CDSCO

Decoding India’s Pharmaceutical Neutral Code for Exported Drugs

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In the Indian pharmaceutical industry, export products are marked with a “neutral code” or “special code” to keep the manufacturer’s identity confidential, complying with international regulatory requirements. This system supports India’s robust position in the global market by ensuring regulatory compliance and maintaining confidentiality. Manufacturers must apply to the CDSCO with necessary documentation to obtain a neutral code, facilitating the export process. When multiple firms share the same neutral code, it indicates they use a common contract manufacturing facility, promoting streamlined regulatory compliance and business confidentiality. Products with a neutral code are intended exclusively for export, ensuring they do not enter the domestic market.

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Responsibilities of Brands Contracting Pharmaceutical Manufacturing in India

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When a pharmaceutical brand, such as Healing Pharma, contracts a manufacturing facility like QP Pharmachem, both parties must adhere to stringent regulatory standards to ensure product quality and compliance. This involves obtaining necessary licenses from CDSCO, following Good Manufacturing Practices (GMP), and conducting regular audits. The brand is responsible for providing detailed product specifications, ensuring thorough testing, and maintaining comprehensive documentation and traceability. Additionally, establishing robust pharmacovigilance and clear contractual agreements are crucial for maintaining high standards and protecting intellectual property. For more detailed guidelines, refer to resources from CDSCO, CliniExperts, and Intertek.

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Are Indian Pharmacy Manufacturers Required to Post Their Licenses and Accreditation on Their Websites?

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Indian pharmacy manufacturers are not explicitly required by law to post their licenses and accreditations on their websites. However, many choose to do so for several regulatory and market-driven reasons. While the Drugs and Cosmetics Act, 1940, and Good Manufacturing Practices (GMP) guidelines mandate adherence to specific standards, they do not specifically require online publication of licenses. Nevertheless, many companies voluntarily publish this information to build trust, demonstrate compliance, and facilitate international trade. Leading firms like Dr. Reddy’s Laboratories and Cipla exemplify this best practice, enhancing credibility and streamlining audits and inspections. For detailed regulatory information, refer to the official CDSCO website and resources from regulatory consulting firms like CliniExperts.

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