Prosecutions (medicines)

Examples of previous prosecutions

Regina v Gwyn Edge Evans
Mr Gwyn Edge Evans (56) from The Cottage, Millwood Rise, Overton-on-Dee, Wrexham, LL13 0EL was fined £4,000 and £1,500 costs at Southwark Crown Court on 20 October 2008 after pleading guilty to four offences under the Medicines Act 1968 for the illegal assembly, sale and supply of unlicensed medicines, including some sex drugs. The sentencing followed a prosecution by the Medicines and Healthcare products Regulatory Agency (MHRA).

Mr Evans imported unlicensed medicines through his Wrexham-based company G E Evans Holding Company between 25 May 2005 and 27 July 2006. These medicines had been exported from India on behalf of a buyer in Mauritius, addressed to Mr Evans’ company. MHRA investigators visited Mr Evans’ company and found in the corner of his office two tall storage cabinets containing a number of small storage containers on the shelves. Each container contained capsules or tablets in vacuum sealed packets of varying sizes. The contents were unlicensed medicines in the form of Sildenafil and Tadalafil (both used to treat erectile dysfunction), Carisoprodol (used as a muscle relaxant) and Sibutramine Hydrochloride (used to treat obesity). Some 91,000 tablets were seized along with a bundle of documentation which contained records of imports received by the company. In addition to this quantity, 65,670 similar tablets and capsules were seized at Stansted Airport and a document was also identified that showed Mr Evans’ company were in receipt of some 22 consignments of unlicensed medicines between May 2005 and February 2006. These shipments totalled some 475,764 tablets and capsules.

Mick Deats, Group Manager of Enforcement at the MHRA said, “This investigation clearly demonstrates our commitment to safeguard public health. It is essential that medicines for human use are sold safely and licensed correctly. It is right that people like Mr Evans are punished when these rules are flouted. This should serve as a deterrent to others who have little or no regard for public health or the Medicines Act.”

Regina v Dr George Patino
Dr George Patino (aka Giorgio Giovanni Paticciano), 48 years old and a Mexican citizen by birth, was sentenced on 14 October at Kingston Crown Court to 3 years imprisonment. He is the latest in a group of businessmen engaged in a conspiracy to be prosecuted by the Medicines and Healthcare products Regulatory Agency (MHRA) in an operation known as Stormgrand. This operation led to convictions in one of the biggest conspiracies of the supply of counterfeit medicines of its kind in the UK.

Over a period of nine months (February 2005 – October 2005) Dr Patino, with the help of his co-conspirator Ashish Halai, bought nearly $237,000 worth of fake Viagra which was then sold onto patients in the UK and world-wide. During that period, Dr Patino received numerous complaints from buyers, including one which stated that the product was coated with blue paint and was coming off the tablet.

Dr Patino was arrested in October 2005 at Heathrow Airport as he waited to board a plane to travel to Leeds. Upon arrest, he was carrying a laptop and memory stick which revealed files of his business dealings and over 2,000 digital photographs depicting or associated with pharmaceutical products.

Mick Deats, Group Manager of Enforcement at the MHRA said, “Counterfeit medicines can be dangerous - designed so as to deceive people and healthcare professionals whilst generating vast profits for the counterfeiters. The MHRA will not hesitate to use the full range of powers available to investigate and prosecute those who represent a risk to public health.”

Regina v Hussain and Zaidi
Two men from London were sentenced at Kingston Crown Court on 3 July 2008 for the illegal sale and supply of Class C drugs and counterfeit medicines. The sentencing followed an investigation by the Enforcement Group within I, E & S.

Mr Shabbir Hussain (55) of 94 Dollis Hill Lane, Cricklewood, London, NW2 6JD and Mr Mohammed Yasser Zaidi (26) of 19 Budding Circle, Wembley Place, London were found guilty on 14 counts and 8 counts under the Trades Mark Act 1994.

