Drugs approval without ethnic testing amounts to criminal negligence
It has been argued that such a rule will facilitate quick entry of new drugs into India. What is not stated is that the proposed rule, if implemented, will save multinational drug corporations (MNCs) millions of dollars in expense, efforts and possibility of rejection of new drug if serious side effects are discoveredUpdated: Aug 04, 2017, 16:22 IST
Nearly all modern medicines sold in India were discovered in the West. Globally when a new drug is approved, it goes through a series of clinical trials – first on animals and then on humans – to determine its efficacy and safety.
It is known that ethnic and genetic variations play an important role in the metabolism of drugs. For instance, carbamazepine, which is used for treating epilepsy can cause severe allergic reactions in about 15% of Tamilian patients. Similarly, risk of life threatening muscle injury is far higher when cholesterol busting agent simvastatin is administered to Indians. There are scores of other examples.
The effect of ethnic variations on the metabolism of drugs can be determined by conducting large scale clinical trials on various races in local communities. Drugs discovered in western countries undergo trials in their local populations, mainly Caucasians. Hence the effect on Indian ethnic groups is not known. Keeping this in view the Drugs and Cosmetic Rules in India require that results of “local clinical trials” must be submitted for approval of new medicines in the country.
The Parliamentary Committee on Health in 2012 had suggested that enrolment in such local trials should be substantially increased and made more broad based to cover all major ethnic groups living in India such as Indo-Aryans, Dravidians, Mongoloids, Tribals etc.
Ignoring the scientifically sound suggestions of the parliamentary panel, the ministry of health and the Central Drugs Standard Control Organisation (CDSCO) has done exactly the opposite.
First, the number of subjects (at least 100 in three-four centres) in the rules was watered down by removal of minimum numbers. Second, more recently a proposal to permit new drugs without local clinical trials has been floated “if the drug was in use for two years or more without any major adverse effect in one of the six specified countries, namely United States, Canada, Britain, Australia, European Union or Japan.”
It has been argued that such a rule will facilitate quick entry of new drugs into India. What is not stated is that the proposed rule, if implemented, will save multinational drug corporations (MNCs) millions of dollars in expense, efforts and possibility of rejection of new drug if serious side effects are discovered. Thus Indian patients will be exposed to hitherto unknown side effects. These foreign will also get an additional bonanza: the post-marketing data from huge population of India free of charge. They will use this to promote their patented products in other countries with similar ethnic populations such as Pakistan, Bangladesh, Sri Lanka, Malaysia, Singapore, Fiji etc.
In 2016, a survey done on approval of new drugs in the US and European Union (EU) found that 19 drugs approved in the former were not approved in EU while a similar number approved in EU failed to get approval in US. Thus there is no uniformity in the approval process. It is irrational to club the US with the EU or for that matter other countries.
It is also wrong to merely rely on EU while ignoring approval by national drug regulators of its 28 member states. A recent analysis has shown that while centralised EU regulator received 100 applications, national regulators of member states got 1,400 applications for permission to market various drugs.
The selection of six specified countries and exclusion of others is arbitrary and without any scientific data. A review of reports on hitherto unknown side effects of drugs from November 2014 to October 2015 submitted to World Health Organization (WHO) shows that the US due to its policy of voluntary reporting with 0.065 side effects per million population is far behind New Zealand with 1.3 reported side effects per million of population thanks to its compulsory reporting.
Yet New Zealand is excluded. Significantly India was at the rock bottom with not even one side effect reported to WHO.
The clause on two-year use abroad “without any major side effect” is also faulty, if not whimsical. Let us look at the gap between permission to market some drugs and discovery of serious side effects: Sibutramine used in the treatment of obesity was banned after remaining in the market for 13 years; anti-bacterial Gatifloxacin was banned after 12 years; pain killer Rofecoxib was withdrawn after five years of use. In all these cases the damage, if any, done to ethnic populations of India remains unknown. Conclusion: The two-year clause is merely an eye wash meant to hoodwink the public.
It appears the pro-industry tilt in the mindset of those who run the health ministry and CDSCO has not changed. In its written submission to the parliamentary committee on health in 2012, the ministry stated that the mission of CDSCO was to “meet the aspirations…. demands, and requirements of the pharmaceutical industry.”
Actually, like other drug regulators the world over, it was established to safeguard the interest of the people at large. The panel took strong exception to the ministry’s submission and advised it to change its priorities and mindset. Unfortunately, this has not happened.
Chandra M. Gulhati is editor, Monthly Index of Medical Specialties
The views expressed are personal