To ensure uniform and effective implementation of the Drugs and Cosmetics Act and Rules in the country, the Drugs Control Officers Confederation (AIDCOC) strongly feels that it is high time for the Centre to focus on strengthening the state mechanism with increased manpower and requisite training on a priority basis among others. This demand comes in the wake of huge disparity in the quality of implementation or monitoring of the Acts and Rules in some states compared to commendable performance by the state regulatory body in other states.
It is understood that today, though India has a very strong drug regulatory system in place, there are still a lot of gray areas that impede its effective implementation across the country. Industry insiders point out that while the D&C Act & Rules are implemented impeccably in some states like Gujarat, Maharatshtra, Tamil Nadu to name a few the effectiveness of implementation in some North Indian states like Himachal Pradesh, Bihar, Punjab etc are equally worrisome, especially since many Indian generic companies are based out of these states.
AIDCOC points out that one of the biggest reasons for the same is lack of trained manpower in these states, especially drug inspectors with proper knowledge of the law. In fact, one of the biggest concerns among the experts have been the lackluster attitude of the Centre in addressing key issues like increasing the manpower, upgrading the state drug regulatory facilities, training the existing manpower etc. as per the pressing need of this time.
According to AIDCOC general secretary Ravi Uday Bhaskar, under the strenuous market condition wherein regulatory agencies across the globe are enhancing and strengthening their department to meet the growing market challenge, the Indian drug regulatory agency is still struggling to get the funds from the government for the same. “Time and again we have been strongly advocating for strengthening the manpower as per the needs, especially in these areas which are home to many pharma cos. The Centre must realize that to deliver the best, each and every state regulatory body should be equipped with the best staff, lack of drug officials is an issue we have been raising throughout and hope that at least this time this issue will be addressed. The 12th five year plan seems to be promising and we hope that the Centre will take a decisive decision in investing these funds based on the practical needs.”
He further pointed out that the CDSCO should concentrate on developing and nurturing the regulatory mechanism from the state level, starting from those who lag behind their counterparts in implementing the D&C Act & Rules effectively.
Bhaskar pointed out, “There is an urgent need to introspect our strengths and weakness to find out the irregularities in the system and steam-out the same to develop a strong drug regulatory system throughout the country. Upgrade the office and strengthening its functions right from the grassroot level will help us to meet all the changing regulatory challenges, which will further help us in the effective implementation of the Act and Rules.”