Mohammad Abdul Motalib Momin
2013-07-20 23:44:15
GMP refers to the Good Manufacturing Practices promoted by the WHO GMP Guidelines, implemented by the pharmaceutical manufacturers and monitored by the regulations promulgated by the Drug Regulatory Authorities (DRA); the document was published in 1975. The GMP regulations require that manufacturers, processors and packagers of medicines and other medical products and devices take proactive measures to ensure that their products are safe, efficacious and meet the required quality standard. GMP is also sometimes referred to as the cGMP which reminds the manufacturers and the DRAs to make periodic updates of their systems and regulations.
Bangladesh had a severely war-torn economy, seriously disrupted infrastructure and a huge deficit in foreign currency when it earned independence in 1971. All these factors aggravated the overall health care situation of the country. At that time, the country’s health care facilities, including the supply of medicines, were mostly depending on import. In 1982, a National Drug Policy was announced that largely encouraged local production in our pharmaceutical sector. Under the umbrella of this drug policy, a large number of local companies invested in creating local pharmaceutical manufacturing facilities. This trend still continues. Now there are 267 pharmaceutical manufacturers in Bangladesh producing more than 22,000 products comprising of about 1,200 active pharmaceutical ingredients (API) and pharmaceutical sector is the second highest contributors to our national exchequer, and it is the largest white-collar labour-intensive employment sector. Bangladesh is now capable of producing high-quality pharmaceutical products. This was possible because our industry now uses state-of-the-art manufacturing technology, very sophisticated QC equipment and apparatus, and highly skilled human resource.
Today, Bangladesh is successfully exporting its quality products to 87 countries in Asia, Africa, Latin America and Europe. The quality and efficacy of the products being exported from Bangladesh have been highly appreciated in all the countries we are exporting. Bangladesh now has become one of the cheapest sources of quality medicines in the world. In the last 30 years of Bangladesh, there has been a lot of developments in the willingness of the manufacturers to improve upon the GMP at their plants. Quite a few of them have already qualified in the GMP audits of international standards. As a result, for the last few years, there has been a strong positive trend of Bangladeshi manufacturers going global and Bangladesh has emerged as one of the top exporters of pharmaceutical products among the LDCs. The macro picture looks very promising as most of the top 20 manufacturers are in the queue of achieving similar international recognition within the next couple of years. Besides, there are at least another 30 companies in the country that are actively investing resources for improving upon the status of GMP compliance. This is also a very good sign that we are in an optimistic future.
Though we are proud of many of our pharmaceutical companies; still there are complaints that some other companies do not pursue necessary bioethical norms at various levels of their manufacturing processes. From the GMP point of view, it is a matter of concern that there are 267 pharmaceutical manufacturing licenses in Bangladesh. This is a situation that imposes a serious threat to bringing the whole pharmaceutical industry to an acceptable standard of GMP or to the level of satisfying the WHO GMP guidelines. Still a good number of companies sell sub-standard and counterfeit drugs, and yet some are not following the accepted GMP standards. This is very much unfortunate and needs to be addressed properly both for the sake of public health and for the interest of the pharmaceutical companies. In order to elevate the standard of the pharmaceutical sector as a whole and in the absolute interest of the public, in particular, it has become mandatory to bring the manufacturers to the fold of GMP compliance.
