Last Updated on December 31, 2023 by The Health Master
Drug Regulations for Quality and Patient Safety
The Central Drugs Standard Control Organisation (CDSCO) is taking steps to streamline drug regulations in consultation with global regulatory experts, aiming to enhance quality, compliance, and patient safety.
he Drugs Controller General of India (DCGI), Rajeev Singh Raghuvanshi, highlighted the significance of this initiative in promoting a culture of quality and facilitating business operations.
The move is crucial as the pharmaceutical industry is projected to present a lucrative US$500 billion opportunity by 2047.
Discussion at the 9th International Pharmaceutical Exhibition (iPHEX)
During the 9th International Pharmaceutical Exhibition (iPHEX) held in Hyderabad, DCGI Raghuvanshi emphasized the need for optimizing drug regulations.
The event, hosted by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) with support from the Union commerce ministry, spanned from July 5 to July 7, 2023.
Improving Compliance and Support for MSMEs
DCGI Raghuvanshi acknowledged the existing disparity in compliance with drug regulations between large pharmaceutical companies and micro, small, and medium enterprises (MSMEs).
He stressed the importance of designing regulations that cater to both sectors, supporting MSMEs in upgrading their skills to meet global industry standards.
Furthermore, he addressed the non-uniformity in the interpretation and implementation of the law and highlighted the CDSCO’s commitment to rectify this issue.
India’s Pursuit of Global Regulatory Harmonization
Raghuvanshi emphasized that achieving a balance in implementing drug regulations is a challenging task, considering the country’s enormous compliance requirements due to the size of the pharmaceutical industry.
He also noted that India is actively participating in global regulatory harmonization efforts alongside the United States, Europe, and Japan pharmacopeias.
Empowering MSMEs for Growth
Raghuvanshi expressed optimism about India’s future in the pharmaceutical sector and emphasized the importance of empowering MSMEs to enhance their contribution to the industry.
He emphasized the need to attract quality manpower and implement robust quality management systems (QMS) to elevate MSMEs’ position in the value chain.
Indian Pharmacopoeia Commission’s Efforts
To foster a culture of quality, the Indian Pharmacopoeia Commission (IPC) has developed an Adverse Drug Reaction (ADR) reporting form as part of the Pharmacovigilance Programme of India (PvPI).
This initiative aims to facilitate the effective reporting of adverse events resulting from the use of medicinal products.
Over the past decade, the PvPI has made significant progress, generating 13 signals and numerous drug alerts, marking a significant milestone in patient safety.
By rationalizing drug regulations, focusing on compliance, and ensuring patient safety, the CDSCO aims to create an environment that fosters quality within the pharmaceutical industry.
Through collaborations with global regulatory experts and support for MSMEs, India aims to strengthen its position in the global pharmaceutical market and continue its impressive growth story.
Disclaimer: This article contains information derived from Pharmabiz. Our team utilized an AI language model, to rewrite and present the news in a unique format.
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