India Central Drugs Standard Control Organization

India's CDSCO under the Ministry of Health and Family Welfare

DSCSA Track and Trace Compliance Solutions

Ensuring Pharmaceutical Integrity through Traceability in India's Regulatory Framework

India's pharmaceutical industry is governed by various regulatory bodies, and compliance with traceability standards is crucial to ensuring the safety and integrity of medicinal products.
The primary regulatory authority overseeing pharmaceuticals in India is the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare. The CDSCO mandates adherence to stringent guidelines and regulations to uphold the quality, safety, and efficacy of pharmaceuticals built around the iVEDA (Integrated Verification of Exported Drugs & Authentication) portal.

India Central Drugs Standard Control Organization

Key Elements of India's Pharmaceutical Traceability Requirements

Unique Identification and Serialization

Each pharmaceutical product is mandated to bear a unique identifier and serialization, facilitating precise tracking and tracing. This digital footprint ensures the authenticity and origin of pharmaceuticals throughout their lifecycle.

Comprehensive Data Reporting

Companies are obligated to submit detailed data at various stages of the supply chain, encompassing production, distribution, and sales. This data-centric approach empowers regulatory authorities to monitor pharmaceutical movement effectively and respond promptly to any irregularities.

Strategic Compliance Measures

Stringent compliance oversight, including regular inspections and audits, is enforced to assess and ensure adherence to traceability regulations. Non-compliance may lead to severe consequences, emphasizing the importance of proactive compliance measures.

Global Integration

Aligning with international standards, China's traceability requirements promote interoperability, facilitating seamless global trade in pharmaceuticals.


For pharmaceutical entities navigating the Chinese market, embracing these traceability requirements is not just a regulatory necessity but a strategic imperative. Our cutting-edge solutions empower your organization to navigate these requirements seamlessly, ensuring compliance, transparency, and the highest standards of pharmaceutical safety in China. Elevate your operations – choose compliance, choose excellence.

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