The Half-truth Pill

There are many areas of pharmaceutical regulation, including ayurveda, yoga and naturopathy, unani, siddha and homeopathy (AYUSH), in India—permission for the production of medicines and banning of irrational/unsafe medicines; pri­cing of medicines; quality of medicines; marketing practices of pharma companies; patent regime; and use and misuse of medicines. Out of these, The Truth Pill: The Myth of Drug Regulation in ­India deals predominantly with the regulation of the quality of medicines. It is a substantive contribution to a critique of “drug-quality regulation” in India, based on the collection of a lot of information in the public domain as well as unearthing it through the use of the right to information (RTI) and through legal red­ressal. It brings forth structural and functional deficiencies, opacity, fraud, and corruption in the drug-quality regulation in India.

The book begins with tracing the history of drug-quality regulation in the West, then in colonial and independent India followed by the analysis of the dyn­amics of pharma quality regulation at the level of legislation, setting up the organisational framework, its strengths and limitations, illustrated by its track record. It reveals, how, in India, the pharma industry lobby has tried fairly successfully to keep drug-quality regulation more or less perfunctory and how the regulatory regime has favoured the industry at the expense of the people. It exposes leniency and delays in taking ­legal action against manufacturers for “not of standard quality” (NSQ) medicines. However, it also notes that