Islamabad - Drug Regularity Authority of Pakistan (DRAP) – amending the Drug Act – has introduced strict punishments for violation of prescribed rules, an official said on Tuesday.
The amendment has been made following the recommendations of the policy board while the new rules will be implemented on schedule-II and III drugs.
An official said that the new punishment has been divided into three categories and different penalties have been set for the manufacturer, distributor and retailer.
According to the new policy, heavy monetary fines will be charged on businessmen in pharmacy dealings.
As per notification available with The Nation, “In pursuance of Section 35 of the Drug Regularity Authority of Pakistan Act, 2012 (XXI of 2012), the federal government, on the recommendations of the policy board, is pleased to direct that the following amendments shall be made in schedule-II and schedule-III of the said Act.
No person shall himself or by any other person on his behalf sell or offer the sale, any drug in the finished form over and above the maximum retail price as may be fixed by the federal government or determined under the provisions of the Drug Pricing Policy, as notified by the authority.”
The notification said, “On recovery for overcharging, where any person has been convicted under provisions of paragraph (3) of heading, ‘A’ of schedule –II, he shall be liable to the punishment.”
For manufacturer or importer, if found overcharging on drugs, he will be liable to pay fine equal to the overcharged amount based on the countrywide average sale of the respective drug in the last three financial years along with 20 per cent surcharge.
A fine of Rs2 million to Rs10 million on the drug distributor, if he will be found in overcharging, while the retailer will have to pay the penalty of Rs0.1 million on overcharging.
Spokesperson of Ministry National Health Services (NHS) Sajid Hussain talking to The Nation said that the new amendment has been made to regulate and control the overcharging on medicines from its import to sale in the market. He said heavy financial penalties would be imposed for violation of the new law.
Meanwhile, DRAP also included 12 more drugs in the list of scheduled drugs which will result in the reduction in prices of drugs by 20 per cent of the Consumer Price Index (CPI) from the category of 70 per cent for non-scheduled drugs to 50 per cent for scheduled drugs, thus moved to stricter regulation.
As per the statement, Drug Pricing Policy-2015 contains 323 drugs as scheduled drugs and the federal cabinet approved maximum retail prices of drugs fixed in accordance with the provisions of the policy or lower prices demanded by the manufacturers or importers for new therapies/entrants whose registrations are pending due to non-fixation of prices of these drugs.
These prices are only applicable to those drugs whose registrations have not yet been issued and are new drug formulations.
This will ensure availability of new therapies for patients suffering from Hepatitis-C, major depressive disorder (major depression), anxiety, epilepsy, psoriasis, diabetes, hypertension, etc.
Marketing of new drugs will also enhance competition and availability of drugs in the market because prices of drugs, like other consumer items, are affected by the market dynamics with respect to the availability of competitors. Therefore the news items and release on some channels were deliberate attempts of misleading these media sources and spreading baseless allegations and confusing public offices too for groups’ vested interests.
Chief Executive Officer DRAP Dr Aslam Afghani talking to The Nation denied the 15 per cent increase in the drug price.
He said that 12 more drugs have been included in the scheduled category which lower price of the medicine, he said.