As society develops, it also becomes more complex with increasing specialization in different areas.
This is a problem for democracy because our ability to hold our representatives accountable depends on our ability to understand how they are dealing with increasingly technical areas of governance.
This phenomenon can be clearly seen in various aspects of life such as finance, law, climate and environment, technology, civil engineering and consumer protection. It becomes all too easy for governments to make excuses for their failures if citizens do not have the means to question them.
This should explain the importance of books such as The Truth Pill: The Myth of Drug Regulation in India by Dinesh S Thakur and Prashant Reddy T.
Public health and medicinal drugs are not only highly technical and inaccessible areas of knowledge, but they are also areas of regulation that critically affect our well-being and our lives. Whether we like it or not, we are all plagued by conditions that affect our health: common colds and infections, long-standing conditions such as diabetes or asthma, communicable diseases, significant events such as injury or pregnancy, debilitating Curable and incurable diseases and many more. For these things we regularly take medicines.
You would think that a regulatory framework overseeing the manufacture and sale of these products would be a top priority for any government. Such a framework should be up-to-date on developments in the field and rigorously scrutinized for deficiencies that lead to ineffective drugs or immediate or long-term side effects, severe reactions or even death. Unfortunately, as the story recounted in The Truth Pill reveals, this is not the case in India.
The opening chapters of the book set the context of how modern medicine developed and how far it was taken in India. The book then provides an overall view of our drug regulation framework, with each chapter examining a different aspect. Prosecution and punishment of drug related offences, standards for manufacturers, method of approving new drugs, approval for generic drugs, traditional medicines from Ayurveda and Unani, status of Indian pharmacies and supply chain, regulations for advertisements and promotion – Each of these aspects comes under scrutiny and is found to be sorely lacking.
The entire chain, from approval to manufacture to sale to enforcement, is riddled with issues such as lax and outdated standards, lax approval practices, legal loopholes, inadequate laboratories, weak prosecution policies, lenient penalties and extravagance. For a ready-made example of the system’s failures, readers need only look at the deaths of 66 children in The Gambia linked to tainted cough syrup from India. Even before this, five cases of poisoning from the same contaminant have been reported!
Despite this, the government remains unrelentingly combative about criticism. Its regulatory bodies face concerns regarding independence and federal constraints as well as capacity and expertise. Pressure from various industry groups and concerns over wider access to drugs have further complicated the matter.
Researching and communicating the details of the regulatory regime in the tech sector is not an easy task, but the authors have gone to great lengths to collect persuasive data and explain technical concepts where necessary. Unsurprisingly, the book provides a ready guide to the problems of regulation in India in other areas as well. The detail of information may mean that the text drags on in some parts, but the important problems discussed make the book compelling for anyone interested in public health. We have urgent reasons to pay attention to the medicines we take in India.
Book: The Truth Pill: The Myth Of Drug Regulation In India
Author: Dinesh S. Thakur and Prashant Reddy T
Publisher: Simon & Schuster
Price: ₹699
Source- telegraphindia