Drug Regulation

Activities of Drugs Control Administration, Government of Tripura

The Drugs Control Administration works in the Office of the Dy. Drugs Controller headed by Dy. Drugs Controller under Directorate of Health Services, Government of Tripura. The present set up of Drugs Control Administration is given below.

Assurance of quality of medicines / drugs consumed by patients and other persons is the main objective / goal of this Administration.

The Drugs Control Administration has two wings viz. Enforcement and Testing.

The Enforcement wing undertakes issue, suspension and cancellation of licenses, following provisions of the Drugs and Cosmetics Act, 1940 and Rules there under. It also undertakes prosecution against the offenders under provisions of Drugs and Cosmetics Act, 1940 and Rules there under. Not only the above, but also the enforcement wing implements various other allied Acts such as NDPS Act 1985, Drugs and Magic Remedies (objectionable advertisement) Act 1954, Drugs Price Control Order 2013 and essential commodities Act. 1855, Poisonous Act 1919 etc.

The testing wing not only undertakes testing of samples of drugs purchased by Government Institutions but also from trade / market in order to ensure quality of Medicines.

The activities of Drugs Control Administration during last two financial years in brief is given below :-

2015-16

i. Testing wing : In the year 2015-16 around 682 samples were drawn. And test report of 944 (due to back log) samples were received. Out of which 898 samples were found Standard Quality and 46 (samples drawn by IOD – 16, Court samples 10 and Excise samples 20) samples were found Not of Standard Quality. Process have already been initiated for action against the 15 NSQ samples drawn by IOD.

ii. Enforcement Activities : Around 785 Inspections / raids of medicine shops were carried out during that period and action against 8 shops were taken for running the shops violating the provision of Drugs and Cosmetics Act, 1940.

Blood Banking Activities : Regulatory Monitoring of the 8 Blood Banks and 10 Blood Storage Centers are done by Routine visit to ensure safe collection, testing and transfusion of Blood.

2016-17 (up to 31.01.2017)

i. Testing wing : In the year 2016-17 (up to 28-02-2017) around 1178 samples were drawn and tested. And test reports of 1168 samples were received. Out of which 1162 samples were found Standard Quality and 6 samples were found Not of Standard Quality. Process have been initiated for action against the 6 NSQ samples drawn by IOD.

ii. Enforcement Activities : Around 2,102 Inspections/Raids of medicine shops were carried out during that period. A total of 252 Show cause notices were issued for violation of provision of Drugs and Cosmetics Rules 1945. Among them 27 licences were canceled, 112 licenses were suspended, and 84 licensee(s) were warned / cautioned). And show cause of another at least 150 shops are in the pipe-line.

During this period 12 (Twelve) seizures were made and follow up action is under process.

Blood Banking Activities : During the period 2016-17 we could able to issue licence for 5 (five) new Blood Banks at Belonia, Santirbazar, Bishalgarh, Khowai and Dharmanagar and 1 (one) new Blood Storage Centre at Chailengta, LTV. And permission for Component Separation Unit in three Blood Banks namely Udaipur, IGM and TMC and Dr BRAM Hospital at Hapania, which were pending for quite a long period.

Future Activities/Plan :

i. Setting up of Microbiological Section and NABL Accreditation of SDTL : The process has already been stated for the same a few months back and at present the file is now on process for inviting Tender.

ii. Computerization of Drugs Control Office : Steps had already taken with IT Department, Government of Tripura in the month of June, 2016 for Online issue of Drugs Licence, which was excepted to be functional by December, 2016. Initially, I.T Department took lot of interest for implementation of the said project but latter on no positive response has been received from IT Department and it appears that they have almost given up the project work.

Meanwhile we have contacted the NIC, Agartala regarding Online licensing and accordingly we had a Video Conference on the same matter on 24-01-2017 and to implement the same a file is being processed and it is under movement.

(Dr. N. Goswami)
Dy. Drugs Controller In-charge and Licensing Authority
Government Of Tripura, Agartala