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