- We have never witnessed domestic or foreign pharmaceutical companies recall substandard or mislabelled drugs in India.
- India has been mulling the creation of a mandatory recall law for substandard drugs since 1976, and yet no law exists that mandates such medicine be removed from the market to this day.
- The issue has come up repeatedly in regulatory meetings in 1989, 1996, 1998, 2004, 2007, 2011, 2016, 2018 and 2019 but none of them resulted in amendments to the Drugs and Cosmetics Act to create a mandatory recall mechanism.
- In 2012, certain recall guidelines were published but they lacked the force of law.
Why is there no recall law?
The Drug Regulation Section of the Union Health Ministry is not up to the task of tackling complex drug regulatory issues due to a combination of factors including:
- lack of expertise and
- a greater interest in enabling the growth of the pharmaceutical industry than protecting public health.
Implications of not recalling substandard drugs:
- People, including children, are almost certainly dying or suffering from adverse health events because substandard drugs are not swiftly removed from the market.
- Dozens of drugs fail random-testing in government laboratories.
- Ideally, these drugs will be necessarily recalled in a transparent manner, with the people being informed of the failures.
- If this were to actually happen in India, the people would be flooded with alerts on an almost daily basis.
- It would increase the pressure on drug regulators to institute extensive reforms.
SOURCE: THE HINDU, THE ECONOMIC TIMES, PIB