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The image of drug regulation in India has taken a severe beating with first the banning of anti-diabetes drug Pioglitazone and then revoking of the ban in the face of severe protests from a wide cross section of the medical community. This is not the first such setback for the regulator in recent times, but despite the severe criticism of the functioning of the setup so critical for public health, a change in the culture and process of regulation appears distant.
Over the last couple of years the conduct of clinical trials, which also comes under the purview of the Central Drug Standards Organisation (CDSO) headed by the drug controller general of India (DCGI), was the target of wide criticism. In May last year the parliamentary standing committee for the ministry of health, under which drug regulation falls, came out with a scathing report which effectively tore to pieces the state of drug regulation in the country. It is seldom that a parliamentary committee has taken such pains and effort to do so thorough a job.
If this was a severe indictment, what followed was worse. Another report in April this year by the same committee, evaluating the action taken by the government on the original report, must have set a new benchmark in harsh comments. "Most of them (action taken replies) were evasive, inconclusive, dilatory and vague," said the report. But so deeply entrenched is the way in which the drug regulation setup works - or does not - in India, that these remarks also do not appear to have had any immediate impact. The proof of this is in the mess over the ban on Pioglitazone and its subsequent revocation.
For its part the union government has just approved a new Drugs and Cosmetics Bill 2013 which seeks to replace the Drugs and Cosmetics Act of 1940. The bill incorporates some of the major recommendations of the parliamentary committee's report of last year and takes into account critical observations of the Supreme Court in this regard. Its key aim, going by news reports, appears to be to address the duality of central and state control which has been at the root of a lot maladies afflicting drug regulation.
As opposed to state drug controllers currently holding the power to issue manufacturing licences for drugs, the proposed legislation will vest the central government with the authority to allow manufacture of 17 drugs which are life saving, vaccines and DNA product, as manufacturing these requires complex expertise. The bill also proposes a Central Drug Authority as an appellate body, above all central and state drug controllers, with the power to review, suspend or cancel any licence given by central or state authorities. The bill has separate chapters for clinical trials and medical devices. A medical devices technical advisory board will also be set up.
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To understand what is still wrong with drug regulation, it is necessary to recapitulate the Pioglitazone fiasco. Last month the government banned three drugs - painkiller Analgin, antidepressant Deanxit and Pioglitazone. Analgin has been banned across the world for decades and its continued life in India was criticised by the parliamentary committee. Same is the case with Deanxit, which is not allowed to be marketed in even its country of origin, Demark. But it took the regulator a year after the comments by the parliamentary committee to ban Analgin and Deanxit. However, the decision to also ban Pioglitazone, in the same breath so to speak, is what appears odd and the process to do so downright faulty.
Pioglitazone has been effectively banned in two countries (France and Germany) two years ago (2011) and is being sold in the US along with a strong ("black box") warning over risks of inducing urinary bladder cancer. But the ban on the drug had resulted in a volley of protests from doctors and the domestic drug industry association for several reasons. No clinical study has been done among Indian users to ascertain its impact to back this ban. The ministry of health appears to have taken the decision on the basis of a single complaint by a doctor to the prime minister's office, forwarded to the health ministry. Perhaps most importantly, the ban appears to have been hastily undertaken and without due diligence - routing it through the drug technical advisory board, which first met on the issue on July 11 (after the ban had been ordered). On the other hand, the warning by the US Food and Drug Administration (FDA) is seen by experts as a graded response, keeping in mind law suits already filed in the US by patients using the drug. Thus, the drug controller does not act when it should have done long ago (Analgin and Deanxit) and where it does (Pioglitazone), it throws procedure to the winds.
If this is the current reality, the tip of the iceberg, the larger rot underneath has been first carefully outlined by the parliamentary committee and then reiterated in its comments on the action taken by the government. The committee says it is "hugely disappointed" that the government "has chosen to come up with half measures, vague and dilatory responses, to say the least." Where the government agrees with the committee, it is "mere platitude". "The government has done nothing concrete or conclusive… which directly concern the safety, and health of crores of our countrymen."
Against such criticism, the government's response is positively muted and seems aimed at avoiding public debate. The drug controller general of India, G N Singh told BioSpectrum that it is "unfair" to compare the US FDA with the Indian regulator as the former has a staff strength of 14,000, compared to the Indian body which had 327 by the end of 2012. "At present close to 218 countries are importing medicines from India. We cannot say we do not have any regulation at all. But there is a gap that requires to be bridged and the onus is on us to keep our house in order."
In fact, getting more hands on deck seems to be the least of the government's problem. A key recommendation of the parliamentary committee to address the skills shortage - speed up recruitment and engage specialists on contract - has been accepted by the ministry. Another area where action has been taken and in which more can be expected is the centre issuing directives to states under the overriding powers given to it through Section 33P of the Act so that states issue drug manufacturing licences according to the law and only for those entities approved by the drug control authority. A third area is banning the manufacture and sale of drugs banned in well regulated markets (Analgin and Deanxit).
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But there is a huge area where the parliamentary committee is extremely unhappy with what the government has so far done. A key issue is changing the criteria for the post of drug controller. A candidate has to hold a bachelor's degree in Pharma whereas his deputies have to be doctors with postgraduate qualification. The real stumbling block is that the drug controller has to have five years of experience in manufacturing, testing or regulation of drugs. This virtually excludes highly qualified medical doctors. The government's reply is that an earlier attempt to change the qualifications is now before the courts and so it will set up an expert committee to formulate new qualifications in consultation with the law ministry. The committee notes that what was sought to be changed earlier does not address the issues raised in the report. And all that has been done is to decide to set up another committee to go into what an earlier committee has recommended. This "open ended" response is "unpardonable" and the committee asks for an expert committee to be formed to act on its specific recommendations.
A lot of the problems of drug regulation in India can be traced to the inadequate and ad hoc leadership that the setup has had to live with for years. Since 1999, barring a three-year period (2008-11), the country has had to do without a permanent drug controller. The position has become the victim of an insider-outsider tussle in which officials who have worked their way up in the department feel they are being excluded from the top post by the government tweaking the eligibility criteria to make the post into a permanent deputation one. This has caused them to go to court. On the other hand, if India's drug regulation were to get the sort of distinguished leadership that those in developed countries do, and which the parliamentary committee wants, officials working their way up in the department would be automatically excluded. What is worst is that the regulator's office has an extremely poor public image and, going by the grapevine, positions in it command a clearly determined price. Thus the bane of Indian drug regulation seems to be adhocism, poor intellectual leadership and rampant corruption, tell tale signs of it being unearthed by the parliamentary committee.
The culture of work prevailing in the ministry and the office of the drug controller can be gauged from the parliamentary committee recommending that databases be created and linked between the states and the centre so that information like licences issued, cancelled, substandard drugs and prosecution be readily available to all concerned. The government responded by saying that it had taken a data base prepared by Gujarat of 85,000 brands of drug formulations approved by various state licensing authorities and uploaded it on the central website. This list proved to be horrendous. The committee found that there were 65,000 and not 85,000 formulations listed in it. Besides, banned and discontinued drugs appeared on the list and some of the prices stated were ancient and outdated. The committed found the work "unprofessional" and done in "extreme hurry" and recommended that the database be taken off, updated, cleaned up and put back on the website "on a war footing".
The parliamentary committee in its report highlights this and a lot more. Judging by the action taken on the report, the health ministry does not have the will or the ability to respond in the right way. So there is little hope right now of drug regulation in India getting better.
