Fixing India’s Drug Quality Problem
Official estimates say 4.5% of the drugs sold in India are substandard, others say three times as much. Substandard medicines can delay recovery, lead to drug resistance or even kill. In India, 58.2% of the total health expenditure is borne out-ofpocket, of which 70-77% is on medicines that might or might not work. Blame deficient regulation of manufacturing, sale and distribution of drugs. Regulators number 36. Successive governments have failed to bring coherence through centralisation, even though successive committees right from 1954 have recommended it. The absence of a legal framework is compounded by inadequate human resources, both in numbers and quality, paucity of accurate information and uneven, uncoordinated enforcement by central and state regulators. Even the manner in which quality is assessed is a problem. Enforcement of quality takes place at the market place, when the regulators test drugs that are already available. This is not the global practice where the quality control intervention is at the process level. In 2012, a parliamentary committee went so far as to say that the regulator, the Central Drugs Standard Control Organisation, has given primacy to the propagation and facilitation of the drugs industry, while failing to ensure the interest of the biggest stakeholder, the consumer. The public health crisis at home apart, this has had a negative impact on India’s drug exports as well. India is the largest supplier of generic drugs, accounting for 20% of the global market. The good news is that fixing the quality problem is not an impossible task. The prescriptions are there, gathering dust — it requires building a centralised and effective regulatory mechanism, with the right kind of support. Perhaps the real challenge is to find the political will to take action.