Updated: Oct 21, 2022
The lapse of quality control in India is unacceptable if the claim to be the pharmacy of the world is to be sustained. Renu Modi writes: The World Health Organization (WHO) issued an alert about the tragic death of 70 children in Gambia because of acute renal failure after they consumed four cough syrups that contained an unacceptable level of toxic diethylene glycol (DEG) and ethylene glycol as contaminants. These products were manufactured by an Indian company based in Haryana. According to the WHO, the company failed to guarantee the safety of these chemicals used as solvents. The Haryana health minister inspected the site and reported 12 violations of good practices and the fl outing of rules on testing and manufacturing activities. The production of drugs by the defaulter company has been stopped. For decades, India has been exporting affordable and quality medicines, including generics for treating communicable and noncommunicable diseases on the continent. Indian pharmaceutical exports stood at $24.4 billion in 2020–21, and a third of these were to Africa. During the 1990s, when the continent faced the scourge of AIDS, several Indian companies offered the generic triple therapy anti-retroviral drug (ARV) cocktails at low prices, which proved to be a lifeline for those below the safety net. The supply of reasonably priced, quality medicines has been a laudable contribution by India, which has forced multinationals operating in Africa to reduce the costs of their medicines. While “localisation” and “make in Africa” have been buzz words—more so post the pandemic—most countries on the continent import everything, right from packaging material, raw materials, excipients and active pharmaceutical ingredients (APIs). Ironically, it is cheaper to import than manufacture locally. There are several structural constraints as well to manufacturing locally. These include the dearth of an enabling ecosystem for manufacturing due to a lack of skilled workforce, water and transport infrastructure access, and investments in manufacturing and technical know-how. Gambia is the smallest country on the continent and has a population of 2.5 million people. The small market size further acts as a disincentive to external investments. Additionally, there are immense challenges to quality assurance due to a shortage of competent technical staff who can operate quality assurance equipment, cold storage facilities, standard operating procedures and designated warehouses to store damaged or expired products. The fatalities of innocent children bring to light the capriciousness of some companies and can seriously damage the formidable reputation built by the pharmaceutical sector through years of sustained efforts. The lapse of quality controls in India, the “pharmacy of the world,” is unacceptable, and more so because India has the required technical capabilities. Indian pharma companies are also committed to following internationally accepted standards, including the WHO’s standards (good manufacturing practices [GMP], good laboratory practices [GLP], good distribution practices [GDP], good storage practices [GSP]), among others. In this case, the company under the scanner did not conduct the mandatory quality-assurance checks. According to news reports, the company used raw materials that had an expiry date much earlier than the shelf life of the cough syrups that were exported. They also used cheap industrial-grade raw materials, which are banned in medicinal products as per Indian pharmacopoeia standards. It has come to light that the company has been a habitual offender with a track record of selling toxic products in India and externally. The company has fl outed safety standards on earlier occasions as well. Such situations signify the laxity in manufacturing facility inspection and poor data sharing between the state and central regulatory authorities. Can the defaulter company be absolved of their responsibility because these toxic products were sold externally and not in India? Or, because the national drug regulatory authorities (NDRA) in Gambia did not do due diligence and failed to detect the contaminated products? As per a WHO study, most NDRAs in Africa have limited capacity to control the quality of their imports. South African Health Products Regulatory Authority is known to have the most robust regulatory mechanism. Other African countries, such as Ethiopia, Kenya and Ghana, have established policies, legislation and guidelines and enforcement mechanisms, which are still evolving. The tragedy in Gambia is a harsh reminder that products that are not good enough for the Indian markets cannot be exported to other countries. The primary concern is whether these medicines have reached other countries through informal networks. This heartbreaking episode is an urgent reminder that the Indian pharma sector needs to plug in the loopholes in its multilevel fragmented regulatory mechanism, divided between the state and the central regulatory authorities, and shore up its ethical trade practices and accountability mechanisms. While the union health ministry set up an enquiry committee, and the defaulter company’s membership has been terminated by Pharmexcil—the apex export body for pharmaceutical exports—we must learn from this human tragedy and eliminate unscrupulous practices to ringfence the pharma sector—the most signifi cant source of soft power for India and foreign-exchange earner for the country.
Renu Modi (email@example.com) teaches at the Centre for African Studies, University of Mumbai, and was recently a KEYNOTE SPEAKER at the JSAS annual conference.