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nt. In the name of Allah, indefinitely beneficent, boundlessly merciful. The Quran says. THE MAN GETS FOR WHAT HE STRIVES HARD. ????????????????????. “ Think hundred times before you decide. Once you decided, stand by it like a stone” Quaid -e- Azam. TOPIC.

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In the name of Allah, indefinitely beneficent, boundlessly merciful

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In the name of allah indefinitely beneficent boundlessly merciful

nt

In the name of Allah, indefinitely beneficent, boundlessly merciful


The quran says

The Quran says..

THE MAN GETS FOR WHAT HE STRIVES HARD


In the name of allah indefinitely beneficent boundlessly merciful

????????????????????

“ Think hundred times before you decide.

Once you decided, stand by it like a stone”

Quaid -e- Azam


Topic

TOPIC

Why herbal medicines should get registered in D R A P………?


Presented by

Presented by

Noor Muhammad Maher

B.Pharm,

LLB,

M.A (International Relations)


Portfolios

PORTFOLIOS

  • Media Secretary PPA

  • Consultant – Goldsheff International Lahore

  • Advisor – Medibon Pharmaceuticals Lahore

  • Consultant – Hashir Surgical Peshawar

  • Ex. Regulatory Affairs Manager – Export/Import/Local

    (Ferozsons, BF Biosciences, Medipak, CCL)

  • Ex. Medico legal Executive - FDA


D r a p

D R A P………?

Drug Regulatory Authority Pakistan

12 November 2012

President signs Drug Regulatory Authority Bill


D r a p1

D R A P………?

Drug Regulatory Authority Pakistan

Organization

National Regulations And Services Division (NRSD)

Chairperson

&

13 Directors


D r a p d rug r egulatory a uthority p akistan

D R A P………?Drug Regulatory Authority Pakistan

Composition of authority - 13 Directors

  • Director Pharmaceutical Evaluations & Registration.

  • Director Drug Licensing

  • Director Quality Assurance & Laboratory testing

  • Director medical devices and medical cosmetics

  • Director Biological Drugs

  • Director Controlled drugs

  • Director Pharmacy Services

  • Director Health & OTC Products (non Drugs)

  • Director Costing & Pricing

  • Director Budget & Accounts

  • Director Administration, Human Resource & Logistics.

  • Director Legal Affairs

  • Director Management of Information Services


D r a p2

D R A P………?

POLICY BOARD

The General Director, Administration & Monitoring

(Members)

  • National Regulations And Services Division (NRSD) Chairperson

  • CEO Member

  • Representative of ministry of law & justice Member

  • Secretary of concerned Department Govt of Balochistan Member

  • Secretary of concerned Department Govt of Sindh Member

  • Secretary of concerned Department Govt of KPK Member

  • Secretary of concerned Department Govt of Punjab Member

  • Secretary of concerned Department Govt of GilgitBaltistan Member

  • Representative of Federally Administered Tribal Area Member

  • Six experts from Public & Private Sector with equal representation from each province, these members from different specialties, Members


D r a p3

D R A P………?

Drug Regulatory Authority Pakistan

Salient features

  • An autonomous body

  • One window operation

  • Symbol of control, regulate, enforce, implement, legal framework,

  • expedite the registration procedures,

  • Fast track registrations

  • Protection to Pharmaceutical industry, patient’s rights, Health care,

  • Enhance Pakistan’s image,

  • Harmony in inter provisional regulatory affairs,

  • Establishment of policy board

  • Equal representation of public & private sector.


D r a p4

D R A P………?

Drug Regulatory Authority Pakistan

Aims & objectives

  • To prevent the sale of fake, substandard & non registered medicines/ Therapeutics

  • Stop hoarding,

  • To provide a competitive a edge in advance manufacturing technologies like USA, Canada

  • To focus on ISO, cGMP, GLP, GSP etc.

  • To improve the Export standards to create foreign exchange opportunities.

  • To compete the Global market with the theme “ MADE IN PAKISTAN”.

  • To bring harmony in manufacturing, storage, distribution, sales, exports, imports of medicines/ Nutraceuticals/herbal remedies/Unani/Ayuvedic.

  • Develop ethical criteria for drug promotion, marketing , advertising .

  • Registration of herbal medicines to acknowledge, recognize & legalize the role of alternative medicines in modern era.

  • To improve manufacturing standards, scope, worth & Status of pharma related industry

  • To build the confidence of patients, Doctor, Hakeem and allied departments.

  • To develop healthy competition on quality, efficacy & affordability.

  • To build & establish the trust on alternative medicine through global standards.

  • To provide customer friendly environment for all segments of Pharma manufacturing industry.                                                                                    


D r a p d rug r egulatory a uthority p akistan1

D R A P………?Drug Regulatory Authority Pakistan

Composition of authority - 13 Directors

  • Director Pharmaceutical Evaluations & Registration.

  • Director Drug Licensing

  • Director Quality Assurance & Laboratory testing

  • Director medical devices and medical cosmetics

  • Director Biological Drugs

  • Director Controlled drugs

  • Director Pharmacy Services

  • Director Health & OTC Products (non Drugs)

  • Director Costing & Pricing

  • Director Budget & Accounts

  • Director Administration, Human Resource & Logistics.

  • Director Legal Affairs

  • Director Management of Information Services


D r a p5

D R A P………?

Issue

D R A P………?

or

T R A P………?


Ptpma urgent steps

PTPMA - Urgent steps

  • Arrange the Seminars for awareness

  • Training sessions for staff about regulatory requirements &updated knowledge,

  • Invitations to  DRAP & Governments officials for counseling & Guidance,

  • Provincial regulators representatives should be invited to build the understanding about the herbal medicines.


Ptpma

PTPMA

Goals

  • To establish high standards manufacturing Plant

  • To start the PTPMA role as self regulatory body in 1 yr .

  • To be establish PTPMA testing Labs in 2 yrs.

  • To establish R&D Lab for products validation,

  • Regulatory knowledge sharing, include share the raw material developments, LC issues.

  • To publish the Tibbi Pharmacopeia Pakistan.


Mission

Mission

By the grace of almighty ALLAH to converge our selves in to a most trusted and reliable Pharma Industry through our dedicated & motivated team members, high tech state of art manufacturing facility and top quality products as per cGMP standards globally.


Ptpma vision

PTPMA Vision

To prove ourselves as emerging new leader with Human Health Care as our prime focus.


Thank you

THANK you


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