How to Check CDSCO Approved Drugs?

The Central Drug Standards Control Organisation is an Indian regulatory body that controls all rules and regulations for approval of new drugs, manufacturing, imports, exports, marketing or distribution. CDSCO approval is necessary 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 seek the help of experts for regulatory and legal compliance.

Table of Contents

What Are CDSCO-Approved Drugs?

CDSCO-approved drugs are pharmaceuticals that have undergone various evaluation parameters, such as preclinical and clinical studies, to measure the quality, safety, and efficacy of the drugs. 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 updates notifications in detail about new drug approval under the publication section
Download from the 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 Authority 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 reduces the risk for patients and increases the integrity of India’s health system

When to Check CDSCO Drugs Approval?

The various importance of checking CDSCO Drugs Approval is discussed below:

Before Marketing a Drug: It is important to check the CDSCO Drugs Approval before marketing or distribution of pharmaceutical products
For the Procurement of drugs, Any pharmacy shop, customers, or Healthcare institutions must check that the drug is CDSCO-approved to ensure the safety and quality of drugs
Before Prescribing Medication, Doctors or healthcare professionals must prescribe CDSCO-approved drugs to ensure the safety and 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 the institution

Where to Check CDSCO-Approved Drugs?

The CDSCO CDSCO-approved drugs can be checked on the various platforms such as:

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 the drug

What is the validity of 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, such as clinical data, drug standards, and the manufacturer’s response to queries.

Requirements for CDSCO Approval

The crucial importance of CDSCO approval is:
Preclinical Data
Clinical Trial Data
Manufacturing Information
Regulatory Compliance
Labelling and Packaging

Required Documents for CDSCO-Approved Drugs

The various essential documents required for 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 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 drugs can be complicated due to strict requirements, including rigorous clinical data submission, quality assurance and adherence to labelling rules. If a clinical test is manufactured or the data is insufficient, then you may have to face a delay.

How Does CDSCO Ensure Drug Quality Post-Approval?

After approval, CDSCO monitors the quality of drugs through periodic audit, reports and adverse events, and requires manufacturing inspection to provide updates on any quality or safety issues.

Common Misconceptions About CDSCO Drug Approval

Some misconceptions related to the drug approval include thinking all imported drugs are automatically approved or that CDSCO approval guarantees global acceptance. But when you jump into 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.

FAQs

How can I verify if a drug is CDSCO-approved if I don’t have internet access?

If you do not have access to the Internet, you can verify the approval of CDSCO of the drug by contacting the local pharmaceutical control department or the CDSCO office directly. They can provide the necessary information through the phone or an in-practice visit.

How are new drugs approved in the CDSCO?

New drugs are approved by the CDSCO after a full evaluation process, including reviewing pre-pregnancy 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 usually re-evaluated at the time of renewal or expiration, which usually occurs every five years. However, CDSCO can first reevaluate a drug if new safety data emerges or if there are concerns about the efficacy or quality of the drug.

Can I get CDSCO approval for a drug that is already approved in another country?

Yes, you can already apply for CDSCO approval for approved drugs in another country. However, you will need to present the required documents, including relevant clinical testing data for the Indian population, to display the drug safety and efficacy in India.