The pharma challenge

India must act urgently on counterfeit drugs

In August, the deputy drug controller at the Central Drugs Standard Control Organisation (CDSCO) in New Delhi was taken into custody by the Central Bureau of Investigation, reportedly for corrupt practices related to drug approvals. Several other such arrests have been made at the regulator associated with the Union government as well as some state governments. The regulator itself has recognised in the past year or so that there are aspects of its functioning that need to be altered, which is partly why it undertook a massive reorganisation and mass transfer of officers earlier this year. Advocates of consumer protection are nevertheless convinced that drug administration in India is flawed and lets too many counterfeit drugs through; smaller drug makers are convinced, contrarily, that the regulators are too likely to claim their products are substandard, in order to maintain the advantage of larger generics producers. 

The effect of the chaos in India’s drug administration is that nobody is quite certain how reliable medicines sold in the market are. Some official figures claim that counterfeit — which includes substandard — drugs in India are less than 2 per cent of those in stores. This is perhaps difficult to believe. In comparable markets such as many African countries, about a third of drugs have been found to be counterfeit. And, indeed, an overwhelming majority of those counterfeit drugs are imported from India. Unsurprisingly, independent studies such as those by the World Health Organization have shown much higher numbers. But such studies have been dismissed by domestic authorities. Under such circumstances, one of the first and most important steps must be a clearer sense of the actual position in terms of counterfeit and substandard drugs. It is easy to see why there is no clarity in this respect — neither the existing regulator nor the drugs companies would be served by a more general understanding of how they are both under-performing in their mandates. However, a broad, transparent and well publicised survey would not just be important on its own merits, but also be extremely useful in terms of mobilising public and political energy for a broader reform of the pharmaceutical supply chain. 

That such political energy and investment are overdue is unquestionable. Consider the consequences of one sort of counterfeiting — the production of drugs that, while correctly labelled, have too little of the active ingredient. When such drugs are antibiotics, the public health consequences in terms of the mutation of micro-organisms are severe. This is another reason why India is a superbug hotspot — antibiotics are prescribed too often, and they are sometimes substandard. The next step must be to isolate each step in the supply chain of drugs, and ensure that sufficient regulatory capacity has been created and assigned to each of these steps. It is also necessary to ask whether the state and central drug controllers are duplicating their capacity and efforts, and whether an overall reorganisation and harmonisation are necessary. In the end, the crucial additional requirement will be investment in regulatory capacity, and clear accountability on the part of the regulators. Too often, problematic individuals shift to the regulator and then back to the line health ministries to protect themselves from accountability. This practice must end. The pharmaceutical regulator must be properly resourced — and staffed independently of the health ministries.