Indian firms fared better in USFDA inspections in recent years, says IPA
Revised Schedule M implementation is going to be “instrumental” in elevating quality of pharma manufacturing in India as it tries to meet and exceed international standards, felt leading pharma firms.
Meanwhile, there has been a notable improvement in India’s performance when it comes to US FDA inspection outcomes, data shared by the Indian Pharmaceutical Alliance (IPA) suggested.
The share of Official Action Indicated (OAI) status issued after an USFDA inspection for Indian sites has fallen from 26 per cent in 2014 to 13 per cent in 2023. In comparison, the share of OAI in total USFDA inspections has risen from 7 per cent in 2014 to 15 per cent in 2023, thereby indicating more stringency.
Indian pharma accounts for 20 per cent of the global exports of generics by volume and is thus considered a pharma powerhouse. It supplies 47 per cent of US generic medicines demand.
The IPA represents the top 23 research driven pharma companies in India.
It also revealed while Indian pharma companies have improved data integrity and observations, gaps between practices and written procedures have increased from 19 per cent to 23 per cent, gaps in facilities and ancillary infrastructure maintenance have risen from 17 per cent to 23 per cent, and incomplete investigations have grown from 12 per cent to 15 per cent.
It is batting for improving quality.
There has been a reduction in essential cGMP capability-related training, expertise-related observations, lab controls, and core manufacturing process-related observations, each seeing a decrease of around 3 per cent since 2014.
This improvement is attributed to better talent acquisition and more thorough documentation and reporting, spurred by increased US FDA quality benchmarks and a focus on infrastructure-related areas that were previously unexamined. While acknowledging the rise in inspections and observations, the IPA representatives stressed their commitment to transparency and collaboration with the USFDA.
The IPA also feels that Revised Schedule M implementation is key to ensuring quality standards across the board.
Sudarshan Jain, secretary general of the IPA said, “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.”
With an aim to bring better compliance with quality standards, the Ministry of Health and Family Welfare (MoHFW) notified the revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945, in the Gazette of India in January. Schedule M prescribes the good manufacturing practices (GMP) for pharmaceutical products.
The way forward for achieving quality and manufacturing excellence involves several key initiatives.
First, there is a commitment to quality excellence, with that the foundation for the Pharma Academy for Global Excellence (PAGE) is being set up to build talent in the pharma industry with a focus on fostering a “culture of quality.”
This program will target various levels, from shop floor workers to CXOs and graduates, with a focus on aseptic, oral solids, and quality, in collaboration with Parenteral Drug Association (PDA) and ISPE (International Society for Pharmaceutical Engineering (ISPE), and will be based in Ahmedabad and Hyderabad.
Another initiative is the establishment of the US-India Affordable Medicine Partnership, aimed at creating a diversified and resilient supply chain for APIs Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs), bolstering national security and health outcomes in the US, India, and allied nations, and driving investments in pharma manufacturing that prioritise health security, sustainability, and high-quality outputs. Lastly, India is steering towards membership in Pharmaceutical Inspection Cooperation Scheme (PIC/S) and International Council for Harmonisation (ICH), with a roadmap to achieve full membership within 5-6 years.
Other key issues which were discussed included the impact of employee reductions on larger companies and the pressures of competitive pricing in the generic drug market. One pressing question is whether a quality-based metric could realign the industry and restore balance amid these pressures.
The IPA outlined key areas for pharmaceutical companies to prioritise, emphasising the importance of rigorous quality controls, improved regulatory practices, and the need for standardised global practices to address discrepancies in regulatory expectations. The industry is also advocating for the production of nutraceuticals, provided stringent quality standards are maintained to prevent cross-contamination.
First Published: Jun 26 2024 | 10:49 PM IST