Malaysia - Pharmaceutical Products: To ensure quality, safety and efficacy of imported pharmaceutical products, Malaysia has issued a notification which describes that GMP inspection by Malaysia Drug Control Authority (DCA) is compulsory for pharmaceutical manufacturer from non-PIC/S countries including those which have been inspected by any *PIC/S Participating Authority (*PIC/S: Pharmaceutical Inspection Co-operation Scheme). Proposed date of enforcement is 1 July 2016 for Registration of new pharmaceutical products and Renewal of registration for existing pharmaceutical products will be 1 January 2017. India is 10th largest exporter of pharmaceutical products to Malaysia - USD 0.065 Billion, which accounts for 4.24% of Malaysia’s imports of the item. The top 9 countries exporting pharmaceutical items to Malaysia are Germany, USA, Switzerland, France, Australia, China, Ireland, Singapore and United Kingdom, which accounts of 12.91%, 11.03%, 8.53%, 8.31%, 6.89%, 5.13%, 4.94%, 4.74% and 4.40% of Malaysia’s total import of the item. All these 9 countries are member of PIC/S: Pharmaceutical Inspection Co-operation Scheme and holds 66.88 share of Malaysia imports, whereas India is not member of PIC/S: Pharmaceutical Inspection Co-operation Scheme. |