FDA failed in performing its duty: CAG

Source: The Hitavada      Date: 06 Apr 2018 09:40:06


 

By Rajendra Diwe,

Nagpur FDA failed to take action against 61 units whose licenses had expired

Audit reveals 41 per cent licenses in Nagpur and 26 per cent in Yavatmal were renewed by FDA without any inspection

 


 

 


Food and Drugs Administration (FDA) Maharashtra had failed to take action to cancel licenses of 1,535 Drug selling units whose licenses had expired. Out of these 61 units (29 firms) belong to Nagpur division. The inaction of FDA is posing a risk to public health by possible sale of drugs by such units, says a report of the Comptroller and Auditor General (CAG) of India for the year ended March 2017.


As per the report, the renewal of Drug licenses was done without inspection of the premises of the drug selling units and thereby the requirement of adequate physical infrastructure was not ensured before grant of licenses. Inspection/survey was not done to verify that the Drug selling/manufacturing units were not involved in any activities during the suspension period. There were serious shortfalls in the inspection of Drugs manufacturing and selling units.

The shortfall was to the extent of 35 per cent in the case of Drugs manufacturing units and 63 per cent in the case of selling units. Maharashtra State had 2,395 and 73,040 licensed drug manufacturing and selling units respectively as of March 2017. The function of FDA has been defined in the Drugs and Cosmetic Act and rules. FDA has to issue new manufacturing and selling licenses, renewal of licenses after inspection of premises and suspension or cancellation of the licenses for non-compliance with the licensing conditions. Unfortunately, FDA had failed in performing its duties, a report stated.

Expired licenses


The manufacturing and selling units have required renewing their licenses after five years. The audit report stated, “The FDA did not maintain any database of the status of licenses in respect of manufacturing units. However, based on the information furnished by the JC/AC in the test-checked districts it was noticed that there was no case of expired manufacturing licenses.”


On analysing the information furnished by JC/AC the CAG revealed that licenses of 1,535 selling units in the State had expired as at the end of March 2017 but the FDA had not taken action to cancel/remove these licenses from the database after proper inspection. There were 483 expired licenses of selling units (209 firms) in six out of the eight test-checked districts. FDA had failed to take action against the selling units whose licenses had expired. Therefore, the risk to public health by the sale of drugs by such selling units whose licenses had expired cannot be ruled out.

Renewal of licenses without inspection

The FDA renews licenses of the selling units on-line since 2011. Audit test-checked 3,800 renewal cases out of 33,208 renewals done during 2012-17 to verify whether the licenses were renewed after inspection by the DI. The findings in this regard revealed in 1,286 (34 per cent) out of 3,800 cases test-checked, the licenses were renewed without inspection. Nagpur district had 142 (41 per cent) and Yavatmal district had 51 (26 per cent) such cases of renewal of licenses without inspection. Audit also observed that the on-line system did not have inbuilt controls to prevent renewal of licenses, without inspection being done as required under the Rules.

Suspended licenses not monitored

Scrutiny in Audit revealed that no records were maintained by the Licensing Authorities regarding inspection/survey done to verify that the selling/manufacturing units were not operating during the suspension period. The very purpose of suspension of license is negated if compliance with the suspension orders is not ensured.

Shortfall in inspection of drug manufacturing and selling units


The year-wise status of shortfall in the inspection of drugs manufacturing and selling units in the test-checked districts stated that there was a 35 per cent shortfall in inspections during 2012-17. The shortfall in inspection increased from 16 per cent in 2012-13 to 31 per cent in 2016-17 and the shortages were in category of ayurvedic, homeopathic and cosmetic units.


The shortfall in the inspection of selling units has increased from 34 per cent in 2012-13 to 61 per cent in 2016-17. Though the number of selling units had been increased from 35,977 (2012-13) to 42,494 (2016-17), the number of inspections carried out decreased. Audit observed that 45,758 (63 per cent) out of 73,040 selling units in the State had not been inspected as of March 2017. The position of inspection of selling units in the test-checked districts as on 31 March The FDA did not fix any internal targets for inspection of the manufacturing/selling units by the DIs after considering the risk profile of the licensing units and manpower available. Thus, an important regulatory function of inspection of the manufacturing/selling units as stipulated in the D&C Rules was not fully discharged, CAG stated.

Latest details as per FDA


-As on April 5, 2018, the selling units in Maharashtra are 83, 655.

-Total Licenses issued by FDA are 2,48, 942.

-On-line applications received to FDA are 2,71,615 [Licenses Granted = 250463, Rejected = 13858].
-Samples tested =44,094 [NSQ (Not of Standard Quality) = 3027] ,

-Inspections done =1,85, 345 [Licenses Cancelled =33,066, StopSale order given = 25 , licenses Suspended = 27]