DRAP cancels licences of four drug manufacturers
Around 30 licences suspended last year for violating good manufacturing practices
Drug Lawyers Forum says substandard medicine is killing patients in Punjab. STOCK IMAGE
ISLAMABAD:
Drug Regulatory Authority of Pakistan (Drap) has stopped four companies from making medicines in addition to the 30 firms that faced similar action last year.
In its 252nd meeting of central licensing board, the drug regulator suspended licences of four manufacturers due to noncompliance of rules.
Around 30 manufacturing licences of various firms were suspended last year following raids and detection of violations of rules under Drug Act.
All chief drug inspectors of provincial governments and expert pharmacists participated in the central licensing board meeting. The board also granted three new drug manufacturing licences and five licences were renewed.
Drug manufacturing licence of firms was cancelled on reports of non-compliance of good manufacturing practices (GMP) whereas one licence was suspended for six months due to non-compliance of GMP.
According to a statement of the authority, Drap was committed to provide safe effective and quality medicine with rational use and prescribing practices and there would be no compromise on quality of medicine. Its joint efforts and actions will continue till cleanup of spurious or substandard drugs from the country.
Meanwhile, an inspection panel comprising federal and provincial drug inspectors raided the premises of a pharmaceutical company in Azad Jammu and Kashmir (AJK), on complaints and declaration of substandard drugs, declared by DTL, Lahore.
This panel comprising chief drug inspector, AJK, additional director National Biological Laboratory, Additional Director QA and federal drug inspector Islamabad inspected the Vetcon Pharmaceutical Bimber Azad Jammu and Kashmir.
There were poor hygienic conditions, lack of pressure gauges in the areas, deficiency in documentation, and technical staff. The firm requested for voluntary stoppage of the production of veterinary medicines. However, panel recommended for suspension of drug manufacturing licence for six months.
During this period firm was directed to undertake repairs and maintenance of the required areas, make changes as per GMP requirements and also compliance of other requirements, improvement in documentation and quality control and in process checks and other facilities are addressed too.
Published in The Express Tribune, March 19th, 2017.
Drug Regulatory Authority of Pakistan (Drap) has stopped four companies from making medicines in addition to the 30 firms that faced similar action last year.
In its 252nd meeting of central licensing board, the drug regulator suspended licences of four manufacturers due to noncompliance of rules.
Around 30 manufacturing licences of various firms were suspended last year following raids and detection of violations of rules under Drug Act.
All chief drug inspectors of provincial governments and expert pharmacists participated in the central licensing board meeting. The board also granted three new drug manufacturing licences and five licences were renewed.
Drug manufacturing licence of firms was cancelled on reports of non-compliance of good manufacturing practices (GMP) whereas one licence was suspended for six months due to non-compliance of GMP.
According to a statement of the authority, Drap was committed to provide safe effective and quality medicine with rational use and prescribing practices and there would be no compromise on quality of medicine. Its joint efforts and actions will continue till cleanup of spurious or substandard drugs from the country.
Meanwhile, an inspection panel comprising federal and provincial drug inspectors raided the premises of a pharmaceutical company in Azad Jammu and Kashmir (AJK), on complaints and declaration of substandard drugs, declared by DTL, Lahore.
This panel comprising chief drug inspector, AJK, additional director National Biological Laboratory, Additional Director QA and federal drug inspector Islamabad inspected the Vetcon Pharmaceutical Bimber Azad Jammu and Kashmir.
There were poor hygienic conditions, lack of pressure gauges in the areas, deficiency in documentation, and technical staff. The firm requested for voluntary stoppage of the production of veterinary medicines. However, panel recommended for suspension of drug manufacturing licence for six months.
During this period firm was directed to undertake repairs and maintenance of the required areas, make changes as per GMP requirements and also compliance of other requirements, improvement in documentation and quality control and in process checks and other facilities are addressed too.
Published in The Express Tribune, March 19th, 2017.