We have often noted on this blog and in a recent working paper that India's medicine safety laws are atrociously obsolete, and a menace to global public health (although principally a menace to Indians' own health). This is hardly open to controversy: after all, India's Drugs and Cosmetics Act is a 1940 law, and the Drugs and Cosmetics Rules are dated 1945. Both are colonial laws that precede India's independence in 1947. Although Indian legislators have floated amendments over the years, none has truly brought the laws up to date, and all have been band-aid measures that were outdated even before they became law.
It is lamentably accurate to say that India's approach to drug safety is stuck in the last century, and like a vintage car, it is quaint but dangerous.
We are not alone in this point of view. A recent paper in The Lancet by Peter Roderick and colleagues is starkly entitled "India Should Introduce a new Drugs Act". These scholars also criticize India’s too-little-too-late approach to amending its ancient laws, and we can do no better than to quote them:
“When examining India's drug laws, several conclusions stand out. First, the current Drugs and Cosmetics Act is old and deficient. The core primary legislation presently regulating drugs was passed in 1940 and has been amended at least ten times. It contains no duty on the regulator to be satisfied about the safety and effectiveness of a drug before marketing. This duty was only introduced for new drugs in secondary rules in 2001… India has badly drafted and weak rules on clinical trials, which were weakened further in 2005… The Drugs and Cosmetics (Amendment) Bill 2013 fails to provide a rigorous foundation for putting effectiveness, safety, rationality, and need at the heart of India's drug regulatory system. Indeed, it does not even attempt it. Rather, it is another patch on the 74-year-old, pre-Independence Act whose structural design has arguably been stretched beyond breaking point.”
Yet despite these facts, partisan apologists for India's sub-par drug industry like Anne Roehmer-Mahler or DG Shah continue to perceive that anyone urging action on improving drug quality standards has an ulterior motive, be it to place barriers before India’s pharmaceutical industry, or to boost intellectual property protection. To such persons, it is as if honest criticism of deficient safety laws is impossible, and there must always be a hidden agenda somewhere. Perhaps if they won’t believe us, they will believe what people unconnected to us published in The Lancet.