| Lupin
Lupin
| Lupin
Mumbai-based pharmaceutical company Lupin puts compliance at the heart of its business activities, and its 13-person legal team has a hugely important role to play in this mission-critical endeavour. The...
What are the most significant activities that your legal team has been involved with recently? A bird’s-eye-view of the broad level of activities include: •M&A and JVs: Documentation/ Negotiation of clauses/ shortlisting and negotiations with attorneys/lawyers. The company has been engaged in aggressive M&A deals in the past year. •Documentation: Negotiating, advising, drafting and vetting of agreements and documents of all types. •Global trademarks: The entire gamut covering searches, application, opposition, conflict management, acquisition/assignment, advisory; Central Global Trademarks Centre; data mining, consolidation and repository creation. •Legal Notices: Addressing all notices received with endeavor to settle the issue amicably where feasible, putting forth effective defences including attaining a desired objective through the issuance of potent notices. •Litigation: Comprehensive litigation management and dispute resolution aimed at zealously protecting and safeguarding the interest of the company, including advisory and counsel briefing. •Ethics and compliance: Business ethics and compliance is intended to ensure compliance with laws. The policies and procedures are designed to be proportionate to the risks that the company faces and tailored to the nature, scale, and complexity of its business operations. Amongst others, a few major achievements of the legal team in the past two years are:
•Lupin is one of the pioneers in the Indian pharma industry to voluntarily adopt a business ethics and compliance framework and is setting an example for others in the industry to emulate. •Implementing a competition law framework. •Undertaking a board of directors risk profiling assessment. •Launching an effective narcotic drugs and psychotropic substances (NDPS) compliance framework. Lupin as an organisation, has always strived to be a paragon of good corporate governance by promulgating a culture of accountability and ethical behaviour. What recent political, economic or regulatory changes in India have impacted your company and the team the most? It is well recognised by us that the regulatory environment, being dynamic, faces continual changes in relation to laws and regulations. The regulators today have enhanced capabilities to detect and plug non-compliance and the opening of the economy and consequent adoption of best international practices is imperative. Further the risk of adverse impacts on the impeccable international reputation of Lupin, mandates the need to develop a strong compliance management system that would effectively weave each stakeholder into a cohesive unit securing the highest compliance standards. The following are recent regulatory changes that have affected Lupin: First, the FDC Ban: Several Fixed Dose Combinations (FDCs) were banned by the government. We challenged the ban and in several instances were successful to obtain a stay on the ban. Second, recent amendments to Rule 96 of the Drugs and Cosmetics Act, 1940 led to a major revision of artworks of over 6,000 product packs. Our team successfully completed the herculean task within the given timelines. Third, the NPPA has in recent times capped trade margins in respect of several non-scheduled formulations thereby impacting profit and sales. Lastly the FSSAI had recently banned use of heme iron as a source of iron. We made several representations to FSSAI and its technical committee and were successful in having the ban released What will be the main focus for the company in the next 12 months and how does the team intend to assist with this? By the very nature of its activities, the in-house legal team is not actively involved in business and decision making related thereto. However, the legal team has changed the paradigm. With astute business sense painstakingly developed over the years, honed by professional legal expertise the legal team is able to bring to the table a unique blend of business sense married to legal yet practical insights that enables it to provide pragmatic solutions while at the same time effectively protecting the interest of the company. The range and depth of influence of this team on business is distinctly a cut above all other peers. The legal team is geared up to assist the company in the following initiatives over the next one year: the creation of a global intellectual property platform; the launch of new drugs and expansion of the OTC segment; technological updates; R&D initiatives; strengthening compliance and ethics initiatives; and acquisitions and JVs. How has the team harnessed technology to improve output or drive efficiencies? The following systems have been successfully implemented by the legal team: a contract management system to have a comprehensive contract life cycle management tool offering effective controls, reporting, transparency, MIS with robust repository management capabilities; a compliance management system to track and monitor legal and regulatory compliances; a trademark management system for global trademark life cycle management; and a litigation management system to track litigations and legal notices with robust repository capabilities. Can you sum up the team culture/ethos? Giving some information afterwards about how this is developed. As a team, we are a unique blend of different competencies and diverse skill sets. The team has grown exponentially in stature and now has the competency and capability to influence every facet of business. The team has been contributing in every field and touch all aspects of business including but not limited to litigation, documentation, M&As, competition law, ant-bribery laws, legal notices handling and drafting, artwork clearance, trademarks, copyrights, compliance management and advisory to name a few. In a conventional corporate environment, the legal team is perceived as being purely a service function expected to play a reactive role of handing litigations and other non-litigation disputes. This team has however changed the paradigm in-as-much – as it is looked-up to as a critical front-line team that brings to the table legal yet practical perspectives on each issue. The team banks on the rich, diverse and professional expertise of its team members. The team, by its continual and consistent professional service levels commensurate to standards bench marked to the best in the industry, has succeeded in spreading its influence across business units in the company. The legal department plays three primary roles as an integral member of the management team, a participant on decision making processes, offering both legal and strategic business advice and a manager of legal affairs within the entire organisation.