ISLAMABAD: Drug Regulatory Authority of Pakistan (DRAP) has recently announced to fix the maximum retail prices (MPR) of 253 drugs on the basis of its packing sizes with certain other conditions.
According to a notification issued by DRAP, the decision was made with the approval from the Federal government and in the exercise of powers conferred by clause (a) of section 7 of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012) read with section 12 of the Drugs Act, 1976 (XXXI of 1976).
The maximum retail price will be subject to the conditions like importers and manufacturers of the drug will furnish MRP of the drug to the Division of Costing and Pricing of the DRAP while the MRP will be printed on the label in the manner prescribed by the Drugs (Labeling and Packing) Rules, 1986.
Similarly, MRP as mentioned in column (4) of the notification table will not be applicable on drugs whose registrations under sub-rule (4) of rule 29 of the Drug (Licensing, Registration and Advertising) Rules, 1976 were issued before the issuance of this notification, unless otherwise stated expressively, the notification said.
As per the notification, a four-column table has been formed to fix maximum retail prices specified in column 4 of the table on which the drugs specified in column 2 having packing sizes specified in column 3, will be sold, subject to the conditions specified in paragraph 2 of the notification.
These medicines were related to high blood pressure, cancer, hepatitis and other diseases.
It is pertinent to mention here that the Ministry of National Health Services had referred the matter of fixing drug prices as per packing size to the federal cabinet one month back, which was approved by the cabinet after detailed discussion.
Meanwhile, an official of DRAP said that the authority will officially launch its Pakistan Integrated Regulatory Information Management System (PIRIMS) from November 2 to facilitate the pharmaceutical industry.
He said that the Integrated Regulatory Information Management System will ensure easily online linkage of pharmaceutical companies and applicants with the authority.
He said that this system will promote transparency while it will be able to further improve the functioning of DRAP besides monitoring the performance of DRAP’s officers and staff.
He said that Integrated Regulatory Information Management System has been established with having incorporated mechanisms among various divisions of DRAP including licensing, registration, lab testing, inspection and pharmacovigilance.
The official said that DRAP is on the way to become a world-class regulatory organization at par with international standards and best practices, through effective management strategies for implementations of regulations and their enforcement throughout the country.
He said that DRAP is adopting the globally harmonized science-based standards for the evaluation, registration and monitoring of safety, quality and efficacy of therapeutic goods.
He said that the harmonization of regulatory standards will improve the acceptance of products in international markets, enhance product quality and will ultimately promote public health.
He said that several innovative steps have been taken for maintaining the quality and availability of necessary medicines in the country. He said that as a national regulatory body, DRAP ensures access to safe, quality and efficacious therapeutic goods at affordable prices in the country.
-Courtesy by APP