The pharmaceutical industry wants the government to make major changes in the way the Central Drugs Standard Control Organisation (CDSCO) functions across the country, so as to ensure better transparency and accessibility of regulatory services to all the stakeholders. Experts point out that considering the rate at which the Indian pharma industry is growing, there is an urgent need to bring in some major administrative re-structuring at the centre which will help in better functioning and timely delivery of services.
Many in the industry feels that lack of transparency within the regulatory body is causing a lot of confusion and discontent within the stakeholders which in turn is affecting the morale and confidence of the industry. Kapil Bhargava, an industry expert and retired Deputy Drugs Controller (I), CDSCO stressed that the only way to tackle this issue is by making sure that the whole regulatory procedure and their services are easily accessible to all the interested parties.
He informed, “Today most of the work done at the centre is either stuck in a logjam or is delayed because there is no clear cut job definition for the top posts. All the technical and administrative work is handled by the same person when actually there is a need for creating a definite post differently for both the important job profiles. Government should create at least two post of joint drug controllers so that one can handle all the technical aspects of the regulatory issues whereas the other can handle administrative aspect of the same. This will make the whole system organised and help in timely delivery of services.”
He further added that lack of skilled and trained work force is a major issue that needs to be tackled at the latest thus it is imperative to create a separate post for administrative purpose totally aimed at training the CDSCO officials on how to handle their job responsibilities properly.
“It must be noted that the time-line laid by the DCGI for delivery of any of its regulatory services and the time-line in which it is actually completed varies tremendously. This not only affects the performance of the industry but also leads us to question the integrity and competency of the workforce at the CDSCO's office. Today we hardly know about the qualification or the expertise of most of the officials working at the CDSCO even though they handle one of the most responsible job profiles in the country,” he pointed out.
He suggested that to ensure clarity in this area it is essential to initiate steps that will help in bringing more transparency in this field by duly informing the stakeholders about the regulators so that they are educated and sensitised about the others duties and expertise. According to Bhargava one of the most ideal way to tackle this issues would be by uploading the resume of the CDSCO's officials on its website so that it is available in the public domain for everyone to access.
“This will not only give universal acceptance to the CDSCO officials among the stake holders but also will ensure building of confidence among the industry as they will be less apprehensive on the competency of the officials,” he stressed.
Sources inform that considering the huge amount that the Government has set aside for CDSCO in the 12th five year plan i.e. of Rs.5500 crore, measures should be taken to ensure that it is invested appropriately with a view to address the pressing issues at the centre that will ensure better delivery of its regulatory services. Bhargava added, “Breakdown of the expenditure should be made available at its website so that we know where and how the money is invested most importantly this will lead to accountability of all their.”