DrugsThe clinical trials of 162 new chemical entities will continue to be on the hold as Supreme Court on Monday said that the technical committee and the apex committee will examine the benefits of these trials for the country. A bench of Justice R.M.Lodha and Justice Shiva Kirti Singh said that 157 new chemical entities which were cleared for clinical trials till December 31, 2012, would be reviewed by the two apex committees.

‘It is not possible to pass any order in respect of the clinical trials of 157 new chemical entities. We are not passing any order. You will tell us the findings of the apex committee and the technical committee,’ the bench told Additional Solicitor General Siddarth Luthra who had appeared for the government.

Reviewing the clearance for clinical trials of 157 new chemical entities by the National Drugs Advisory Committee and the Drug Controller General of India, the court said the technical and apex committees would look into the assessment of risk vs benefits to the patients, innovation vis-a-vis existing therapeutic options and the unmet medical needs of the country.

The court said the apex committee will examine whether the new chemical entities that are being put to clinical trials are actually required in the country.

In respect of five other new chemical entities for which approval has been granted for the clinical trials in 2013, the court accepted the statement of Luthra which said that appropriate directions will be issued with regard to audio visual recording of the consent of the subject participating in such trials.

The court directed that such documents in the wake of the video recording shall be preserved and the principle of confidentiality and transparency would be observed. In the course of the arguments, senior counsel Colin Gonsales informed the court of the Aug 30 report of the Parliamentary Standing Committee which had made damning findings about the working of the office of the Drug Controller General.

He said that the Standing Committee has said that it were the invisible hands that were writing the report and were being approved by the office of the DCGI. At this, Justice Lodha said: ‘We should have a balanced approach. These are the issues where you can’t have one sides approach. We should allay their (of the petitioner) apprehensions reasonably. The clinical trials should help us.’ Gonsalves said that the ministry of health and family welfare was using a committee headed by Ranjir Roy Chaudhury to derail the regime set up by the Standing Committee. He sought the disclosure of the 162 new chemical entities.

Assailing the position of Chaudhury, Gonsalves said that he wanted to make India a hub of clinical trials even in the phase I and Phase II in which healthy people are subjected to the testing of the new chemical entities.

The next hearing of the matter will take place Dec 16.

The story so far…

On September 30 the Supreme Court passed a ruling which said that no new clinical trials should be allowed for new drugs till a mechanism is put in place to monitor them. The Centre also assured the apex court that it will not allow clinical trials for 162 drugs permitted by it earlier.

The bench also asked the Centre to consider suggestions of various stakeholders in putting in place the mechanism to avoid any serious and adverse impact. The court had earlier said that clinical trials of untested drugs on humans require certain mandatory standards to be followed and had also directed the government to put in place a mechanism to monitor them.

Centre failed to stop the ‘rackets’ which caused deaths

The SC had directed the Centre to convene a meeting of Chief Secretaries or Health Secretaries of all the states to frame a law for regulation of clinical trials of drugs by multi-national pharma companies. Earlier, the apex court had said that uncontrolled clinical trial of drugs by multinational companies was creating ‘havoc’ and slammed the Centre for failing to stop the ‘rackets’ which caused deaths.

Observing that the government has slipped into ‘deep slumber’ in addressing this ‘menace’, the court had ordered that all drug trials will be done under the supervision of the Union Health Secretary.

In an affidavit, the Centre had admitted that 2,644 people died during clinical trials of 475 new drugs from 2005 to 2012. ‘Serious adverse events of deaths during the clinical trials during the said period were 2,644, out of which 80 deaths were found to be attributable to the clinical trials,’ the affidavit had said.

‘Around 11,972 serious adverse events (excluding death) were reported during the period from January 1, 2005 to June 30, 2012, out of which 506 events were found to be related to clinical trials,’ the Centre had said. The court was hearing a PIL, filed by NGO Swasthya Adhikar Manch, alleging large scale clinical drug trials across the country by various pharmaceutical firms using Indian citizens as guinea pigs in those tests. The NGO had alleged that the clinical trials by several pharmaceutical companies were going on indiscriminately in various states. 

