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Indian pharma navigates compliance challenges to maintain global credibility by managing cost efficiency
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Nandita Vijayasimha, Bengaluru
May 24 , 2025
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Indian pharma has chalked out a proactive approach to regulatory compliance by relying on digital technology. This enables higher supply chain traceability and audit of contract manufacturers and third-party vendors.
Munab Ali Beik, head, compliance advisory practices, Core Integra noted that companies will need to partner with experienced compliance consultants or liaison partners to help navigate regulatory changes and maintain up-to-date compliance, ensuring smooth operations.
Compliance involves cost, but it is essential in pharma industry, as any deviation from regulatory requirements can lead to sub-standard products that may adversely affect human health. Indian pharma is the third largest by volume and continues to grow rapidly, catering to both domestic and international markets. Given that these products directly impact human life and health, strict adherence to regulatory compliance is critical, he added.
The industry is constantly under scrutiny by regulatory authorities, certifying bodies, third-party auditors, and buyers to ensure all applicable regulations are being followed. These inspections are not limited to the products themselves, but cover parameters such as business registration, record maintenance, mandatory displays, safety standards, labour law compliance, return filings, and more, said Beik.
Compliance clearance is a mandatory requirement for pharmaceutical brands. Without proper compliance documentation, products manufactured by these companies will not be accepted or purchased. Therefore, maintaining compliance is not just a regulatory requirement but it is essential for business continuity and reputation in the industry, Beik told Pharmabiz in an email.
Pharma compliance presents several challenges. For these there are state-specific legislations. Lack of uniformity creates complexities. Manual interventions, physical document submissions, site visits, and repeated follow-ups are typically required, resulting in delays that can impact business operations when compared to more streamlined international systems, he noted.
Despite the provisions of the Information Technology Act, 2000, under which electronic records are legally acceptable, the regulatory authorities frequently insist on maintaining physical records at work sites. This leads to duplication of documents, increasing administrative burden instead of simplifying compliance. Many regulatory returns and compliance reports are still paper-based and involve manual processes. This outdated approach adds inefficiencies and complicates the overall compliance workflow, said Beik.
There is a growing need for governance, risk, and compliance (GRC) tools to monitor and manage compliance at each location. However, the current systems in use by regulatory bodies are predominantly manual, and the absence of integrated digital platforms hampers efficiency.
Many companies lack in-house subject matter experts who can effectively address non-compliance issues and implement corrective and preventive actions. This gap increases the risk of prolonged non-compliance and potential penalties, he said.
Therefore best practices for compliance in the pharmaceutical industry need to be adhered. These are tracking regulatory changes, utilising a SaaS-Based compliance tool Implementing a licensed, cloud-based compliance management system helps in real-time tracking, monitoring, and maintaining regulatory requirements efficiently.
Collaborating with specialized compliance partners can help companies stay current with regulatory updates and ensure consistent adherence to applicable laws. These partners can also provide expert guidance and support during audits and inspections, he said.
The regulatory compliance domain for Indian pharma begins with adhering to the detailed requirements outlined in the drug acts. There are updates or changes making compliance management even more complex. To effectively manage this complexity, it is essential for companies to establish a dedicated compliance team, supported by a robust GRC or SaaS-based compliance monitoring tool, said Beik.
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