Panel asks govt to submit response from five state govts on strengthening drug regulatory mechanism

New Delhi, September 28, 2022:

The Department-Related Parliamentary Standing Committee for ministry of health and family welfare has sought the Centre to submit the response from the five states including Maharashtra, Uttar Pradesh, among others on the proposed project proposals for strengthening their state drug regulatory system.

The Committee, in a latest report on the action taken by the Ministry on its recommendations from previous report, said that it is of the considered view that vibrant, dynamic strengthened drug testing laboratories is concomitant efficient and effective drug regulatory mechanism to avert the prevalence of sub-standard drugs

“…. therefore, the Ministry should instruct and guide the State Governments to strengthen state drugs regulatory system,” it said.

“Moreover, the Committee wants to be informed of the response of State Governments of Maharashtra, Uttar Pradesh, Bihar, Tamil Nadu and Karnataka to the Ministry’s perusal for submitting the project proposals matching the indicative amount of each state. Understandably the Ministry will continue to monitor optimal utilization of fund earmarked for the scheme,” it added.

In the previous report, the Committee took into account the lack of adequate drug control infrastructure and drug testing facilities across the States.

“The Committee strongly believes that for development of a vibrant drugs manufacturing industry, issues related to supply of poor quality drugs need to be resolved. It is an established fact that Strengthening of state drug regulatory system is the keystone for addressing the issues of substandard drugs,” it said in the previous report.

It also noted the plea of the Ministry that the lack of proposals from States for Strengthening of state drug regulatory system has been one of the primary reasons for underutilisation under the Scheme. The non submission of proposals from states especially, States with higher allocation of the indicative amount, is not tenable.

It then recommended that states, especially, Maharashtra, Uttar Pradesh, Bihar, Tamil Nadu, Karnataka may be persuaded to submit the project proposals matching to the indicative amount. The Ministry may also follow up with all the states and make efforts to set up sufficient number of laboratories The Committee emphasized on the need of cooperation between the States and the Union government to establish a vibrant, dynamic and effective drug regulatory regime.

In response to this previous report, the Ministry responded that it has been making concerted efforts for implementation of the Scheme of Strengthening of state drug regulatory system with all the states/UTs for signing the Memorandum of Understanding under the scheme and submitting project proposals for release of grant –in-aid.

All the states/UTs, which have received Grants-in-Aid, have also been requested to furnish Utilization Certificate (USs) and detailed progress reports of the projects undertaken through a number of virtual meetings and repeated communications.

Up to March 31, 2022, Grant-in-Aid of Rs. 642.18 crore has been released to the states/UTs. This Scheme has paved the way for setting up of 17 new drugs testing labs and renovation/up – gradation of 26 existing ones as also for setting up of 48 new offices for drugs controllers and upgradation of 27 existing similar offices.

In line with the recommendations of the Committee, the States of Maharashtra, Uttar Pradesh, Bihar, Tamil Nadu and Karnataka are being persuaded to submit the project proposals matching their indicative amount, said the Ministry. Further, all the other states/UTs are also being requested to set up a sufficient number of drug testing laboratories to meet their requirements, it added.  Financial Express