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CDSCO takes proactive measures to fortify India's reputation as reliable supplier of high-quality products to the world: DCGI
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Shardul Nautiyal, Greater Noida
August 30 , 2024
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Drug Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi has announced significant strides in the regulation and safety of pharmaceutical manufacturing in India. Speaking at the three-day event, iPHEX 2024, organised by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) in Greater Noida, Dr Raghuvanshi detailed about the comprehensive measures undertaken by the CDSCO to ensure compliance and traceability within the industry. These initiatives are designed to fortify India's reputation as a reliable supplier of high-quality pharmaceutical products to the global market.
Highlighting the proactive measures taken by the Central Drugs Standard Control Organization (CDSCO), Raghuvanshi stated that over 700 pharmaceutical manufacturers and analytical laboratories have undergone risk-based inspections over the past one and a half years. These inspections are part of a streamlined effort to regulate the pharmaceutical sector more effectively, ensuring that manufacturers adhere to stringent quality standards. "Risk-based inspections have become a cornerstone of our regulatory framework, allowing us to focus our resources on high-risk areas and ensure compliance across the board," said Dr Raghuvanshi.
In a move to combat malpractices in the pharmaceutical supply chain, the Indian government has mandated the inclusion of QR codes on every active pharmaceutical ingredient (API) package. This requirement aims to facilitate track-and-trace capabilities, allowing for the monitoring of any unscrupulous activities within the supply chain. The QR codes will provide real-time information about the source, authenticity, and movement of API shipments, significantly reducing the risk of counterfeit or substandard products entering the market.
Dr Raghuvanshi also addressed the issue of international complaints against Indian pharmaceutical manufacturers, which had raised concerns about quality control in the past. He reported that from October 2022 to July 2023, fourteen international complaints were resolved, and there have been no new complaints for over a year now.
"These complaints were aberrations, and corrective measures have been implemented to rectify the issues," Dr Raghuvanshi noted. He emphasized that these actions have helped restore confidence among global partners, reaffirming India's commitment to maintaining high standards in pharmaceutical manufacturing.
The measures announced by the DCGI are part of a broader strategy to enhance India's pharmaceutical sector's reputation for quality and safety. By implementing risk-based inspections, mandating QR codes for traceability, and addressing international concerns swiftly, the Indian government is reinforcing its position as a trusted supplier in the global pharmaceutical market. These efforts align with the government’s vision of establishing India as a leader in the pharmaceutical industry, capable of meeting the world's growing demand for safe, effective, and affordable medicines.
India's pharmaceutical regulatory framework is undergoing significant enhancements, focusing on compliance, traceability, and safety. Under the leadership of Dr Raghuvanshi, these initiatives are building a robust quality assurance system that not only protects the domestic market but also strengthens India's position in the global pharmaceutical supply chain. With no new international complaints in over a year and ongoing improvements in regulatory practices, India is set to continue its growth as a key player in the global pharmaceutical industry.
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