Mr Shabbir Hussain was sentenced to 4 years imprisonment and Mr Mohammed Yasser Zaidi was sentenced to 51 weeks imprisonment, suspended for two years, and to 150 hours community service.

The case started in June 2006. Mr Hussain ran a business called AST International, buying and selling medicines. Mr Zaidi worked for Mr Hussain. On 13 June 2006, MHRA investigators searched Mr Hussain’s address in Dollis Hill Lane and inspected a large brick shed used as an office and storehouse at the bottom of his garden. It was in the shed that a large quantity of prescription-only medicines was found. These were Xenical, Reductil, Propecia, Plavix, Levitra, Viagra and Cialis. Class C drugs were also found namely Diazepam (Valium), Phentermine and five different types of steroids. These were Decca Durabolin, Oxabolone, Sustanon, Anabol and Nandrolene Decananoate. Neither Mr Hussain, Mr Zaidi nor AST International has been issued with licences by the Home Office to deal in Class C Drugs in accordance with the Misuse of Drugs Act 1971. Samples of the prescription-only medicines were analysed and found to be counterfeit. These fake medicines and Class C drugs were smuggled into the UK. A network of addresses in the Wembley area was used to receive parcels. Fictitious consignee names were given to delivery companies. The parcels were mis-described as ‘samples of food supplements’ so as not to alert Customs authorities here and abroad.

Regina v Hitendra Patel
Hitendra Patel (41), a suspended pharmacist, of 2 St Mary’s Copse, St Mary’s Road, Worcester Park, Surrey KT4 7LA was fined £3,000 and given a confiscation order of over £200,000 at Kingston Crown Court on 25 July 2008 for illegally selling and supplying the erectile dysfunction medicine Viagra. The sentence follows a prosecution by the Medicines and Healthcare products Regulatory Agency (MHRA).

The case began in 2003. Mr Patel was illegally importing Viagra from Pakistan and selling it in the UK to then be sold onto the US market.

Mick Deats, Group Manager of Enforcement at the MHRA said, “The MHRA will take action against people illegally supplying medicines to the public and will strive to maintain the integrity of the supply chain.”

Regina v Hafid Essadki
Mr Hafid Essadki (39) formerly of 341 Boardwalk Place, Trafalgar Way, London, E14 5SQ was fined £1,000 and ordered to pay £1,500 costs yesterday (23 July 08) at Snaresbrook Crown Court for the illegal online sale and supply of Viagra and Cialis. The sentencing followed a prosecution by the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA started investigating Mr Essadki in January 2006 after receiving information from Pfizer that customers had complained about two websites advertising Viagra and Cialis for sale on www.pfizer-viagra.co.uk and www.viagra-cialis-express.co.uk. On March 2006 MHRA enforcement officers, accompanied by representatives from Pfizer and Eli Lilly together with the Metropolitan Police, went to Mr Essadki’s home address and found a quantity of Viagra and Cialis tablets. These were seized along with computers, mobile phones and a laptop.

Mick Deats, Group Manager of Enforcement at the MHRA said, “The MHRA will not hesitate to take action against those who undermine public health. There is considerable risk to the public from obtaining medicines through unregulated websites. A medicine bought in this way has no guarantee of safety, quality or effectiveness. It could be counterfeit. It may not contain the right amount of medicine. At worst it may cause a severe side effect."

Regina v Arshad Mahmood
Mr Arshad Mahmood (48) of 42 Sevenoaks Road, Brockley, London SE4 1RE was fined £4,000 and ordered to pay over £4,500 in costs at Tower Bridge Magistrates Court on 23 July 2008 for the illegal sale and supply of unlicensed medicines and banned cosmetics. His company, of which he was director, called Sabina Hair & Cosmetics (Peckham) Ltd was also fined £4,000 and over £4,500 in costs. This follows a joint investigation by the Medicines and Healthcare products Regulatory Agency (MHRA) and Southwark Trading Standards.

