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