Denial issued by the DCGI stating that there was no move to bring Contract Research Organizations under a licensing or registration system has surprised many pharmaceutical companies and regulatory officials here.
Informed sources confirmed to Pharmabiz that some senior officials in the Central Drug Standard Control Organisation (CDSCO) have been asked to prepare the draft proposal for the licensing framework. Under the circumstances, the intention behind the DCGI's denial is grossly mysterious.
The government's move to bring in a direct monitoring system for CROs is to ensure the competency of the institutions and to boost the credibility of their services in the international market. Since pharmaceuticals and related services are the key export hopes for India, the country cannot afford anymore drug delistings by international bodies like WHO, drug experts pointed out.
Denial of such plan by senior government officials at this stage can only please a section of the industry and CROs which are weak but such a loosely regulated environment could surely encourage the unfair practices and the country might have to pay a heavy price for that, they said.
It may be recalled that the pharma industry and the CRO community had earlier tried to hush up a Pharmabiz report, on the revelation of certain pharma research organizations on the compromises they are forced to do in the clinical investigation and the drug analysis projects, soon after the WHO delisted antiretroviral formulations of two Indian majors.
It is the same scare, which has made them to ridicule the government move to put a regulation on the CROs, said the informed sources. "It is a fact that gross manipulations take place while the clinical/ bioequivalence/ bioavailability studies are documented for the purpose of drug approvals, which are often known to the sponsors and investigators," the industry sources said.
"These manipulations due to compromises between the sponsors and the CROs are mainly due to noncompliance with standards and incompetency of the CROs. It is therefore an urgent need to have a strict monitoring system on the CROs to safeguard the quality drug/service exports of the country," the drug experts said.