India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has barred Haryana-based Maiden Pharmaceuticals Limited from manufacturing medicinal drugs. This was after some of the cold-and-cough syrup it manufactured and exported to The Gambia were marked out by the World Health Organization (WHO) as being linked to the deaths of 66 children there. The concoctions were apparently contaminated with diethylene glycol (DEG) and ethylene glycol that may have caused acute kidney failure. The Indian government has said that a full report from WHO, establishing a clear, causal link is awaited. The Union Health Ministry has constituted a technical committee to advise the Government on its future course of action against the company. The provisions of India’s Drugs and Cosmetics Act, in theory, come down heavily on manufacturers for making adulterated drugs, and on gross violations of prescribed manufacturing practices with imprisonment up to 10 years and fines up to ₹10 lakh. These provisions have been rarely executed despite multiple instances of DEG poisoning in India. In 2020, cough syrup made by the Himachal Pradesh-based Digital Vision killed 13 children in Jammu and Himachal Pradesh; tests showed the presence of DEG. Other inspections by regulatory bodies found that Digital Vision had violated mandatory manufacturing practices that would have ensured drugs were not contaminated with DEG. However, there have been no successful prosecutions, because, as in other instances of adulteration, there is little sustained follow-up to prove to the courts that the products were directly responsible for the deaths.
Given that the deaths in The Gambia have evoked an international outcry — it was highlighted by WHO and India has a reputation as a major global supplier of drugs and vaccines — there will likely be greater scrutiny of India’s actions. Early responses from India’s health establishment have not been encouraging, with assurances that the drugs were only cleared for export to The Gambia and not for sale in India. In any case, this is disingenuous as Maiden Pharmaceuticals, whose products were banned in Kerala earlier and flagged for substandard quality in Tamil Nadu, has marketed the same formulation under different names, and there is no reason to assume that their domestic wares undergo a higher standard of production. In the global market of pharmaceuticals, the pandemic burnished the credentials of India’s vaccine manufacturers as vital to ensuring that the whole world accessed medicine equitably. To rise up the value chain, whether it be vaccines or drugs, India has to work harder at its image of having an impartial and independent regulator that can be trusted internationally as well as domestically.
To read this editorial in Tamil, click here.
To read this editorial in Hindi, click here.
