Concerned by the dearth of drug regulators in the country, the All India Drugs Control Officers' Confederation (AIDCOC) has urged the government to urgently focus on strengthening the regulatory mechanism with adequate manpower. The association pointed out that immediate intervention from the government with clear focus on beefing up the numbers is essential, especially since 2015 will be busy year for Indian regulators with some drugs going off patent.

Come next year, lot of top blockbuster drugs will be going off patent, providing opportunities galore for generic Indian companies. While, this opens up huge market for the generic players, it will also throw challenging regulatory scenarios for the Indian regulators, who though competent are not adequate to meet the growing requirements, according to experts.

Ravi Uday Bhaskar, secretary general of the AIDCOC pointed out that while the generic industry is booming with activities, there aren't enough drug regulators either in the state or in the CDSCO to actively regulate and monitor their movement effectively. Sadly, the gap in the ratio of regulators currently working compared to their actual requirement is huge.

He informs that according to statistics there are only close to 2100 drug officials in the drug regulatory department, i.e. 1800 drug regulators from all the states combined while close to 300 officials in the CDSCO to look over the smooth and effective functioning of the Drugs and Cosmetics Act.

"There is no question on the efficaciousness and quality parameter of the drugs that are manufactured in India, neither on the capabilities of the Indian drug regulators. However, the MNC lobbies working against the generic companies are sure to misutilise whatever loopholes they may find to tarnish the Indian image. Thus not addressing the issues of manpower crunch when we have the time is like giving them an opportunity in a platter. Steps needs to be taken on an immediate basis to address this lacunae and ensure that we provide no opportunity for the critics to hold us from any growth opportunity," he stressed.

Another concerning fact that the association has been trying to bring into attention of the Centre has been the under usage of the allotted seats, wherein the state governments have repeatedly failed to fill it up.  Citing examples, he said that states like Maharashtra, which is one of the leading generic hubs of the country, West Bengal etc have vacant seats which are yet to be filled. This gross oversight is committed even when there is a huge dearth of drug officials in the state, due to loose planning and red tape in the system.

Experts point out that while the 12th five year plan did touch base with need for strengthening the regulatory mechanism through up-gradation of the facilities and capacity building measures, not much have been done about increasing the manpower. Bhaskar stressed that, to ensure a healthy growth environment, the government needs to act upon addressing it at the earliest, as it is the reputation of the Indian industry as well as the regulatory agency at stake.