Save our Pharmaceutical Industry
Md. Shah Amran
When I read the news in the internet version of newspapers that some vested quarters are trying to destroy our pride, our pharmaceutical industry by nullifying the legal role of pharmacists conferred to them by the ordinance of drug control, 1982, and including graduates from any discipline to supervise the manufacture and quality control of pharmaceutical products, then I remember the tale of pondit Ishwar Chandra Bidhiya Sagar. When the authority of the Fort Willium College appointed a Briton to teach English without any background in English literature, then Bidhiya Sarar tendered his resignation letter and told the authority that his service as a teacher of Bengali is no longer needed. Any cart puller can do this job because he can speak Bangla. Understanding the heaviness of Ishwar Chandra's speech, they authority instantly cancelled the appointment of the Briton as English teacher.
In the drug control ordinance of 1982, a legal role is conferred to the pharmacists in the manufacture and quality control of pharmaceutical products and the manufacturers of pharmaceutical products are compelled to follow the Good Manufacturing Practice (GMP). And the subsequent history is well known to all. Our pharmaceutical industry is freed from the clutch of multinational companies (MNC), and the national companies have taken the lead. Bangladesh now produces about 97% of its domestic need and Bangladesh has turned to be a medicine exporting country within this short span of time. The annual market value of our pharmaceutical industries in 1972 was 118 crores, in 1982 it was 243 crores, in 1990 it raised to 579 crores and in 2000 the market value become 1800 crores with more than 90% contributed by national companies. Many Pharmaceutical industries, including ACI, Square, Beximco and Novartis have been certified for their world standard and unique quality and management systems by ISO 9000 and European Union. After ready made garments (RMG), pharmaceutical sector has become the second largest sector in earning foreign currency.
Let us examine what is written in the much talked clause 13 of the drug ordinance:
13. Employment of pharmacists-(1) no person shall manufacture any drug except under the personal supervision of a pharmacist registered in Register 'A' of the pharmacy council of Bangladesh:
provided that this provision shall not apply to the manufacture of any drug under the ayurvedic, unani,or homeopathic or biochemic system of medicine.
(2) No person , being a retailer, shall sell any drug without the personal supervision of a pharmacist registered in any Register of pharmacy council of Bangladesh:
Provided that this provision shall not apply to retail sale of any drug under the ayurvedic, unani,or homeopathic or biochemic system of medicine.
Now let us see what is written regarding obeying the GMP:
15. Good practices in the manufacture and qualitycontrol of drugs-(1) every manufacturer of drugs shall follow the good practices in the manufacture and quality control of drugs recommended by the world health organization.
(2) If any manufacturer does not follow such good practices his manufactured licence may be cancelled or suspended.
The various divisions of a pharmaceutical company are- manufacture, quality control (recently, this term is replaced by quality assurance, because quality can not be controlled, it must be built in each and every step during manufacture), packaging, marketing, research and development etc. The multidisciplinary education of pharmacy curriculum makes a pharmacist a complete legally competent and professionally expert to exert his duties in all the above mentioned divisions in a pharmaceutical company. Therefore, the roles of pharmacists in pharmaceutical industries are unavoidable and indispensable. A shift of the legal role of the pharmacists to the graduates from other discipline would be tantamount to the suicidal attempt for our ever-growing, our pride, our pharmaceutical industry.
Those who raise the question of shifting the legal role or changing the clause 13 of drug control ordinance are those personnel who completely failed in their own profession and workplace (for example, think about our chemical industries!). They are now trying to destroy another field with some non-relevant and ambiguous logic. As a multi-sector industry, pharmacist and related authority always welcome the experts from other disciplines and they are working with harmony with pharmacists.
Bangladesh (its health minister) currently holds the post of the president of WHO. I would request the honorable health minister and secretary to look at the WHO manuals regarding manufacture, quality control, packaging and marketing of Pharmaceutical products. Even the role of pharmacist in manufacture, quality control, packaging and marketing of Pharmaceutical products have been made mandatory in ASEAN countries, also in our closet neighbor India. The role of pharmacists is also ensured in the pharmaceutical sector of Brazil which is the world's sixth largest market in term of value and leading market in the Latin America.
Medicines are not luxurious commodity. It is directly related to the health and well-being of human beings. If manufacture and marketing of drugs are not strictly controlled by the guidelines of WHO then the havoc is waiting to grasp our export oriented pharmaceutical sector.
It may be argued that, pharmacists are involved in manufacture, not in quality control of drugs according to the clause 13 of drug control ordinance. The fact is that the term quality control is no longer in use in pharmaceutical world. This word is replaced by quality assurance. Merely some physical, chemical or microbiological tests cannot guarantee the control of quality. Rather, quality is such a delicate thing that it can not be controlled, it must be ensured during each and every step starting from initial step (Dispensing) to the last phase i.e. consumption by patients. This assurance of quality can be ensured only by the pharmacists.
Because, pharmacy is a multidisciplinary subject. Its curriculum includes (1) chemistry and biochemistry, (2) Chemical engineering (3) Microbiology, (4) Pharmaceutical sciences and technology (also, Cosmetology), (6) Pharmaceutical management and marketing, (7) Pharmacology and Toxicology, (8) Physiology and pathology.
This curriculum nicely meets the guideline of WHO regarding the educational quality of the peoples involved in manufacture and quality control of medicines. In the 4 years course, pharmacy students learn all these subjects meticulously to build them as legally competent and educationally/professionally expert to handle any aspect of drug manufacture.
Therefore, there are ample scopes to question the motives of the vested quarters who are trying to nullify drug control ordinance of 1982. Should not we collectively resist those sons/daughters of Mir Jafar and Ghoseti Begum? Sometimes I wonder how frequently they (ghosts of Mir Jafar and Ghoseti Begum?) comeback and try to capture the stage?
Md. Shah Amran
University of Yamanashi
Yamanashi
Japan