Pharmabiz
 

Health & pharma malpractices with lax regulatory structure a norm than an exception: Dr Bobby George

Nandita Vijay, BengaluruTuesday, March 21, 2017, 08:00 Hrs  [IST]

Unethical practices in healthcare and pharma sectors have become a norm rather than an exception in recent years. From over pricing of drugs and medical devices to doctor’s prescriptions and investigations, there can be no denial to the existence of collusion of various healthcare service providers, said Dr. Bobby George, vice president & head, regulatory affairs, Reliance Life Sciences and author of the book ‘The Act that Wasn’t.

Dr. George has provided a critical analysis of the current system of healthcare and pharma industry in the country through his latest book: The Act that Wasn’t. “There are diverse Acts, guidelines and policies directly or indirectly related to healthcare which regulate this sector and these have to work in tandem. In India, many Acts though enacted, largely remain in a way unenforced due to the indifference and general apathy of the healthcare fraternity and drug industry which refuses to be cowed down by legislation,” stated Dr. George.

“Being concerned on the erosion of social values and dominance of anti- social, unethical market forces in health sciences, this book highlights shortcomings in the healthcare related Acts and unhealthy practises of stakeholders and trying to exploit loopholes for their vested interests,” Dr. George, told Pharmabiz.

Even the most perfect laws would remain ineffective without the efficiency of the enforcement agencies implementing the same. Apart from the suggested improvements, attempts have been made to draw comparison between the Acts prevailing in the developed countries and in India, so that our industry and regulated agencies imbibe the best for the country. “The unethical practices may be small but leave a sizeable impact on the society at large. This is not acceptable in healthcare management in any civilised society,” he pointed out.

The book priced at Rs.399 and available online has 12 chapters with cross referencing. The first chapter is on ‘Acts and acts’ with specific examples covering process of framing a legislation and the Archaic statutes, some of which need to be repealed and replaced; the status of the judiciary in terms of lack of adequate resources to clear the backlog of cases. It also deals with the issues in implementation of these enactments. The remaining 11 chapters titled Clinical Establishment Act, Referral acts, Blood borne acts, User Fee Acts, Pediatric Acts, Surrogacy Acts, Biosimilar Acts, Acting on Fixed Dose Combinations, Whistle Blower Protection Acts and Reformative acts. Besides highlighting the challenges faced by stakeholders, it provided recommendations to adopt the best possible practices to plug in the loopholes in each of these domains, he said.

 
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