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- Test category by sumit
The government’s failed attempt to link all state drug regulatory authorities through a common e-platform even after it was first mooted in 2003 is perhaps a glaring example of how implementation fails to achieve the desired effect. The first issue was the delay in getting the States shift to a single digital platform. The compatibility issues created problems with real time data transfer. Data upgradation - be it number of samples picked up, new products approved, or prosecutions taken – are all mission imperfect even to this day.
Wide Angle | The Slip Is Showing, India
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Indian food regulator may end up with egg of its face when it finds that the product it has banned has been given OK nod in much evolved and advanced regulatory systems, says Joe C Mathew
If there has been one very positive outcome of the Maggi instant noodle ban, it was the revelation that India lacks adequate number of food testing laboratories and, the ones that are functional, need serious quality upgradation.
Extensive media coverage highlighted the gaps that exist, and the on-going government efforts to strengthen India’s food regulatory system. However, very few took a critical view on how respective governments over the last decade or so, spoiled the country’s chance to develop a quality food and drug testing and regulatory system in the country as the problem with India’s food and drug regulatory system was known for umpteen number of years now.
The most ambitious attempt to overhaul the country’s food and drug testing and regulatory capabilities happened in 2003, when the central government launched a World Bank funded Food and Drugs Capacity building project with exactly the same vision. To be fair, the archaic Prevention of Food Adulteration (PFA) Act got repealed during this time, drug laws got amended, and the FDA Bhawan, which houses the Food Safety and Standards Authority of India (FSSAI) and the Central Drug Standard Control Organisation (CDSCO) was built. Modernisation of testing laboratories and augmentation of regulatory checks also happened during this period. The project got completed in 2009. The World Bank must have assessed it to be a moderately unsatisfactory project, but the Magi episode points out that it was worse.
|Joe C Mathew|
What is consistent is the promise to deliver. If the latest reports are to be trusted, the government is once again trying to revamp the drug and food regulatory system and increasing its manpower multiple folds. New divisions to regulate emerging sectors such as medical devices are also in the works.
It would be worth looking at the operational problems highlighted by the World Bank in 2009 while embarking upon new programmes. To quote the report: “The food and drugs sector being in the Concurrent List of the Indian Constitution, both the Centre and the States have independent authority to pass legislations. This division of responsibilities between the Centre and the States in legislation and implementation of food and drug regulation in a large country like India with varied state capacities and commitment was a major challenge throughout the project”.
The World Bank analysis makes it further clear. “The Concurrent nature of the food and drugs sector was one factor which led to a lack of interest and commitment in some states to a project mandated by the centre. States were particularly slow in addressing human resource issues which were at the heart of achieving effective oversight and regulation in the food and drug sectors”.
It also points out that during implementation it turned out that the design was too ambitious in assuming that the complexity of multiple Center-State interactions can be managed centrally and advises that with the benefit of hindsight, one might have chosen a more focused design with only a few States selected for capacity building along with the Center and more decentralized implementation.
Since the problems that turned the World Bank project “moderately unsatisfactory” remain the same, it would be prudent for the government to realise that mere efforts and shifting deadlines will not improve the country’s food and drug regulatory infrastructure.
More work has to be done, otherwise, Indian food regulator may end up with egg of its face when it finds that the product it has banned has been given OK nod in much evolved and advanced regulatory systems in other parts of the world.