The drugs controller-general, the central government’s drug regulator, has been trying to deliver through administrative action what could not be legislatively empowered when the last Lok Sabha failed to pass a comprehensive law to overhaul India’s archaic drug regulatory system. One recent step has been to hire more inspectors; another to float the idea of a quality mark for generic medicines (which have no patent cover). While the former is the right thing to do, the latter will fail to deliver and risks creating a false sense of security. An ISI mark on a product is supposed to signify that it adheres to certain manufacturing standards. The reality is that innumerable manufactured items bearing the mark do not really pass a quality test. The certification authority, the Bureau of Indian Standards, has been short-staffed and is ineffective. So there is little reason to expect that an ISI mark on a medicine pack will guarantee quality, especially when spurious drugs flood the market. The issue is more complicated than usual because the knowledge embedded in pharmaceutical products is complex.
The poor quality of even some “genuine” generic products is related to the dual regulatory regime that governs them. A new molecule has to be approved by the central drug regulator, but the subsequent licensing of manufacture (including approval of fixed dose formulations) is in the hands of state drug regulators. There is wide variation in the standards followed by different state regulators; Maharashtra and Gujarat, where the pharmaceutical industry is concentrated, take the job seriously but some other states have neither the ability nor the inclination to do so. That complicates matters for everyone, because something approved in one state can be marketed in the entire country.
The irony is that India exports large quantities of cheap and effective generic products, but within the country the regulatory regime is highly unsatisfactory. Draft legislation that tried to remove this duality by concentrating approval in the hands of the central regulator, failed to go through because states sought to protect their turf and the manufacturers who would have had to change their ways lobbied their respective state governments.
It is not as if the problem cannot be addressed even within the present system and the existing laws, if the authorities set their minds to the task. An initiative to make available useful generic medicines at affordable prices, taken by the district administration of Chittorgarh in Rajasthan, led by Samit Sharma, a former doctor, shows one way of doing this. While the medicines are distributed through a cooperative network, state procurement has been restricted to a list of two dozen reputed manufacturers. Not just the quality of medicines available through the public health system but also their prices can be effectively administered by the state government through its procurement policy. The government, being the biggest buyer, can make manufacturers fall in line on quality and price, thus rendering unnecessary the elaborate price control mechanism that politicians have sought to perpetuate. But this implies will and enthusiasm on the part of a state government.
