There are over 20,000 prescription drug products approved for marketing by The United States Food and Drug Administration, this does not include the sea of over the counter medications and supplements. With this large array of medication, there is the need to keep a tab on pharmaceutical companies and their good manufacturing practice status.
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.
If a pharmaceutical company is on a blacklist, they are seen by a government, other organizations or the consuming public as being one of a number of firms who cannot be trusted or who have done something wrong. Black listed pharma companies are often implicated in fake or substandard drug production. Falsified and substandard drugs may contain toxic doses of dangerous ingredients and cause mass poisoning. Poor-quality medicines compromise the treatment of chronic and infectious diseases, causing disease progression, drug resistance, and death.
Black Listed Pharmaceutical Companies
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the following under listed companies from the wholesale or manufacture of medicines and medical products.
The pharmaceutical companies whose authorizations were revoked are listed in the table below:
|Company name||Licence revoked||Date of revocation||Reason|
|IRMAAN LIMITED||WDA(H) 43652||12-Mar-21||Regulatory Action|
|PHARMAGONA LIMITED||WDA(H) 30472||18-Dec-20||Regulatory Action|
|HEDIGEN LIMITED||WDA(H) 43927||18-Dec-20||Regulatory Action|
|WEBSTAR DIXON LIMITED||WDA(H) 42440||04-Nov-20||Regulatory Action|
|ST HELENS MILLENNIUM CENTRE SERVICES LIMITED||WDA(H) 35902||16-Jun-20||Regulatory Action|
|LION CARE PRODUCTS||WDA(H) 23055||30-Dec-19||Regulatory Action|
|EXMED WORLDWIDE LIMITED||WDA(H) 48434||27-Sep-19||Regulatory Action|
|PRO-HEALTH PHARMACY LIMITED||WDA(H) 41286||19-Sep-19||Regulatory Action|
|HUNDLANI WHOLESALE||WDA(H) 32403||08-Aug-19||Regulatory Action|
|EDWIN C. FARRALL (TRANSPORT) LIMITED||WDA(H) 46535||24-Apr-19||Regulatory Action|
|ALMERIC PHARMACY LIMITED||WDA(H) 19568||17-Apr-19||Regulatory Action|
|RIVERSIDE (BOURNEMOUTH) LIMITED||WDA(H) 40930||14-Feb-19||Regulatory Action|
|SOKA BLACKMORE LIMITED||WDA(H) 19916||28-Dec-18||Regulatory Action|
|SYNERGEY PHARMA LIMITED||WDA(H) 46813||14-Nov-18||Regulatory Action|
|PHARMEX-UK LIMITED||WDA(H) 48117||16-Oct-18||Regulatory Action|
|BIRCH AND BEECH LIMITED||WDA(H) 28401||16-Oct-18||Regulatory Action|
|SUPAMED LIMITED||WDA(H) 44007||17-Aug-18||Regulatory Action|
|BEST SELLING LIMITED||WDA(H) 1879||09-Aug-18||Regulatory Action|
|KUBRI DISPENSING CHEMIST||WDA(H) 19938||21-Jun-18||Regulatory Action|
|HEALTH-CARE EQUIPMENT AND SUPPLIES COMPANY LIMITED||WDA(H) 32585||13-Jun-18||Regulatory Action|
|RELIABLE MEDICARE LIMITED||WDA(H) 46138||15-Feb-18||Regulatory Action|
|STYVECHALE PHARMACY||WDA(H) 34965||17-Aug-17||Regulatory Action|
|DOORSTEP DISPENSAREE LIMITED||WDA(H) 45045||07-Aug-17||Regulatory Action|
|TEMPLE PHARMACY (EALlNG) LIMITED||WDA(H) 41801||05-Jul-17||Regulatory Action|
|GALAXY PHARMA LIMITED||WDA(H) 40171||30-Jun-17||Regulatory Action|
|JALAL AND SONS LIMITED||WDA(H) 36315||19-May-17||Regulatory Action|
|NESTOR LIMITED||MIA 31866||06-Apr-17||Regulatory Action|
|ISS PHARMACEUTICALS LIMITED||WDA(H) 42581||22-Mar-17||Regulatory Action|
|GORDON DAVIE CHEMIST LIMITED||WDA(H) 42115||15-Feb-17||Regulatory Action|
|BRAYSCALE LIMITED||WDA(H) 34303||16-Jun-16||Regulatory Action|
|ROYA HEALTH LIMITED||WDA(H) 40498||08-Apr-16||Regulatory Action|
|RJP IMPEX LIMITED||WDA(H) 40903||29-Mar-16||Regulatory Action|
|RAM ENTERPRISE (WHOLESALE) LIMITED||WDA(H) 22484||01-Mar-16||Regulatory Action|
|PARS RAM DHANDA||WDA(H) 36433||27-Jan-16||Regulatory Action|
|MR M P IQBAL||WDA(H) 39535||31-Dec-15||Regulatory Action|
|OCTAVIAN PHARMA LIMITED||WDA(H) 42548||01-Oct-15||Regulatory Action|
|ACOMED LIMITED||WDA(H) 36824||18-May-15||Regulatory Action|
|VINAYAK PHARMA LIMITED||WDA(H) 42580||15-Nov-14||Regulatory Action|
|EURO TRADE (WHOLESALE) LIMITED||WDA(H) 40708||20-Sep-14||Regulatory Action|
|LAUDON DISPENSING CHEMIST LIMITED||WDA(H) 32450||23-Jul-14||Regulatory Action|
