Source : http://www.dawn.com/2011/03/12/regulating-the-drugs-industry.html
The first legislation which was promulgated for regulating the import, export, manufacture, storage, distribution and sale of drugs was the Drugs Act, 1940. It was promulgated as a result of a resolution which the legislatures of all the provinces had passed in terms of Section 103 of the Government of India Act, 1935.
In this act, essential powers were conferred on the federal government, which related to the constitution of a drugs technical board, a central drugs laboratory, an advisory committee and making rules to implement the provisions of the act.
Other powers were conferred on the provincial governments including the power to amend standard quality schedule, prohibit manufacture and sale of certain drugs, appoint government analysts and inspectors and make relevant rules. In Pakistan, the Drugs Act, 1940 was then replaced with the Drugs Act, 1976. The purpose of this act is to regulate the import, export, manufacture, storage, distribution and sales of drugs.
In this regard, vital powers are vested with the federal government, including the power to regulate the import and export of drugs, set up a central licensing board for granting licences, a registration board for registering drugs, the Pakistan National Formulary, an appellate board for the disposal of appeals, committees of experts on evaluation of drugs, a federal drugs laboratory and other institutes and drugs testing and research laboratories as well as drugs courts.
Under this law, the centre is also supposed to appoint federal government analysts and inspectors, fix the prices of medicines, and to make rules.
The rest of the powers were conferred upon the provincial governments under this act including the power to regulate the sale of drugs, take steps to ensure compliance with the conditions for registration of drugs, set up a provincial quality control board, a provincial drugs testing laboratory, appoint government analysts and inspectors and to make the rules.
Since the 18th Amendment has been passed and integrated into the constitution, the process of delegating the powers to restructure and administer institutions has started and would end by June, 2011. The legal and constitutional issues regarding the administration of those institutions have not only been discussed efforts have also been made to overcome these challenges.
The Drugs Act, 1976 was promulgated while exercising the powers conferred on the legislature under item 20 of the Concurrent Legislative List of the Fourth Schedule of the constitution of 1973.
This item was omitted from the Fourth Schedule as a result of the 18th Amendment. Through this amendment the power to amend the Drugs Act, 1976 has been transferred to the provincial assemblies. Now, these assemblies will work on it according to their needs.
Considering the above, the issues that should be highlighted include the regulation of import and export of drugs, establishment of a central licensing board, registration board, a federal drugs laboratory and fixing the prices of medicines. However, import and export is a federal subject according to the provisions of the constitution. The importance of this subject increases when it relates to the import and export of drugs. Hence the transfer of this subject to the provinces is against the provisions of the constitution and this issue needs to be sorted out.
Just think of the situation when powers would be transferred to the provinces and according to the new regulatory framework there will be four licensing boards, registration boards, drugs laboratories and every province will be free to fix the prices of medicines.
Irrespective of the above situation, there will be various other drastic consequences including a dark future for health programmes started by the federal government through donations received from international agencies, import and export across customs frontiers, inter-provincial trade and commerce, trade and commerce with foreign countries, lack of skilled persons within regulatory bodies, lack of trust in provincial governments, the loss of foreign direct or indirect investment and manufacturing of various fake medicines.
It is suggested that since drugs have been a federal subject they should remain with the federal government. In various countries including the US, the UK, Australia, Canada and India, drugs are controlled by the federal or central governments because they have been categorised as a federal subject.
Also, the non-establishment of a regulatory body has been a big loophole which could not be rectified even though new legislation was promulgated in 1976.
A number of regulatory bodies were established under the Drugs Act, 1976 but none were established to regulate the general powers. In contrast, various countries have established regulatory bodies to regulate general powers.
In the US, it is the Food and Drug Administration, in the UK it is the Medicines Commission, in Australia it is the Therapeutic Goods Administration and in India it is the Drugs Technical Advisory Board.
From independence until recently, drugs remained a federal subject. Therefore, the constitutional reform committee should give this issue some attention in consultation with the experts of this field. If the constitutional reform committee fails, the provincial governments can amend the Drugs Act, 1976 by passing a consensus resolution for the well-being of the general public. n
Hopefully, the committee will soon take steps to solve this issue. Otherwise, much confusion will reign when it comes to regulating the drugs industry in Pakistan.
The writer is an advocate.
m.janjuah@gmail.com
WITH the passage of the 18th Amendment, the constitutional, legal and economic effects this legislation will have on the drugs industry, and how far it would be helpful to the common man, needs to be discussed.
