i. State Drugs Controller:
The State Drugs Controller shall be the overall in-charge of the organization. All the Drugs Control Officers who shall act as Inspectors appointed by the government shall be under his control for the purpose of administration and disposal of the work under the Drugs and Cosmetics Act 1940. The Drugs Controller shall have below mentioned functions and responsibilities:- • Outlining the policies and guidelines. • Grant of Narcotics licences in medicine formulations. • Coordinating and arranging the meetings of the department. • Grant of prosecution orders in contravention of legal provisions. • Periodical review of the performance of Drugs Control Officials subordinate to him. • Initiation of the annual confidential reports of Drugs Control Officers and Zonal Assistant Drugs Controllers. • Approval of Drugs Formulations of highly sensitive products such as vaccines, Seras, Large Volume Parenterals and Cyto-toxic products. Grant of Certificate of Pharmaceuticals products (COPP) under W.H.O GMP certification scheme. • Attending the meeting of national/ international levels. • Regulation of sale and distribution of highly sensitive products.
II) Deputy Drugs Controllers:-
The Deputy Drugs Controller will be incharge of their respective zonal offices at the aforementioned five locations and shall have below mentioned functions and responsibilities:- • Grant and renewal of retail sale drugs licences. • Ensure to cause at least one inspection in a year of all the establishments/ licensed for the sale of drugs within the area of his zone. • Monitoring of investigation reports pertaining to spurious/ not of standard quality drugs and their timely actions. • Monitoring of institution of prosecutions in respect of breaches of the Act and Rules made there under. • Guidance to the Drugs Inspectors in technical matters and in prosecution cases. • Actions against the chemists for suspension or cancellation of retail sale drugs licences under the provisions of Rule 66. • Filing of replies against the appeals in matters of suspension/ cancellation of retail sale licences. • Filing of replies in various cases of suspension/ cancellation of retailers and in other matters. • Collection of data/ information for replying to Parliament/ Rajya Sabha/ Assembly questions or supplying information to the CDSCO. • Arranging awareness programs for the public and for the chemists etc. • Inspect the drugs manufacturing units and blood banks with assistance of Drugs Inspectors. • Monitoring and supervising of inspections of sales establishments. • Disposal of applications under R.T.I Act 2005. • Monitoring the quota of drugs sample allocated to each inspector in his zone. • To get investigated the complaints against the chemists/ manufacturers successfully at an early date.
iii) Assistant Drugs Controller: -
The Assistant Drugs Controllers shall have functions and responsibilities as under:- • To assist the State Drugs Controller and Joint Drugs Controller. • Shall file the replies against the writ petitions filed against the department. • Organize the trainings for the Assistant Drugs Controllers and Drugs Inspectors. • Grant and renewal of whole sale drugs licenses. • Random verification of recommendation of whole sale licences by the Drugs Inspectors. • Implementation of Drugs Price Control Order 1995, Indian Medical Council Act 1956, Implementation of Cigarette and other tobacco products Act 2003 etc. • Regulation of sale of alleged to be habit forming drugs. • Collection of information regarding manufacture, sale and distribution of spurious, Not of Standard quality drugs, habit forming drugs through watchers/ informers and ensuring the actions against the culprits. • Scrutiny of the applications for grant of whole sale licences. • Ensure the expedition of prosecution orders against the persons/ firms without license and in respect of spurious/ not of standard quality drugs within a period of 6 months or before the expiry of the drugs whichever is earlier. • Arranging meetings for deciding the cases pertaining to spurious drugs as per guidelines of Central Drugs Standards Control Organization. • Disposal of complaints against the chemists and unregistered medical practitioners. • Arranging joint raids to check the menace of habit forming drugs. • Collection of data and filing replies in matters of Parliament/ Rajya Sabha/ Assembly Questions or supply of information to Central Drugs Standards Control Organization.
iv) Duties and Responsibilities of Drugs Inspectors :-
• Inspect pre licensing establishment. • Inspect post licensing establishment not less than once in a year to satisfy himself that the conditions of the licences are being observed and are intact. • Procure and send samples for test and analysis. • Detect the contraventions if any. • Investigate any complaints against the retailer/ whole seller and manufacturers etc. • Investigate the matter w.r.t. spurious/ adulterated/ not of standard quality drugs make enquiries and inspections as may be necessary to detect the sale of drugs in contravention of the Act/ Rules. • Maintain records of all inspections made and action taken by him in the performance of his duties and submitting the information to the controlling authority to detect the import of drugs into the state which is prohibited. • Institution of prosecutions in respect of the breaches of the Act and Rules there under. • Inspect not less than once a year the manufacturing premises if specially authorized. • Filing of replies in court cases. • Defending the cases launched in the court of law. • Disposal of applications under R.T.I. Act. • Implementation of provisions of the Drugs and Cosmetics Act 1940 and Rules 1945, Drugs Price Control Order 1995.
v) Drug Analyst :-
The Drug Analyst shall be the overall incharge of the Drug Testing Laboratory, shall have administrative control on the other subordinate officers and shall have the below mentioned functions and responsibilities:- • Shall act as Notified Government Analyst. • Shall be incharge of secrecy for receiving and distributing the samples to the scientific and junior scientific officers. • Shall guide the Senior Scientific and Junior Scientific Officers. • Shall be responsible for accreditation of the laboratory from NABL. • Shall review the performance of the officials subordinate to him. • Shall be responsible for purchase of the chemicals and reagents on day to day basis. • Monitoring of the equipments and their periodical maintenance. • Shall be responsible for validation and revalidation of the methods/ techniques. • Shall be responsible for arranging the periodical audit of the lab and for corrective action & preventive action (CAPA). • Shall be responsible for arranging the periodical audit of the lab and for corrective action & preventive action (CAPA).
vi) The Senior Scientific Officers and Scientific Officers: -
The Senior Scientific Officers and Scientific Officers shall have the below mentioned functions and responsibilities: • They shall be notified as analyst for the purpose of test and analysis of the drug samples including samples of schedule C drugs. • Shall device the SOPs for each and every activity. • Shall calibrate all the lab equipments and instruments. • Shall declare the status of equipments/ instruments. • Shall validate/ revalidate the standardization of chemicals or reagents • Shall store the raw data/ worked out data. • Shall be responsible of archival and retrieval of the test and analysis data of the drugs.
vii) Lab Attendants-
The Lab Attendants shall have the functions and responsibilities as under:- • Monitoring cleaning and sanitation in the lab. • Collection and transfer of material required for the lab use. • Cleaning and drying of the Apparatus. • Monitoring cleaning and maintenance of lab instruments and equipments. • Operation of autoclave etc. • To assist the Senior Scientific, Scientific and Junior Scientific Officers in their day to day work. • Dispatch of test reports. • Disposal of left- over quantity of the used sample portions.