Swasthya Adhikar Manch, the NGO fighting against the irregularities in clinical trials, has asked the government to come out with a position paper on how the new chemical entities (NCEs) and new molecule entities (NMEs) are cleared for trials in the country.
The NGO spokesman said they made the demand for the position paper in the affidavit filed in the Supreme Court on Monday, during the hearing of its petition filed in February 2012 alleging that the NCEs and NMEs were benefiting the multinationals at the cost of human lives in India.
The petitioner, which pushed the government to the wall on clinical trials issue and prompted Supreme Court to take a harsh view about the alleged irregularities in trials, also wanted the Union Health Ministry to provide details of 162 approved clinical trials-- name of molecule, indication, name of sponsor, protocol, sites, number of subjects, name of investigators and minutes of New Drug Advisory Committee, apex and technical committee meetings.
“When the Court enquired on how many out of 162 trials had molecules patented outside country and benefited MNCs instead of development of new drug, Additional Solicitor General representing the government could not give the answer,” the NGO said.
The Supreme Court has ordered the re-examining of 157 trials approved by the Drugs Controller General of India (DCGI) during 2012 while pointing out that the trials should benefit the people and not the MNCs. The Bench headed by R M Lodha also directed the government to put in place fool-proof mechanism including audio-video recording before allowing the commencement of five trials, approved by the DCGI this year.
Sanjay Parikh, counsel for the petitioner, also pointed out contradictions in data given in affidavit filed by Ministry on July 26 wherein it was stated that 26 global clinical trials were approved while in current affidavit of October 18, it was stated that only five trials are approved after January, 2013 by the apex and the technical committee.
The petitioner also raised serious concerns about Ranjit Roy Chaudhry expert Committee report on issues like conflict of interest etc. The Ranjit Roy Committee also was not able to explain benefits to India by allowing NCEs/NMEs testing within the country, the counsel said.