At this point, it would be helpful to have an overview of the earlier legislation passed with regard to drugs` regulation in the subcontinent.The first legislation which was promulgated for regulating the import, export, manufacture, storage, distribution and sale of drugs was the Drugs Act, 1940. It was promulgated as a result of a resolution which the legislatures of all the provinces had passed in terms of Section 103 of the Government of India Act, 1935.
In this act, essential powers were conferred on the federal government, which related to the constitution of a drugs technical board, a central drugs laboratory, an advisory committee and making rules to implement the provisions of the act.
Other powers were conferred on the provincial governments including the power to amend standard quality schedule, prohibit manufacture and sale of certain drugs, appoint government analysts and inspectors and make relevant rules. In Pakistan, the Drugs Act, 1940 was then replaced with the Drugs Act, 1976. The purpose of this act is to regulate the import, export, manufacture, storage, distribution and sales of drugs.
In this regard, vital powers are vested with the federal government, including the power to regulate the import and export of drugs, set up a central licensing board for granting licences, a registration board for registering drugs, the Pakistan National Formulary, an appellate board for the disposal of appeals, committees of experts on evaluation of drugs, a federal drugs laboratory and other institutes and drugs testing and research laboratories as well as drugs courts.
Under this law, the centre is also supposed to appoint federal government analysts and inspectors, fix the prices of medicines, and to make rules.
The rest of the powers were conferred upon the provincial governments under this act including the power to regulate the sale of drugs, take steps to ensure compliance with the conditions for registration of drugs, set up a provincial quality control board, a provincial drugs testing laboratory, appoint government analysts and inspectors and to make the rules.
Since the 18th Amendment has been passed and integrated into the constitution, the process of delegating the powers to restructure and administer institutions has started and would end by June, 2011. The legal and constitutional issues regarding the administration of those institutions have not only been discussed efforts have also been made to overcome these challenges.
The Drugs Act, 1976 was promulgated while exercising the powers conferred on the legislature under item 20 of the Concurrent Legislative List of the Fourth Schedule of the constitution of 1973.
This item was omitted from the Fourth Schedule as a result of the 18th Amendment. Through this amendment the power to amend the Drugs Act, 1976 has been transferred to the provincial assemblies. Now, these assemblies will work on it according to their needs.
Considering the above, the issues that should be highlighted include the regulation of import and export of drugs, establishment of a central licensing board, registration board, a federal drugs laboratory and fixing the prices of medicines. However, import and export is a federal subject according to the provisions of the constitution. The importance of this subject increases when it relates to the import and export of drugs. Hence the transfer of this subject to the provinces is against the provisions of the constitution and this issue needs to be sorted out.
Just think of the situation when powers would be transferred to the provinces and according to the new regulatory framework there will be four licensing boards, registration boards, drugs laboratories and every province will be free to fix the prices of medicines.
Irrespective of the above situation, there will be various other drastic consequences including a dark future for health programmes started by the federal government through donations received from international agencies, import and export across customs frontiers, inter-provincial trade and commerce, trade and commerce with foreign countries, lack of skilled persons within regulatory bodies, lack of trust in provincial governments, the loss of foreign direct or indirect investment and manufacturing of various fake medicines.
It is suggested that since drugs have been a federal subject they should remain with the federal government. In various countries including the US, the UK, Australia, Canada and India, drugs are controlled by the federal or central governments because they have been categorised as a federal subject.
Also, the non-establishment of a regulatory body has been a big loophole which could not be rectified even though new legislation was promulgated in 1976.
A number of regulatory bodies were established under the Drugs Act, 1976 but none were established to regulate the general powers. In contrast, various countries have established regulatory bodies to regulate general powers.
In the US, it is the Food and Drug Administration, in the UK it is the Medicines Commission, in Australia it is the Therapeutic Goods Administration and in India it is the Drugs Technical Advisory Board.
From independence until recently, drugs remained a federal subject. Therefore, the constitutional reform committee should give this issue some attention in consultation with the experts of this field. If the constitutional reform committee fails, the provincial governments can amend the Drugs Act, 1976 by passing a consensus resolution for the well-being of the general public. n
Hopefully, the committee will soon take steps to solve this issue. Otherwise, much confusion will reign when it comes to regulating the drugs industry in Pakistan.
The writer is an advocate.
m.janjuah@gmail.com
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