ISLAMABAD, Aug 19: Criticism on hasty deliberation process to amend the Drug Act 1976 forced the government here on Monday to form a committee comprising all stakeholders to review the act.
A source told Dawn that the meeting was called to suggest amendments in the act to make it more business-friendly.
All the stakeholders, including representatives of the health ministry and four provincial health departments, Pharma Bureau, Pakistan Pharmaceutical Manufacturers Association, Pakistan Chemist Association and different consumer rights watchdogs, were invited to attend the meeting which was presided over by the director-general of health, Maj-Gen Mohammad Aslam (retired).
However, the participants, protesting the late delivery of invitations of the meeting, argued that since the process of amending the act was a very serious business, therefore, ample time and opportunity should be provided to every stakeholder to study and suggest improvements in the amendments.
They said: “Owing to late delivery of the invitation, they made no preparations for the meeting.” They requested the chair to allow them to deliver presentations.
The committee will again meet on August 23 to finalize the amendments.
The source said that the meeting was held under the directives of the economic coordination committee (ECC). The committee so formed has been entrusted with the job to review all the 45 sections of the Drug Act 1976.
One of the participants on condition of anonymity said the purpose of the meeting was to bring the act in line with the deregulation policy.
Meanwhile, a source said the amendments in the act were necessary since during the last three years, a huge growth had been witnessed in the pharmaceutical industry which expanded with a huge investment of Rs10 billion despite the fact that negative investment trend was noticed in other sectors.
He said it was a general feeling among the pharmaceutical manufacturers that introduction of amendments in the act would make it more business-friendly while making the law compatible with the provisions of trade-related intellectual property rights (TRIPS) being imposed in 2005.
Explaining the Drug Act, the source said: “The act regulates all the aspects of the pharmaceutical industry like import of raw material, export of medicines, sale, manufacturing and registration of drugs etc.” The Drug Act of 1976 also ensures availability of safe, effective and quality products at reasonable prices in Pakistan.
The source said under the law comprehensive rules had been framed on different aspects of drug control. The law provides a system of licensing of each manufacturing house registration of all finished drugs with a view to ensure efficacy, safety and quality of drugs sold in the market.
For licensing and registration of medicines, the Central Licensing and Registration Board consisting of experts from the field of medicines and pharmacy have been established while the quality control was ensured through inspection and laboratory services.
The law also provides for compliance of good manufacturing practice by the manufacturers, for fixing drug prices and for regulation of imports, exports and sale of drugs.































