Pharmaceutical companies operate in one of the most dynamic environments. Changes in regulations by leading bodies such as US Food and Drug Administration (USFDA) and the European Medicines Agency (EMA) have increased the significance of regulatory compliance management for drug manufacturers. Pharma companies across the globe are compelled to alter their compliance practices to conform to changes in regulations and stringent anti-corruption laws. The US FDA oversees regulatory activity across the globe forcing pharma & life sciences companies to identify quality issues before they impact the production.
Historically pharmaceutical industry has been dealing with malpractices across the value chain ranging from improper branding to masking safety information and disregarding quality manufacturing standards. This has led to regulators keeping a strict watch on the pharma companies. Enforcement agencies the world over have become more active. Any violation of regulatory methods or non-compliance of standards could tarnish a company’s reputation, risking its future. According to the 2014 global survey on reputation risk conducted by Deloitte, reputation problems had a severe impact on revenue, loss of brand value and regulatory investigations.
In the US and European markets, companies have become increasingly cautious about regulatory compliance. Leading pharma companies in these markets have reportedly implemented effective compliance management systems internally, suggests an article published by The Smart Cube, a firm offering research and analytics services. However, the situation in Asian market and India in particular is not encouraging. Increased regulation, concerns over data integrity have only contributed to the compliance challenges facing the industry. A survey titled ‘Analyzing the state of Data Integrity Compliance in the Indian pharmaceutical industry’ conducted by E&Y in 2015, noted that the Indian pharma industry has been struggling with regulatory compliance. The reports indicate that companies lack skilled / well-trained compliance teams/practices and that many companies did not consider investing in compliance a priority.
Pharma companies, importantly the ones operating in India, will need to realign their quality and compliance structure to conform to the constantly evolving regulatory guidelines. With the FDA and other regulators broadening the scope of compliance requirements, it helps if companies have a holistic approach and make regulatory compliance part of their corporate strategy. This includes effective training, proper timely communication, periodic reviews, and support from the top management. Companies ought to be proactive in setting up stringent internal controls as part of their commitment towards quality and compliance. Regulators have to focus on aligning country-specific regulatory frameworks to global standards enabling harmonisation of standards and help companies drive efficiencies.
-- Issue 24 --