Lax drug regulation
Source: By Dinesh C Sharma: Deccan Herald
On the last day of the winter session of the Parliament on December 18, an important piece of legislative work was tabled in both the houses but it failed to grab any attention as all eyes were set on the contentious Lokpal Bill.
It was the report of the parliamentary standing committee on health; on a subject which has been hanging fire for the past four decades -- drug regulation. The report reviews the Drugs and Cosmetics (Amendment) Bill, 2013, making a series of recommendations.
Whenever we hear about controversies surrounding illegal human clinical trials or use of banned drugs in India, there is talk of tightening rules and expert committees are set up. Things don’t move beyond this. The Indian government has been struggling to set right its drug regulatory process – or at least has been pretending to do so -- since 1975. Such efforts, however, end up with turf wars among ministries of health, chemicals, pharmaceuticals and industry. This has been the case since the first such attempt made in the form of Committee on Drugs and Pharmaceutical Industry – popularly known as the Haathi committee – in 1975.
If the government had any inclination to reform the system, it would have set up a National Drug Authority (NDA) to overhaul rules governing licensing and manufacturing of drugs, as recommended by the Haathi panel. Instead, the report was duly consigned to dustbin. Somehow the idea of NDA keeps resurrecting in some form or other. A policy document issued in 1986 recommended setting up a similar body called National Drug and Pharmaceutical Authority with a permanent secretariat, but no such body ever saw light of the day.
Nearly a decade later, the government woke up from its slumber and the drug policy of 1994 revived the idea of an independent NDA, which it said should act as “an efficient mechanism for ensuring quality control and rational use of medicines”. Another decade passed without any action, and in 2003 the Mashelkar committee for review of drugs regulatory system was set up. It did not suggest any new body but wanted the existing Central Drugs Standard Control Organisation (CDSCO) to be converted into “an empowered, independent and professionally managed” agency with “the status of Central Drug Administration (CDA)”.
Exactly a decade after the Mashelkar committee report, the government in 2013 has proposed a Central Drugs Authority (CDA) as the regulator reporting to the ministry of health and having an array of ex-officio secretaries of various ministries as its members. The parliamentary panel, in its latest report, has shot down this idea and wants it replaced by an independent Central Drug Administration. It is unlikely that Parliament and the government will have time to consider these recommendations, make suitable changes in the Bill and pass it before the expiry of the present government’s term.
Fundamental flaws
As committees after committees ponder, drug regulation continues to limp and be governed by the Drugs and Cosmetics Act enacted in 1940 when most modern drugs and medical procedures were yet to be discovered. Of course, the government has kept amending rules under this Act – mostly under directives from the parliament and judiciary or pressure from industry. Rules relating to human clinical trials have been amended several times, yet we are far from a situation where patient safety and interests are fully safeguarded, and where violators are punished. The scandal involving approval of Fixed Dose Combination (FDC) drugs based on questionable grounds –exposed by parliamentary investigations – provided evidence of collusion between regulator, industry and medical experts.
Rules relating to cosmetics are lax, as analysis of leading brands of cosmetics by the Centre for Science and Environment has show this past week. Rules governing medical devices are fuzzy, while food supplements and so-called nutraceuticals are not yet under any regulatory scanner. Drugs based on Ayurveda, Unani and homeopathy systems are not regulated at all.
Besides the lack of autonomy and professionalism, there are fundamental flaws in India’s drug regulatory system, as pointed out in an analysis of the Drugs and Cosmetics (Amendment) Bill 2013 published in medical journal The Lancet last week. The journal has pointed out that the new drug authority proposed under the 2013 Bill does not require the regulator to be satisfied of the effectiveness of new drugs and compounds. It is critical to distinguish between effectiveness and efficacy of drugs.
Typically clinical trials which are used as the basis for getting marketing approval of drugs show ‘efficacy’ rather than ‘effectiveness’. Therefore, The Lancet analysis has argued, marketing approvals should be given for a short period of time. Confirmed approval should come only after there is evidence of effectiveness of the drug in wider use. This is must to ensure that approved drugs are not only safe and effective but also are “medically needed and therapeutically justified”.
At present, regulation of drugs, pharmaceuticals, medical devices as well as clinical trials in India is ridden with adhocism, corruption, conflict of interest and lack of professionalism. There is too much discretion in the hands of drug controllers and there is complete lack of transparency and accountability in the way discretionary powers are exercised. Any piecemeal approach to merely reform the existing structures of CDSCO, Drug Controller General of India (DCGI) and state drug controllers would be futile.
These rusted and compromised structures need to be fully replaced with a new regulatory system which is modern, independent and professional. Patient safety and rights – and not industry profits – should be the focus of drug regulation. The regulator should be independent of both the ministry of health and the department of pharmaceuticals. Drug regulation is too serious and technical matter to be left to whims of a bunch of generalist bureaucrats.
