It is easily among the biggest tragedies in living memory, domestic drugmakers say. Sixty-six young lives lost in Gambia, possibly from the consumption of four “contaminated” paediatric cough syrups from India.
The deaths in itself are staggering, and require quick and efficient action against who ever is responsible. But the medical product alert on these syrups being sounded by the World Health Organization Chief is a blaring red warning siren that the pharmaceutical industry and drug regulators will do well to heed.
The possibility of contamination tells a tale of a larger concern on sourcing and manufacturing across products — a supply chain that makes the difference between life and death, especially when it comes to medicines. In this case, early investigations point to the presence of the toxic DEG (di-ethylene glycol). And this could be from a possible adulteration of the solvent that is usually used (propylene glycol) with a less expensive solvent (DEG), explain industry-insiders.
Even while information gaps remain and are being investigated, a singular thought coming through from industry and regulatory officials is that it is obligatory on India (or for that matter any exporting country) to ensure that quality medicines leave their shores. Telling another country to ensure that medicines sent to them are kosher, is no more than shifting accountability, points out an industry veteran.
The ethical obligation is a good enough reason for drug companies of all hues and sizes to ensure safe medicines are distributed inside and outside the country.
For that, the pharma industry will need to expand present efforts of drilling quality into their work-culture beyond the top players of the 3,000-companies strong industry. There are an estimated 10,000-odd manufacturing facilities as well, and the message needs to percolate through, from the owners and management across companies to the rank and file.
The WHO and other UN agencies procure medicines, syringes, and vaccines from Indian companies. And in all fairness, Indian companies have played their part in supplying quality products (from HIV drugs to vaccines), and at economical prices. But one transgression is all it takes to put all that good legacy of the “pharmacy to the world” at risk. Africa accounts for close to 16 per cent of India’s $24.6 billion exports. And the developed markets account for 55 per cent of exports, according to the Pharmaceuticals Export Promotion Council of India (Pharmexcil).
In the past, there have been incidents when products claiming to be from India were in fact fakes that went from another region to Nigeria.
This was followed by reputed industry players adopting anti-counterfeiting technologies. Indian authorities further mandated companies to adopt track and trace technologies to prevent supply mishaps.
The world of medicine supply is cloaked in its own intrigue and politics, which is why it’s important for the Indian health authorities to step up and come out with a transparent report on the incident.
The first alert on the Gambia incident was given to the Indian drug regulator on September 29. There is no time to lose. Between the business of dealing in medicines and the ethics of it, Indian authorities need to act quickly and decisively.