New guidelines already drafted 

Earlier, the National Human Rights Commission had also written to the Union Health Ministryto seek their view on guidelines prepared by the NHRC on clinical trials. The NHRC’s expert committee also suggested that standard operating procedures (SOPs) should be written down and followed in all clinical trials based on prevailing good clinical practices (GCP) guidelines for biomedical research on human participants and there should be an effective mechanism for monitoring the implementation of the SOPs.

Participants of the clinical trial should be provided medical care from the time of enrolment in the study, for the duration of study and for the period of follow up as specified in the protocol, the guidelines on clinical trials suggested.  The Commission in a statement said that it has also decided to file an affidavit before the Supreme Court and intervene in the pending matter related to clinical drug trials.

The PATH of darkness

The can of worms was opened when reports revealed that phase IV clinical trial for an HPV vaccine was carried out on unsuspecting tribal girls. ‘There were also reports of deaths of seven girls in the same trial which led to suspension of the whole process a year later (April 7, 2010) and a committee was constituted to enquire into the alleged irregularities,’ said a senior health ministry official. There were also indications that on several counts where the US-based called PATH NGO which was conducting the aforementioned trials behaved irregularly. In some cases the consent forms actually read ‘You will not be charged for your daughter to receive the vaccine’.

‘However, the NGO conducting the trials was let off with a warning letter only asking them to be careful in future,’ the official said. (Read: India’s drug control body’s hall of shame)

India – the testing ground for Big Pharma?

Various sources also suggested that major global pharmaceutical companies were using India as their testing ground for different drugs for cancer and antibiotics.  The SC had also pointed out the government’s failure to halt unethical clinical trials by multinational drug companies on Indian patients who were used as ‘guinea pigs’. Referring to a May 2012 report of the Parliamentary Standing Committee on health and family welfare, Judges R.M. Lodha and Anil R. Dave said ‘it really pains us that illiterate people and children of India are being used as guinea pigs by the multinational drug companies’. The health ministry data shows the number of trials being approved has also gone down: from 529 permissions granted in 2010 to 283 in 2011 and 253 in 2012. What is even more shocking is the fact that the vaccines were provided by Merck and GlaxoSmithKline and was in collaboration with the Indian Council of Medical Research (ICMR) – the country’s apex body for the formulation of biomedical research and was reportedly funded by the Bill and Melinda Gates Foundation!

A silent spectatorial regulatory body

A parliamentary panel report took note of these violations around a month ago and even lashed out at the Drug Controller General of India (DCGI), the head of the CDSCO who it claimed ‘remained a silent spectator even as its own regulations were being violated’ while there were also irregularities in the approval of the clinical trials, the import licenses and even the marketing approvals. While the issue was reported in 2010, the new report points to a horrendous amount of irregularities. It’s almost as if than rather than acting as a regulatory body, the ICMR was acting actively to promote the interest of the HPV vaccine manufacturers.

The report also pointed out that the cases of serious adverse events (SAE) weren’t monitored during the studies. Shockingly, the vaccines were given to children irrespective of age. The panel has demanded further tightening of regulations and stricter action against the wrongdoers and strict monitoring of SAEs. 

The Drugs and Cosmetics (Amendment) Bill 2013 – the beginning of a new dawn?

About two months ago, the Drugs and Cosmetics (Amendment) Bill 2013 was introduced in Rajya Sabha by Union Health Minister Ghulam Nabi Azad with an aim of strengthening the drug regulatory system in India and provides the scope for setting up of a Central Drugs Authority as an overarching body for regulation of drugs and cosmetics. It looked to establish a 19-member overarching body to regulate the drugs and cosmetics sector that will be headed by the Secretary, Health and Family Welfare. The amended bill is a comprehensive legislation to cover various aspects of drugs and cosmetics including regulation of clinical trials and the medical equipment sector, having separate chapters on clinical trials and medical devices. The bill that seeks to replace the Drugs and Cosmetics Act, 1940, was introduced in the Rajya Sabha by Health and Family Welfare Minister Ghulam Nabi Azad said who also withdrew the Drugs and Cosmetics (Amendment) Bill, 2007. (Is the new Drugs and Cosmetics Act 2013 going to change things?)

With inputs from agencies