How CDSCO Certification Enhances Exports For Indian Products?

The Indian pharmaceutical industry is one of the largest exporters of medical products in the world. Currently ranked third in production by volume, the pharmaceutical industry supplies over 50% of global vaccine demand. The total market size of the industry is expected to reach $450 billion by 2047 where global expansion will remain a key driver in spearheading innovation and growth in the sector.

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority that approves, registers and supervises pharmaceuticals, medical devices, and cosmetics in India. The authority operates under the guidance of the Ministry of Health and Family Welfare, Directorate General of Health Services. CDSCO has delegated the responsibility to grant licences for critical drugs like sera, IV fluids, blood and blood products and granting authorization for medical devices, new drugs, cosmetics, and clinical trials.

CDSCO Product Registration is essential to both import and export pharmaceutical products to/from India. Exports are regulated to ensure safety and product quality before it reaches international markets. For this, CDSCO issue a valid export licence under Form 10, the Drugs and Cosmetic Rules, 1945.

This comprehensive blog outlines key guidelines for exporting pharmaceutical products, the benefits of getting a CDSCO certificate, rules related to branding and packaging, and documents required for registration.

CDSCO Guidelines for Exporting Pharmaceutical Products

Understanding the CDSCO recommendations for exporting pharmaceutical products from India is crucial for entities involved in international exchange. These guidelines specify that pharma products intended for export to international markets must have manufacturing facilities that comply with GMP (Good Manufacturing Practice) standards.

To obtain CDSCO Product Registration for exports and comply with GMP, exporters must possess manufacturing units with appropriate air filtration and layout, have qualified staff, clearly written SOPs (Standard Operating Procedures) for all manufacturing processes, robust quality control system, and ensure proper maintenance of all equipment. In addition, exporters have to obtain the following certificates:

● COA: Exporters are required to obtain a Certificate of Analysis (COA) that assures that the product is true to the specifications advertised by its producer and meets quality control standards. The COA is necessary to verify the purity, quality, and potency of the medical product and is issued by a certified and accredited laboratory.

● COPP: Exporters must obtain a Certificate of Pharmaceutical Product (COPP) issued by CDSCO. The certification showcases that manufacturing is done in compliance with Indian regulatory standards and allows drugs to get registered in foreign nations.

● FSC: Lastly, CDSCO issues an FSC (Free Sale Certificate) also referred to as the certificate of export which certifies that the product is safe for export. To qualify for FSC, exporters must comply with the FSC checklist, have no past record of complaints against their product, and must be in the notified categories. The certificate will demonstrate that the product is freely marketed and sold in India with no restrictions and quality or safety issues.

Benefits of Getting CDSCO Registration for Exports

Obtaining a CDSCO authorization for exporting medical devices and pharmaceuticals can offer numerous benefits. The certification opens up export opportunities in countries that require prior regulatory approval from the country of origin.

Moreover, CDSCO Product Registration is also essential to avoid any repercussions like legal penalties and a blow to both country and brand reputation in the overseas market. Understanding the Competitive Advantage of CDSCO Certification for Your Brand is crucial, as it helps demonstrate compliance with regulatory standards and a commitment to the highest quality. By obtaining CDSCO certification, your brand can enhance its credibility, gain customer trust, and open doors to new business opportunities, positioning your products favorably in both domestic and international markets.

Some of the key benefits of obtaining CDSCO registration are as follows:

● Regulatory Compliance: The certification is a key indicator that specifies the medical product has undergone rigorous evaluation. The CDSCO certificate shows that pharmaceutical products complies with regulatory requirements and crosses the safety and quality threshold. This helps manufacturers and exporters to demonstrate their fulfilment of legal obligations which is necessary to market and sell products in India and overseas.

● Increased Credibility: CDSCO is the supreme authority that ensures the quality and safety of drugs, cosmetics, and medical devices. Thus, having a CDSCO certificate enhances the credibility of products that will be sold, marketed, and exported in the international market. It shows that the product is evaluated and approved by a competent authority which further boosts its reputation and chances of acceptance by international medical regulators.

● Market Access: A CDSCO certificate is a prerequisite to market pharma products in India. Without the certification, no medical device or pharmaceuticals can be manufactured, sold, imported, or distributed in the Indian market. However, it also became a prerequisite to export medical products further in the large international pharmaceutical markets in the world.

What are the Documents Required for CDSCO Licence?

