While the Drug Controller General of India (DCGI) attributes the complete blame on the personnel shortage for the reported malfunctioning of the Central Drugs Standard Control Organisation (CDSCO), majority of the existing operational posts at the department are lying vacant since 1992 due to sheer inertia of the department head. This paradoxical state of affairs in the department is despite a World Bank aid granted years ago for the enhancement of infrastructure and personnel at the CDSCO.

The CDSCO, which has 73 operational posts ranging from deputy drug controllers to the drug inspectors responsible for disbursing key functions of the department, is currently running with less than half of the strength. Though there are no technical hurdles like government clearances and financial constraints as far as the appointments are concerned, the informed sources claim that the department head, who himself is on a temporary posting, has never attempted to fill the vacancies for mysterious reasons.

Following this, several of the important drug manufacturing and trade zones in the country are neither facilitated with necessary services nor monitored for quality manufacturing and sales. Informed sources from within the department confirmed that with the absence of the required drug inspectors/technical officers at the head office as well as zonal offices, proper inspection of drug manufacturing facilities are not being conducted at many places across the country, which in turn results into proliferation of substandard and spurious products in the market.

The CDSCO currently has only 26 drug inspectors, which is only 30 per cent of the required strength and since there are no fresh appointments in place of retirements, some of the zonal offices are literally with zero field staff. Besides, with no adequate number of technical staff at these offices often the drug companies face unwarranted delays in services, which leads to alarming rise in corruption in the department.

Although the DCGI's office repeatedly complains about extra workload with no adequate staff, the DCGI is much reluctant to distribute work among the zonal offices, which would dilute the workload as well as ease the public service by decentralization.

Industry observers feel the incident is only a tip of the iceberg, and is a perfect example on the malfunctioning of the CDSCO offices in the country. When Pharmabiz reported a complaint of the pharmaceutical companies about the chronic delays in clearing various regulatory approvals by the CDCSO in its July 22 issue, the DCGI himself had come forward to deny the allegations. Further, Pharmabiz had brought to light many issues related to the malfunctioning of the CDSCO in subsequent editions.

Soon after the Pharmabiz reports, the union ministry of health and family welfare had initiated a departmental inquiry into the functioning of the central drugs standard control organization (CDSCO), which the DCGI denied, terming it only as an internal work arrangement.