India’s drug regulator colluded with global pharmaceutical companies to expediate medicine approvals without proper testing, according to a parliamentary report published on Wednesday.
The results of a year-long investigation by parliament’s health committee revealed that the Central Drugs Standard Control Organisation, which oversees the trials, licensing and marketing of medicines in India, committed serious regulatory violations that could jeopardise the lives of millions of people.
The report said that many CDSCO officials had been colluding with international manufacturers and medical experts to dodge rules and speed up the approval of drugs.
“There is sufficient evidence on record to conclude that there is [a] collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts,” said the report.
The committee, which reviewed 42 randomly selected medicines approved by CDSCO, said that 11 drugs had not conducted mandatory Phase III trials, which determine whether people of different ethnicity can use the drug safely.
Drugs from a number of international pharmaceutical companies were among those listed as having been approved without Phase III tests.
“On an average [the regulator] … is approving one drug every month without trials. This cannot be in public interest by any stretch of imagination,” said the report. “Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk.”
The report also said that 13 of the medicines that were approved in India had not been approved for sale in their home countries.
These were just a few of a series of irregularities revealed by the parliamentary committee, which has demanded that the government take swift action.
The Financial Times tried to contact a CDSCO spokesperson but calls were not returned.
The findings of the report raised serious questions over the ability of the regulatory body to oversee the trials and licensing of drugs, as the CDSCO was portrayed as highly understaffed and lacking any form of medical expertise.
The committee said it was told by the regulator that several drugs were approved without testing them in India as they had undergone strict trials abroad, including on people from various ethnic groups.
However, the committee said that tests conducted in Europe and the US on Caucasian or African American patients could not be valid for Indian patients, as people of different ethnic background can react differently to the same drug.