JIBRAN KHAN
   It was the branch of the Government, which was    the department for provision of medical services,    responsible to ...
   The Constitution (Eighteenth Amendment) Act,    2010 was unanimously passed with the support of    all political parti...
DEVOLUTION OF MINISTRYOF           HEALTH Pakistan Ministry of Health was abolished on 30th of June and a number      of  ...
       With the passage of the Eighteenthamendment Bill, Health is going to becomeexclusively a provincial subject.   Ac...
Ministry of National Regulation and ServicesNational Regulation and Services Division    Drug Regulatory Agency
Dr. Firdous Ashiq Awan                 Minister   National Regulations and Services          Mr. Imtiaz Inayat Elahi      ...
   President issued Ordinance for establishment of Drug    Regulatory Agency which was immediately implemented.   Accord...
   Agency for preparations    of medicines and    issuance of license,    Prices determination,    Issuance of Quota and ...
   DRA will work under the Policy board which consists of 15    members. Chair person of Board will be Secretary of    Fe...
   Dr Hussein A Gezairy, regional director of the    WHO for the Eastern Mediterranean, expressed    concern over the dev...
   According      to    Pakistan     Pharmaceutical    Manufacturing Association (PPMA) Ministry to    Province     under...
   Pakistan’s pharmaceutical industry has operated in a legal    vacuum since 2010, when a constitutional amendment    di...
   Antibiotics, hypnotics and injectables such as    steroids are sold without prescriptions, and    many traditional med...
   The government has not yet announced any    funding.   After The Formation of DRA at least 25,000    Registration App...
 The Cabinet Division has requested the Prime Minister to Transfer the Drug Regulatory Agency (DRA) To the province as gu...
   Different countries and regions witness variable    drug effects and reactions. This occurs due to    differences in d...
   Hence through Pharmacovigillance we are able    to improve patient care, safety and public health,    whilst ensuring ...
   Pharmacovigillance efforts are undertaken on a    global level through specialized agencies in    different regions. F...
   In the US, the FDA is responsible for    coordinating these efforts. In India, the    Pharmacovigillance efforts are i...
   The    large   number     of    adverse-event   reports    generated by marketed drugs and devices argues    for   the...
   Execution of commercial services to support    products operating under United States Food    and Drug Administration ...
   WHO strongly suggests establishment of a    mechanism for identification, reporting and    monitoring of adverse drugs...
   Pakistan is in the process of establishing a national    Pharmacovigillance center in Drugs Control    Organization, I...
   Drug abuse and use in pregnancy and lactation is yet    another area to be focused.   Initially, reports on all suspe...
   Another important area of attention would be    development of resistance against antibiotics.    Besides, poison cont...
   Pharmacovigillance     centre    may   also   cover    problems related to medical devices and    equipment, although ...
Drug regulatory agency of pakistan ---------
Drug regulatory agency of pakistan ---------
Drug regulatory agency of pakistan ---------
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Pakistan Drug Regulatory Authority Structure

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Drug regulatory agency of pakistan ---------

