Even as The Lancet report exposes the inadequacies of the functioning of Central Drugs Standard Control Organization (CDSCO), industry stakeholders have called for an overhaul of India's regulatory machinery on a priority basis including staffing policy of the organization.
According to a stakeholder, “A competent CDCSO is of utmost importance and requires a leader who is conversant with the nuances of this highly technical and research-driven business.” Further, he added, the regulator should have a formal pharmacy education, to discharge duties efficiently.
It may be noted that The Lancet in its report dated May 19, 2012 pointed out that “India's drug regulatory authority, is grossly understaffed with paucity of infrastructure, lack of coordination between departments, and a shortage of computer systems”. Lancet’s findings have added more fuel to fire and CDSCOs issues have now become known globally. Earlier the Parliamentary Standing Committee on Health and Family Welfare had also listed the regulator's successive failures and also highlighted its malfunctioning.
Before the situation gets worse, there is need to rectify the Organization as it is bestowed with the duty to provide safe medicines for home and abroad stated sources.
There has been no succession policy so far in the CDSCO and therefore key posts remain vacant in situations like the present where candidates are given additional charge to oversee operations. The government needs to enforce an intensive training programme for the CDSCO leadership on similar lines of Indian Administrative Service. Candidates should be evaluated, assessed for future advancement of career growth and a succession plan should be in place.
The candidate at the helm of CDSCO needs to be candid in his efforts as he has the onus to approve the licenses of drugs and clinical trials being carried out in the country which is actually dealing with the health of people in the country stated sources.
“There should be transparency and accessibility to the CDSCO for the industry to have first-hand information on the latest status of licensing applications. The minutes of the meetings carried out in the department should be recorded and the decisions ensuing from the interactions should be put up on its website at least biweekly. This will allow the stakeholders to comment on new regulations or developments and help the CDSCO to take a direction to implement decisions,” they stated.
The CDSCO also needs to come out with a well thought out manual with guidelines giving no room for ad-hoc decisions. There is a serious dichotomy in the regulatory framework which allows the state drugs department and the central authority to approve the drugs for domestic, international and imported medicines being marketed in the country.
The qualifications of the personnel not just at the top but those employed in the CDSCO across zonal and port offices should also be on the website to ensure that they have the requisite expertise and experience to handle the job. This will the give pharma industry a confidence that their application is in hand of officers who understand subject well for easy and quick review and disposal, pointed out Kapil Bhargava, a retired CDSCO official and an industry expert.