A five-year attempt to equip the country with a modern drug regulatory system which, among other things, addresses the problem of spurious and substandard drugs, has come to naught. A bill introduced in 2007 to comprehensively amend the Drugs and Cosmetics Act of 1940 is unlikely to be passed by the present Lok Sabha whose life is as good as over.
Meanwhile, the US regulator, Food and Drug Administration, is opening an office in India to oversee the quality and manufacturing standards of facilities which export drugs to the US. India has the largest number of US FDA-approved facilities outside the US and is a key exporter of generic drugs to the US, making India’s pharmaceutical industry a major exporter. The combined impact of these two developments is likely to be the abdication of Indian regulation with the only effective implementer of standards being the US authorities. This disregard of sovereign responsibility is shocking.
The result will be that spurious and substandard drugs will continue to be widely sold in the market, affecting the poor the most. These drugs, which have poor brand positioning, are usually sold over the counter (sometimes even prescription drugs are so sold) by pharmacists who push them because their sale earns a hefty trade margin. State-approved drugs with less than the required efficacy, often manufactured by small-scale units, get included in state procurement programmes and form the staple of medicines distributed through the public healthcare system. No wonder that there is a widespread notion that sarkari medicines do not work and if you want medicines which will then go and buy them from private shops.
There is also a deeper scientific problem. The marketing of imported drugs is allowed with little scientific effort to see if they are suitable for the pattern of diseases prevalent in India. Epidemiological data to make this possible hardly exists. Laboratory facilities to carry out effective tests for new medicines or even generic equivalents of old ones are inadequate or non-existent. Recently, the export of Indian biogenerics faced a hurdle because they are supposed to be tested at government laboratories which have been closed down.
The bill sought to create a central drug authority to approve and administer the entire drug regulatory system which will oversee quality and authorise the marketing of new drugs. Currently new drugs and marketing of imports are authorised by the drug controller general of India but state drug authorities authorise the manufacture of drugs which have been around for four years. A drug manufactured in one state can be sold anywhere in the country. The competence of state regulators varies. The setup, for example, in Maharashtra where major pharmaceutical firms are located is quite elaborate but some states have barely any infrastructure. The market is currently flooded with states-approved fixed dose combinations, hundreds of which were banned in 2007 because they were irrational (didn’t make any sense) or even harmful.
The bill ran aground because of opposition from two quarters — the small-scale drug manufacturers and the state drug administrators. The former have made an issue of the costs involved in having to go to Delhi for approvals (they are small, after all) but the real reason is that under the proposed new regime some of the rubbish they sell will not pass muster. They are currently able to do so by pleasing state politicians and the local drug bureaucracy. The latter is officially opposing central regulation on the ground that it will mean loss of state revenue, earned through granting of approvals. But the amount in question is pathetic and can be easily reimbursed. The real reason of course is that the new setup will liquidate their fiefdom.
It is necessary to assert that large pharma companies are not angels. They pamper doctors and private hospitals in a hundred different ways (some downright unethical) to promote sales and the marketing cost naturally gets passed on to patients. Also, the industry fights as one to defeat the aim of keeping the price of essential medicines affordable. The minister does not help matters by seeking to increase the list of medicines under price control as he sees a political dividend for himself in such a stance. A small well-regulated list is ideal but there is no political purchase in that.
The result is big pharma and the price regulator are engaged in an eternal cat and mouse game. It is easy to deliver useful medicines to the poor by vastly enlarging public procurement (there are a lot of poor people who now get no treatment at all) and ensuring both quality and affordability by using the clout of a bulk buyer. Then you do not even need an official price control mechanism.
The amendment legislation owes its origins to a 2003 report by a committee headed by R A Mashelkar, the then director general of the Council of Scientific and Industrial Research. It has been carefully looked at by a parliamentary committee and in its final shape the legislation sought to create a regulator with separate departments to look after things like approval of new drugs, clinical trials, biological and biotechnology products, medical devices and diagnostics, and enforce pharmaco-vigilance, drug safety, and of course quality control.
This is an idea whose time has not just come but which is long overdue. The prevalence of spurious and substandard drugs is a scandal. A regulatory system which effectively rubber-stamps what developed country regulators approve without referring to the large and distinctive genetic pool residing in India is a severe shortcoming. But the country is being held to ransom by some of the least respectable political elements in it.
