Shouryendu Ray

Partner

Rightly justifying its title as the ‘Pharmacy of the World’, India has strongly emerged as a global pharmaceutical manufacturing hub in recent times, con-stituting over 20 percent of global pharma supply chain and catering to around 60 percent of the world’s vaccines demand.

This can be primarily attributed to the numerous government initiatives such as Make in India, 100 percent FDI, PLI and PRIP, which have been pivotal in nourishing domestic pharma R&D and manufacturing.

While this is indeed a welcome sign for the industry and the nation as a whole, the highly regulated nature of the pharma and life sciences industries makes it a herculean task for companies to carry out their daily functions.

In this context, legal consulting firms such as Nora Chambers play a crucial role in providing expert guidance to navigate complex legal and regulatory frameworks, thereby enabling pharmacuetical companies to operate effectively amidst market uncertainties. Based in New Delhi, Nora Chambers was founded in 2022 by Shouryendu Ray and Neelu Mohan, two seasoned legal professionals with extensive expertise in the field.

Sharing his thoughts on the current industry scenario, Shouryendu says, “Owing to expanding healthcare access, increased R&D investments, and its strong positioning as a global manufacturing hub, India’s pharmaceutical and healthcare sectors are undergoing unprecedented transformation.

With the introduction of New Drugs & Clinical Trials Rules 2019 and amendments to the Medical Devices Rules, the regulatory landscape too is evolving drastically, further stressing upon the need for specialized legal expertise and comprehensive regulatory advisory services”.

Diverse Portfolio of Services

Under the able guidance of its Partners, Nora Chambers has evolved into a full-scale dispute resolution and general corporate advisory law practice. Some of its major practice areas include Economic Offences, Direct Tax Litigation & Advisory, Securities Law Litigation & Advisory, General Corporate Advisory, Shareholder & Contractual Disputes, Insolvency & Bankruptcy, Intellectual Property Disputes, Data Protection Advisory, and White-Collar Crimes Investigation & Prosecution.

Pharmaceuticals being one their primary sectors, the firm’s team of expert attorneys possess a clear understanding of numerous intricacies of the pharma business, enabling them to offer integrated solutions that align diverse compliance requirements with overall organizational growth objectives. Most importantly, by anticipating the regulatory changes beforehand instead of responding reactively to them, the firm is successfully bridging the gap between regulatory compliance and business strategy.

Going a step further, Nora Chambers is well-aware of the numerous regulatory frameworks that need to be adhered by pharma companies in terms of advertising and marketing their products. Thus, the firm also advises its pharma clients on their marketing and promotional campaigns in such a way that they’re both compliant as well as commercially effective.

In cases where modern promotional channels such as social media are involved, the firm has devised a unique framework called compliance-by-design, wherein all regulatory considerations are integrated into the earliest stages of content development itself, helping clients stay wary of any platform-specific compliance challenges.

Foresight-driven Approach to Service Delivery

Always treating customer experience and satisfaction as paramount, Nora Chambers is always ready to go an extra mile to ensure that they get nothing short of the ‘best’ quality service. At the heart of this customer-centric service delivery is the firm’s proactive monitoring system that not only tracks changing regulatory frameworks, but also maintains a continually updated database comprising of information pertaining various laws, recent changes & developments surrounding the concerned guidelines, decisions rendered by the Advertising Standards Council of India, and other sectoral regulators. Further, it also conducts a detailed evaluation of the clients’ promotional activities from legal, medical and ethical standpoints, ensuring full compliance even in matters where regulations remain ambiguous.

“The true hallmark of our ability is balancing commercial objectives with regulatory constraints. We also help our pharma clients to develop custom SOPs that operationalize regulatory requirements into actionable protocols, reducing review timelines by 40 percent on an average. Our approach has proven particularly valuable as pharmaceutical companies navigate India’s evolving stance on digital promotion and direct-to-consumer communications, where our guidance helps clients maintain ethical standards while pursuing legitimate business objectives within the bounds of the complex regulatory environment”, adds Shouryendu.

Yet another highlight of Nora Chambers is its ability to facilitate cross-sector partnerships and successful R&D collaborations between pharma companies and academic institutions, a critical component of the drug development process which is often a cause for dispute. To do so, the firm endorses models of shared governance comprising a balanced governance framework featuring advisory boards with equal representation.

This not only prevents institutional imbalances, but also make sure that efficient decision pathways and clear escalation protocols are in place whenever any disputes arise. To further safeguard its clients’ interests, the firm also makes sure that the agreement clearly defines all necessary IP framework and establish predetermined ownership rights based on originating organizations, background IP contributions and financial investments.

Journey So Far, & Beyond

Given such industry-best practices, Nora Chambers has not only been conferred with numerous awards and recognitions that include those from Asian Legal Business, Thomson Reuters and India Business Law Journal, but Shouryendu also features in the prestigious list of 40-under-40 Indian Lawyers by BusinessWorld Legal in 2022.

Going forward, the firm envisions leveraging its research capabilities and industry experience to stay at the forefront of the ever-changing pharma and life science sectors, while also strengthening its domain expertise and expanding the collaborative approach to client service as well.

“At Nora Chambers, we recognize the upcoming challenges for pharma and life sciences companies in terms of increasingly complex regulatory frameworks, novel IP considerations and cross-border affairs. We look to serve our clients in the sector with exceptional work product that not only addresses immediate needs, but also establishes foundations for sustainable growth and innovation.

Also, we will remain steadfast in our commitment to excellence and providing the strategic counsel our clients need to navigate an evolving industry landscape”, concludes Shouryendu.