The MHRA became involved after being contacted by Southwark Trading Standards to assist in a joint inspection at the shop. Southwark Trading Standards had previously conducted two test purchases of tubes of Movate Cream back in May 2007. This cream contained the cortico-steroid Clobetasol Propionate. The inspection of the shop revealed a significant amount of unlicensed steroid creams and banned cosmetics masked as skin lightening creams which were seized and removed. Analysis of the products revealed that they contained cortico-steroids and hydroquinone (a banned cosmetic).

Mick Deats, Enforcement Group Manager at the MHRA said, “Mr Mahmood has put the public at risk by selling potent medicines that are not licensed and therefore have no guarantee of safety. There are dangers associated with the long-term use of steroid creams, such as thinning the skin. This case serves as a reminder that we will continue to clamp down on those who put public health at risk.”

Regina v Brian Wilsher
Mr Brian Wilsher (57) of 11 Erin Road, Duckmanton, Derbyshire, S44 5HQ was sentenced at Derby Crown Court on 18 July 2008 to 34 weeks imprisonment, suspended for 18 months and 200 hours unpaid work for the illegal sale and supply of an unlicensed medicine and a Class C drug. The sentencing followed a joint prosecution by the Medicines and Healthcare products Regulatory Agency (MHRA) and Derbyshire Constabulary.

The case began in October 2007 after Police carried out a search at Mr Wilsher’s home address in Chesterfield where a large quantity of tablets was found. These included approximately 50,000 kamagra tablets and 20,000 diazepam tablets. Also found at the address was over 4,000 boxes of kamagra condoms and kamagra oral jelly.

Mick Deats, Group Manager of Enforcement at the MHRA said, “It is illegal to place on the UK market or offer for sale an unlicensed medicine such as kamagra. This product has not gone through the correct licensing regulatory process to assess it for safety, quality and that it works. At best it could be a waste of money, at worst it could be severely detrimental to your health.”

Regina v Hussain and Zaidi
Two men from London were sentenced at Kingston Crown Court on 3 July 2008 for the illegal sale and supply of Class C drugs and counterfeit medicines. The sentencing followed an investigation by the Enforcement Group within I, E & S.

Mr Shabbir Hussain (55) of 94 Dollis Hill Lane, Cricklewood, London, NW2 6JD and Mr Mohammed Yasser Zaidi (26) of 19 Budding Circle, Wembley Place, London were found guilty on 14 counts and 8 counts under the Trades Mark Act 1994.

The case started in June 2006. Mr Hussain ran a business called AST International, buying and selling medicines. Mr Zaidi worked for Mr Hussain. On 13 June 2006, MHRA investigators searched Mr Hussain’s address in Dollis Hill Lane and inspected a large brick shed used as an office and storehouse at the bottom of his garden. It was in the shed that a large quantity of prescription-only medicines was found. These were Xenical, Reductil, Propecia, Plavix, Levitra, Viagra and Cialis. Class C drugs were also found namely Diazepam (Valium), Phentermine and five different types of steroids. These were Decca Durabolin, Oxabolone, Sustanon, Anabol and Nandrolene Decananoate. Neither Mr Hussain, Mr Zaidi nor AST International has been issued with licences by the Home Office to deal in Class C Drugs in accordance with the Misuse of Drugs Act 1971. Samples of the prescription-only medicines were analysed and found to be counterfeit. These fake medicines and Class C drugs were smuggled into the UK. A network of addresses in the Wembley area was used to receive parcels. Fictitious consignee names were given to delivery companies. The parcels were mis-described as ‘samples of food supplements’ so as not to alert Customs authorities here and abroad.

Regina v Viraj Shah
On 2 July 2008, Mr Viraj Shah (37) of 33 Oakfield Avenue, Kenton, Harrow, Middlesex HA3 8TH was sentenced to 51 weeks imprisonment, suspended for two years, and to 40 hours community service for dealing in counterfeit medicines. Mr Shah appeared at Kingston Crown Court following an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA).

