In the modern global economy, the regulation of medicines and medical devices plays a critical role in ensuring public health and safety. With the increasing use of drugs beyond their original intended purpose in a number of sectors, authorities have developed guidelines to address their potential for dual use. One such regulation is the Dual-Use No Objection Certificate (Dual-Use NOC), issued by the Central Drugs Standard Control Organization (CDSCO) in India. This certificate is required for drugs that can be used not only in the pharmaceutical industry but also in other industries such as chemicals, food and cosmetics.

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Understanding CDSCO and its Role 

CDSCO (Central Drug Standard Control Organization) is the national regulatory authority of India responsible for ensuring the safety, efficacy and quality of medicines, medical devices and cosmetics. It regulates medical devices by applying the provisions of the Drug and Cosmetic Act of 1940. To market a medical device in India, the manufacturer must obtain registration, submitting documentation showing that the device meets the required safety and efficacy standards. The CDSCO evaluates the risks associated with this device to ensure that public health is not compromised. It regulates the medical devices registration, ensuring compliance with national regulations.

What is CDSCO Dual Use NOC?

A dual-use NOC (dual-use no objection certificate) is a specific regulatory approval granted by the CDSCO for drugs that have applications across multiple industries. This NOC applies to substances that are used for more than one purpose like a drug can be used in pharmaceutical industry and as well as food industry. The concept of “dual use” refers to substances that can serve more than one purpose, especially in industries where their applications extend beyond the original intended use. For example, some drugs have chemical properties that allow them to be used in the production of food additives, industrial chemicals, or cosmetics.

These substances, originally designed for human consumption or medical use, may have applications in many non-pharmaceutical areas, requiring them to undergo additional regulatory inspection. CDSCO Dual Use NOC ensures that these substances meet the required safety standards not only for their primary use in pharmaceuticals, but also for their secondary use in other industries. It is important to note that this NOC does not apply to all drugs. Instead, it is only issued for drugs that have been proven safe and effective for both pharmaceutical and non-pharmaceutical uses.

Also Read: CDSCO Non-Sterile Non-Measuring (NSNM) Medical Devices (Importer and Manufacturer)

Some industries that Fall under the Dual-Use NOC

A Dual-Use NOC (No Objection Certificate) is applicable to drugs and substances that have applications in multiple industries. It is especially beneficial for sectors that require regulatory approval for substances with cross-industry uses.

• Pharmaceutical industry: This is the primary sector that uses medicines for human health, focusing on treating diseases, alleviating symptoms, and promoting well-being. Strict regulatory requirements ensure the safety, efficacy, and quality of these products.
• Chemical industry: Some pharmaceutical ingredients, such as active pharmaceutical ingredients (APIs), are reprocessed for use in industrial chemicals, solvents, and other products. These drugs can also serve as key ingredients in chemical formulations for various industrial applications.
• Food and beverage industry: Some drugs or pharmaceutical compounds act as additives or preservatives in food production. These substances can enhance quality, texture, flavour, or shelf life, with antibiotics and enzymes.
• Cosmetics and personal care industry: Pharmaceutical ingredients, originally developed for medical use, are often found in skincare products. They include antiseptics, preservatives, and other compounds beneficial to skin health.
• Agricultural industry: Drugs used in human medicine can also be applied in agriculture, such as pesticides or veterinary drugs, to improve crop yields or assist in animal health management.

Importance of CDSCO Dual-Use NOC

Issuance of Dual-Use NOC by CDSCO is very important for both manufacturers and consumers, ensuring safety and regulatory compliance in multiple sectors.

• Ensures safety in all sectors: A dual-use NOC guarantees that the drugs, while safe for pharmaceutical use, are also suitable for other applications. It ensures that the substances do not pose health risks in various industries, meeting safety standards for all intended uses.
• Promotes product innovation: With a dual-use NOC, manufacturers can market their products for multiple purposes, increasing their commercial potential. This opens up new markets, diversifies product portfolios, and allows businesses to explore more opportunities.
• Clarifies regulatory compliance: NOC streamlines the drug approval process with diverse applications, providing clarity and helping manufacturers meet regulatory requirements across industries without confusion.
• Prevents misuse: By approving drugs for various uses, CDSCO ensures that they are not misused or used in harmful ways. This oversight supports ethical practices and protects public health.
• Promotes economic growth: Expanding drug markets across sectors can drive economic growth. It boosts production, sales, job creation, and encourages investment in research and development, further stimulating innovation and business expansion.

Also Read: CDSCO Manufacturing License for Medical Devices

Process to Obtain CDSCO Dual-Use NOC

The process to obtain CDSCO Dual-Use NOC is quite comprehensive and involves several steps:

1. Login: Visit the SUGAM portal and log in with your existing credentials if you have a valid license for drugs or cosmetics. Applicants from the non-drug sector will have to register by selecting “Dual-Use NOC (Trader)” during sign-up.
2. Submit the form: After logging in, access the dashboard, select “Submit Application”, select the department as “NOC (Zone)” and select the form type as “Dual Use NOC”. Agree to the self-declaration and proceed to fill the form.
3. Form verification: Complete the form correctly, with no corrections in the missing letters. Preview the form, and if correct, proceed to the next step.
4. Upload document: In the checklist step, upload the required documents (digitally signed by the authorized signatory) in PDF format. Make sure the total size does not exceed 50 MB.
5. Submit application: Submit the application, and a unique application number will be generated for reference.

Conclusion

The CDSCO Dual Use NOC plays a vital role in ensuring the safe and regulated use of pharmaceutical drugs across multiple industries. By monitoring substances that serve both medical and non-medical purposes, it ensures compliance with safety standards, protecting public health. This certification fosters innovation, expands market opportunities, and streamlines the regulatory process for manufacturers. Furthermore, it helps prevent misuse by contributing to ethical practices, ensuring appropriate use across all sectors. Ultimately, the CDSCO Dual-Use NOC promotes economic growth by opening new avenues for business, encouraging research and development, and creating jobs. As industries evolve, such regulatory measures will continue to be important in maintaining safety and promoting sustainable development.