A public notice concerning a batch of medication that had been mistakenly distributed to the market was published in newspapers on April 25 by the global pharmaceutical company Abbot.
Since 1976, India has debated passing legislation requiring the removal of tainted medications from the market, but as of today, no such law has been passed.
Because unsafe pharmaceuticals are not taken off the market as soon as possible, people, including children, are virtually likely to die or experience terrible health outcomes. In government laboratories, dozens of pharmaceuticals consistently fail random testing.
Points to Ponder:
Contrary to the United States, India does not have a statute requiring forced drug recalls.
Because India doesn’t have a law requiring forced recalls, medicine manufacturers are not compelled to remove faulty or mislabeled products from the market.
In India, discussions of enacting legislation requiring recalls started in 1976, but no changes to the Drugs and Cosmetics Act have been made to establish a binding framework to compel such recalls.
The Central Drugs Standard Control Organisation (CDSCO) published recall guidelines in 2012, however, they lacked legal status.
The Union Health Ministry’s Drug Regulation Section’s indifference and lack of experience, as well as India’s extremely disjointed regulatory structure—each State has its drug regulator—are the main causes of the absence of a mandatory recall statute.
Even though medications produced in one State can easily cross borders to be sold in all States across the nation, the pharmaceutical industry and state drug regulators have resisted increasing centralization of regulatory powers.
Since India should have a single regulator if it were a single market for medications, the argument against centralization is illogical.
It’s possible that India’s drug authorities are aware that a forced medicine recall system, which would necessitate extensive publicity, would draw attention to the plight of the pharmaceutical business.
The recent focus on the problem of drug failures abroad has not led to any changes in India’s current situation.
