Abstracts
Theme: Health
Panel: Critical Issues in Pakistan's Health Care
Session III: Pharmaceutical Industry/Drug Pricing/Narcotics
 An Overview of Quality Assurance System of Drugs in Pakistan
Farnaz Malik*
Pakistan has a fairly well established pharmaceutical formulation industry comprising well over 390 licensed units engaged in production of a variety of dosage forms of almost all important therapeutic classes of drugs. The country’s total Pharma Market size is arround Rs. 72 billion with average annual growth rate of 11.6% . Almost over 95% of these units are engaged in manufacture of drugs by the way of formulation while there are a couple of units engaged in basic and semi basic manufacturing of pharmaceutical ingredients. But on the whole the industry relies heavily on import for meeting their requirements of pharmaceutical raw materials.
The Drugs Act 1976 is the prime regulation under which the Pharmaceuticals Industry is regulated in Pakistan. The import, export and manufacturing of drugs is primarily regulated by the Federal Government (through Federal Ministry of Health) while the sale of drugs is regulated by provincial governments through their health departments. The Drugs Act 1976 places responsibility of quality assurance of drugs both on the manufacturers and regulators. The Good Manufacturing Practices (GMP) notified under the Act, lays down detailed guidelines, procedures, systems and documentation required to be adopted by the licensed manufacturers of drugs.
A fairly well elaborated regulatory system is functioning under the Drugs Act 1976 both at Federal and Provincial levels. Major component of this system includes the apex statutory bodies likes Central Licensing & Registration Boards at the Federal Ministry of Health and Provincial Quality Control Boards, Federal & Provincial Drug Inspectors to monitor the quality of drugs at production sites and in market, and Federal & Provincial Drug Testing Laboratories and Drugs Courts. Keeping in view the existing resources, the present regulatory system is functioning fairly well to monitor the quality of locally produced and imported allopathic drugs.
* Dr. Farnaz Malik is the Drugs Controller in the Ministry of Health, Islamabad.
Pakistan’s Pharmaceutical Industry in the New Trade Regime: Problems and Prospects
Shafqat Shehzad*
The establishment of the World Trade Organization (WTO) in 1995 brought a new arena in the world trade. The trading principles under WTO included acceptance by members for trade agreements, non-discrimination between trading partners and trade liberalization. Pakistan’s pharmaceutical industry is a multi-billion business and one the fastest growing in Pakistan. However, Pakistan is still not self-sufficient in producing all types of required drugs. Although, the government is making efforts to ensure availability of safe, effective and affordable medicines to all in the light of the World Health Organization’s essential drugs’ concept, many challenges persist. The national drugs policies are being formulated to address issues of affordability, safety and efficacy. However, issues like how quickly Pakistan can become self-sufficient and be able to get significant share in the international market due to relatively drug production costs remain to be addressed.
The paper will present an overview of the existing situation of Pakistan’s pharmaceutical industry and how this compares with other developing countries based on the WHO data. The paper will examine potential problems in light of the fact that more than 90% of global drug production takes place in only seven industrializes countries. However, improvements in drug quality reassure that Pakistan can benefit from trade to other countries due to advantage of low production costs.
* Dr. Shafqat Shehzad is Research Fellow (Health) at Sustainable Development Policy Institute (SDPI).
Impact of Globalization on Health in Pakistan: Implications for Health Policy
Talib Lashari*
The emergence of new disease and re-emergence of old ones have posed a global health threat. In 1993, WHO declared Tuberculosis as a global emergency. In the same year, the World Bank pledged for scaling up investment in health. Meanwhile, the global epidemiological shift towards new and threatening horizons is confronted with hope through global advancement in medical technology: availability of new treatment techniques and medicines at global scale. But the fact remains that this may be seen with caution. After the advent of the World Trade Organization (WTO) in 1995, some agreements along with opportunities present concerns for developing countries including Pakistan.
Researchers have been engaged on pros and cons of Agreements on Trade Related Aspects of Intellectual Property Rights (TRIPS) with regard to supply of and access to medicines in developing countries. General Agreement on Trade and Services (GATS) may have potential risks in case services in health sector are liberalized.
The paper will examine the impact of globalization from the standpoint of emergence global initiatives in response to diseases; health related role of international development agencies and their subsequent role in case of Pakistan; consequences of WTO-related agreements on health in Pakistan. Furthermore, the paper will explore potential implications of the situation for National Health Policy and planning. In this context an attempt has been made to set an agenda for health policy in the wake of new global realities.
This will be a review paper based on the secondary data including documents of WTO, the role of international development agencies, Pakistan’s health sector, and published articles.
* Dr. Talib Lashari is a researcher, health policy analyst and a medical doctor. He is working as Research Associate at National Health Policy Unit, Ministry of Health, Government of Pakistan. Dr. Lashari is author of a published book on ‘Pakistan’s National Health Policy: Quest for A Vision’. His main expertise includes health policy analysis; health systems development; health sector reform; poverty, equity and the social determinants of health and healthcare financing. |
