Implications of US FDA and EMA Standards on Indian Pharma Exports

Indian pharmaceuticals export 47% of all generic prescriptions in the US Market, according to the latest report by the IQVIA Institute.  Europe accounted for approximately 21% of India’s pharmaceutical exports in 2022. These figures show that Indian medicines are integral to these two large markets. But of late, Indian medicines are facing stringent regulatory scrutiny from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) owing to the fatalities caused by cough syrups made in India. Both regulatory bodies emphasize rigorous quality management, thorough documentation, regular audits, and adherence to CGMP compliance and GMP guidelines that ensure the safety and efficacy of pharmaceutical products. Compliance with these standards is mandatory for companies exporting medicines to the US and European markets.

The regulatory bodies have set high standards for drug safety and efficacy, which has impacted the pharmaceutical sector in India. Adhering to these regulations will alter the way how India produces and markets its medicines internationally.

"Quality control within generic drug manufacturing constitutes a multifaceted endeavor, encompassing a series of meticulous processes aimed at guaranteeing adherence to regulatory standards and predefined specifications," Kannan Jakkan, Senior Director, QC & Analytical Research, ANI Pharmaceuticals.

Regulatory Compliance

Meeting the US FDA and EMA standards demands significant investment in quality management systems (QMS), infrastructure and training. Pharmaceutical companies must ensure that their manufacturing facilities, processes, and products comply with CGMP and GMP guidelines. This often necessitates substantial capital expenditure, which can be a monetary burden, particularly for small and medium-sized enterprises (SMEs).

Indian pharma companies are developing standardized processes across all levels of production and quality control. This ensures consistent adherence to regulatory requirements and minimizes the risk of deviations. A prominent example of this is Dr. Reddy's, they have developed detailed SOPs to standardize its processes across all manufacturing units. They have also implemented a centralized electronic document management system to ensure consistency and compliance.

"It is essential for healthcare organizations to carefully plan and execute the implementation, considering factors such as scalability, security, and compliance with healthcare regulations," Rajesh Pawar, India Head, Yantra Inc.

Frequent Inspections and Audits

These two agencies periodically conduct inspections and audits of manufacturing facilities. Non-compliance can result in warning letters, import alerts and even bans on specific products or facilities. These inspections are carried out in a thorough fashion, and minor deviations from the stipulated guidelines yield grave consequences. Companies must perform regular internal audits that help identify and alleviate potential compliance issues before external inspection agencies point them out.

Cipla conducts regular internal audits via dedicated quality assurance teams to ensure continuous compliance with CGMP and GMP guidelines. The purpose of these audits is to identify any compliance variable that may land them in hot water. 

"Since operations in the healthcare sector are largely human-dependent and labor-driven, it is paramount for every healthcare organization to have the necessary SOPs in place to optimize performance and process outcomes," Dr. Shilpa Tatake, Group COO, Jupiter Hospital.

Cost Implications

Implementing necessary changes which are in line with US FDA and EMA standards is a costly affair, but the cost of not adhering to this is far greater. The changes can range anywhere from technology required to the training of staff. Additionally, the costs associated with regulatory submissions, including clinical trials, bioequivalence studies, can be a huge barrier for some companies.

Many Indian pharmaceutical companies are implementing automated systems for production, packaging, and quality control. Digitalization of processes, including the use of blockchain for supply chain transparency, is also being adopted to ensure data integrity and traceability. Sun Pharma has implemented electronic quality management systems (eQMS) to streamline documentation processes, enhance traceability, and improve compliance with regulatory requirements.

"In the pursuit of meeting the demand projected in the market while maintaining quality, industry players will be required to strike the right balance between the pricing and availability of pharma products to strengthen their position in the international market," Deepesh Upadhyay, Asst. Vice President, Delair India Pvt. Ltd.

Market Access and Competition

While compliance opens the door to lucrative markets, it also exposes Indian companies to fierce competition from global pharmaceutical giants who have long-standing expertise in navigating these regulatory landscapes. Indian firms must therefore not only meet compliance requirements but also innovate and improve their product offerings to stay competitive.

The process of aligning with US FDA and EMA standards can drive innovation and improvement within Indian pharmaceutical companies. The need to meet high regulatory standards encourages the adoption of best practices, advanced technologies, and continuous improvement processes. This not only benefits compliance but also enhances overall operational efficiency and product quality.

Biocon uses AI and machine learning to analyze large datasets for quality control and compliance purposes. These technologies help in predicting potential compliance issues and taking corrective actions proactively.

"The integration of AI, algorithms, and machines requires a thoughtful and collaborative strategy due to the inherent complexities in healthcare delivery," Gaurav Parchani, CTO and Co-Founder, Dozee.

While the guidelines may be financially intensive, it is best to understand these guidelines came into place because not having these at one point resulted in a lot of casualties. While it is an intensive process, adhering to these will result in Indian pharmaceuticals opening themselves to new untapped markets. In the long run, following these practices will yield a net profit.