A year on, the long shadow of the cough syrup controversy lingers

It’s been a year since the World Health Organization alerted India on four locally-made cough syrups being potentially linked to the death of over 60 children in Gambia.

There have since been reports from other regions including Uzbekistan, and involving other products—eye drops, for instance, red-flagged by the US Food and Drug Administration (FDA). Recent reports from Gambia point to legal options being explored against the Indian manufacturer and in Uzbekistan, foreign media reports allege bribery to allow local distribution.

But for the industry that supplies medicines and medical products across the world, reports on “contaminated” products and questions on quality are troubling issues that need to be investigated and dealt with firmly to build greater confidence in products that go out with an India-tag. Till then, industry representatives will have to field questions on these incidents that risk sullying the reputation of the larger industry, says an exporter not to be named.

The industry treads with fear, nay caution, he says, urging regulators to show zero tolerance to faulty products—in the interest of local and overseas consumers. Pharmaceuticals are more than an export commodity—they are medicines and impact lives, says another exporter, also calling for strong and swift action.

In the last several months, Indian health authorities have initiated measures to address the situation—including calling for testing of cough syrups before export; creation of a digital footprint across the supply chain/vendors of raw materials etc, cracking down on manufacturing facilities that are not upto scratch and upgrading GMP (good manufacturing practices) norms.

But regulatory experts say, there’s still a need to connect the dots across geographies on the cough syrup incidents—through investigations and root-cause analysis—sto fix accountability. A logical conclusion still eludes the cough syrup incidents, instead the waters have only been muddied further with allegations and counters, they point out.

Last September, the WHO had alerted Indian authorities on cough syrups from India being possibly linked to deaths in Gambia. The “contaminated” paediatric products contained the toxic elements diethylene glycol (DEG) or ethylene glycol. Initially, State authorities acted against the company named in the incident. Later, though, a strongly-worded letter to the WHO from the then drug controller general of India, said the control samples were not contaminated. Pointing to another oddity on manufacturing, an industry representative points out, the two companies in the dock were reportedly GMP compliant companies.

Maharashtra FDA’s former Commissioner, Mahesh Zagade, says that it’s important for the regulatory authority to be consistent in its action. If there is a complaint, it needs to be investigated and acted upon, he says, laying the responsibility at the doorstep of the regulatory authorities.

There is a “double fool-proof” regulatory system in place that requires batches to be tested, the purity of raw materials to be checked and documented before the product is made, and similarly with the finished product, he says. Every medicine has its challenges with impurities, and while people react to reports of death, there are adverse events too that need to documented, he points out. “Well designed laws are in place,” says Zagade, but it comes down to their implementation across States.

‘Hand-hold’

Countries like Nigeria have successfully instituted pre-shipment testing of Indian products, and other regions too are exploring similar action, said an exporter. Companies that have a reputation to protect are cautious, but there are those that may need regulatory hand-holding and financial support to navigate this space, and the authorities should not merely throw the rule-book at them, he added.

In fact, Pharmexcil (Pharmaceuticals Export Promotion Council of India) has urged the Centre to allow more accredited laboratories to test products, said Director General Ravi Udaya Bhaskar on measures to ensure the quality of products. The agency has also supported requests from large drugmakers seeking exemptions from pre-shipment testing, saying they would take responsibility for their product tests/documentation.

A common thread runs across industry, regulatory experts and civil society, when it comes to responding to incidents like the cough-syrup-linked deaths. Scientific studies need to be done to identify the problem (if the raw material was contaminated), says KM Gopakumar with Third World Network. “The air should be cleared, otherwise it gives rise to speculation and propaganda that undermines affordable medicines,” he says, voicing an increasing call for action and accountability.