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Priyam Rajkumar

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Associate in the Pharmaceutical, Life-sciences and Healthcare practice at the Delhi NCR office of Cyril Amarchand Mangaldas. Priyam graduated from the University of Edinburgh, United Kingdom in 2019 and completed his Bridge Course from the National Law University, Delhi in 2020 and specializes in regulatory compliance, advisory work, tender matters and litigation pertaining to the pharmaceutical, medical devices, digital health, clinical trials and the life-sciences industry. He also has prior experience in technology, media and telecommunications (TMT) advisory, education matters and labour and employment matters. He can be reached at priyam.rajkumar@cyrilshroff.com

Introduction

There is no denying that India is one of the most significant players in the global pharmaceuticals space, especially in the generic and affordable vaccines segment. Emerging markets such as India are expected to become further crucial in the foreseeable future, given the global supply chain disruptions and discontinuities. Fifty percent of the global demand for various vaccines is met by the Indian pharmaceuticals industry and as per the Indian Economic Survey 2021, the domestic market is expected to grow 3x in the next decade. It is expected to develop at an annual rate of 11% over the next two years, possibly exceeding $60 billion in value.[1] India’s healthcare market is expected to reach $372 billion, driven by rising income, better health awareness and increasing access to insurance. India’s healthcare public expenditure stood at 2.1% of GDP in 2021-22 against 1.8% in 2020-21. Furthermore, in Union Budget 2022-23, Rs 86,200.65 crore ($11.28 billion) was allocated to the Ministry of Health and Family Welfare (MoHFW).…

Continue Reading Examining the Regulatory and Operational Issues Affecting M&A in Pharmaceuticals and Healthcare Industry

Advances in drug research over the years have resulted in the development of blockbuster drugs, which have increased the life expectancy of mankind. In the past decade, scores of patients across the globe suffering from rare or chronic ailments had limited treatment options due to unavailability / pending approval of life-saving drugs in their countries. From a legal standpoint, a drug is only permitted to be obtained and used by a patient once such drug has been granted the requisite approvals from the requisite drug regulatory authorities of such country after following proper clinical trial protocols that establish safety and efficacy of such drugs. With rising costs of drug trials, not every drug is submitted for approval in every country yet disease conditions that warrant use thereof still exist. Following representations from medical professionals and stakeholders to cater to such situations, drug regulators realized the need to ensure that such drugs are made available to those who need them irrespective of approval status. Currently, numerous expressions such as ‘usage on compassionate grounds’, ‘expanded access’ and ‘preapproval use’ exist to describe this concept and are used interchangeably[1].    …

Continue Reading Use of unapproved drugs in India on compassionate grounds- Unravelling the Regulatory Conundrum