  1. 1. JIBRAN KHAN
  2. 2.  It was the branch of the Government, which was the department for provision of medical services, responsible to frame the health policies and to enforce the same at a national level. It was headed by the Health Minister of Pakistan on democratic level, while controlled by the Federal Secretary as well as the Director General Health of Pakistan on bureaucratic level.
  3. 3.  The Constitution (Eighteenth Amendment) Act, 2010 was unanimously passed with the support of all political parties in the Parliament and was promulgated on 20 April 2010. The Act includes 102 amendments in all, which amended, substituted, added or deleted various provisions of the Constitution of the Islamic Republic of Pakistan.
  4. 4. DEVOLUTION OF MINISTRYOF HEALTH Pakistan Ministry of Health was abolished on 30th of June and a number of Federal Health responsibilities were placed under the jurisdiction of seven other ministries/Division.
  5. 5.  With the passage of the Eighteenthamendment Bill, Health is going to becomeexclusively a provincial subject. According to the constitutional requirements,all the department under the Federal Healthministry are to be absorbed gradually in theProvincial Health administration. This Include theRegistration and Regulation of medicines.
  6. 6. Ministry of National Regulation and ServicesNational Regulation and Services Division Drug Regulatory Agency
  7. 7. Dr. Firdous Ashiq Awan Minister National Regulations and Services Mr. Imtiaz Inayat Elahi SecretaryNational Regulation and Services Division.  Dr. Qazi Saboor Chief Executive Officer Drug Regulatory Agency Of Pakistan
  8. 8.  President issued Ordinance for establishment of Drug Regulatory Agency which was immediately implemented. According to Article 144, DRA consists of Chief Executive and other 7 members including member registration, Medicines, Licensing, Pharmacy, Prices determination, Men power and Legal Affairs.
  9. 9.  Agency for preparations of medicines and issuance of license, Prices determination, Issuance of Quota and governing all matters relating to medicines
  10. 10.  DRA will work under the Policy board which consists of 15 members. Chair person of Board will be Secretary of Federal Health Division where as members will consist of Chief Executive Agency, Representative of Ministry and Law whose grade will not less than 20, Health Secretary of all provinces, Gilgit and Biltastan, Chief Executive will be secretary of board. The time period of all members will base on 3 years and extension will be given for once.
  11. 11.  Dr Hussein A Gezairy, regional director of the WHO for the Eastern Mediterranean, expressed concern over the devolution of the Ministry of Health to the provinces under the 18th Amendment, as it will cast severe impacts on the health sector because the provinces did not have the capacity to provide services to the people.
  12. 12.  According to Pakistan Pharmaceutical Manufacturing Association (PPMA) Ministry to Province under 18th amendment, the Pharmaceutical Industry may face colossal losses, closure of business as well as a Sharp decline of exports. There standpoint is that drug registration, issuing license, etc are Federal Subject.
  13. 13.  Pakistan’s pharmaceutical industry has operated in a legal vacuum since 2010, when a constitutional amendment dissolved the ministry of health and shifted responsibility to the countrys provincial governments. The provinces, however, lacked the funds, facilities and personnel to run such a system. “Registration of 6,000 drugs in the last two years indicates weak control over registration and possibly many drugs might have been registered in return for bribery.
  14. 14.  Antibiotics, hypnotics and injectables such as steroids are sold without prescriptions, and many traditional medicines are unregulated. One health official estimates that Pakistan has more than 400 drug companies, and that 70,000 different drugs are available in the country.
  15. 15.  The government has not yet announced any funding. After The Formation of DRA at least 25,000 Registration Applications are in pending.
  16. 16.  The Cabinet Division has requested the Prime Minister to Transfer the Drug Regulatory Agency (DRA) To the province as guaranteed under the 18 th amendment-a move which could finalize the Devolution process.
  17. 17.  Different countries and regions witness variable drug effects and reactions. This occurs due to differences in diseases, genetics, diet, prescribing practice, and drug manufacturing process impacting its quality, amongst others. Pharmacovigillance is practiced to ensure the quality of medicines is maintained and to prevent any harm to patients.
  18. 18.  Hence through Pharmacovigillance we are able to improve patient care, safety and public health, whilst ensuring a rational and effective use of medicines and therefore also providing cost benefits through use of the medicines. In addition, through this process we are able to encourage better understanding and clinical training, and educate the public on key aspects in medicine.
  19. 19.  Pharmacovigillance efforts are undertaken on a global level through specialized agencies in different regions. For example, in Europe, these efforts are coordinated by EMA (European Medicines Agency) and the NCA (National Competent Medicine Authority). By developing and maintaining a database of adverse reactions to medicines in Europe, these agencies ensure the public at large is adequately protected.
  20. 20.  In the US, the FDA is responsible for coordinating these efforts. In India, the Pharmacovigillance efforts are in progress as instituted by the DCGI, but are still in their infancy. The challenges in standardizing processes for Pharmacovigillance is still being ascertained and conceptualized.
  21. 21.  The large number of adverse-event reports generated by marketed drugs and devices argues for the application of validated computerized algorithms to supplement traditional methods of detecting adverse-event signals. The US-FDA is evaluating a Bayesian data mining system called Multi-item Gamma Poisson Shrinker (MGPS) to enhance the FDAs ability to monitor the safety of drugs, biologics, and vaccines after they have been approved for use.
  22. 22.  Execution of commercial services to support products operating under United States Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS) should be developed in collaboration with the brand team, drug safety and/or regulatory department, the coordinating center, and in compliance with the requirements for the industry.
  23. 23.  WHO strongly suggests establishment of a mechanism for identification, reporting and monitoring of adverse drugs reactions (ADRs) in its member countries. Many countries have responded to this requirement by setting up Pharmacovigillance system.
  24. 24.  Pakistan is in the process of establishing a national Pharmacovigillance center in Drugs Control Organization, Islamabad. Although primarily concerned with pharmaceutical products, Pharmacovigillance system can also be expanded to vaccines, diagnostics, radiologic contrast media, drugs used in traditional practice etc.
  25. 25.  Drug abuse and use in pregnancy and lactation is yet another area to be focused. Initially, reports on all suspected adverse reactions will be considered. Pakistan is also aim to have reports on lack of efficacy and suspected pharmaceutical defects keeping in view the possibility of manufacturing problems and availability of counterfeit drugs.
  26. 26.  Another important area of attention would be development of resistance against antibiotics. Besides, poison control and drug information system will be included once the pharmacovigillance center is well established.
  27. 27.  Pharmacovigillance centre may also cover problems related to medical devices and equipment, although different expertise will be required. The reporting by health care professionals and public will be voluntary. It can however, be a mandatory responsibility of pharmaceutical companies to report suspected adverse drug reactions to the center.

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