Drug Regulatory Agency of Pakistan (2012) : Ordinance Issued

Ordinance of Drug Regulatory Agency Pakistan

Daily Express Karachi, February 18, 2012

Daily Jang Karachi, February 17, 2012 (online edition)

Daily Jang Karachi, February 16, 2012

Daily Jang Karachi, February 16, 2012

Daily Jang Karachi, February 16, 2012

Daily Jang Karachi, February 7, 2012

18th amendment, in the constitution of Pakistan was unanimously passed in National Assembly of Pakistan. According to this mighty amendment several ministries was either dissolved or merged at federal level, whereas, some ministries was completely handed over to provinces. It took a long time to formulate the procedure for this transfer. Ministry of Health was among the last ministries to be transferred to provinces.

From July 1, 2011, Ministry of health was supposed to be controlled by provincial governments. Unfortunately, the pathetic political tussle and conflict of interest between federal and provincial bureaucracy, literally left ministries of health paralyzed. Specially, the matters of  Drug Registration and Manufacturing Licenses, and their renewal was made unnecessarily complicated and thus suspended, by some officials of federal government and pharma sector representatives.

In this scenario Supreme Court asked government to formulate a federal drug regulatory authority by February 17, 2012. On February 17, 2012 President of Pakistan issued  Drug Regulatory Authority Ordinance (DRAO) 2012.

Was it necessary to issue this ordinance?

• Section 5 of the Drug Act 1976 deals with regulating the manufacture of drugs by the central licensing board, set up by  the federal government.

• Section 12 of the Drug Act 1976, deals with the power of federal government to fix maximum prices of drug.

• Section 7 of the Drug Act 1976 deals with regulating the registration of drugs by the registration board, set up by  the federal government.

Both of these boards are 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.

It is the need of the hour to remove any deficiency in the central licensing board and registration board, 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.




Bibiliography: http://www.dawn.com/2012/02/18/drug-control-authority-some-facts.html

Fate of an Ordinance

Article 89 of the constitution of Pakistan after 18th amendment (2010) states that an ordinance will be repealed (obsolete) at the expiration of 120 days from its promulgation (implementation). If that ordinance is to be continued then it should be laid before the National Assembly and get it passed. National Assembly may by a resolution extend the Ordinance for a further period of one hundred and twenty days; that extension for further period may be made only once.

Federal government has to laid this ordinance in the parliament before June 17, 2012 or the ordinance be repealed. Alternatively, government may further extend this ordinance for further 120 days. (Maximum time till October 17, 2012)

During May and June 2012, Federal government is expected to present but, and during budget session no other bill could be laid before national assembly. 

As rumours and stance of government shows that somewhere in October national assembly is going to be dissolved for next general election, then at that moment DRAP will repealed automatically. If there was no national assembly in october then the senate will be the only forum to approve that ordinance as bill, otherwise another vaccum will likely to be occur regarding Drug Regulatory authority in october 2012.

Note: A lawyer by profession may address the said issue better,( and I'll wellcome it!)


My Opinion !!!!!!!
Kamran Zaheer
kamranzaheer.blogspot.com