The Indian pharma industry needs to not just keep pace with the regulations for clinical trials and good manufacturing practices, but also those of anti-bribery, corporate governance, cyber security, and environmental health and safety, said French Caldwell, Chief Evangelist, MetricStream.

Pharmaceutical companies have to keep up with both industry specific rules. This landscape is ever shifting because of the ongoing regulatory change globally, he added.

The drug manufacturing industry in India has the advantage of latent talent in terms of people with qualifications and experience. The qualified workforce here also understand the process rigor in terms of capturing, recording, documenting and auditing product and process related non-conformance issues, investigations, reporting, complaint handling and for developing and executing corrective and preventive action (CAPA) plans.

Further automation of these key business processes on an integrated compliance platform will enable Indian pharma to improve operational efficiencies, lower the cost of regulatory compliance and create a transparent environment for proactively identifying, tracking and resolving quality issues. The system will be compliant with FDA 21 CFR Part 11 requirements for electronic records and information systems, Caldwell told Pharmabiz.

As a market leader in Governance, Risk and Compliance (GRC), we are well positioned to cater to the Indian pharma requirements. It is already working with Pfizer, J&J, Boehringer Ingelheim, Edwards LifeSciences, Roche- Genentech, Novartis and Amgen.

Our online portal is the world’s largest provider of life sciences compliance training with a network of 60,000 professionals relevant to the pharma industry. The software, M7 GRC platform and apps have simplified the user experience, making compliance, audit, and risk management tasks’ cycle time much shorter. The user experience is personalized and configurable. The organic reporting is flexible, providing reports and dashboards that are personalized and configured. Also, in the pharma industry, there is a search for cost savings and a move to the cloud computing platforms. This is where our  M7 is designed for the same, he said.

India is the fourth largest supplier of pharma to the US. The country accounts for over 200 US FDA units outside the US. Companies here are taking proactive steps to ensure FDA compliance, repurposing and investing in people, processes and infrastructure towards automation, technology-based solutions and training. The bridge between government and private enterprise is getting strengthened annually as the Indian Export Inspection Council (EIC), the Food Safety Standards Agency of India (FSSAI), the Drugs Controller General of India (DCGI), and Ministry of Health and Family Welfare working closely towards growth, noted Caldwell.

MetricStream can help pharmaceutical companies track and manage regulatory and non-regulatory compliance obligations, and mitigate various types of risks. Companies are leveraging our apps and solutions to document compliance requirements, and collaborate across departments to ensure timely and effective closure of open issues and risks. Our future efforts are to enable Indian pharma help face the challenges ahead, said Caldwell.