The case started back in May 2006, when HM Revenue & Customs officers were conducting routine examinations of a number of consignments at Heathrow Airport. A shipment of healthcare products was selected for examination, destined for the Bahamas from a company called Oyster Corporation based in United Arab Emirates. The shipment consisted of 23 boxes on four pallets, weighing 385kgs. Each box was opened and was found to contain further unmarked boxes containing packages of branded medicines. In total the officers found seven different types of prescription-only medicines: Nexium, Diovan, Propecia, Actonel, Lipitor, Ezetrol and Hyzaar. The packaging of the boxes, particularly Nexium, appeared inconsistent in colouring with each other and so the shipment was detained to make authenticity checks with the manufacturer. Samples of the seized medicines were sent for analysis and found to be counterfeit in every case.

In June 2006, investigators from the MHRA and the police visited Mr Shah’s address where they found a yellow bag in the garage. This bag contained 10 blister packs each containing 14 dark blue and white tablets marked “Reductil”, a prescription-only medicine to treat obesity. Samples of the packaging and tablets were analysed and found to be counterfeit.

Mick Deats, Group Manager of Enforcement at the MHRA said, “Anybody engaged in the distribution of counterfeit medicines represents a significant threat to public health, both to individual patients and in undermining the health system. The MHRA will not hesitate to take action against those involved in this serious criminal activity.”

Regina v Guy's and St Thomas' NHS Hospital Trust
On Friday 23 May 2008 the Guy's and St Thomas' NHS Hospital Trust was sentenced in respect of an offence under Section 64 Medicines Act 1968. They had previously pleaded guilty to the offence on 13 March 2008 at City of Westminster Magistrates Court. An investigation was started when G & T NHS Trust reported to the MHRA that an incident had occurred at Chelsea and Westminster Hospital in which a premature baby had died following the administration of a Total Parenteral Nutrition (TPN) intravenous feed which had been prepared at G & T NHS Trust. The TPN was seized by the MHRA and examined by The laboratory of the Government Chemist where it was found to contain significantly higher proportion of glucose than it should have done. Evidence regarding the composition of the TPN was given by an MHRA Inspector to the Coroner who investigated the death. The coroner found that the administration of the incorrectly constituted TPN was a contributory factor to the death of the baby. The baby was very premature and its twin had recently died prior to this incident, so death can not be attributed exclusively to the incorrectly constituted TPN.

The Guy's and St Thomas' NHS Trust were charged with a single offence under s64 Medicines Act 1968 of supplying a medicinal product which was not of a nature or quality specified in the prescription. They pleaded guilty to the offence on 13 March 2008 and were sentenced on 23 May 2008. The sentence was a fine of £75,000.00 and costs of £2916.00

Regina v Hudson and Hodgkiss
Two men were sentenced on 21 May 2008 at Lewes Crown Court for the illegal sale and supply of an unlicensed medicine used to treat male erectile dysfunction under the Medicines Act 1968. The sentencing followed an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA).

Colin Richard Hudson (52) of 3 Pitreavie Drive, Hailsham, East Sussex BN27 3XG was sentenced to eight months and two weeks imprisonment suspended for two years. Scott Hodgkiss (37) of 57 Ogden Street, Stoke-On-Trent, Staffordshire, ST1 3BX received 120 hours community service. They had both previously pleaded guilty to a conspiracy charge under offences contrary to the Medicines 1968 Act concerning the illegal sale and supply of Kamagra on the Internet over a period of nearly a seven months.

MHRA enquiries revealed that Mr Hodgkiss operated a website called www.kamagra100.co.uk. In February 2006, a search by MHRA enforcement officers of Mr Hodgkiss’ home address discovered a large quantity of Kamagra in tablet and jelly form with an estimated street value of £23,000. Further investigation pointed to Mr Hudson as being Mr Hodgkiss’ supplier who was operating a website called www.kamagraman.co.uk. A search of Mr Hudson’s home address recovered documentation referring to Kamagra from his computer.

