ROYAL GOVERNMENT OF BHUTAN

                    POSITION DESCRIPTION


1.1    Position Title:                 Drug Controller

1.2    Position level:                 P1
1.2    Major Group:                    Medical Services Group

1.3    Sub Group:                      Pharmaceutical Services

1.4    Job Code No.:                    15-690-05

1.5  Job Location (Complete as appropriate):
     Ministry: _____MoH_____; Department: __DRA_____, Division:
__DRA___; Section: ____________; Unit: __________________.

1.6   Title of First Level Supervisor: (Official title of Supervisor). Bhutan Medicines

2. DUTIES AND RESPONSIBILITIES: Describe the main duties and
responsibilities, indicating what is done and how it is done. Duties should be
presented in decreasing order of percentage of time spent on them, or in order of
relative importance.

Purpose: To safeguard the Human and Animal Health against harm resulting
from poor quality, Spurious or adulterated or counterfeit drugs and medicines. To
control and regulate manufacture, sales, import, export, distribution of medicinal
products. Prepare and formulate policies and plans to protect and safe guard
citizens simultaneously enhance economic growth.
SL.   Duties and Responsibilities                                                       % Time
1.    i. Prepare and formulate policies and plans on regulations and control 60
      measures. Develop control and regulatory strategies related to drugs and
      vaccines. Set vision for the authority and prepare both long and short term
      plans. Liaise with Pharmaceutical Companies from abroad on registration and
      import/export matters. Conducts studies and generate reports on drugs and
      related issues for the Ministries to consider as national policy.

      ii. Develop documents required for registration of medicinal; products
      including veterinary in the Kingdom. Supervise scrutiny of documents for
      registration and approve registration of drugs and medicinal products.

      iii. Develop protocols and standard operating procedures for drug inspectors
      and supervise inspectors.

      iv. Approve Good Laboratory Practices developed by Drug Testing
      Laboratory and get samples of drugs tested to assure safety, quality and

      v. Liaise with Appellate Laboratory, Courts, Revenue and Customs, Trade and
      Industry, local shop and police on regulatory and enforcement matters.

      vi. Be the Chairperson of the registration Committee, member Secretary to the
      Bhutan Medicine Board. Authorization for manufacture, import, export, sale,
      distribution of medicinal products in the country. Ensure control of the prices
      of the medicinal products. Award technical authorization for competent

      vii. Supervise, control and motivate sub-ordinates working as registrars, Drug
      Inspectors and Government Analyst.

      viii. Advise Government on issues related to drugs and their control.

      ix. Assess the training needs, promotion and location / relocation of the staff
      to carry out the functions of Authority effectively and efficiently.

2.    Work, interact and liaise with other relevant departments or agencies at both 20
      intra-ministerial and inter-ministerial agencies to raise, negotiate and justify
      issues that are important and significant at the national level. Then prepare
      programs and guidelines and propose necessary changes in the Bhutan
      Medicine Act 2003 and Bhutan Medicine Rules and Regulation 2005.
3.    Liaise with internal agencies such as UNODC (United Nations Office on 15
      Drugs and Crime), INCB (International Narcotic Control Board), UNDCP
          (United Nations Drug Control Programme) and WHO on matter related to
          drugs as a national Competent Authority and submit periodic report as a part
          of fulfillment to the UN conventions of 1961, 1971 and 1988. Representing
          the country in forums and put forward issues of national interest and involve
          in negotiation of issues that are important both for the National and
          international level.

4.        Train Health personnel, DRA staff and public on various issues related to 3
          regulation, inspection, and registration of drugs.

5         Attend the seminars, workshop both at international, regional and national
          level and add programs or make necessary changes in the programs for 2
          implementation as per the outcomes, recommendations and resolutions of
          such seminars and workshops to strengthen DRA.

3. KNOWLEDGE & SKILLS REQUIREMENTS: Minimum requirement for
performance of work described (Level of Knowledge, Skill and Ability).

 3.1 Education: Masters degree in the relevant field of study with working experience of
5 years in the Pharmaceutical industries or relevant field.

3.2 Training: He/She should have undergone training in regulations and medicines acts.

3.3 Length and type of practical experience required: Minimum of 4 years of
experience in various fields of regulations and Pharmaceutical industries or relevant field
of pharmaceutics as Dy. Drug Controller or equivalent experience. The person should
have sound knowledge on regulations of medicinal products both at national and
international levels.

He/she should have sound knowledge on the principles of planning and programming
applied to the government program and demonstrated extraordinary skills in giving
strategic direction to the Authority. He/she should have strong ability to take quick and
relevant decisions on complex issues. Skills and experiences to liaise with international
organizations, central programs and other agencies both within and outside the Kingdom
to justify and negotiate issues that are significant and are of national importance OR
equivalent experience.

