New Delhi, Jun 27 (KNN) Indian pharmaceutical companies are making significant strides in improving manufacturing quality and meeting international standards, according to recent data from the Indian Pharmaceutical Alliance (IPA).

The industry is placing particular emphasis on the implementation of Revised Schedule M, which is expected to play a crucial role in elevating quality standards across the sector.

Recent data shows a marked improvement in the quality of Indian pharmaceutical manufacturing. The share of Official Action Indicated (OAI) status issued after U.S. FDA inspections for Indian sites has decreased from 26 per cent in 2014 to 13 per cent in 2023.

Despite the overall improvements, some areas still require attention. While progress has been made in data integrity and observations, there are persistent gaps between practices and written procedures, as well as issues with facilities maintenance. The industry is actively working to address these challenges to further enhance its quality standards.

To drive continuous improvement, the industry is focusing on quality excellence through various initiatives. These include the establishment of the Pharma Academy for Global Excellence (PAGE) and the US-India Affordable Medicine Partnership.

Looking ahead, India is working towards gaining membership in key international pharmaceutical organisations. The country aims to join the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and International Council for Harmonisation (ICH) within the next 5-6 years.

Sudarshan Jain, Secretary General of the IPA, emphasised the importance of Schedule M, stating, "Schedule M will be instrumental in elevating the quality of pharmaceutical manufacturing in India. It aligns with the goal to meet and exceed international standards, ensuring the safety and efficacy."

The industry faces ongoing challenges, including competitive pricing pressures in the generic drug market and the need for standardised global practices to address regulatory discrepancies.

The Indian pharmaceutical sector continues to play a significant role in the global market. It accounts for 20 per cent of global generic drug exports by volume and supplies 47 per cent of U.S. generic medicine demand.

However, the focus on quality improvement and regulatory compliance is expected to strengthen India's position as a global pharmaceutical powerhouse.

(KNN Bureau)