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CDSCO Mandates Batch-Wise Clearance for High-Risk Solvent Drugs; Pharmexcil Stresses Quality Standards

The directive marks an important regulatory development for the pharmaceutical industry, bringing greater focus on quality assurance, manufacturing practices and compliance across the supply chain.

CDSCO Introduces Mandatory Batch-Wise Clearance for High-Risk Solvent Drugs

The Central Drugs Standard Control Organisation (CDSCO) has recently issued an order mandating batch-wise clearance through the Online National Drugs Licensing System (ONDLS) before the distribution of syrups and formulations containing high-risk solvents.

The directive marks an important regulatory development for the pharmaceutical industry, bringing greater focus on quality assurance, manufacturing practices and compliance across the supply chain.

Speaking in this regard, Bhavin Mehta, vice chairman of the Pharmaceuticals Export Promotion Council of India (Pharmexcil) and Whole-Time Director of Kilitch Drugs, said, “The pharmaceutical industry’s credibility, both in domestic and international markets, rests on its ability to consistently uphold stringent quality standards and robust manufacturing practices. Quality assurance must remain an integral part of the entire manufacturing and supply chain, supported by rigorous testing protocols, effective documentation and adherence to established regulatory standards.”

He added, “As India continues to strengthen its position as a trusted global pharmaceutical supplier, maintaining these quality benchmarks is essential to safeguarding patient interests and reinforcing confidence in Indian pharmaceutical products across markets.”

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