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Pharmaceutical Legislation

Law Opinion    

Published : Thursday, 30 August, 2018 at 12:00 AM  Count : 832
Sourav Paul


Pharmaceutical Legislation

Pharmaceutical Legislation

For promoting better health care service, standard quality of medicines is pre-requisite along with the experienced physicians. The right of basic health care is recognized as a fundamental human right, as stated in the article 25 of Universal Declaration of Human Rights (1948) and as per article 15 of the Constitution of the People's Republic of Bangladesh. Obtaining medicines that reach a standard of safety and quality is a compulsory part of health care.
The use of substandard medicines instead of the standard quality of medicines can result in therapeutic failure, exacerbation of the disease, resistance to medicines and sometimes death. It also undermines confidence in health systems, health professionals, pharmaceutical manufacturers and distributors.
Moreover, substandard medicines also have social and economic effects. Patients who consume substandard medicines also suffer economic losses, as they spend income on ineffective medication. Furthermore, since the use of substandard medicines often leads to illness, additional costs for health-care workers are incurred. The government has to establish modernized law and regulation, to protect and promote civic health.
Currently, more than 97% of medicines are being produced in the country and being exported to 113 countries across the globe, including developed countries. However, this sector faces challenges in ensuring product quality in the supply chain.
A drug quality and information program implemented by United States Pharmacopeia (USP) noted that 69 percent of Paracetamol tablets and 80 per cent of Ampicillin capsules produced by minor companies were substandard in quality.
Despite the enormous potential of this sector and above regulatory measures, some problems and anomalies persist in the pharmaceutical sector. Widespread allegations are against some companies that they are producing fake and substandard medicine and some are not following good manufacturing practices and against marketing and selling of medicine.
The regulation and monitoring of drug sector in Bangladesh are done with the help of Drug Act, 1940; Drug Rules, 1945; National Drug Policy 2016 and Drug Control Ordinance, 1982not adequate to address contemporary issues and challenges.
In the Drug Control Ordinance 1982, provisions to form different drug committees were mentioned; however, committees' formation criteria, operation processes, the number of members were not clearly defined in the law. It was mentioned in Section 11 of Drug Control (Ordinance) 1982 that the government would issue gazette on maximum retail prices of drugs considering the prices of raw materials.
However, no specific timeframe was mentioned to issue gazette notification. Nothing was mentioned in law to regulate the doctors' prescription to prevent unjustified and misuse of drugs and no punishment was mentioned anywhere for producing drugs in an unhealthy environment.
On the other hand, as per the Drug Control (Ordinance); doctors were forbidden to prescribe non-approved drugs; however, no punishment was declared for such offence. It is observed that absence of severe punishments and in some case inconsistency between punishments and fines. For example, in the Drug Act, 1940 maximum punishment was set 3 years jail and undefined fine for drug offences and 5 years jail and undefined fines for recurrence of same offences. On the other hand, in the Drug Control Ordinance maximum punishment was set 10 years jail and BDT 2 lakh as fine.
Finally, rationalization to fortify pharmaceutical regulation in Bangladesh is undeniable because of the intermix contribution in improving health care and economic development. Strengthening and building manpower capacity of the DGDA, updating and implementing drug regulatory functions, ensuring uniformity between punishments and fines, strengthen control to produce quality drugs in healthy environment and doctors' prescription to prevent unjustified and misuse of medicines can ensure quality, safety, and efficacy of medicines and support the achievement of quality standards in pharmaceutical manufacturing in Bangladesh.
Sourav Paul is LL.M student at the Department of Law,
University of Chittagong

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