India’s drug regulator, it would seem, needs to be itself regulated, to go by a public suit the Supreme Court will hear on Monday.
The Central Drugs Standard Control Organization (CDSCO), the suit says, suffers from inadequate infrastructure and shortage of staff, while new drugs are being approved for marketing by short-circuiting the clinical trials and in some cases, not conducting them on Indian patients.
Petitioner Manohar Lal Sharma has sought a directive that pharma giant Ranbaxy be prohibited from manufacturing and marketing sub-standard drugs in the wake of its $500 million out of court settlement with the US Food and Drug Administration (FDA) for falsifying data and selling substandard drugs
Contending that India’s drug control regime was far too inadequate infrastructurally, technically and in terms of manpower, Sharma has annexed the report of the Parliamentary Standing Committee on Health and Family Welfare which had examined CDSCO’s functioning and had taken a dim view of its working.
“The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO. For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. the consumer has never been ensured” the committee said in its report.
Referring to the “corrupt practices” in the CDSCO, the public suit refers to the parliamentary committee report that of the 39 drugs for which information was available, in the case of 11, the mandated Phase III clinical trials were not conducted. In the case of two drugs, the trials were conducted on just 21 and 46 patients whereas statutorily it should have been on 100 patients for each drug.
In the case of four drugs, not only were the Phase III trials not carried out but even the opinion of the experts was not sought. “The decision to approve these drugs was taken solely by the non-medical staff of CDSCO on their own”, the committee report said.
The public suit quoted the report as saying that 31 new drugs were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients. The figure is understated because two drugs were somehow not included in the list.
“Thus there is no scientific evidence to show that these 33 drugs are really effective and safe on Indian patients”, the committee observed.
The committee, the public suit said, favoured a non-discretionary, well laid down written guidelines on the selection process of outside experts as it noted: “There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts.”
Taking strong exception over the way CDSCO was conducting its affairs, the parliamentary committee has asked for the formulation of CDSCO’s Mission Statement forthwith to convey in “very unambiguous terms that the organization is solely meant for public health”.