CDSCO Product Registration is granted to importers, exporters, Indian agents, corporates, and Indian subsidiaries of foreign businesses. The grant could be for cosmetics registration, test licence, blood bank registration, import or manufacturing of drugs, export NOC, formulation of research and development (R&D) organization, dual-use NOC for traders, and bioequivalence (BE)/ bioavailability (BA) approved sites. However, Common CDSCO Registration Challenges, such as navigating complex documentation, meeting compliance requirements, and addressing regulatory delays, can arise. Solutions include working closely with regulatory experts, ensuring thorough preparation of all necessary documents, and staying updated on regulatory changes to streamline the registration process.

In the entire procedure, the Role Of CDSCO Consultants In Regulatory Processes is equally significant to other key players. The entities provide assistance to medical device enterprises by offering guidance, advice, and expertise throughout the CDSCO registration process.

To obtain registration, the following documents are required:

● Identity Proof can include an Aadhar card or other government-approved ID.
● Address Proof of registered business.
● Corporate address proof and wholesale licence or manufacturing licence (Form 20B and Form 21B).
● Free sale certificate issued by product’s country of origin specifying that product is freely sold there.
● Detailed information on the product’s composition, strength, formulation, and usage.
● Record of each production batch.
● Application form attested with all the requested documents.

To export pharmaceutical merchandise from India, the following documents are required:

● Application form for obtaining an export licence.
● Certificate of Good Manufacturing Certificate (GMP).
● Certificate of Pharmaceutical Product (COPP).
● Free Sale Certificate (FSC).
● Invoice Proforma.
● Certificate of Origin.
● Airway Bill/ Bill of Lading.
● Insurance Certificate.
● Packing List.

Moreover, exporters have to submit a No Objection Certificate (NOC) for the export of drugs that are approved, unapproved, new, or banned in India. Manufacturers holding valid licences through Form 25 and 28 can obtain this NOC from Zonal or sub-zonal offices of CDSCO. For the export of drugs, the NOC requires the following attested documents:

● Cover Letter: The cover letter must be attached to the application form specifying the intent of the application. It must include a list of documents being submitted by creating an index and page number. The letter should contain the list of products to be exported including its name, quantity, dosage, composition details and name of the country where it will be exported. The letter must be signed and stamped by the authorized signatory.

● Purchase Order: The application should contain information on the order from the foreign buyer, a list of products that will be exported, a valid purchase order number, and a recent date.

● Manufacturing Licence: A copy of the licence obtained from the State Licencing Authority must be attached to each application.

● Invoice: Include an invoice signed by a competent authority and addressed to the manufacturer mentioning the quantity of the bulk drug.

● Registration Certificate: A registration certificate is required to export drugs that are banned in India. The application must contain a certificate along with the strength and composition of the exported drug.

Rules Related to Export of Drugs from India

As per the CDSCO Product Registration rules, there are certain requirements stipulated to manage the packaging and labelling of drugs exported from India, excluding homeopathic medicines, such as:

● Mandatory Details: Labels on containers or packaging of drugs should mention the drug’s name, name and address of the manufacturer, licence number under which it is manufactured, batch number, and date of expiry. These particulars must appear in a conspicuous position in the container that contains the drug and every other covering. If the medicine is for external application, it must have ‘FOR EXTERNAL USE ONLY’ clearly printed on the label.

● Prohibition: No person can sell or distribute drugs without labelling them as per the regulations.

● Manner of Labelling: The information must be either written or printed in indelible ink. It must appear on the innermost container of the drug and include name, purpose, and other details.

Conclusion

Overall, the CDSCO (Central Drugs Standard Control Organization) registration is a strategic approach to enhancing exports and regulating the entire pharmaceutical industry. The licence ensures compliance with safety, quality, and efficacy standards while exporting medical devices, drugs, and cosmetics to international markets.

CDSCO registration is crucial to tap the global pharmaceutical markets, enhance the brand’s reputation and credibility, and demonstrate that medical products have been tested and passed through rigorous safety and quality protocols. The certification also ensures that the manufacturer is complying with regulatory requirements including GMP.

We are here to assist you meet all the legal requirements and connect you with specialised experts to seamlessly obtain CDSCO Product Registration. Our professional team will help expedite the entire authorization process and answer all your queries to obtain a license in minimal time and budget. Get in touch with Legal Raasta to receive end-to-end support and assistance in crafting compliance strategies, training, and audits.