The week gone by may have brought upon considerable reputational damage to India’s pharma industry – which is estimated to account for over 20 per cent of global supplies by volume. On October 5, the WHO issued a statement that linked the deaths of 66 children in Gambia to “sub-standard” cough syrups sold by Haryana-based Maiden Pharmaceuticals. The WHO tested the samples to discover “unacceptable amounts” of diethylene glycol (DG) and ethylene glycol (EG), which damage the kidney and liver. The Health Ministry has argued that the connection between the contaminants and the unfortunate deaths in Gambia is yet to be established. This is besides the point.

The issue is how a firm with a dubious track record – its products have been identified by States such as Gujarat, Kerala and Bihar as sub-standard, while Vietnam too has banned its products in 2014 – could have carried on producing and exporting medicines for years. For a country that has chosen to position itself as the pharma factory of the world, this episode will once again turn the global spotlight on its regulatory practices. Meanwhile, it will provide those who want to tarnish all of India’s pharma producers with the same brush with the excuse they are looking for, while helping the West erect unreasonable non-tariff barriers in the name of meeting ‘standards’. Therefore, India should set misgivings at rest by conducting a thorough probe into this case. It should recall Maiden’s products from other markets. The contamination should be traced back to solvent suppliers of propylene glycol to pharma producers; it was in these supplies that DG and EG were found and subsequently not tested for the same by the pharma producers. The solvent supplies should be traced to other pharma buyers and recalled. The Haryana government should act along these lines.

Cough syrup deaths have been reported in India in early 2020, which implies that regulation all-round needs to be better. On paper, the process of a State issuing a licence cannot really be faulted. The producer needs to spell out every detail of the process. The Drugs and Cosmetics Act spells out a 10-year jail term for adulterated drugs and a fine of ₹10 lakh. The trouble is that the drugs inspection authorities do not follow up on whether these processes are observed, or turn a blind eye to violations. They are short staffed as well. This shortcoming should be addressed. In the case in point, it is curious that the earlier lapses of the firm have not been placed in the public domain. In a digitised scenario, coordination between drug control authorities is not a tall ask. At present, exporters are issued an ‘import-export code’ on the basis of a manufacturing licence. It will not be a bad idea to have separate export certification norms for LDCs, which have weak regulatory systems. They must be encouraged to deploy pre-shipment checking systems, as Nigeria has done. India’s pharma practices should be above board -- and seen to be so.