Easily Obtain CDSCO Performance Certificate for Drugs in India

The CDSCO performance certificate for drugs is a certificate demonstrating excellence in quality, safety, and efficacy. The certificate is issued for pharmaceutical products that comply with regulatory guidelines. Hence, drug manufacturers try to secure the performance certificate as a proof of excellence of their product. Basically, it is used to certify the quality and safety of the drugs being manufactured are of industry standard. This certificate provides an edge to drugs and companies over those without this certificate. We at Pharmadocx Consultants are aimed at simplifying the application process for the performance certificate.

What is a performance certificate?

The performance certificate is a document proving the pharmaceutical products meet the set quality and safety benchmark. Additionally, they will perform as intended when sold in the market. The Central Drugs Standards Control Organization (CDSCO) issues this certificate. The CDSCO is the apex regulatory body for drugs, medical devices, and cosmetics entering the Indian market. The CDSCO performance certificate for drugs demonstrates the pharmaceutical products being manufactured is safe and of high quality.

The Indian pharmaceutical industry is heavily regulated for the safety and wellbeing of the patients. Furthermore, the CDSCO regulations are aimed at protecting the public health and improving the Indian healthcare system. As drugs form the backbone of the healthcare industry, they have to be stringently regulated. The performance certificate is a proof the pharmaceuticals manufactured by you meet quality, efficacy, and safety standards. Our team of experts will help you easily secure this certificate.

A CDSCO performance certificate is used to prove the following:

• There has been no of reports of spurious or adulterated drug manufactured by the manufacturer.
• There has been no instance of suspension/cancellation of a part of the license issued to the manufacturer owing to a certain drug manufactured by them being not of standard quality.
• There has been no instance of suspension/cancellation of factory license (full license) due to any reason.
• The pharmaceutical manufacturer has his/her own quality control unit.
• The manufacturer has a valid CDSCO drug manufacturing license. Additionally, the manufacturer has been actively manufacturing and selling pharmaceutical products in the Indian market.
• In the past 3 years, the manufacturer has not been convicted under the Drugs and Cosmetics Act, 1940.
• No administrative action has been launched against the manufacturer under the Drug and Cosmetics Act, 1940, for any pharmaceutical product manufactured by them.

Eligibility criteria for obtaining the performance certificate:

A valid CDSCO drug manufacturing license is required. The manufacturer should be registered with the Drugs Control Department.

Documents required to apply for CDSCO performance certificate

• Cover letter with Rs. 2 Court Stamp stating the intent of the application. Additionally, it should mention the list of documents that are being submitted for this application.
• A copy of the valid drug manufacturing license.
• A copy of product permission for the drug for which the certificate is being applied for
• Format of the certificate in the tender form if applicable.
• A copy of the valid GMP /WHO-GMP certificate.
• List of the products for which the CDSCO performance certificate is being applied for.
• Certificate issued by the charted accountant stating the production and sales activities for the particular period along with invoices for these products for the particular period.
• Government fee challan for the CDSCO performance certificate application.
• Tax invoices copy
• A copy of the tender notice demanding the CDSCO performance certificate.
• A copy of the commune panchayat trade licence.
• No of batches manufactured during the past 3 years and record of the data for these batches.
• An affidavit on a Rs. 100 stamp paper stating that no not of standard quality report has been furnished against the particular product.
• A copy of air and water consent order from the pollution control board.
• Annual turnover for the past 3 years
• Sales invoices for the past 3 years
• Copy of the power of attorney/authorization letter for the person who has signed the documents.

How to apply for the CDSCO performance certificate?

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Why should you obtain a CDSCO performance certificate?

A performance certificate is a proof of drug quality and safety, which benefits the pharma company in multiple ways. The following are some of the benefits of performance certificate for pharma companies:

• Pharmaceutical products with a performance certificate have a competitive edge over those that are not certified. Thus, providing more business opportunities to these companies.
• A performance certificate makes it easier to secure tenders and contracts. Companies with this certificate are preferred over those that do not have the certificate.
• The performance certificate for pharma companies improves their credibility and reputation among suppliers, investors, and customers.

Why choose Pharmadocx Consultants as your performance certificate application support?

Armed with more than 27 years of experience and having served over 600 clients, we have in depth knowledge of the CDSCO regulatory requirements. We have simplified the CDSCO regulatory journey for all our clients. Our service ranges from licensing and certification to documentation and plant designing. Our team of experts provides a comprehensive support for CDSCO regulatory compliance in India.

To demonstrate the quality and safety of your pharmaceutical product, you will need the CDSCO performance certificate. This certification proves the drug is of high quality, safe, and effective and complies with industry regulations. However, the application process is not simple. Proper knowledge of the application process and correct preparation of supporting documents are required. Navigating through this process may be difficult. Fret not! Performance certificate is one of our areas of expertise. Pharmadocx Consultants will be your trusted ally throughout the application process. Our team of experts will prepare the documents so that the certificate application process will be seamless without any hiccups. We will simplify the application process by guiding and mentoring you.