Combating the menace of fake drug
Friday, 19 September 2008
DR. Mohammad Hossain
JUST a couple of days ago, a leading newspaper carried reports on marketing of counterfeit drugs in the country. The Directorate of Drug Administration (DDA) has passed a simple comment that they do not have adequate manpower to look into the matter. Is it a responsible answer from the drug authority? What are the roles of the Ministry of Health and Family welfare in this case? If the drug authority has limited manpower, why is not the case being taken with the ministry of Health on a priority basis? It is hard to understand why such responsible institutions (DDA, BSTI) do not have enough personnel to run their organizations and why has not the responsible authority been taking right steps so that the institutions can run smoothly? Is it not a crime to manufacture and market fake drugs? For all practical purposes, our life is at risk and nobody is there to look after it. That's why the World Health Organization (WHO) argued that the Directorate of Drug Administration, the national drug regulatory authority of Bangladesh, needs to be strengthened and provided with the necessary financial and human resources. On the DDA website, there is an important document, the Code Pharmaceutical Marketing Practices. As per its web site this Code of Pharmaceutical Marketing Practices has been drawn up by a committee with the Director of Drugs Administration as the Chairman and the representatives of the following bodies as the members:
a. Pharmacy Council of Bangladesh
b. Bangladesh Medical Association
c. Bangladesh Pharmaceutical Society
d. Bangladesh Pharmaceutical Manufacturers' Association
The section 4.1 says: A pharmaceutical product must not be promoted prior to the granting of the product license authorizing its sale or supply, and in section 4.2 it states: Pre-registration feasibility studies, awareness campaigns or promotional activities of any other form may be conducted with prior approval of the licensing authority of the relevant authorities and that should be confined to a reasonable extent. Now my question is how can a fake pharmaceutical product be sold in the open market in our country when such provision of the law exists? We know that counterfeit drugs pose a global public health problem causing death, disability and injury affecting adults and children. The fake drug causes pain in the alimentary canal and stomach and damages to kidney, nervous system and liver. No country is free of this problem, which plagues developing and developed countries alike.
As per World Health Organization (WHO), a counterfeit medicine means "a medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging". It has been reported by the WHO that the prevalence of drug counterfeit in the developing countries is alarming. For example, in Africa it is 50-60 per cent; in Mexico 40 per cent; in Brazil 30-40 per cent, and in India 15-20 per cent. In the industrialized countries the prevalence of counterfeit is 22 per cent.
We believe an essential responsibility of government is to ensure that only legitimate, law abiding organizations are licensed to distribute pharmaceutical products. The drug authority must have taken their licence and inspection responsibilities seriously. In addition, this writer suggests that the authority concerned and the policymakers, like in the other developing and developed countries, should create a National Health Authority (NHA) which will only be responsible for distributing medicine to the pharmaceutical shops. The pharmaceutical manufacturing companies will not sell any medicine to the outsiders. On the contrary, NHA will buy their product at the agreed price as well as will test the quality of medicine.
It if believed, this is the only way through which the government can protect the health of the citizens and restore public confidence in the locally produced drugs. However, the government may also call national seminar on this issue and can take expert opinion to create National Health Authority. At least we must have long vision about how to overcome this bad situation. Even in India, two important bills from the Health Ministry were submitted to Parliament. The first Bill seeks to bring in stricter punishments for spurious drug manufacturers which include a fine of Rs 1million and life imprisonment. The second Bill will set up a Central Drug Authority which will make the Drug Controller-General of India office an autonomous body and enhance its powers. The health and safety of our nation, literally, is at stake. We do not believe there is a single approach to solve this problem; rather, a combination of many approaches is required, involving the government and all stockholders. DDA must devise proactive strategies to prevent and fight it efficiently. Here are some suggestions to confine drug marketing to establishments authorized by the DDA.
- To constitute a focal point network on drug counterfeiting at the district level with establishing a regional network of communication.
- To adopt national standards of good practices for all the stages of the drugs chain.
- To have mechanism and technologies to trace drugs effectively in the different stages of the drugs chain (from production to dispensing), including the number of batches in the purchase and sale documents.
- To adopt rules and measures to prevent the use of equipment left by illegal manufacturers.-
- To strengthen the national programs for drug surveillance of post-marketing.
- To strengthen government regulation, oversight and enforcement.
