Embed Size (px)
Citation preview
History DRAP Composition of DRAP Function of DRAP Policy board Funds and budget of DRAP Real picture of DRAP Other agencies References
2
Before twenties Impure and adulterated food
1906 pure food and drug act
1938 food and drug administration (FDA)
1976 drug act for all authorities
3
Mrs. Saira Afzal Tarrar Minister
National Regulations and Services
Muhammad Ayub Sheikh Secretary
National Regulation and Services Division.
Mr. Muhammad Arshad KhanChief Executive Officer
Drug Regulatory Authority Of Pakistan
Formation Of AuthorityFormation Of Authority
4
Drug Regulatory Authority of Pakistan (DRAP) has been established in NOV13,2012 for effective coordination and enforcement of the Drugs Act, 1976.
The Drug Regulatory Authority of Pakistan (DRAP) is an autonomous body working under the administrative control of Ministry of National Health Services.
The Authority is expected to regulate, manufacture, import, export, storage, distribution and sale of therapeutic goods.
5
The authority may set up its establishments including sub-offices and laboratories at province capital and such other places from time to time.
The existing Federal Drug Control Administration(FDCA)
and sub offices set up in all provinces are called Central Drug Laboratory
For example;• National Control Laboratory on Biological, Karachi • Federal Drug Surveillance Laboratory, Islamabad
6
Chief executive officer
Director Pharmaceutical Evaluations and Registration
Director Drug Licensing
Director Quality Assurance and Laboratory Testing
Director Medical Devices and Medicated Cosmetics
Director Biological Drugs
The authority shall consists of;
7
Director Controlled Drugs
Director Health and OTC Products (non-drugs)
Director Costing and Pricing
Director Budget and Accounts
Director Administration, Human Resource and Logistics
Director Legal Affairs
Director Management Information Services
8
Evaluation and Registration of pharmaceutical drugs, medical devices and medicated cosmetics, alternative medicines And Licensing of Drug Manufacturing facilities.
Regulation of controlled drugs and biological drugs.
9
DRA will work under the Policy board which consists of 15 members.
Chair person of Board will be Secretary of Federal Health Division
Members will consist of Chief Executive of Agency, Health Secretary of all provinces.
Functions of policy board Monitor and supervise all function of the DRAP. Approve the budget of the DRAP. Determine all fees and leaves.
10
Loans and grants from the national and international agencies received by the federal government and provincial government to finance the function of the authority.
Grat-in aid in term of salaries and retirements benefits of the existing staff provided by the federal government.
Charges and fees collected by the authority to recover the cost of regulated activities
11
Central research fund collected from pharmaceutical industry.
The authority shall, in respect of each financial year prepare an annual budget for approval from board and shall sent to the federal government for appropriate provision and allocation.
12
Dr Hussein, 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.
The provinces, however, lacked the funds, facilities and personnel to run such a system.
13
According to Pakistan Pharmaceutical Manufacturing Association (PPMA) Ministry to Province under 18th amendment, the Pharmaceutical Industry may face massive losses, closure of business as well as a Sharp decline of exports.
“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
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
The government has not yet announced any funding.
After The Formation of DRA at least 25,000 Registration Applications are in pending
15
Country Drug Regulatory Authority
united states of Americaunited states of America •The Pan American Health The Pan American Health Organization (PAHO)Organization (PAHO)•Food and Drug Food and Drug Administration (FDA)Administration (FDA)
United KingdomUnited Kingdom National Institutes for Biological National Institutes for Biological Standards and Control (NIBSC)Standards and Control (NIBSC)Medicines and Healthcare Products Medicines and Healthcare Products Regulatory Agency (MHRA)Regulatory Agency (MHRA)
IndiaIndia Central drugs standard control organization (CDSO):
16
PPMA www.ppma.org.pk Pharma Bureau www.oicci.com WHO www.who.int Ministry of Commerce
www.commerce.gov.pk
17
18
