THIS is apropos of the directives of the Supreme Court to form a drug regulatory authority in the backdrop of the PIC drug reaction fiasco in Lahore. I would like to invite the attention of the health ministry executives and the legal fraternity to certain solutions to get out of this mess.

After the enactment of the 18th Amendment the issue of regulating manufacturing, licensing, registration and sale of drugs is in a state of suspension.

Being in the profession of legal practice of drugs for the last more than 30 years, I think that section 5 of the Drug Act 1976 deals with regulating the manufacture of drugs by the central licensing board of the federal government, which is a high-powered committee regulating the pharmaceutical industry.

There is also a drug registration board under the Drugs 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 the Drugs Act 1976. This means that the central licensing board so set up under section 5 of the Drugs Act is, in fact, a regulatory authority, which is protected by article 270 AA (6) which deals with the declaration and continuance of the law. The law is reproduced as below:

"Notwithstanding the omission of the Concurrent Legislative List by the Constitution (18th Amendment) Act, 2010, all laws with respect to any of the matters enumerated in the said list (including ordinances, orders, rules, by-laws, regulations and notifications and other legal instruments having the force of law) in force in Pakistan or any part thereof, or having extra-territorial operation, immediately before the commencement of the Constitution (18th Amendment) Act, 2010, shall continue to remain in force until altered, repealed or amended by the competent authority."

This clause clearly says that any law in force will continue to remain in force till the new law is altered, repealed or amended by the competent authority.

Even the board set up under section 5 of the Drugs Act 1976 is a regulatory authority as such and can be treated as a drug regulatory authority established under the federal law, i.e., Drugs Act 1976, and mentioned in para six of part II of the fourth schedule (federal list).

It is a mistaken belief that there is no system of checks and balances as regards manufacturing of quality drugs.

It is the need of the hour to remove any deficiency in the central licensing board, which is the regulatory body. The federal government may notify the central licensing board as a drug regulatory body till some improved version of it or necessary regulatory body is made so that the vacuum, which has created confusion and is hindering the implementation of Drugs Act 1976, may be filled.

There is not much need to make new laws every now and then. Rather there is a dire need to implement the Drugs Act 1976 and abide by the constitution in letter and in spirit.

SHEIKH MUHAMMAD NAWAZ

Lahore