On the last day of the winter session of the Parliament on December 18, an important piece of legislative work was tabled in both the houses but it failed to grab any attention as all eyes were set on the contentious Lokpal Bill.
It was the report of the parliamentary standing committee on health; on a subject which has been hanging fire for the past four decades -- drug regulation. The report reviews the Drugs and Cosmetics (Amendment) Bill, 2013, making a series of recommendations.
Whenever we hear about controversies surrounding illegal human clinical trials or use of banned drugs in India, there is talk of tightening rules and expert committees are set up. Things don’t move beyond this. The Indian government has been struggling to set right its drug regulatory process – or at least has been pretending to do so -- since 1975. Such efforts, however, end up with turf wars among ministries of health, chemicals, pharmaceuticals and industry. This has been the case since the first such attempt made in the form of Committee on Drugs and Pharmaceutical Industry – popularly known as the Haathi committee – in 1975.
If the government had any inclination to reform the system, it would have set up a National Drug Authority (NDA) to overhaul rules governing licensing and manufacturing of drugs, as recommended by the Haathi panel. Instead, the report was duly consigned to dustbin. Somehow the idea of NDA keeps resurrecting in some form or other. A policy document issued in 1986 recommended setting up a similar body called National Drug and Pharmaceutical Authority with a permanent secretariat, but no such body ever saw light of the day.
Nearly a decade later, the government woke up from its slumber and the drug policy of 1994 revived the idea of an independent NDA, which it said should act as “an efficient mechanism for ensuring quality control and rational use of medicines”. Another decade passed without any action, and in 2003 the Mashelkar committee for review of drugs regulatory system was set up. It did not suggest any new body but wanted the existing Central Drugs Standard Control Organisation (CDSCO) to be converted into “an empowered, independent and professionally managed” agency with “the status of Central Drug Administration (CDA)”.
Exactly a decade after the Mashelkar committee report, the government in 2013 has proposed a Central Drugs Authority (CDA) as the regulator reporting to the ministry of health and having an array of ex-officio secretaries of various ministries as its members. The parliamentary panel, in its latest report, has shot down this idea and wants it replaced by an independent Central Drug Administration. It is unlikely that Parliament and the government will have time to consider these recommendations, make suitable changes in the Bill and pass it before the expiry of the present government’s term.
Fundamental flaws
As committees after committees ponder, drug regulation continues to limp and be governed by the Drugs and Cosmetics Act enacted in 1940 when most modern drugs and medical procedures were yet to be discovered. Of course, the government has kept amending rules under this Act – mostly under directives from the parliament and judiciary or pressure from industry. Rules relating to human clinical trials have been amended several times, yet we are far from a situation where patient safety and interests are fully safeguarded, and where violators are punished. The scandal involving approval of Fixed Dose Combination (FDC) drugs based on questionable grounds –exposed by parliamentary investigations – provided evidence of collusion between regulator, industry and medical experts.
Rules relating to cosmetics are lax, as analysis of leading brands of cosmetics by the Centre for Science and Environment has show this past week. Rules governing medical devices are fuzzy, while food supplements and so-called nutraceuticals are not yet under any regulatory scanner. Drugs based on Ayurveda, Unani and homeopathy systems are not regulated at all.
Besides the lack of autonomy and professionalism, there are fundamental flaws in India’s drug regulatory system, as pointed out in an analysis of the Drugs and Cosmetics (Amendment) Bill 2013 published in medical journal The Lancet last week. The journal has pointed out that the new drug authority proposed under the 2013 Bill does not require the regulator to be satisfied of the effectiveness of new drugs and compounds. It is critical to distinguish between effectiveness and efficacy of drugs.
Typically clinical trials which are used as the basis for getting marketing approval of drugs show ‘efficacy’ rather than ‘effectiveness’. Therefore, The Lancet analysis has argued, marketing approvals should be given for a short period of time. Confirmed approval should come only after there is evidence of effectiveness of the drug in wider use. This is must to ensure that approved drugs are not only safe and effective but also are “medically needed and therapeutically justified”.
At present, regulation of drugs, pharmaceuticals, medical devices as well as clinical trials in India is ridden with adhocism, corruption, conflict of interest and lack of professionalism. There is too much discretion in the hands of drug controllers and there is complete lack of transparency and accountability in the way discretionary powers are exercised. Any piecemeal approach to merely reform the existing structures of CDSCO, Drug Controller General of India (DCGI) and state drug controllers would be futile.
These rusted and compromised structures need to be fully replaced with a new regulatory system which is modern, independent and professional. Patient safety and rights – and not industry profits – should be the focus of drug regulation. The regulator should be independent of both the ministry of health and the department of pharmaceuticals. Drug regulation is too serious and technical matter to be left to whims of a bunch of generalist bureaucrats.
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