ISLAMABAD: The Drug Regulatory Authority Pakistan (DRAP) has started taking strategic steps for ensuring access of quality, safe and effective medicines at affordable price and other therapeutic goods to the people of the country.
According to an official of DRAP, such changes are apparent in the form of efficient registration process of drugs, better market surveillance for stopping the menace of counterfeit, spurious and falsified drugs and therapeutic goods, and preparation and implementation of new regulations.
He said that the DRAP’s registration board considers new formulations, anti-cancer drugs, antiretroviral drugs, Thalassemia, blood products and blood bags etc., in order to provide latest treatment options to the patients in need.
He added new drugs for treatment of Hepatitis-C were registered keeping in view the prevalence of the disease in the country.
In addition, addressing to patient needs for drugs suffering frequent shortages, also get preferential registration to avoid life saving essential drug’s shortages. Similarly, a new policy for orphan and critically needed drugs has been developed.
He said that successful registration of Sofosbuvir and Ledipasvir, and Daclatasvir after assuring the appropriate quality as per international standards was done through rigorous yet robust registration mechanism.
He said that in a combined effort by Ministry of National Health Services, Regulation and Coordination and DRAP, these drugs have been made available in the country at most economical rates. Furthermore, registration priority has been given to life saving medicines like Fludrocortisone, D-Pencillamine, Hydrochlorothiazide and Nitrofurontion.
He said that in accordance with Drug Pricing Policy 2015, MRPs of 192 new drug formulations and 198 additional packs of registered drugs were determined in year 2016, subsequently approved by Federal Government.
Similarly, in 2017, Federal Government granted the approval of 113 cases of fixation of prices of new drug formulations and 132 additional packs of registered drugs.
He said that new initiatives of Costing and Pricing has been made by incorporation of strict punishment to control black marketeering and over charging on drug prices by amendments in schedule II and III of DRAP Act, 2012.
He said that authenticity and quality of drugs in the market is further assured by introduction of 2D Barcodes on the packaging of the drugs. Furthermore, a complete track and trace system enables regulators and manufacturers to monitor the movement of the drugs and ensuring that no falsified drug has been sold.
He said that the resultant approaches for regulation of therapeutic goods including medical devices, Health and OTC products, and Pharmaceutical and Biological drugs contributed towards the overall increase in the efficiency of the authority, that is evident from the recently published reports of WHO and USP PQM determining DRAP as the fastest growing regulatory authority in the region.
He said that long standing pendency in its registration and licensing division and long queue of public health urgency drugs also created problems in form of shortages of life-saving medicine.
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