Export Compliance in Pharma: New Regulations
New documentation rules affect API exports significantly. Exporters must now provide detailed traceability reports and adhere to stricter packaging standards. The Directorate General of Foreign Trade (DGFT) has issued guidelines to ensure compliance, aiming to boost India’s reputation as a reliable pharma exporter.
In-depth Details:
The updated regulations require exporters to maintain comprehensive records of every batch, including source materials and distribution channels. Packaging standards have been revised to ensure product integrity during transit, with a focus on tamper-evident seals and eco-friendly materials. The DGFT’s new digital portal simplifies the submission of compliance documents, reducing processing times. Exporters are encouraged to participate in training sessions organized by industry bodies to stay updated on best practices. These changes are expected to enhance transparency, minimize the risk of counterfeiting, and strengthen India’s position in the global pharmaceutical market.