Rapid responses are electronic comments to the editor. They enable our users
to debate issues raised in articles published on bmj.com. A rapid response
is first posted online. If you need the URL (web address) of an individual
response, simply click on the response headline and copy the URL from the
browser window. A proportion of responses will, after editing, be published
online and in the print journal as letters, which are indexed in PubMed.
Rapid responses are not indexed in PubMed and they are not journal articles.
The BMJ reserves the right to remove responses which are being
wilfully misrepresented as published articles or when it is brought to our
attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not
including references and author details. We will no longer post responses
that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
Dear Editor
Every pharmaceutical product administered to humans or animals must be manufactured under good manufacturing practices (GMP) standards. Worldwide, each country uses a GMP regulation based on the WHO guide or the EU guide. The first GMP guide was published in 1971 in the UK (the Orange Guide) (1). Pharmaceutical industries are benefiting from technological advances that offer new opportunities to improve people’s health, but also create new uncertainties and risks. For each of these industries, evidence indicates that products that slipped through a porous regulatory framework have put some individuals at risk.
Worldwide, the principal GMP regulations are the EU Guide, the FDA Code of Federal Regulations (21 CFR Parts 210, 211, 610), and WHO GMP Guide, which have minor differences. (2, 3) These guidelines were enforced because of certain tragedies in clinical trials due to use of un-standardized medicinal products however these guidelines are not being followed stringently.
There is big range of medicinal products ranging from medicines, vaccines, food supplements, miRNA based products, cell therapy products, gene therapy products, herbal products, diagnostics etc that come under preview of GMP. There are few associated products which are being used as food supplements and cosmetics but are not following guidelines as per prescribed standards due to some loopholes in the system. According to a recent study about 80% of US consumers report using dietary supplements. Many of them help improve people’s health, but some contain dangerous or unexpected ingredients or may be used in unsafe ways. According to a recent study between 2004 and 2013, the FDA received more than 15 000 reports of health problems linked to dietary supplements, including nearly 4000 hospitalizations. A recent survey found that people overestimate the scope and strength of the FDA’s regulation of supplements, mistakenly believing that the FDA reviews or tests products before they reach the market. (4)
Similarly most cosmetics are safe, but consumers currently have no reliable way to know what is in their products, to be alerted if a product has safety issues, or to be protected if a manufacturer fails to act to address clear safety problems. Calls for reforms have been made repeatedly when safety issues have arisen, most recently in 2019, when asbestos was found in some cosmetics that were marketed under popular brands (5).
Academic medicine serves to advance the scientific field and provide the highest quality of clinical care. Hospital-based Good Manufacturing Practice (GMP) facilities which support primarily investigator-initiated clinical trials, are increasingly involved in interactions with industry. Although the missions of academic and commercial GMP facilities are different, both are bound by industry standards and often engage in technology transfer with industry partners. The successful set-up of an academic GMP facility requires striking a unique balance between commercial and academic priorities. (6)
Due to some unavoidable circumstances like COVID-era, few relaxations were given in inspections that included virtual inspections; however these types of relaxations may be misused at the other end at the cost of patient health. There are few products where specialized trained inspectors might be needed. Due to lack of stringent GMP guidelines, lack of regular quality audits, profiteering intentions, lack of proper equipments and inspection tools, delayed legal procedures; there have been chaos in following guidelines. There is a need to implement policy regulations as well as policing action to avoid whims and fancies of manufacturers for playing with public health in name of GMP certified pharmacies.
1. Sharp JR. Guide to good pharmaceutical manufacturing practice 1983. (No Title). 1983.
2. Sandle T. Technologies and GxP considerations for vaccine development. Pharm Mach Technol. (2022) 16:18–28
3. Gottlieb S, McClellan MB. Reforms Needed to Modernize the US Food and Drug Administration’s Oversight of Dietary Supplements, Cosmetics, and Diagnostic Tests. JAMA Health Forum. 2022;3(10):e224449.
4. Trust PC. Fact Sheet: Congress should prioritize dietary supplement reform as part of its efforts to strengthen public health. Published April 22, 2021.
5. US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, MD, and Susan Mayne, PhD, director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety. Published March 5, 2019. Accessed October 12, 2022.
6. Iancu EM, Kandalaft LE. Challenges and advantages of cell therapy manufacturing under Good Manufacturing Practices within the hospital setting. Curr Opin Biotechnol. 2020 ;65:233-241
University Center of Excellence in Research, Academic Block, Baba Farid University of Health Sciences, Faridkot, Punjab, India.
