In accordance with Drugs Act 1976; all drugs/vaccines/sera for consumption in Pakistan are to be registered. Registration and local manufacturing licenses are given by the Ministry of Health, Government of Pakistan after due process as per the guidelines and SOPs laid down. Brief procedure is:

• Approval of production site
• Approval of building and plant layout plan before commencement of civil works
• Request to carry out the inspection after completion of civil works and installation of machinery and equipment. Simultaneously; product registration dossier will be submitted.
• Inspection of manufacturing facility.

After physical inspection and satisfactory report from Ministry of Health, Manufacturing License is granted along with registration of product. Manufacturing and marketing cannot be started without above said license.The Health department through PD/ BoD will ensure timely availability of license and other certification deem necessary for product use.