FDA fails in creating consumer awareness

Source: The Hitavada      Date: 07 Apr 2018 08:46:33


By Rajendra Diwe,

Comptroller and Auditor General of India (CAG) has rapped Food and Drugs Administration (FDA) for lack of effective mechanism for creating consumer awareness. CAG, in its audit report, revealed that the FDA did not have an effective mechanism for creating consumer awareness in terms of plans for dissemination of information through print, electronic and other mass media, the nature of information to be disseminated, the periodicity of disseminating the information etc.

Though the FDA is vested with powers to ensure the quality of drugs, sale of drugs at authorised prices etc., consumer awareness about substandard drugs and cosmetics, misleading advertisements, overcharging of prices more than the maximum retail price plays an important role and supplements the efforts of the department to a great extent. To ensure this, regular dissemination of information though print, electronic media etc., is of vital importance. Further, to protect consumer interest in view of the proliferation of e-Commerce and sale of various kinds of drugs on the Internet through misleading advertisements, creating consumer awareness assumes even greater significance. Unfortunately, no such effective mechanism is available with FDA, the report stated.

The report referred the statement of FDA Commissioner in September 2017. FDA Commissioner had stated that mechanism for creating consumer awareness was being prepared and a proposal for comprehensive media plan had been submitted (July 2017) to the Directorate General of Information and Public Relations (DGIPR). Separate fund allocation of Rs two crore was also made for this purpose.CAG stated that the reply of FDA Commissioner had confirmed that the FDA did not have an effective mechanism for creating consumer awareness.

Deficiencies in monitoring mechanism

Existence of effective monitoring mechanism to ensure the implementation of the relevant Acts and Rules is crucial to detect any deviation and take corrective action for future planning. The Commissioner receives monthly reports from the field offices regarding licenses issued/renewed to drug manufacturing/selling units, inspection of drug manufacturing/selling units, action taken on the basis of inspection conducted, prosecution cases pending and preferred, details of sample drawn etc.

What scrutiny in audit revealed

The monthly reports did not indicate the manufacturing/selling units which have not been inspected for more than one year so as to identify the districts which are lagging behind in inspection, for appropriate action.

The stock of seized/confiscated drugs held, physical verification of such drugs, the status of its destruction or distribution to Government hospital/Charitable institutions as per Court order, were not indicated.

Further, there was no Management Information System in respect of the following key issues:

The time taken by the three DCLs in issue of test reports on the drug samples along with the reasons for the delay.

Number of manufacturing/selling units whose licenses have expired, number of licenses suspended, inspection done or pending in respect of such expired/suspended licenses.

Number of licenses which were renewed without inspections.

The above deficiencies therefore indicated weaknesses in the monitoring mechanism.


CAG has recommended that the State Government may ensure that testing of drugs and cosmetics would be done expeditiously by providing the required manpower, equipment and material for conducting the tests. The Government may also ensure safety, efficacy, purity and quality of drugs and cosmetics by carrying out all the required tests through well-equipped Drug Control Laboratories.

The Government may review the reasons for delay and take concrete steps for timely recall of Not of Standard Quality Drugs to minimise the risk of its consumption by public.

The Government may also consider setting up of a dedicated Legal Cell to provide legal assistance to the staff for handling prosecution cases in the Courts to ensure maximum convictions.