In a rare occurrence, on April 25, Abbot, a multinational pharmaceutical company, published a public notice in newspapers alerting people about a mislabelled batch of medicine that it had inadvertently shipped to the market.
While such recalls take place regularly in the U.S., including by Indian companies, we have never witnessed domestic or foreign pharmaceutical companies recall substandard or mislabelled drugs in India.
Mulling the law
One of the reasons for this difference in their behaviour in India and the U.S. is because the law in the latter country requires pharmaceutical companies to recall from the market those batches of drugs that have failed to meet quality parameters.
India, on the other hand, 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.
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In 1976, the Drugs Consultative Committee (DCC), which consists of all the state drug controllers along with senior bureaucrats from the Ministry of Health and the national drug regulator, the Central Drug Standard Control Organisation (CDSCO), discussed the issue of drug recalls.
The minutes of this meeting record a discussion on how drugs ordered to be recalled by a state drug controller in one state were found to be on sale in a neighbouring state. The meeting resolved to have greater cooperation between various state drug controllers in order to facilitate better coordination to recall and destroy drugs that failed tests. But this decision never translated into amending the law to create a binding legal structure to enforce such recalls.
The issue of recalls came up again in meetings of the DCC in 1989, 1996, 1998, 2004, 2007, and 2011 but none of them resulted in amendments to the Drugs & Cosmetics Act to create a mandatory recall mechanism.
Limited power
In 2012, after a scathing report by the Department Related Parliamentary Standing Committee on Health & Family Welfare raised the issue of recalls, among other issues, the CDSCO proposed a set of draft recall guidelines – except the national regulator lacks the power to convert guidelines into a binding law. Only the Ministry of Health or, more importantly, the Drug Regulation Section of the Ministry, can initiate the process to make binding rules or legislation.
The then Drug Controller General of India (DCGI) had announced that the guidelines would become binding law in a few months, but that never happened. In any event, the guidelines were not very thorough.
The issue of recalls resurfaced in 2016 at meetings of the DCC and at another committee, called the Drugs Technical Advisory Board (DTAB). Nothing changed on the ground. The same issue came up again in 2018 and 2019 at the meetings of the DCC, but India still lacks a recall law, 46 years on.
Three possible reasons
Why has this issue been pending for so long in India with no redress? There are three possible answers.
The first is that the Drug Regulation Section of the Union health ministry is simply not up to the task of tackling complex drug regulatory issues due to a combination of different factors including apathy, lack of expertise in the area, and a greater interest in enabling the growth of the pharmaceutical industry than protecting public health.
The second possible factor is India’s highly fragmented regulatory structure, with each state having its own drug regulator. But despite the fragmentation, drugs manufactured in one state can seamlessly cross borders to be sold in all states around the country.
To create an effective recall mechanism, the responsibility of recalling drugs has to be centralised, with one authority that has the legal power to hold companies liable for failures to recall drugs from across the country, and further, to also search and seize batches of failed medicine.
But both the pharmaceutical industry and state drug regulators have resisted greater centralisation of regulatory powers. This opposition has little grounding in logic or legal theory. If India is a single market for drugs, it follows that it should have one regulator. If not, the incompetence of a regulator in just one state can lead to adverse effects for patients in other states, whose citizens have no influence or electoral power to demand accountability of that regulator.
The third possible factor is that India’s drug regulators are aware of the fact that a mandatory drug recall system, which necessarily has to be centred on a system of wide publicity, will bring to public attention to the rotten state of affairs in India’s pharmaceutical industry.
Consequences of delay
Every month, dozens of drugs fail random-testing in government laboratories. Ideally, these drugs will be mandatorily recalled in a transparent manner, with the people being informed of the failures. But if this were to actually happen in India, the people at large would be flooded with alerts on an almost daily basis, which then would increase the pressure on drug regulators to institute extensive reforms.
If the bureaucracy’s intention is to avoid accountability, it might prefer to keep quiet and let substandard drugs, even those with dangerous consequences for consumers, circulate in the market. This has been their modus operandi for decades, until recently, when drug failures overseas brought attention to this issue.
People, including children, are almost certainly dying or suffering from adverse health events because substandard drugs are not swiftly removed from the market. Yet nothing seems to change on the ground.
Dinesh Thakur and Prashant Reddy T. are co-authors of The Truth Pill: The Myth of Drug Regulation in India.
- Abbot, a multinational pharmaceutical company, published a public notice in newspapers alerting people about a mislabelled batch of medicine that it had inadvertently shipped to the market. While such recalls take place regularly in the U.S., including by Indian companies, 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.
- If the bureaucracy’s intention is to avoid accountability, it might prefer to keep quiet and let substandard drugs, even those with dangerous consequences for consumers, circulate in the market. This has been their modus operandi for decades, until recently, when drug failures overseas brought attention to this issue.