3.4 Knowledge of language(s) and other specialized requirements:

        Person should have good sense of leadership and integrity.
        The person should have a good command of speaking, reading and writing in
         English and Dzongkha.
        The person should have skills for writing high quality scientific papers and
         provide advisory support and guidance to the head of the agency as well as to the
         subordinate staff.
   Ability to express ideas clearly and concisely both orally and in writing to a wide
    range of audience.
   The person should have sound knowledge on international conventions and
    treaties, national laws and understand their sensitivities.
   Good working knowledge of computer application.

4. COMPLEXITY OF WORK. Describe the intricacy of tasks, steps process or
methods involved in work, difficulty and originality involved in work.

The work demands a highest-level professional knowledge related to the drugs,
vaccines and medicinal products. It would also require vast administrative knowledge
and experience pertaining to the enforcement of the regulation. Work requires
extensive in-depth analysis in identifying problems, carrying out analysis of reports,
taking important decisions, preparing plans and programs, defining and changing the
course of works as per the findings and needs of the government policies and plans.

He/she should take the main roles and responsibilities in strengthening and take the
Authority forward.

The work would also require providing recommendations and initiating necessary
changes in the acts, rules and regulations and latest trends in drugs and

 5. SCOPE AND EFFECT OF WORK: Describe the purpose, breadth of work
performance, and the effect the work has on the work of others or the functions of the

The work carried out by him/her is very important as it involves preparation and
formulation of plans and policies at national level concerning the safety of drugs both
for human and animal health. The implementation of the Bhutan Medicines Act and
Regulation has a very significant bearing on ensuring safety, quality and efficacy of
drugs and protect the citizens from the risk of spurious and adulterated drug. Also
minimize resistance to antibiotics by regulating its import, distribution and sales thus
reducing the overall cost on Health Services. Regulate and control the use and abuse
of Narcotic Drugs and Psychotropic Substances in the kingdom.

The work also relates to fulfilling Kingdom’s obligation towards international
conventions such UN Single Convention on Narcotic Drugs 1961, Convention on
Psychotropic Substances 1971 and UN Convention Against Illicit Traffic in Narcotic
Drugs and Psychotropic Substances of 1998. The work of enforcement of law
requires liaising with other agencies both government and non government and
private sector demands tactful handling of situation and issues. There is need to send
the reports to various international agencies as a part of obligation. Interact with such
agencies on the behalf of the government and present the case and accord financial
        6.1     Instructions: Describe controls exercised over the work by the Superior;
                how work is assigned, reviewed and evaluated.

     Instructions and guidelines available in terms of broadly defined missions and
     functions in the Bhutan Medicines Act 2003, Bhutan Medicine Rules and Regulation,
     Narcotic Drugs, Psychotropic Substances and Substances Abuse Act 2005 and
     international Convention on specific matters. The broad guidelines and instructions
     are also given by the board.

     6.2 Guidelines: Indicate which written or unwritten guidelines are available, and the
     extent to which the employees may interpret, adapt or devise new guidelines.

     Over all frame work is covered by the Bhutan Medicine Act 2003. The plans,
     programs, designs and guidelines prepared by him/her more or less independently
     under the broad instructions and guidelines that are applicable to Bhutanese situation
     and the necessary amendments in the acts he/she recommends would be mostly
     accepted as technical matter.

     7. WORK RELATIONSHIPS: Indicate the frequency, nature and purpose of
     contacts with others within and outside the assigned organization (other than
     contacts with superiors):

     He/she should also maintain constant touch and interact constantly on behalf of
     Authority with the concerned officials and offices of international organizations such
     as UNODC (United Nations Office on Drugs and Crime), INCB (International
     Narcotic Control Board), UNDCP (United Nations Drug Control Programme) and
     WHO on matter related to drugs as a national Competent Authority and submit
     periodic report as a part of fulfillment to the UN conventions. He is closely with
     Ministry of trade and Industries, Ministry of Finance, Ministry of Agriculture, Royal
     Bhutan Police, Legal bodies and private sectors.

     8 SUPERVISION OVER OTHERS: Describe responsibility for supervision
     of other employees, including the nature of supervisory responsibilities and
     categories and number of subordinates.

     Provided directions, coordination and supervision, monitoring and evaluation DRA
     staff and provide professional leadership and motivate to produce results and achieve

9.      JOB ENVIRONMENT:                 Describe physical exertion required, such as
        walking, standing, lifting heavy objects, etc., and/or any risks or discomforts like
        exposure to hazards such as exposure to chemicals, infections, radiation, extreme
        weather and other hostile working conditions.
He is mainly based at the head quarters with occasional travel to field units for
physical and technical verification and monitoring the works carried out by the field
staff. Most often work will demand extra-working works wherein much mental
efforts needs to be put in emergency situations for giving the new direction and
instructions to subordinates. Such works would demand long working hours and
mental exertion.

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