The writer resides in Qatar. He can be reached at
hossain_mohammad@hotmail.com
JUST a couple of days ago, a leading newspaper carried reports on marketing of counterfeit drugs in the country. The Directorate of Drug Administration (DDA) has passed a simple comment that they do not have adequate manpower to look into the matter. Is it a responsible answer from the drug authority? What are the roles of the Ministry of Health and Family welfare in this case? If the drug authority has limited manpower, why is not the case being taken with the ministry of Health on a priority basis? It is hard to understand why such responsible institutions (DDA, BSTI) do not have enough personnel to run their organizations and why has not the responsible authority been taking right steps so that the institutions can run smoothly? Is it not a crime to manufacture and market fake drugs? For all practical purposes, our life is at risk and nobody is there to look after it. That's why the World Health Organization (WHO) argued that the Directorate of Drug Administration, the national drug regulatory authority of Bangladesh, needs to be strengthened and provided with the necessary financial and human resources. On the DDA website, there is an important document, the Code Pharmaceutical Marketing Practices. As per its web site this Code of Pharmaceutical Marketing Practices has been drawn up by a committee with the Director of Drugs Administration as the Chairman and the representatives of the following bodies as the members:
a. Pharmacy Council of Bangladesh
b. Bangladesh Medical Association
c. Bangladesh Pharmaceutical Society
d. Bangladesh Pharmaceutical Manufacturers' Association
The section 4.1 says: A pharmaceutical product must not be promoted prior to the granting of the product license authorizing its sale or supply, and in section 4.2 it states: Pre-registration feasibility studies, awareness campaigns or promotional activities of any other form may be conducted with prior approval of the licensing authority of the relevant authorities and that should be confined to a reasonable extent. Now my question is how can a fake pharmaceutical product be sold in the open market in our country when such provision of the law exists? We know that counterfeit drugs pose a global public health problem causing death, disability and injury affecting adults and children. The fake drug causes pain in the alimentary canal and stomach and damages to kidney, nervous system and liver. No country is free of this problem, which plagues developing and developed countries alike.
As per World Health Organization (WHO), a counterfeit medicine means "a medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging". It has been reported by the WHO that the prevalence of drug counterfeit in the developing countries is alarming. For example, in Africa it is 50-60 per cent; in Mexico 40 per cent; in Brazil 30-40 per cent, and in India 15-20 per cent. In the industrialized countries the prevalence of counterfeit is 22 per cent.
We believe an essential responsibility of government is to ensure that only legitimate, law abiding organizations are licensed to distribute pharmaceutical products. The drug authority must have taken their licence and inspection responsibilities seriously. In addition, this writer suggests that the authority concerned and the policymakers, like in the other developing and developed countries, should create a National Health Authority (NHA) which will only be responsible for distributing medicine to the pharmaceutical shops. The pharmaceutical manufacturing companies will not sell any medicine to the outsiders. On the contrary, NHA will buy their product at the agreed price as well as will test the quality of medicine.
It if believed, this is the only way through which the government can protect the health of the citizens and restore public confidence in the locally produced drugs. However, the government may also call national seminar on this issue and can take expert opinion to create National Health Authority. At least we must have long vision about how to overcome this bad situation. Even in India, two important bills from the Health Ministry were submitted to Parliament. The first Bill seeks to bring in stricter punishments for spurious drug manufacturers which include a fine of Rs 1million and life imprisonment. The second Bill will set up a Central Drug Authority which will make the Drug Controller-General of India office an autonomous body and enhance its powers. The health and safety of our nation, literally, is at stake. We do not believe there is a single approach to solve this problem; rather, a combination of many approaches is required, involving the government and all stockholders. DDA must devise proactive strategies to prevent and fight it efficiently. Here are some suggestions to confine drug marketing to establishments authorized by the DDA.
- To constitute a focal point network on drug counterfeiting at the district level with establishing a regional network of communication.
- To adopt national standards of good practices for all the stages of the drugs chain.
- To have mechanism and technologies to trace drugs effectively in the different stages of the drugs chain (from production to dispensing), including the number of batches in the purchase and sale documents.
- To adopt rules and measures to prevent the use of equipment left by illegal manufacturers.-
- To strengthen the national programs for drug surveillance of post-marketing.
- To strengthen government regulation, oversight and enforcement.
The writer resides in Qatar. He can be reached at
hossain_mohammad@hotmail.com