PR No.170 Islamabad: March 18, 2017
Drug Regulatory Authority of Pakistan is committed to provide safe effective and quality medicine with rational use and prescribing practices and there will be no compromise on quality of medicine. Its joint efforts and actions will continue till clean up of spurious or sub standard drugs from the country.
An inspection panel comprising of Federal and provincial drug inspectors raided the premises of a pharmaceutical company in AJK, on complaints and declaration of substandard drugs, declared by DTL, Lahore.
This panel inspected the Vetcon Pharmaceutical Bimber Azad Jammu and Kashmir comprising of Chief drug inspector, AJK, Add. Director National Biological Laboratory, Additional Director QA and Federal drug inspector Islamabad.
There was poor hygienic conditions, lack of pressure gauges in the areas, deficiency in documentation, technical Staff, etc. The firm requested for voluntary stoppage of the production of veterinary medicines.
However, panel recommended for suspension of drug manufacturing license for six months. During this period firm was directed yo undertake repair & maintenance of the required areas, make changes as per GMP requirements and also compliance to other requirements, improvement in documentation and quality control and in process checks and other facilities are addressed too, as indicated by the panel for GMP compliance, the premises will be re-inspected, as soon the firm submits its compliance report to DRAP.
DRAP efforts for drug quality and GMP compliance are being enforced through its Central licensing board. The press statement further inform that in its 252 meeting of Central Licensing board was held under the chairmanship of Director Licensing, where manufacturing licences of four firms were suspended/ cancelled due to non compliance reports. Around 30 manufacturing licences of various firms on raids and non compliance and violations of rules under Drug Act and Drap Act have been suspended/ cancelled during 2016 and no compromise was made on safety of patients and all pressures, threats and media trials were boldly faced by DRAP.
All the chief Drug inspector of provincial governments and experts of drug participated in the meeting.
3 new Drug Manufacturing Licences were granted. 5 license were renewed. On addition various new site plans and additional sections approvals were granted too.
Drug Manufacturing Licence of 4 firms were cancelled on reports of non compliance of GMP. Whereas 1 licence was suspended for 6 months on non compliance of GMP.