Patralekha Chatterjee | Drug regulators in India must do better oversight

Is Big Pharma hatching a plot to smear India’s low-cost generic drug makers? Or does the India pharma industry suffer from severe shortcomings in regulatory oversight?

Troubling revelations in recent days calls for deep introspection and course-correction.

Yet another Indian pharmaceutical company is making news, and not for laudable reasons. It has had to stop producing eye drops after the US Centres for Disease Control and Prevention (CDC) said these could be linked to the death of one person and infection in 55 patients across 12 states in the United States. “Patient outcomes include permanent vision loss resulting from cornea infection, hospitalisation, and one death due to systemic infection,” the CDC noted. The incidents took place between May 2022 and January 2023. The eye drop in question was being distributed by US-based EzriCare, which had sourced it from a Tamil Nadu-based company called Global Pharma Healthcare. “CDC is collaborating with the Food and Drug Administration (FDA) and state and local health departments to investigate a multi-state outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa… Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating for whether contamination may have occurred during manufacturing…” the CDC said in its alert. The Indian company has stopped production of all 14 ophthalmic solutions and initiated a recall process of the product. India’s regulatory agencies — teams from the Central Drugs Standard Control Organisation (CDSCO) and Tamil Nadu’s state drug controller — are now investigating if there was any lapse in the manufacturing process in the contract manufacturing plant.

The controversy comes in the wake of two other damning incidents. Last October, Gambia, a small West African nation, had jumped onto national and international headlines following the death of 66 children in that country. The children had consumed cough syrups manufactured by Haryana-based Maiden Pharmac-euticals. An official probe was launched into Maiden Pharmaceuticals, but subsequently, the Indian government told the World Health Organisation that samples of cough syrups taken from the Sonipat-based company and sent for testing were found to comply with the required norms. Gambia, however, had a different take. “The select committee concludes that all the cases of the AKI (Acute Kidney Injury) are linked to the consumption of contaminated medical products imported by Atlantic Pharmaceutical, and manufactured by Maiden Pharmaceuticals Ltd, India,” said Amadou Camara, chairperson of the select committee on health in Uganda. Last December, there was another case — Uzbekistan’s health ministry alleged that cough syrups sourced from another Indian company, Marion Biotech, was behind the deaths of 18 children in Uzbekistan. This followed an internal inquiry by Uzbekistan’s regulatory agencies. The World Health Organisation said laboratory tests showed that Marion Biotech’s cough syrups contained unacceptable levels of diethylene glycol and/or ethylene glycol as contaminants. Marion Biotech has stopped manufacturing its cough syrups.

All three cases throw up serious questions about the effectiveness of India’s drug regulatory framework.

Problems afflicting India’s drug regulatory system is an old story, says Amar Jesani, a well-known public health researcher and editor of Indian Journal of Medical Ethics. In 1986, the Justice Lentin Commission, which probed the deaths of 14 people at Mumbai’s JJ Hospital, came out with a 289-page report that vigorously argued for a strong regulatory authority and implementation of Good Manufacturing Practices. The deaths were caused by DEG, or diethylene glycol, a poisonous substance that should not have been in the medicine.

In 2012, the Parliamentary Standing Committee on Health and Family Welfare came out with scathing observations on the lack of transparency in the regulator’s functioning. The committee recommended that CDSCO come up with a clear set of written guidelines on the selection process of experts with emphasis on expertise in the area of drugs.

But little has changed.

CDSCO and the state regulatory bodies, Mr Jesani points out, continue to be understaffed, under-resourced and often short of the necessary equipment. “Then, there is the issue of contract manufacturing. Big multinational companies as well as Indian generic companies often outsource a lot of their manufacturing on contract to smaller companies. The regulatory system as it exists is not equipped to do regular and thorough quality checks on all these small units,” he adds. Most recently, The Truth Pill: The Myth of Drug Regulation in India, a book authored by public health activist Dinesh S. Thakur and lawyer Prashant Reddy Thikkavarapu, has sought to focus attention on many of these structural issues affecting India’s drug regulatory system.

“How can an organisation which is tasked with quality assurance also be asked to investigate possible violations of quality? Second, investigations are done after giving enough notice. That defeats the purpose of doing a real investigation when a problem is suspected,” says Mr Jesani.

Arguably, medical scandals are not India’s monopoly. They have erupted in several other countries as well. In 2021, a French court found pharma giant Servier guilty of “aggravated fraud” and “involuntary manslaughter” over a diabetes and weight loss pill blamed for hundreds of deaths in one of the country’s worst health scandals.

But it would be dangerous whataboutery to argue that because medical scandals have happened elsewhere, we must close our eyes to the lapses in India. At stake are human lives, within and outside the country, and India’s reputation.

“India must put its house in order”, says Mohan Rao, a public health expert and former professor at Jawaharlal Nehru University’s Centre of Social Medicine and Community Health. In India, Mr Rao points out, “the State has done well when it comes to helping the country emerge as the provider of low-cost generic drugs and vaccines. But it has not done a good job when it comes to the regulatory framework, that is regulation of manufacture and distribution of medicines”.

The regulatory system is under-funded, without the proper equipment, laboratory capacity and human resources.

There is also the issue of pressure on the government to protect small-scale industry. This, as Mr Rao notes, is short-sighted if such protection comes at the cost of quality.

India is justifiably proud of being the world’s pharmacy, its main generic drugs supplier. But it must take the spate of regulatory warnings more seriously. It’s true that multinational pharma companies have a strong business rivalry with India’s low-cost generic drug makers. It is equally true that many Indian pharma companies are cavalier about good manufacturing practices. This is unacceptable. We must recognise that cost-cutting and lapses in safety in manufacturing medicines affect everyone, within and outside India. India’s drug regulators must do a better job to detect non-standard quality drugs before an international alert. They must also show zero-tolerance for deviations from safety norms.