Dr Bobby George critiques both the lawmakers and law breakers in his book, The Act That Wasn’t and manages to deliver on his promise of being ‘an insider’s view on healthcare laws, loopholes and reforms
With an intriguing title like The Act that Wasn’t, author Dr Bobby George’s book is sure to hook anyone who is researching the legal framework prevalent in India. Focusing on legislative measures impacting the healthcare and pharma sectors, the author also lays out the loopholes along with suggested reforms. As Vice President & Head Regulatory Affairs, Reliance Life Sciences, the author has spoken on these topics at various fora and has published in quite few journals. This book adds to his already sizable work on this subject and manages to delivers on its promise of being ‘an insider’s view on healthcare laws, loopholes and reforms’.
Published in March this year, with a foreword by Justice KT Thomas, former Judge of the Supreme Court of India, and testimonials from Dr Eswara Reddy, Joint Drugs Controller of India and Dr YK Gupta, Prof & Head, Department of Pharmacology, AIIMS, New Delhi, the book comes highly recommended by some of the doyens who have been involved with shaping the very laws and their implementation that George critiques in his book.
As Dr Gupta points out, the author describes the background and details of the Acts (laws) put in place, as well as reviews the acts (wrong deeds) of the industry. He also details how regulators have engaged with stakeholders while formulating these policies and regulations.
Priced at around Rs 400 and accessible on e-commerce sites, the slim volume consists of 12 chapters, each focusing on key legislation ranging from the Clinical Establishment Act to fixed dose combination drugs and biosimilars. It also analyses laws regulating referrals, surrogacy, organ transplants, etc. While analysing the nuances of the Acts, the book also details the unsavoury practices that the laws seek to control.
For instance, in the fourth chapter titled Blood Borne Acts, the author starts with the technicalities of blood banking and transfusion, then goes on to detail the menace of unlicensed blood banks, the shortage and wastage of blood products even as there is rampant ‘trading in blood/ components/ plasma’ and overpricing. George ends each chapter with recommendations to government on how the laws can be strengthened as well as some advice to industry stakeholders. The common refrain, not very different from other writers on this subject, is that while the laws are in place, their implementation lacks sustained and systematic vigour. But this is a book that will hopefully trigger renewed effort from both regulators and industry to meet on the same page and protect the interests of the patient.
The author’s exhaustive analysis of global laws, juxtaposed with the scenario in India, will prove to be invaluable to both industry professionals tasked with compliance within their organisations. It will also serve as a research guide for health policy researchers as well as students hoping to make a career for themselves in this vital yet much abused sector.