DRAP ACT 2012 PDF

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No, F. 9(12)/Legis,—The following Act of Majlis-e-Shoora No, XXI OF An Act to provide for the establishment of Drug Regulatory. Ministry of National Health Services, Regulations and Coordination (XXI of ), read with clause (a) of section 7 thereof and section. Activities in Drug Licensing Division from to pdf, Download. Activities in Drug Licensing Division from AMENDED DRAP SERVICE RULES pdf, Download DRAP Act_pdf, Download. DRAP.


Drap Act 2012 Pdf

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Pakistan is committed that its domestic law and policies should be consistent with .. Drug Regulatory Authority of Pakistan (DRAP) ACT , the Division of. PDF | Drug regulation has been identified as a crucial impediment to the However, after two years, the Drug Act of reestablished direct federal .. with duplicated labels are currently registered (“Non-functioning of DRAP”, ). PDF | This article discusses the development of a more effective pharmaceutical Drug Regulatory Authority of Pakistan (DRAP)Act of

II Application complete in all respect and addressed to Director, Health and OTC Products are to be submitted in the same office through recorded post or in person or through the representative against a receipt.

IV New manufacturer or importer of Alternative Medicines and Health Products may also submit applications under the rules. V All applications shall be evaluated as per laid down criteria.

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Current status and future prospects of pharmacovigilance in Pakistan

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DRAP enlistment must for medicines and raw materials import

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Popular in Health Treatment. Ranjeet Kumar. Karl Jimenez Separa. Leslie Luscombe. Pinkpulp Pussypulp. The evaluation mechanism is known as pharmacovigilance, which involves detection, assessment, understanding and prevention of adverse drug effects [ 3 ].

The aim of pharmacovigilance is to identify a possible harm, which is then analyzed and investigated to minimize the hazard.

This information is further communicated to the healthcare professionals and general public to improve the healthcare and patient safety [ 4 ]. Why pharmacovigilance is important? Medicines, during clinical trials are evaluated for their safety profile on carefully selected individuals only. However, after their release in the market, medicines are monitored during post marketing surveillance phase which relies on spontaneous reporting of adverse drug reaction ADR [ 2 ].

It happens due to number of reasons, such as the limitation of scope of clinical trial data to a specific population sample, patients may experiencing co-morbidities or using other drugs, off-label use of drugs or variation in the genetic makeup of individuals [ 6 ].

Due to Thalidomide disaster in early 60s, thousands of babies were born with no or malformed limbs [ 7 , 8 ]. Following this incident, in , the WHO, established a program for international drug monitoring for early detection of ADRs with other member countries [ 9 ].

WHO also recommended every country to establish a national pharmacovigilance center to identify medicines which are more prone to exhibit ADRs. Currently, member countries are working with UMC in Sweden including both developed and developing countries. This lower number of pharmacovigilance systems in LMICs is due to lack of resources and infrastructure [ 10 ].

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Pharmacovigilance in Pakistan Pakistan ranks 6th among the most populous country and has a population of about In , it was mentioned in the National Drug Policy of Pakistan to establish a drug monitoring and surveillance system [ 13 ]. However, the work on pharmacovigilance did not started until , when an adverse drug reaction ADR due to a locally produced drug Isotab 20 mg Isosorbide mononitrate, batch number J resulted in the deaths of more than patients in Lahore [ 14 ].

Following the incident, the Supreme Court of Pakistan ordered the government to establish an independent drug regulatory authority WHO, Drug Regulatory Authority of Pakistan DRAP also established a National Pharmacovigilance Centre in as well as other regional pharmacovigilance centres in the country in [ 15 , 16 ].Pakistani policy makers should select policies that are aligned with the objectives and suit the context of Pakistan healthcare system.

Referencing to incorrect choice of reference countries, particularly using high-income countries and countries with different market structure may lead to high medicine prices.

The budget shall be approved by the Policy Board of the Authority. Front Pharmacol. Andreea Corina. It must be noted that fixing prices for medicines by regulators is commonly practiced elsewhere. Apart from this, there is little research on pricing, and no attempt at periodic updating of information.

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