Head of legal and compliance | Sun Pharmaceutical Industries
Rakesh Chandra Sinha
Head of legal and compliance | Sun Pharmaceutical Industries
Team size: 20
Have any recent political, economic, or regulatory changes impacted your work? How are you dealing with this?
The pharmaceutical sector has been consistent in dealing with extreme market conditions due to Covid-19, and stringent government regulations to ensure drug quality and affordability of drug for the masses. I have been participating in most of such initiatives from a legal perspective representing the pharmaceutical industry in India. These recent regulatory changes have definitely impacted us. However, we should not forget the fact that, even though new regulation can put value at risk, it also creates new opportunities and unlocks new growth levers. We have dealt with the situation by a rigorous, quantified assessment of the value at stake from these risks and opportunities, over both the short- and the long-term and we believe that it is critical to prioritise an organisation’s outreach efforts. It helped us to quickly anticipate, identify, and understand the key regulatory issues that will affect our business and leverage an in-depth understanding of industry profit pools, as well as getting some unique insights into the growth levers. In this process, we learnt to build superior capabilities to map and manage external stakeholders and also mobilised the organisation towards a clear growth trajectory
What are some of the most significant cases and transactions you have worked on recently?
I am providing details of transactions in the public domain:
A major labour litigation with union contested up to Supreme Court of India.
Acquisition of the Uractiv portfolio from Fiterman Pharma in Romania. The Uractiv portfolio comprises food supplements including minerals, vitamins, and adjuvants; cosmetics and medical devices used for maintaining urinary tract health.
Exclusive patent licensing agreement with H. Lundbeck A/S to market and distribute its own version of Vortioxetine in India under the brand name, VORTIDIFTM. Vortioxetine is a novel antidepressant with multimodal activity, which is approved to treat Major Depressive Disorder in adults.
License and Supply Agreements with Cassiopea SpA, a specialty pharmaceutical company, for exclusive right to commercialise Winlevi in the United States and Canada. Winlevi has been approved by the United States Food & Drug Administration as a novel drug with a unique mechanism of action for the topical treatment of acne in patients 12 years and older.
Entered into a license agreement with Ferring Pharmaceuticals Pvt. Ltd, a subsidiary of Switzerland-based biopharmaceuticals MNC Ferring Pharmaceuticals, to commercialise a Room Temperature Stable formulation of obstetric drug, CARITEC in India. CARITEC is indicated for the prevention of excessive bleeding in women after vaginal or caesarean childbirth. The condition is commonly known as post-partum haemorrhage.
Entered into a voluntary licensing agreement with Eli Lilly and Company for expanding access to Lilly’s drug, baricitinib in India. Sun Pharma will manufacture and distribute the drug in India. Baricitinib is used in combination with remdesivir for the treatment of suspected or laboratory confirmed Covid-19 in hospitalised adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Head of legal and compliance | Sun Pharmaceutical Industries
Associate vice president – legal and compliance (head legal and compliance) | Sun Pharmaceutical Industries
Rakesh Chandra Sinha joined Sun Pharmaceutical Industries, a major Indian multinational pharmaceutical company, in March 2016 to head its legal and compliance functions in the capacity of associate vice president...