Drug approval norms violated to fleeze the consumer?

When protectors become predators

Maneesha & Abhay

Hippocratic Oath—‘First, do no harm’ pledged by physicians and healthcare professionals is losing its sanctity! Often the oath is disregarded for gains beyond saving human lives. Life savers are ready to sell life for personal favours and many a times the highest governing authorities become the part of this dirty game. This unholy collusive nexus between drug manufacturers, independent medical experts and officials of Central Drugs Standard Control Organisation (CDSCO) in granting approvals to new drugs is highlighted in the shocking report recently submitted by the Parliamentary Standing Committee for health and family welfare. The report says that drugs banned, discarded or withdrawn in developed countries are allowed to be circulated in India. The Committee also pointed out that since 2008, the Drug Controller General of India (DCGI) is approving one drug every month without any trials and serious lapses and irregularities are happening in granting approvals to new drugs.

In order to scrutinise new drug approvals, the Committee sought details on randomly selected 42 medicines from the list of approved 2,167 new drugs by CDSCO. Of these, 38 drugs were approved in the years 2004 to August 31, 2010; one drug had been approved earlier in 2001. Three drugs had been approved earlier in mid 90s. Out of 42 drugs, the Ministry could not provide any documents on three drugs on the grounds that files were non-traceable. All these drugs had been approved on different dates and different years creating doubt if disappearance was accidental. Strangely, all these cases also happened to be controversial drugs; one was never marketed in US, Canada, Britain, Australia and other countries with well-developed regulatory systems while the other two were discontinued later on. In India, all the three drugs are currently being sold.  For remaining 39 drugs, approvals were granted either based on suboptimal clinical trials or without any trials at all.

DCGI has the power to approve drugs without clinical trials in “Public Interest.” But what constitutes Public Interest? How can approvals be given to foreign drugs without testing on Indians is in Public Interest? Some of the reasons given for irregular approvals are: “Serious disease” (all the more reason to conduct clinical trials to ensure that patients in India really benefit from such imported, exorbitantly expensive drugs), “Rare disease status according to United States Food and Drugs Administration (USFDA)” (How can USFDA decide which disease in India is rare?). Inspite of these inherent contradictions, approvals were granted for new drugs without appropriate testing and currently many untested drugs are sold in Indian market.

Now the question that needs to be asked is, whether this unethical nexuses between medical experts, drug manufacturers and officials of Drug Control Organisation is limited to India? Or is it a worldwide phenomenon?

Unfortunately, it is a universal plague putting human health at risk. Last week in US, pharmaceutical giant Abbott arrived at $1.5 billion settlement with the federal government for illegal marketing practices, including promoting prescription drugs for uses not approved by the FDA, paying financial inducements to increase sales and engaging in practices that pose grave danger to the patients.

Not long ago, there have been multiple instances, when pharma giants like Pfizer, Eli Lilly, GlaxoSmithKline, Johnson and Johnson, and many more have been fined for illegal practices. In 2009, Pfizer paid $2.3 billion to the government while Eli Lilly settled civil and criminal charges earlier for $1.4 billion.

Last November, GlaxoSmithKline (GSK) announced that it had reached an agreement in principle to pay $3 billion to resolve multiple government investigations into its sales and marketing practices. GSK was charged with illegal marketing of Avandia, a diabetes drug that was severely restricted last year after it was linked to heart risks. The company had paid doctors and manipulated medical research to promote the drug.

Johnson & Johnson (J&J) reportedly is in negotiations with the government to pay more than $1 billion to settle civil charges for the off-label marketing of Risperdal and Invega.

In another instance, last December, the Irish drug maker Elan agreed a $203.5m, half in criminal penalties, half in a civil payment, to settle an investigation of its illegal marketing of the anti-seizure medicine Zonegran. Elan sales staff had promoted it for weight loss and mood disorders.

The cost of fraud and kickback fines for top drug companies since 2006 is at $20bn and adding legal fees, the total would be at least double.

Although the collusion between medical experts, drug manufacturers and officials is a global phenomenon, at least in western countries, pharma companies are heavily penalized for gross irregularities. But unfortunately in India, either actions against felony are not taken and if taken are very weak creating an impression that India is a banana republic.

There wouldn’t be a better opportunity than now, especially after the scorching report by the Parliamentary Standing committee to initiate the process for completely reforming the mechanism of granting approvals to new drugs by making is more transparent.  Moreover, arbitrary,  discretionary powers of DCGI need to be either curtailed or rationalised. Unless stern measures are taken, innocent Indians will continue to become guinea-pigs for multinational pharma giants.

Undoubtedly, India is emerging as economic global power, now it’s time for us to be the leaders in ethical practices too!