President, Pakistan Pharmaceutical Entrepreneurs and Investors Forum (PPEIF), Dr Mushtaq Noorwala, has urged President of Pakistan Asif Ali Zardari and Prime Minister Syed Yousuf Raza Gilani to let the health ministry continue to look after interest governed under Drugs Act, 1976.
In a letter to President and Prime Minister, he noted that the provincial autonomy and decentralisation of power to the provinces is panacea for many existing problems being faced and confronted by the provinces. The 18th Amendment passed by the Parliament a year ago, paved way for complete autonomy of the provinces after nearly three decades; it is a right step in right direction and enhanced the image of the democratic institution which is highly laudable.
He noted that implementation committee so constituted in this regard, comprising of the eminent parliamentarians belonging to different political parties having been entrusted with the challenging task to recommend the modus operandi to devolve 22 ministries to the provinces, but the members of the committee somehow or other ignored the fact that the ministry like health, which comprises important division of drug control administration, governed and controlled under Drugs Act, 1976, an act of parliament, cannot be done away with totally or can't be made in-operative, without opening or making alternate arrangements or new legislation at the provinces' end as a result the day-to-day affairs came to a stand still, causing alarming situation for the industry as well as for the importers.
The implementation committee as we understand is neither equipped with such mandate, nor the intention of the legislation of the 18th Amendment was to wind up the existing smooth running system established some 35 years ago and regulated under Drugs Act, 1976, prior to the passage of 18th Amendment as has been done or for that matter, such power has not been delegated to the implementation committee.
Thus the concerned section of the health ministry just cannot be devolved or transferred to the provinces in an ordinary manner or merely due to misinterpretation of law or on personal whims and will, which would otherwise open door for corruption and result into complete breakdown of the existing sectarian machinery, the impact of it would be shortages of important life saving medicines, vaccines, etc, etc, from the market.
He further noted that the ministries which are likely to be devolved to the provinces, amongst other includes ministry of health also, which deals with several issues, having several divisions, and sub-division; the health ministry not only is responsible for primary and basic health care, but also runs several institutions, looks after programme funded by EPI, etc, etc, regulates pharmaceutical sectors under Drugs Act, 1976, which covers licensing, drug registration, import and export, grants permission for the imports of psychotropic/narcotics drugs, basic manufacturing of raw material and surgical as may be used in the hospitals with a major responsibility of monitoring quality, safety and efficacy profile.
The regulatory structure build and operated until now under one centralised system of the registration, manufacturing, quality assurance and adjudication of contravention of the Act would now be jeopardised and the fate of nearly 80,000 registered life saving drugs and vaccines, 600 manufacturing license will be paralysed until new arrangements or legislation are made, thus the entire industry and trade would be ruined, which involves billions of rupees of the Entrepreneurs and investors.
Ironically sooner the ministry of health was devolved to the provinces on 30th of June 2011 under 18th Constitutional Amendment, there exist no federal institution which should be answerable regarding health related issues including quality, efficacy, and safety of drugs at the federal level and every thing is hanging on as is where is basis until rains settle the dust.
The concurrent list which was supposed to be abolished and devolved to the provinces after completion of ten years from the passage of 1973 Constitution for that's. in 1983, unfortunately remained un-devolved due to the circumstances prevailing then and thereafter for another 28 years until the 18th Amendment is adopted by the National Assembly on 8th of April 2010 but the journey under Drugs Act, 1976, which started 35 years ago continued unabated, which is very difficult to rebuild a fresh in five federating units and Islamabad Capital territory now in the presence of Drugs Act, 1976.
As it appears that the devolution process has been done in haste amid confusion and uncertainty prevails across the country, particularly in the provinces where no legislation has so far been done to regulate the system, this would adversely affect the whole process and does not seem to be practicable.
In the absence of proper legislation, the fragmentation of the Drugs Act, 1976, into five federating units and Islamabad capital territory as well as Azad Jammu and Kashmir would lead to chaos and uncertainty, market is likely to be flooded with spurious Drugs, resulting into further complication and new tug of war would start between the provinces and conflict of jurisdiction particularly in presence of Drugs Act, 1976, which is an Act of Parliament and is still alive and parallel law to control would create problems.
A sustainable approach is urgently needed in the present situation by taking suitable measures for alternate solution and by taking the stake holders into confidence otherwise it is feared that the industry and trade will bound to succumb at the hand of 18th Amendment and would have to face unbearable crisis and injury, so also the consumers will also likely suffer with complete breakdown of the system of the sector which is considered as the third pillar of Pakistan's economy, the wheel of the industry and the trade will come to an halt.
He pointed out at this stage that the Drugs Act, 1976, succeeded the Drugs Generic Act, 1973, the Brain Child of Sheikh Rashid Ahmed, Central Vice-President of PPP and the then Federal Health Minister in Zulfiqar Ali Bhutto's cabinet, the drug Generic Scheme was the best scheme for the country and encouraged industrialisation in the sector, but failed due to the fact that policy was not implemented in its original spirit, despite the fact it envisages competition regime guarantees and ensures both quality and affordable economical price to suit poor masses of the country.
In the larger interest of the country and the poor ailing masses, he urged the concerned authorities to act quickly and swiftly to resolve this issue to avert shortages of life saving drugs and medicines in the country and to overcome the feared disastrous effect before it is too late. He suggested the health ministry should continue to look after interest governed under Drugs Act, 1976, so as to enable to prevent and as far as possible must not permit any thing that happens against the interest of the country.