Drugs which are banned in developed countries are approved in India without clinical trials
Under the garb of serving public interest, the Union health ministry, on an average, is approving one drug a month to be sold in the country without any scientific evidence establishing its safety. The observation was made by the Parliamentary Standing Committee on Health and Family Welfare in its report tabled in the Parliament on May 8, 2012.
The report on the functioning of the Central Drugs Standard Control Organisation (CDSCO), the department under the Union health ministry that regulates the marketing of drugs in the country, says that the Drug Controller General of India (DGCI) had approved 2,167 drugs between January 2001 and November 30, 2010. A total of 31 new drugs were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients. After scrutinising the reports on each drug, the commission notes that there is “no scientific evidence” to show that these drugs are really effective and safe for Indian patients. Neither could the ministry provide surveillance data on the drugs approved without trials.
For any new drug to be sold in India, its safety and efficacy has to be established by conducting phase three clinical trials on patients. Same rules apply for selling combination drugs. But a clause under the Drugs and Cosmetics Act says that the DGCI can approve a drug without clinical trials in “public interest”.
The committee, headed by Brajesh Pathak, member of Parliament, blames the ministry for misusing the clause and approving drugs that serve no public interest. “No explanation is available as to what constitutes public interest. None of the 33 drugs approved fall under the category of emergency treatments. Besides many drugs were launched in overseas markets years ago with ample time to conduct trials in India,” notes the report.
Some of the drugs cleared without trials are:
Daptomycin (Cubicin) produced by Novartis (for skin and soft tissue infections) was launched overseas on September 13, 2003 and approved in India on January 28, 2008 after a gap of over four years;
Pemetrexed (Alimta) of Eli Lilly (chemotherapy drug) was approved on February 5, 2004 in the United States. After a gap of more than two years, it was approved by DCGI on June 28, 2006 without trials
Raltegravir (Isentress) of Merck Sharp and Dohme (for HIV infection) was launched abroad on October 12, 2007 and approved in India on January 27, 2010 without conducting clinical trials.
“It is the implementation of the law that is at fault,” says Amit Sengupta, of People’s Health Movement, a group of non-profits working on health. “Corruption is rampant in the drug control department of the government. There is a nexus between the drug companies and the drug departments. Drugs have been approved in the past without clinical trials and no action has been taken on it. This is not the first time the drug control department has been accused of corruption. Unfortunately, there is no mechanism to bring these people to book,” he adds.
Doctors in the dock
Noticing huge manpower crunch in the drugs control department, the committee notes that there is no permanent panel of medical experts attached to CDSCO. Experts from institutes like Postgraduate Institute of Medical Education and Research, Chandigarh, All India Institute of Medical Sciences (AIIMS), Indian Council of Medical Research (ICMR), King Edward Memorial Hospital of Mumbai and Christian Medical College of Vellore as well as individual medical practitioners are contacted for their expert opinion on the new drugs before the drugs are marketed.
After reviewing the opinions of experts on various drugs, the commission found that the majority of the opinions were not based on scientific data. Also, the opinion paper submitted by one doctor was identical to the submissions of another doctor. “Many opinions were actually written by the invisible hands of drug manufacturers and experts merely obliged by putting their signature,” notes the report.
Drugs which were cleared on the basis of such expert opinion are:
Clevudine by Pharmasset Inc. (for chronic hepatitis b infection);
Sertindole by Serdolect of Lundbeck (Schizophrenia drug);
Doxofylline (used to treat asthma);
Rivaroxaban by Bayer (used for preventing clotting);
Ademetionine (used for neurological disorders);
Pirfenidone by Cipla (for lung diseases);
Dapoxetine (for treatment of premature ejaculation);
Nimesulide injection (anti-inflammatory)
The committee notes that the experts involved have violated the Code of Ethics of the Medical Council of India and MCI should take action against them.
The public health activists, however, are not surprised by the findings of the commission. “We have raised these issues with the MCI; several letters have been written to the health minister and the officials concerned, but these complaints were ignored. We finally asked for the minutes of the meetings of the past one year of the ethics committee under the MCI and found that the issue of clinical trials and approving new drugs was not raised even once in their meetings,” says Anand Rai, health activist from Indore, Madhya Pradesh.
Rai adds that the malpractices at the CDSCO have put public interest at stake and a separate commission should be formed to take action on the findings of the report. “The health minister should resign,” he says.
The Drug Controller General of India G N Singh could not be contacted for his comments.