Sub: GMP Inspection for the purpose of Registration / Renewal of Pharmaceuticals products registered by the National Pharmaceutical Control Bureau (NPCB) of Malaysia.
You may be aware of the fact that the Malaysian National Pharmaceutical Control Bureau (NPCB) has proposed issuing a notification mandating inspection/plant audit by Malaysian Health Authorities effective July 2016 of all non-PIC/S countries including India. So far, similar to Singapore, Malaysian Authorities have been giving product registration to Indian companies, which are approved by FDAs of developed countries, like USA, UK, Australia and also PICs approved company without separate inspections.
We would like to inform you that immediately upon information regarding the proposed notification, PHARMEXCIL immediately took up the matter with the Ministry of Commerce & Industry, Department of Commerce, Government of India for redressing the issue through appropriate Government Forums. Simultaneously, the matter was also taken with our High Commission of India at Kuala Lumpur and the local distributor, who met the officials of our High Commission and explained the details.
We have been informed by our High Commission that our High Commissioner had taken up the matter with the Hon'ble Minister of Health of Malaysia and also met the Director of National Pharmaceutical Control Bureau (NPCB) of Malaysia in March 2016 itself, to address the concerns of Indian exporters / pharmaceutical Association. We also understand that the matter is being reviewed internally after our intervention from our High Commissioner. However, our Mission feels that the Pharma lobby outside Malaysia are also clearly active in Malaysia trying to influence the Malaysian Policy-makers against Indian products.
In view of the above developments, our Mission strongly suggests that our Pharmaceutical Associations and major pharmaceutical companies mount their own pressure on the Malaysian Government on their own to support our Mission in respect of the recent policy initiatives in Malaysia.
As your company is one of the top exporter to Malaysia, Pharmexcil would like to suggest that you may urgently visit Malaysia and also coordinate through your local distributor / local office to take up the matter strongly from your end. You may also exert pressure through the Local Associations in Malaysia for redressal of the issue.
Pharmexcil would be ready to take a delegation to Malaysia, if exporter-members suggest.
We look forward to your urgent views / feed back on this subject and further steps proposed / taken.
Thanks & regards
Dr. P V Appaji
Director General
