1 / 19

In the name of Allah, indefinitely beneficent, boundlessly merciful

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.

wilbur
Download Presentation

In the name of Allah, indefinitely beneficent, boundlessly merciful

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. nt In the name of Allah, indefinitely beneficent, boundlessly merciful

  2. The Quran says.. THE MAN GETS FOR WHAT HE STRIVES HARD

  3. ???????????????????? “ Think hundred times before you decide. Once you decided, stand by it like a stone” Quaid -e- Azam

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

  5. Presented by Noor Muhammad Maher B.Pharm, LLB, M.A (International Relations)

  6. 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

  7. D R A P………? Drug Regulatory Authority Pakistan 12 November 2012 President signs Drug Regulatory Authority Bill

  8. D R A P………? Drug Regulatory Authority Pakistan Organization National Regulations And Services Division (NRSD) Chairperson & 13 Directors

  9. 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

  10. 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

  11. 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.

  12. 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.                                                                                    

  13. 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

  14. D R A P………? Issue D R A P………? or T R A P………?

  15. 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.

  16. 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.

  17. 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.

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

  19. THANK you

More Related