Last Updated on December 31, 2023 by The Health Master
Introduction: Quality Standards for Pharmaceutical Exports
In a bid to enhance the quality of pharmaceutical products exported from India and align with global standards, the health ministry may extend mandatory quality improvement norms to more products, according to a senior official.
The Directorate General of Foreign Trade (DGFT) has already mandated that cough syrup exporters must undergo testing at designated government laboratories before obtaining permission for outbound shipments.
This article explores the official’s statements and the implications for the pharmaceutical industry.
Pharmaceutical Products to Meet Global Standards:
Director General Foreign Trade (DGFT) Santosh Kumar Sarangi emphasized the importance of adhering to global standards and quality requirements for all pharmaceutical products.
The DGFT’s recent notification highlights the need for exporters of cough syrup to subject their products to testing at specified government labs, effective June 1, 2023.
This measure ensures that exported cough syrups meet the minimum quality standards prescribed by the authorities.
Commitment to Quality Improvement:
During an event, Sarangi confirmed that the initiative to enhance quality standards began with cough syrup and emphasized the government’s commitment to ensuring that all cough syrups exported from India meet the required benchmark of quality standards.
He stated that any necessary actions for quality improvement in the pharmaceutical sector will be taken based on the advice of the Central Drugs Standard Control Organisation (CDSCO) and the health ministry.
Expanding Quality Improvement Norms:
In response to inquiries about whether other pharmaceutical products will be subject to similar quality improvement norms for export, Sarangi stated that the decision will be made based on the advice of the CDSCO and the health ministry.
The aim is to establish more stringent global benchmarking for pharmaceutical products wherever necessary.
Testing Requirements for Exporting Cough Syrup:
The DGFT’s notification stipulates that exporters of cough syrup must comply with specific regulations to be eligible for export.
Effective from June 1, 2023, exporters must have their export samples tested and produce a certificate of analysis issued by designated laboratories.
The specified laboratories include:
- The Indian Pharmacopoeia Commission,
- The regional drug testing lab (RDTL) in Chandigarh,
- The central drugs lab (CDL) in Kolkata,
- The central drug testing labs (CDTL) in Chennai, Hyderabad, and Mumbai,
- The RDTL in Guwahati,
- And the drug testing labs of state governments accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL).
Conclusion:
India is taking proactive steps to enhance the quality standards of pharmaceutical products exported from the country.
By subjecting cough syrups to mandatory testing at designated government laboratories, the government aims to ensure that these products meet the required quality benchmarks.
Additionally, the health ministry, in consultation with the CDSCO, will assess the need to extend these quality improvement norms to other pharmaceutical products to align with global standards and strengthen India’s position as a reliable exporter of high-quality pharmaceuticals.
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