CONCEPT OF NATIONAL CONFERENCE ON HARMONIZATION OF REGULATORY PROCESES
Health care is a major factor for mankind and every government in the world is concerned about this issue. Since the innovation of first synthetic drug (penicillin) a very vibrant Pharmaceutical industry has come up that is a recognizable force in economics of the world. A major share in research throughout the scientific world is done with the active involvement of this very industry resulting in innovation of old molecules and many new discoveries in the field of medicine.
This growth in pharmaceutical industry necessitated the requirement of regulations to control the development of new drugs and their availability for treatment of diseases. All over the world, the governments have made their own laws and the regulatory authorities for this purpose.
After the independence of Pakistan till 1976 the regulation of the Pharmaceutical industry was done through the provisions of pre-independence legislation that is the Drugs and Cosmetics Act of 1940. The said act was meant to regulate the Import and sale of Drugs and was not sufficient for a local production industry that was coming up in Pakistan at a fast pace. The MNCs were also putting up their plants in Pakistan, as did some vibrant businessmen. Therefore, the Government of Pakistan enacted a very comprehensive legislation for the future vibrant industry in the form of DRUGS ACT 1976.
The Drugs Act 1976 helped in establishment of a vibrant pharmaceutical industry and today the Pakistan Pharmaceutical industry is a high technology, essential and strategically important industry for the country. However the regulatory processes in the country remained static since the Drugs Act 1976 resulting in Pakistan remain legging much behind then rest of the world and this include even the least developed countries where all the products are regulated by the authority/government, as they value the health and wellbeing of their nations.
Prior to 18th constitutional amendment Ministry of Health was responsible to regulate the pharmaceutical products only. However fortunately the DRAP established under the Act of Parliament in 2012 has been authorized to regulate all therapeutic goods including Pharmaceutical/Biological/Medical Devices/Alternate Medicines/Cosmetics and disinfectants etc. This is a good omen for the nation and all measures need to be adopted for effective implementation of the Act resulting in effective regulations.
The DRAP Act 2012 is a comprehensive document requiring the Authority to implement internationally recognized standards such as GLP, cGMP GDP cold chain management, bioequivalence studies, Stability Studies, anti spurious codes, clinical trials, dissimilar evaluations, and enforcement and systematic implementation of WHO, ICH and FDA Guidelines. The Act also require the Authority to take steps for development and promotion of pharmacy services and to undertake awareness campaigns regarding prevention of diseases, patients rights, healthcare privileges etc., through media, seminars, publications, and other available means of information technology.
This is a huge task but is highly important for the country to become a force to be recon at international level in the field of Therapeutic Goods Manufacturing. However this is achievable and with good planning and implementation can be achieved in a short span.
It is in this background that the concept of NATIONAL CONFERENCE ON HARMONIZATION OF REGULATORY PROCESSES is developed and is proposed to be made an annual event so the Regulatory Processes and Industry develop in line with the international standards and be productive.