Essential Documents Checklist For CDSCO Registration

The Central Government monitors and oversees the pharmaceutical sector through the national regulatory authority – CDSCO (Central Drugs Standard Control Organization). To import, manufacture, sell, and distribute pharmaceutical products in India, it is necessary to obtain CDSCO Registration from the said authority.

Through the Drugs and Cosmetics Act 1940, the Drugs and Cosmetics Rules 1945, and the Medical Devices Rules 2017, CDSCO govern the drugs, cosmetics, IVDs, and medical devices in India. The organization operate under the Ministry of Health and Family Welfare and ensures the safety, quality, and efficacy of healthcare products before it reaches the market.

This comprehensive blog outlines the key documents required to seamlessly obtain the CDSCO licence and ensure compliance with the regulatory obligations.

What is a Cover Letter in CDSCO Registration?

A cover letter is an essential part of the CDSCO application process. The letter requires an applicant to clearly specify their intent of application. This means that accurate and detailed information is needed to be provided regarding whether the registration is being submitted for the first time, or is it for renewal, etc.

A cover letter must include the name and address of the enterprise and a list of documents that are being submitted. It must be duly signed and stamped by the concerned authority whose name, designation, and other relevant details must be mentioned.

Documents Required for CDSCO Registration

To obtain a CDSCO licence, the applicant must provide accurate and complete documentation related to the product, labelling, packaging, storage conditions, shelf-life, clinical trial results, and other relevant information. Applicant must provide the following documents:

• Application Form: To apply for CDSCO Registration, the applicant has to fill out an online application form. Form 40 must be filled out by the manufacturer or his authorized agent to sell and distribute drugs in India. Similarly, Form 44 is used to grant permission to undertake clinical trials or import new drugs. Form 10 grants permission to import Biologicals. Thus, users have to select the appropriate form to obtain registration from the CDSCO portal.
• Product Details: To obtain authorization, the applicant must submit comprehensive information on the product including its composition, manufacturing process, name, dosage, and intended use.
• Clinical Trial Details: Clinical trial refers to a systematic study of any new drug that verifies its clinical content and assesses its adverse effects to determine its efficacy and safety. CDSCO require applicants to conduct clinical trials using the form CT-04.
• Manufacturing Information: Applicants are required to submit details about the manufacturing site, if production is being carried out at multiple sites then details about activities of each manufacturing site, etc. Further, they must inform the authorities whether they comply with GMP (Good Manufacturing Practices) and other relevant quality standards.
• Authorization Letter: An authorization letter designates an individual as an authorized representative to act on their behalf when submitting documents, applications, or interacting with CDSCO. The letter must reveal the name and designation of the authorized person. It must be submitted along with the application form.
• Power of Attorney: A power of attorney authorizes the Indian agent to act on behalf of a foreign manufacturer. The POA must be executed and authenticated either in India or the country of origin of the products. It must specify the name and address of the Indian agent (who must have a valid wholesale licence). In addition, the POA must contain the name of the manufacturer and its manufacturing site along with the name of the drugs.
• Labelling and Packaging: For registration of medical devices, information such as name, intended use, manufacturer name and address, expiry date, warnings and procedure, is required. Similarly, registration related to cosmetics requires additional information like batch number, directions for safe use, manufacturing country, etc.

Quite often the question arises How CDSCO Certification Enhances Exports? CDSCO Registration ensures the quality and safety of drugs, cosmetics, and medical devices meet the required threshold. It shows that the product is evaluated and approved by a competent authority which boosts its reputation and credibility.

Other Key Documents Required for CDSCO Registration

The CDSCO grants permission for importing or exporting drugs with a certain degree of residual shelf-life. Shelf life refers to the period in which a drug or medical device remains suitable for its intended usage.

According to rule 31, the Drugs and Cosmetic Rules 1945, every imported drug is mandated to comply with quality, standard, and purity standards. The licencing authority cannot allow any drug with a residual shelf-life of less than 60% to enter the Indian markets. However, certain exceptions were provided in cases where the drug was necessary for emergencies, testing purposes, and sudden outbreaks of some diseases.

CDSCO Registration application for shelf-life extension of drugs that are being exported requires the following documents:

• Information on the name of the applicant, date of application, and name of drug/drugs.
• A cover letter that states which country the drugs will be exported to, the name of the drugs, and their purpose.
• Copy of Accelerated and Real-Time Stability Data for the drugs that will be exported.
• COA (Certificate of Analysis) from three consecutive batches of the drug to be exported.
• Shelf-life approval of products from the importing country’s National Regulatory Authority.
• Original purchase order from the international buyer for the applied product.
• An undertaking specifying that the buyer will accept the drug with the proposed shelf-life.
• Exported Product’s Original Label.

While applying for CDSCO Registration, applicants often face some Common CDSCO Registration Challenges and Solutions such as excessive documentation and regulatory delays. To tackle these challenges, CDSCO transitioned to an online registration system through its SUGAM portal.

Documents Required to Sell Imported Drugs

Rule 37, the Drugs and Cosmetics Act 1945 governs the repackaging of drugs imported in bulk to sell in Indian markets. To apply for permission to import and repackage the drug, the following documents are required:

• A cover letter that specifies the intention of making an application.
• Documents specifying whether the drug is propriety or patent medicine.
• Copy of valid registration certificate that permits importing drugs in bulk amount.
• Form 10 licence copy for import of bulk quantity drug.
• Copy of valid manufacturing licence of the concerned activity that can be filing, packaging or labelling.
• Bulk container original label.
• Hold time stability data that will identify the maximum time a bulk drug can be stored safely before proceeding to the next step. Provide information on temperature excursions and transport duration.
• Original label of outer carton and innermost container of the end product.
• Standard Operating Procedure (SOP) for assigning shelf-life to the product.

Documents Required to Import Cosmetics into India

To import cosmetics in India, an applicant has to acquire an IRC (Import Registration Certificate) from the CDSCO. The following documents are required along with the application form to obtain CDSCO Registration:

• Covering letter mentioning the purpose of the application
• List of ingredients and their percentage contents.
• Proposed product’s label
• Testing methods and other specifications
• Authorization from Manufacturer
• Pack insert
• Free Sale Certificate that must be duly authenticated
• Manufacturing Licence for no provision of manufacturing licence in the nation.
• Non-animal testing declaration
• Application in Form COS-1
• Declaration for Hexachlorophene and heavy metal content
• Receipt of any fees paid

SUGAM: CDSCO Registration and Key Documents

The SUGAM portal provides an avenue to register corporate, Indian agents, importers, and foreign business having Indian subsidiaries engaged in the pharmaceutical industry. The portal registers the following users with different purposes through the specified forms:

Conclusion

CDSCO Registration is granted for cosmetics registration, test licence, blood bank registration, formulation of research and development (R&D) organization, dual-use NOC for trader, import or manufacturing of drugs, export NOC, and bioequivalence (BE)/ bioavailability (BA) approved sites. The certification demonstrates that the product has undergone rigorous safety and quality checks before being marketed and sold in the market.

CDSCO authorization requires a large volume of technical and administrative documentation; disclosures such as clinical trial data, manufacturing information, and labelling data, among others. This makes it a complex regulatory procedure, which is both a costly and time-consuming affair. Consult with Legal Raasta to receive end-to-end support and avail the services of the most experienced professionals that are here to assist with timely and accurate applicate submission. Minimize errors and delays with us and obtain your certificate in fastest time possible.