|OVERDRAKE LIMITED||WDA(H) 33449||20-May-14||Regulatory Action|
|PHARMA CURE HEALTH CARE LIMITED||WDA(H) 34535||07-May-14||Regulatory Action|
|LIFE PHARMACEUTICALS||WDA(H) 32124||26-Jan-14||Regulatory Action|
In 2021, the Indian government issued show cause notices to, and may soon blacklist, eight Chinese pharmaceutical companies found to be supplying poor quality raw material to drug manufacturers in this country. According to documents available the eight companies are M/S Qilu Tianhe Pharmaceuticals, M/S Hinan Xinxiang Pharmaceuticals, M/S Zhuhai United Labratories, M/S Guangzhao Baiyunshan Pharmaceuticals, M/S Shouguang Fukang Pharmaceuticals, M/S Qilu Antibiotics (Linyi) Pharmaceuticals, M/S Qindao Brightmoon Seawoods and M/S Shanghaoi Xiandia Hasen (Shangqiu) Pharmaceuticals. According to sources in the DCGI, the companies on the verge of getting blacklisted are currently supplying a huge chunk of raw material to the Indian drug manufacturers.
In 2019, The Bureau of Pharma PSUs of India (BPPI) barred as many as 12 pharmaceutical firms from doing business for two years as the companies were found supplying substandard medicines to Jan Aushadhi centers across India. The companies which are blacklisted and barred from doing business for two years include Overseas Health Care, Hanuchem Laboratories, Legen Health Care, Jackson Laboratories, Mascot Health Services, Jackson Laboratories, Legen Health Care and Terrace Pharmaceuticals.
The firms who have been identified to be supplying substandard medicines include Modern Laboratories, Ravian Life Sciences, AMR Pharma India Private Limited, Maxchem Pharmaceuticals, Theon Pharmaceuticals and Mascot Health Service.
On February 16, 2015, Hainan Baozhiyuan Medical Technology Co., Ltd. (Baozhiyuan) was put on a provincial blacklist for a duration of two years. Baozhiyuan is a private company registered in the Hainan Province. It was alleged that the company paid kickbacks to the medical personnel of 12 hospitals based on a percentage of sales.
On October 16, 2014, Chongqing Weixin Medical Supplies Co., Ltd. (Weixin) was put on a provincial blacklist for a duration of two years. It is the first company to be blacklisted based upon the 2013 Recording Measures. Weixin is a private company registered in the Chongqing Municipality and specialized in selling medical equipment. It was alleged that its General Manager provided the former head of the Equipment Division of Chongqing No. 13 Hospital with “favor fees” amounting to CNY 135,000 (approximately USD 21,787) during a procurement project.
In December 2013, MEP released a blacklist of 18 pharmaceutical companies illegally emitting wastewater. The MEP conducted inspections at 178 pharmaceutical manufacturing companies and 7 pharmaceutical manufacturing sewage treatment facilities across 13 provinces.
In November 2016, 39 Indian drug companies including Aurobindo Pharma, Cadila and Mcleods Pharmaceuticals were blacklisted by Vietnam for quality standard violations. Antibiotics made by Aurobindo and Mcleod, and Cadila’s anti-rabies vaccine Lyssavac have been banned. Along with the Indian companies, the Vietnamese drug regulator has also banned companies from Bangladesh and South Korea on its website, but has not specified the reason for the ban. Lyssavac, Cadila’s anti-rabies vaccine was also banned by World Health Organization in January that year.
The US FDA maintains a tainted products data base which lists a good number of tainted products and the pharmaceutical companies that market them as dietary supplements. This list only includes a small fraction of the potentially hazardous products with hidden ingredients marketed to consumers on the internet and in retail establishments. FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients.
Even if a product is not included in the list, consumers should exercise caution before using certain products. To learn more about how to reduce your risk of encountering a product marketed as a dietary supplement with a hidden ingredient please visit FDA’s Medication Health Fraud webpage link here FDA’s Medication Health Fraud Page.