Dr.Cherry Bansal, MBBS, MHA,(MD), Department of General Medicine, Himalayan Institute of Medical Sciences, Jolygrant, Uttrakhand, India. All India Institute of Medical Sciences, Rishikesh
Good Manufacturing Practices (GMP) porous regulatory frame work!!! -are the manufacturers serious about public health? Policing vs policy requirements.
Dear Editor
Every pharmaceutical product administered to humans or animals must be manufactured under good manufacturing practices (GMP) standards. Worldwide, each country uses a GMP regulation based on the WHO guide or the EU guide. The first GMP guide was published in 1971 in the UK (the Orange Guide) (1). Pharmaceutical industries are benefiting from technological advances that offer new opportunities to improve people’s health, but also create new uncertainties and risks. For each of these industries, evidence indicates that products that slipped through a porous regulatory framework have put some individuals at risk.
Worldwide, the principal GMP regulations are the EU Guide, the FDA Code of Federal Regulations (21 CFR Parts 210, 211, 610), and WHO GMP Guide, which have minor differences. (2, 3) These guidelines were enforced because of certain tragedies in clinical trials due to use of un-standardized medicinal products however these guidelines are not being followed stringently.
There is big range of medicinal products ranging from medicines, vaccines, food supplements, miRNA based products, cell therapy products, gene therapy products, herbal products, diagnostics etc that come under preview of GMP. There are few associated products which are being used as food supplements and cosmetics but are not following guidelines as per prescribed standards due to some loopholes in the system. According to a recent study about 80% of US consumers report using dietary supplements. Many of them help improve people’s health, but some contain dangerous or unexpected ingredients or may be used in unsafe ways. According to a recent study between 2004 and 2013, the FDA received more than 15 000 reports of health problems linked to dietary supplements, including nearly 4000 hospitalizations. A recent survey found that people overestimate the scope and strength of the FDA’s regulation of supplements, mistakenly believing that the FDA reviews or tests products before they reach the market. (4)
Similarly most cosmetics are safe, but consumers currently have no reliable way to know what is in their products, to be alerted if a product has safety issues, or to be protected if a manufacturer fails to act to address clear safety problems. Calls for reforms have been made repeatedly when safety issues have arisen, most recently in 2019, when asbestos was found in some cosmetics that were marketed under popular brands (5).
Academic medicine serves to advance the scientific field and provide the highest quality of clinical care. Hospital-based Good Manufacturing Practice (GMP) facilities which support primarily investigator-initiated clinical trials, are increasingly involved in interactions with industry. Although the missions of academic and commercial GMP facilities are different, both are bound by industry standards and often engage in technology transfer with industry partners. The successful set-up of an academic GMP facility requires striking a unique balance between commercial and academic priorities. (6)
Due to some unavoidable circumstances like COVID-era, few relaxations were given in inspections that included virtual inspections; however these types of relaxations may be misused at the other end at the cost of patient health. There are few products where specialized trained inspectors might be needed. Due to lack of stringent GMP guidelines, lack of regular quality audits, profiteering intentions, lack of proper equipments and inspection tools, delayed legal procedures; there have been chaos in following guidelines. There is a need to implement policy regulations as well as policing action to avoid whims and fancies of manufacturers for playing with public health in name of GMP certified pharmacies.
1. Sharp JR. Guide to good pharmaceutical manufacturing practice 1983. (No Title). 1983.
2. Sandle T. Technologies and GxP considerations for vaccine development. Pharm Mach Technol. (2022) 16:18–28
3. Gottlieb S, McClellan MB. Reforms Needed to Modernize the US Food and Drug Administration’s Oversight of Dietary Supplements, Cosmetics, and Diagnostic Tests. JAMA Health Forum. 2022;3(10):e224449.
4. Trust PC. Fact Sheet: Congress should prioritize dietary supplement reform as part of its efforts to strengthen public health. Published April 22, 2021.
5. US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, MD, and Susan Mayne, PhD, director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety. Published March 5, 2019. Accessed October 12, 2022.
6. Iancu EM, Kandalaft LE. Challenges and advantages of cell therapy manufacturing under Good Manufacturing Practices within the hospital setting. Curr Opin Biotechnol. 2020 ;65:233-241
Competing interests: No competing interests