Local Drug control author Authorities department
Why Is CDSCO Approval Important for Public Health?
CDSCO approval is important for drugs because it shows that the drugs are safe, effective and meet quality standards. By regulating pharmaceuticals, CDSCO minimizes risks to patients and upholds the integrity of India’s healthcare system
When to Check CDSCO Drugs Approval?
The various importance of checking CDSCO Drugs Approval is as discussed below:
- Before Marketing a Drug: It is important to check CDSCO Drugs Approval before marketing or distribution of pharmaceutical products
- For Procurement of Drug: Any pharmacy shop, customer, or Healthcare institution must check that the drug is CDSCO approved or not to ensure the safety, or quality of drugs
- Before Prescribing Medication: Doctors or healthcare professionals must prescribe CDSCO approved drugs to ensure the safety or quality of the drug and avoid any legal problems
- For Clinical Trials: The approval status of drugs used in clinical trials must be checked by Researchers and institution
Where to Check CDSCO Approved Drugs?
The CDSCO Approved Drugs can be checked on the various platforms like:
- Official CDSCO Website: is the primary source for checking approval
- SUGAM Portal: an online portal that provides information about drugs
- Notification and publication section of the CDSCO website: Have updated data about all the approved drugs
- State Drug Control Department: Provide Regional verification about drug
What is the Validity of CDSCO Approved Drugs?
The validity of an approved Drug is for five years and it depends upon the type of approval granted, the drug safety profile, and any new data added. After this period, the drug undergoes re-evaluation to ensure quality standards
Renewal of CDSCO-Approved Drugs
The Renewal of CDSCO Approved Drugs can be done before or after the actual approval expires. The Renewal of Approved Drugs requires all the documents, any new clinical data, data of any adverse events, and any manufacturing processes. If a drug cannot be renewed then the drug is withdrawn from the market.
Timeline For CDSCO Approved Drugs
The timeline for CDSCO approval may take several months to a few years depending on the drug type and the documents submitted. The timeline is affected by various factors clinical data, drug standards, manufacturer’s response to queries.
Requirements for CDSCO Approval
The crucial importance for CDSCO approval are:
- Preclinical Data
- Clinical Trial Data
- Manufacturing Information
- Regulatory Compliance
- Labelling and Packaging
Required Documents for CDSCO Approved Drugs
The various essential documents required for CDSCO Approved Drugs are:
- Application form
- Clinical Trial Form
- Manufacturing Details
- Safety Data
- Labelling Information
- Stability data
What Are the Consequences of Using Non-CDSCO Approved Drugs?
Using non-CDSCO approved drugs can result in health risks due to unknown quality and safety issues. Legal consequences for healthcare providers or sellers can also occur, as distributing unapproved drugs violates regulatory laws.
What Is the Role of the SUGAM Portal in Drug Registration?
The SUGAM PORTAL is a central online platform for the approval and registration of drugs from CDSCO. It allows the Manufacturers to submit the applications, track the status, and manage the post-approval changes, simplifying regulatory compliance.
Can a Drug Lose Its CDSCO Approval?
YES, a drug can lose its CDSCO approval if it fails to meet ongoing safety and quality standards. The second reason is if any adverse effect is reported. In these cases, the drugs are restricted and recalled from the market to protect public health.
How Can Patients Verify a Drug’s Approval Status?
If you are willing to check whether the drugs are approved or not then you can do it by visiting the CDSCO or SUGAM PORTAL. On behalf of patients pharmacies and health providers can also assist by verifying the drug’s approval status.
Challenges Faced in Obtaining CDSCO Drug Approval
The approval process of the drugs can be complex due to stringent requirements, including rigorous clinical data submission, quality assurance, and adherence to labelling regulations. If the manufacturing or data of clinical trial is insufficient then you may face delays.
How Does CDSCO Ensure Drug Quality Post-Approval?
After granting the approval CDSCO Monitors drug quality through periodic audits, reports, adverse events, and inspections of manufacturing are required to provide updates on any quality or safety issues.
Common Misconceptions About CDSCO Drug Approval
Some misconceptions related to drug approval include thinking all imported drugs are automatically approved or that CDSCO approval guarantees global acceptance. But, when you jump into the reality you will find that it requires separate approvals in each country, and CDSCO approval is specific to India.
Does CDSCO Approval Apply to Over-the-Counter (OTC) Drugs?
Yes, CDSCO regulates both prescription and over-the-counter drugs. OTC drugs must meet the same safety, efficacy, and quality standards as prescription drugs before they are made available to the public.
Why to Choose ELT Corporate?
ELT Corporate is your reliable partner for solving the complex regulatory environment of CDSCO. We offer expert consultancy services that simplify the document collection process, simplify the drug approval process, reduce the time, and ensure compliance with all regulatory requirements.
Frequently Asked Questions (FAQs)
How can I Verify if a Drug is CDSCO-Approved if I Don’t Have Internet Access?
If you do not have internet access, you can verify a drug’s CDSCO approval by contacting the local drug control department or the CDSCO office directly. They can provide the necessary information through phone or in-person visits.
How are New Drugs Approved in CDSCO?
New drugs are approved by CDSCO after a thorough evaluation process, which includes reviewing preclinical and clinical trial data, assessing the manufacturing process, and ensuring compliance with regulatory guidelines.
How Often are Drugs Re-Evaluated for CDSCO Approval?
Drugs are typically re-evaluated at the time of renewal or expiration, which usually occurs every five years. However, CDSCO may re-evaluate a drug earlier if new safety data emerges or if there are concerns about the drug’s efficacy or quality.
Can I get CDSCO Approval For a Drug that is Already Approved in Another Country?
Yes, you can apply for CDSCO approval for a drug already approved in another country. However, you will need to submit the required documentation, including clinical trial data relevant to the Indian population, to demonstrate the drug’s safety and efficacy in India.
How can I verify my Indian Drug License online?
You can verify your Indian drug license online through the CDSCO’s SUGAM portal.
What is the full form of CDSCO?
The full form of CDSCO is the Central Drugs Standard Control Organization.
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