Abroad Deaths put focus on India’s drug sector

THE deaths of 13 Indian women allegedly given tainted antibiotics after undergoing sterilisation surgery have raised fresh questions about India’s giant drug industry, already under international scrutiny for its troubled safety record.

India exports $15-billion (about R166-billion) worth of over-the-counter and generic prescription drugs

The US Food and Drug Administration has in the past few years banned generic versions of popular medicines such as the acne drug Accutane, the anti-pain medicine Neurontin and the antibiotic Cipro after investigators determined they were adulterated.

It remains unclear exactly what caused the deaths of the 13 women who had undergone surgery at staterun mass sterilisation camps in central India, but a claim by local officials that the antibiotics they took were laced with rat poison has created damaging headlines.

This would act as a wake-up call for tougher regulation, said DG Shah, secretary-general of the Indian Pharmaceutical Alliance, which is made up of Indian drug companies.

Even if the drugs consumed by the women involved only a small manufacturer distributing products locally, it reflected on the image of the country, he said.

Bejon Misra, founder of the Partnership for Safe Medicines India, said it only took “one unsafe medicine to threaten patient safety” — and with it, the industry’s reputation.

“These things happen because of an ill-designed procurement procedure with no checks on the quality of drugs bought — people buy the drugs because of the lowest price,” said Misra.

Japanese-owned Indian company Ranbaxy pleaded guilty last year to seven US charges of falsifying clinical data and distributing adulterated antibiotic and other drugs. It paid a record $500-million fine.

A 2009 Indian government survey suggested that 0.5% of drugs sold were substandard — but a 2010 survey of New Delhi pharmacies by NGOs said the problem was far greater.

It found 12% of sampled drugs to be below standard — although most contained substances such as talcum powder rather than deadly ingredients.

Roger Bate, author of Phake: The Deadly World of Falsified and Substandard Medicines, studied more than 6 000 drug samples from Asia and Africa, of which nearly half were made in India.

The quality of many was degraded or they contained too little of the active ingredient, Bate’s investigation found, concluding that the best solution would be to improve oversight not just by US regulators, but by Indian ones too.

“India does not treat regulatory standards seriously,” Bate said in a February report.

A parliamentary standing committee last year accused the health ministry of “paralytic inertia” in tackling drug regulation.

But India’s top drug regulatory body, the Central Drugs Standard Control Organisation, has a staff of just 124, according to a 2012 parliamentary report. That compares with some 14 500 for its US counterpart, the FDA.

The FDA announced in February that it was strengthening its regulatory presence in India to 19 investigators from 12.

“We need the same level of oversight whether it is within our borders or outside,” it said at the time.

GN Singh, India’s drug controller-general, promised in May to set up testing labs at ports to ensure exports meet global quality standards.— AFP