This is with reference to the direction of the Supreme Court to form a drug regulatory authority in the backdrop of PIC drug reaction fiasco in Lahore. I want to invite the attention of executives of health ministry and legal fraternity to certain solution to get out of this mess. Previously, both the provincial government of the Punjab and federal government have been levelling allegations against each other on the deaths of approximately 150 patients due to tainted substandard medicine used by PIC patients. After the enactment of 18th amendment of the constitution, the issue to regulate the manufacturing, licensing, registration and sale of drugs is lying in the air hanging.
Being in the profession of legal practice of drugs for the last more than 30 years, it is my considered opinion that section 5 of Drug Act 1976 deals with regulating the manufacturing of drugs by Central Licensing Board of the federal government which is a high powered committee regulating the pharmaceutical industry. There is also Drug Registration Board under the Drug Act 1976.The purpose of Drug Regulatory Authority is to regulate the manufacturing of drugs for which provision of law is already provided under section 5 of Drugs Act 1976 which means that Central Licensing Board so set up under section 5 of Drugs Act is in fact a regulatory authority which is protected by the article 270 AA(6) of Constitution of Pakistan.
Even the board set up under section 5 of the Drugs Act 1976 is a regulatory authority as such and can be treated as the Drug Regulatory Authority established under the federal law ie, Drug Act 1976. It is misconception prevailing in the society that there is no system of check and balance in connection with manufacturing of quality drugs.
Now the question arises where the actual fault lies. From where we will bring “angels” to run the proposed DRA which will resolve all the drug related issues and prove to be a panacea for all the ills. It is the need of the hour to remove any deficiency in Central Licensing Board and notify officially the Central Licensing Board as the drug regulatory body till some improved version of it or necessary regulatory body is made so that vacuum may be filled which has created confusion and hindering the implementation of Drugs Act 1976.
There is not much need to make new laws every now and then; rather there is a dire need to implement Drug Act 1976 and abide by the constitution in letter and spirit.
SHEIKH MUHAMMAD NAWAZ
Lahore
Good effort and eye opener for those who make hue and cry for DRA and do not know the law.
It is very good approach that you have pointed out that Drug Act 1976 is in place and laws are available to follow. But, I would like to know that after devolution, where are the bodies that can implement these laws or follow it up. After devolution, there is so much of confusion of responsibilities and this all lies with the Govt when they were taking decision to devolve Health to provinces without any plans to implement it and without foreseeing its implications. Systems are made by top levels and then needs implementation. When systems or decisions are made by people who are non professional or not competent enough for a specific field, then these kind of issues arises.
Another important factor needs to be highlighted is that we all should know the difference between DRA and MOH( The setup that was there before devolution) . It is imperative to have a DRA an autonomous body and involving professionals who have no association to bureaucracy. Als this DRA should be working under the model of FDA or European standards and guidelines.
After promulgation of 18th Amendment, the subject and many functions relating to "Health"stand devolved to Provinces and there are questions on the status of Registration Board, Licensing Authority, DTL and Appellate Authority etc; which were mainly headed by either Secretary or DG Health.. these positions no more exist. In order to regulate and monitor manufacture,sale, movement and use of Drugs, I think that creation of an independent, autonomous and powerful statutory body or authority like DRA is essential.
Wat ever the matter …..or law it’s enough Govt should take prompt action in dis regard
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