Probing the deaths of 13 women who participated in a government-organised mass sterilisation, Indian authorities last week raided a home in an upscale residential neighbourhood of Chhattisgarh’s state capital, Raipur. Inside the house was Mahawar Pharmaceuticals, a small operation that made the antibiotics the women were given after their procedures.
Authorities suspect fake, diluted or contaminated drugs made by the small-scale enterprise were responsible for killing the women and severely sickening scores of others. Drug samples are undergoing laboratory analysis, and the father-and-son duo who ran the operation have been arrested, although they have insisted that they did nothing wrong.
While final forensic results are still awaited, Indian drug industry executives and health activists say the questions over the medicine distributed at the sterilisation camp highlights the urgent need for tougher regulation of India’s domestic pharmaceutical industry.
In particular, they say, India urgently needs to crack down on thousands of small, fly-by-night drugmakers that typically supply government hospitals, and overhaul its official procurement process to ensure distribution of high-calibre medicine to the poor.
“India has a generic drug industry that makes the best quality medicine and exports it to the rest of the world, but then those medicines are not reaching Indian patients,” says an official with an international health organisation, who asked not to be identified.
“This is one of the biggest public health challenges for the government,” she said. “Procurement is a burning issue in India.”
DG Shah, secretary-general of the Indian Pharmaceutical Association, which represents India’s largest domestic drugmakers, said the tragedy should be “a wake-up call” to the Indian government about the need to strengthen the regulatory system.
“This is what we have been talking about,” he says.
India has a well-developed, globalised generics drug industry, which last year exported $15bn worth of medicine, including to tightly regulated markets such as the US and Europe.
Leading Indian drugmakers, such as Cipla and Sun Pharmaceuticals, have various production and research tie-ups with multinational companies. India has 374 drug manufacturing facilities approved by the US FDA – more than any other country except the US itself – although some companies have had difficulties after running afoul of the rigorous US regulator.
India’s biggest 300 drugmakers, including local subsidiaries of multinationals, supply the lion’s share of medicine used in India’s domestic market. But India also has thousands of tiny drugmakers who make pills in bare-bones premises, with little regard for hygiene or good manufacturing practices.
At one small operation in northern India, a shocked IPA executive watched as seven employees, sitting on the floor, filled gelatin capsules with a powder with their bare hands. “They cut corners on reduction of the active pharmaceutical ingredients, they have poor manufacturing practices and there is risk of contamination,” Mr Shah said.
Yet it is small, little-known enterprises that provide much of the medicine distributed by India’s state and district-level public hospitals, where officials are mandated to buy drugs at the lowest prices, and have no means to assess medicines’ quality. Pills made by small, little-known firms are also sold in the open market in many semi-urban and rural areas.
On paper, India has an elaborate regulatory system. As well as a national drug regulator there are state-level regulators that are supposed to license and monitor drugmakers in their states. But in reality the national regulator is severely understaffed and lacking in modern equipment and resources.
At state level, drug regulators lack the expertise to do their jobs properly, are susceptible to accepting hush money to avoid reporting infractions and lack authority to bring about the immediate shutdown of facilities suspected of churning out substandard medicines.
When regulators cite violations of basic standards it kicks off protracted legal battles, during which companies can usually keep operating unhindered.
Some states have tried to tackle the problem of bad medicine in their public health system. Tamil Nadu, a hub of manufacturing industries, has a state company that centrally procures drugs for all government hospitals and inspects factories before suppliers can participate in government tenders. It also has elaborate post-bid quality-control procedures.
Mr Shah and patient groups say the Chhattisgarh tragedy drives home that other states urgently need to follow suit to strengthen their own regulatory and procurement framework.
“It’s a political issue,” he says. “It won’t change overnight. But over time these units will either have to upgrade or shut down. And procurement processes must be transparent and improved.”
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