ISLAMABAD: Parliamentary Secretary for National Health Services, Regulations and Coordination Dr Darshan Wednesday informed the National Assembly that the government was promoting sale of effective and quality generic drugs at affordable prices to the patients.
Replying during Question Hour in the House, Dr Darshan said that after the promulgation of Drug Regulatory Authority of Pakistan (DRAP) act, registration process of generic drugs has been revamped and strengthened to ensure safety, efficacy and quality of drugs.
He said that to further improve the system many steps have been taken and are in different phases of implementation including that manufacturing of generic drugs is being encouraged and facilitated.
Priority facilitation is being given to the manufacturers of generic drugs and to make their investment fruitful in the shortest possible time. For that purpose, meetings of the various boards are being held frequently, he added.
Dr Darshan further said that Pharmaceutical Cell has been established to institutionalize and harmonize evaluation of pharmaceutical registration dossier of generic drugs.
Parliamentary secretary said that for approval of post registration variations of already registered drugs, standard Operating Procedures have been prepared and uploaded on DRAPs website for keeping applicants and licenses updated.
He said that rules pertaining to contract manufacturing of drugs have been amended to promote generic drug manufacturing. Plans are underway to introduce electronic comprehensive technical document format to evaluate registration dossiers for generic drugs for their safety, efficacy and quality as practiced in the developed countries.
Dr Darshan said that guidelines are being developed to introduce bio-equivalence studies as a per-requisite for registration of generic drugs to ensure that a generic drug is essential similar to that of innovators' product.
He said that all the previous registered generic drugs will be reviewed in terms o safety, efficacy and quality.
The government has taken several steps to provide medicines to the common man at affordable prices included manufacturing of generic drugs is being encouraged and facilitated, as by and large the generic products are cheaper than the branded drugs, Dr Darshan said.
He said that priority is being also given to grant new licenses to increase production of drugs that will result in the reduction of prices.
Dr Darshan said that a policy to rationalize the prices of drugs in under consideration of the policy board of drug regulatory authority, Ministry of National Health, Services, Regulation and Coordination.
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