The Union Health Ministry recently published a new draft Bill to replace the antiquated Drugs and Cosmetics Act, 1940. While we salute the Ministry for recognising the need for a new legislation, there is much to disagree with the new Bill. To begin with, although the Ministry has described it as being consistent with the government’s move to review obsolete pre-Independence legislation, most of it is a copy of the old law. There is nothing new in this Bill regarding drug regulation. And the Bill does nothing to address burning issues thrown up over the last decade since the Ranbaxy scandal.
Regulatory theory
The original Act was enacted when the Indian pharmaceutical industry was in its infancy. At the time, the guiding theory of this law was based on testing manufactured drugs purchased by drug inspectors from the open market. If a drug failed quality testing, the manufacturer could be jailed. This was not the most efficient system of regulation because it depended entirely on luck or fate – only if a drug inspector picked a certain drug on a certain day and it failed testing would the manufacturer face legal action. Much of the world has shifted to a more rigorous system of regulation centered around the compliance of manufacturing units with good manufacturing practices (GMPs). In theory, a drug manufactured in compliance with GMPs is subject to so many checks that it is unlikely that it would fail quality tests once shipped to the market.
