In spite of repeated recommendations by various expert committees to strengthen the manpower within the drug regulatory system, Central Drugs Standard Control Organisation (CDSCO) continues to be gravely crippled with just a fraction of the required staff existing in its rolls. Even the much-publicized World Bank funded Capacity Building Project in Food and Drugs may end up having just physical infrastructure if vacancies in CDSCO are not filled up on a war footing. The absence of adequate staff has maimed its functional capacity, it is feared.
According to sources, CDSCO has just 10 per cent sanctioned posts of what has been projected as the ideal staff strength by the Mashelkar Committee three years ago. Unfortunately, even the sanctioned posts are not completely filled and the department is having only 30 per cent of its sanctioned employee strength today. In the absence of immediate recruitment, the central government's plan to have a US FDA model drug regulatory structure is to remain a pipe dream.
"The government's plans to have a grandiose Central Drug Authority (CDA) will achieve nothing if there are no regulatory officials to manage the system. Existing vacancies should be filled before new posts are created," an industry source pointed out.
It should be noted that the major gap within the existing system, as identified by the Mashelkar Committee was 'inadequacy of trained and skilled personnel and infrastructure support at Central as well as State levels'. While the infrastructural bottlenecks are to be taken care of through the Capacity Building Project, nothing much has been done on augmenting the human resource strength till date. Ironically, an earlier expert committee, the Pharmaceutical Research & Development Committee (PRDC) also headed by R A Mashelkar, had recommended comprehensive strengthening of CDSCO in 1999 itself. The PRDC wanted a strengthened CDSCO to carry out the multifarious activities that the Department was expected to perform, especially in the context of post 2005 scenario, when the Indian drug industry would have to rise to entirely new set of challenges.
Three years after, Mashelkar Committee, which did a comprehensive examination on drug regulatory scenario, had reminded the government failure to implement its recommendations. It repeatedly stressed the need for more drug officials, but fours years gone, the situation continues to be worse, it is learnt.
By implementing most of the recommendations of PRDC, other than its suggestion to augment staff strength, the government has put in rules without proper monitoring or regulating mechanism in place.
It should be noted that the Central Drugs Authority proposed by Mashelkar had 10 major divisions with qualified pharmaceutical and pharmacological scientists, legal and other competent officers at the headquarters, at the zonal offices and at the drug testing laboratories to perform their functions more effectively and expeditiously.
The additional posts recommended by the committee were Joint Drugs Controllers (3), Deputy Drugs Controllers (2), Assistant Drugs Controllers (6), Drugs Inspectors (50), Technical Experts (5), Administrative Officer (1), Accounts Officer (1), Computer Operators (15) and adequate supportive staff. It was also mentioned that the functions of central regulatory agency being multi-disciplinary in nature, considerable sourcing of expertise from external experts and institutions would be required.
"It is necessary that such consultations are managed speedily, since drug development activities are very cost and time sensitive. This would require provision of sufficient funds at the disposal of office of DCG(I) to support sourcing of external expertise and an easy mechanism to make payments of honorarium and travel expenses without delay, as per the systems available with CSIR and ICMR" the report had noted.