New Delhi: A report by a parliamentary committee has shown that the drug industry regulator, the Drug Controller General of India (DCGI), has been approving, on average, one new drug a month without conducting mandatory clinical trials or seeking expert medical opinion—findings that expose the deep flaws prevalent in India’s drug approval process.
The committee has asked the health ministry to withdraw the discretionary powers given to the Central Drugs Standard Control Organization (CDSCO), which is headed by DCGI, to grant approvals to drug companies.
The panel found “sufficient evidence” to establish a collusive nexus between medical experts, drug companies and CDSCO officials.
The parliamentary committee looked into the functioning of CDSCO for nearly 18 months and concluded that “most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities of CDSCO”.
“For decades, it has been according primacy to the propagation and facilitation of the drugs industry...,” the report noted.
The committee asked the health ministry to reformulate an “unambiguous mission statement” for CDSCO to emphasize that the organization is solely meant for promoting public health.
The investigators picked 42 drugs available in the Indian market and asked DCGI and the health ministry to furnish approval papers.
The committee found that an “overwhelming” majority of the drugs were being approved on the basis of personal prescriptions and without any scientific evidence. The report concludes that “there is adequate documentary evidence to show that (expert) opinions are written by the invisible hands of drug manufacturers and experts merely oblige by putting their signatures”.
Health secretary P.K. Pradhan was unavailable to comment on the report.
“We will give the health ministry time to take action on officials and pharmaceutical companies involved,” said Sanjay Jaiswal, a member of the parliamentary panel.
Of the 42 drugs scrutinized, 11 were approved without phase-III clinical trials for safety and efficacy being conducted.
According to the committee’s findings, CDSCO approved 33 new drugs (including Cipla Ltd’s colistimethate and pirfenidone, Novartis Pharmaceuticals’s aliskiren and GlaxoSmithKline’s ambrisentan) between January 2008 and October 2010 without conducting clinical trials and 25 drugs without seeking the opinion of medically-qualified experts.
It also found that four drugs (Novartis’s everolimus, UCB Biosciences Inc.’s buclizine, Eli Lilly and Co.’s pemetrixid, and a fixed-dose combination of Theon Pharmaceuticals’s pregabalin) were approved by “non-medical staff of CDSCO” without the mandatory clinical trials or opinion of medical experts and that 13 drugs were actually banned in developed countries.
Spokespersons for Cipla, Eli Lilly and GlaxoSmithKline were unavailable for comment. A Novartis spokesperson said, “The nature of the query is very specific to a product and hence the company will have to gather information in order to be able to respond.”
One of the drugs scrutinized, nimesulide, was banned globally for prescription to children in 2005, the report, which has been reviewed by Mint, said, but CDSCO was loath to act against the drug’s manufacturers despite a media outcry.
The parliamentary committee has forwarded a list of medical experts, who colluded with the drug companies, to the Medical Council of India for action.
Pharmaceutical companies that find mention in the report include Belgium-based UCB, which might lose its manufacturing licence for bucilizine, a drug banned in Belgium, but being sold in India; Novartis, for selling the anti-cancer drug letrozole to address issues related to female fertility in India; and Denmark-based Lundbeck for anti-depressant drug deanxit, which was approved without any paperwork and continues to be banned in most developed countries.
UCB and Lundbeck couldn’t be immediately reached for comment on Tuesday evening.
Terming the report “path-breaking”, Anand Rai, a petitioner in the unethical clinical trial case in the Supreme Court, said civil society organizations would take the recommendations of the parliamentary committee to a logical conclusion in court.
“This is an extraordinary report and we are already consulting our lawyers to file this document in the Supreme Court as supporting material in our case,” he said. “This gives us hope that our demand for a complete restructuring of the system will take place and Indians will not be used as guinea pigs.”
Rai formed the Clinical Trial Victims Welfare Society after 94 allegedly unethical clinical trials were conducted at a government medical college in Indore.