Sterilisation deaths spotlight India drug safety record

Bejon Misra, founder of the Partnership for Safe Medicines India, said it only took “one unsafe medicine to threaten patient safety".

An Indian patient, recovering after complications following a sterilisation operation, rests in a special ward in CIMS Hospital at Bilaspur.- AFP

New Delhi: 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 over its troubled safety record.

India exports $15 billion in over-the-counter and generic prescription drugs annually and is the second-largest supplier of drugs to the United States after Canada, earning it the title of “pharmacy to the world”.

But some of its biggest pharmaceutical companies such as Sun Pharma, Ranbaxy and Wockhardt have faced a string of US import bans over quality concerns.

The US Food and Drug Administration (FDA) 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 the agency’s investigators determined they were adulterated.

While it remains unclear exactly what caused the deaths of the 13 women who had undergone surgery at state-run mass sterilisation camps in an impoverished part of central India, a claim by local officials that the antibiotics they took were laced with rat poison has created damaging headlines.

“This will act as a wake-up call” for tougher regulation, D.G. Shah, secretary general of Indian Pharmaceutical Alliance, made up of Indian drug companies, told AFP.

“This reflects on the image of the country,” Shah said, even if the allegedly sub-standard drugs consumed by the women involved only a small manufacturer distributing products locally, he added.

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,” Misra told AFP.

The products of most Indian pharmaceutical companies are of top-notch quality, but critics say lack of regulatory oversight means there are also lapses.

Japanese-owned Indian company Ranbaxy pleaded guilty in 2013 to seven US charges of falsifying clinical data and distributing adulterated antibiotic and other drugs and paid a record $500 million fine.

A 2009 Indian government survey suggested 0.5 percent of drugs sold were substandard, while a 2010 survey of New Delhi pharmacies by non-governmental organisations said the problem was far greater.

It found 12 percent of sampled drugs to be below-standard — though 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 either degraded or 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 Organization — 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 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.

G.N. Singh, India’s Drug Controller General, promised in May to set up testing labs at ports to ensure exports meet global quality standards and follow “a zero tolerance standard for any laxity”.

Misra said regulatory improvements were happening in states such as Tamil Nadu, Maharashtra and Gujarat, where information about whether drug companies’ products made the grade is available online.

“There needs to be ruthless regulatory oversight,” he added.