Mick Deats, Enforcement Group Manager at the MHRA said, “There is considerable risk to the public from obtaining medicines through unregulated websites. The websites operated by Mr Hodgkiss and Mr Hudson were offering an unlicensed medicine. A medicine bought in this way has no guarantee of safety, quality or effectiveness.”

Regina v Dinesh Maini
The Medicines and Healthcare products Regulatory Agency (MHRA) successfully prosecuted a man from Nottingham at the City of London Magistrates Court on Wednesday 23 April 2008 for illegally possessing with intention to sell and advertising the unlicensed drug, Lipostabil®, for cosmetic purposes.

Dr. Dinesh Maini, a GP based at the Lenton Surgery, 266 Derby Road, Nottingham, NG7 1PR, pleaded guilty to three charges and was ordered to pay over £10,000 in costs and fines.

In 2005, Dr. Maini advertised Lipostabil® and referred to the drug as ‘Fat Jab’ in an advert placed in the Nottingham Evening Post. He was contacted by the MHRA to stop advertising the unlicensed medicine. However, he continued to advertise on a website called www.nottinghamlaserclinic.com. The MHRA subsequently visited the Lenton surgery and seized 187 full packs and 3 incomplete packs of Lipostabil®.

Mick Deats Head of Enforcement and Intelligence of the MHRA said “This successful prosecution highlights the robust action the MHRA takes against those who illegally advertise, sell and administer unlicensed medicines for cosmetic purposes. Consumers should be aware of those who sell and administer Lipostabil®, as it not for cosmetic use and could cause health risks.”

Regina v Huxley & Pownall
The Medicines and Healthcare products Regulatory Agency successfully prosecuted Robin Huxley (age, 45) from Barnsley and Stephen Pownall (age, 45), Newark, Notts, on Friday 14 March 2008 at Sheffield Crown Court for the illegal sale and supply of medicines, Reductil and Xenical.

On the 28 November 2007 Mr. Huxley pleaded guilty to five counts under the Medicines Act 1968 at Sheffield Crown Court and subsequently was sentenced to fourteen months imprisonment. Stephen Pownall was ordered to pay a total of £7497.80 in fines, confiscation and costs.

From May 2001 to 31 March 2005 Mr. Huxley was employed in the pharmaceutical industry, where he used his knowledge and expertise to obtain large quantities of prescription only medicines namely Reductil. (Which is usually prescribed for clinical obesity.) He also obtained large amounts of Xenical from Roche Pharmaceuticals Ltd. He then went on to sell these products in his various slimming and weight loss clinics, based in Barnsley, without any of his clients having been given a prescription or an appropriate medical consultation.

Mick Deats, Head of Enforcement and Intelligence said “This successful prosecution highlights the robust action the MHRA takes against those who flout the law for their own personal gains.”

Regina v Azim Dad
On 11 January 2008 Mohammed Azim Dad (30) of 116 Chippenham Lane, Slough, SL1 5BA was sentenced to 250 hours community service on three counts under the Trade Marks Act 1994 relating to counterfeit erectile dysfunction medication, namely Viagra, Cialis and Levitra. Mr Dad appeared at Reading Crown Court following an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA).

Mr Dad was charged on 4 November 2005 after he was caught selling the counterfeit products to undercover agents from the drug manufacturer, Eli Lilly. The undercover agents purchased some of the products over the internet. When tested, the prescription only medicines did not contain the correct amount of the active ingredients. When Mr. Dad was interviewed by the MHRA, Mr Dad admitted to buying Viagra and Cialis from China and selling them on eBay for £4.00. Whilst being actively investigated by the MHRA Mr. Dad continued to sell the counterfeit medicines over the Internet. Mr Dad’s home was raided in July 2005, where the counterfeits were seized, with the estimated value of £45,000 - £50,000. He pleaded guilty to the offences in July 2006.

Regina v Shaan Hussein
Also on 11 January 2008 Mr Shaan Hussein was sentenced at Kingston Crown Court to pay a fine of £1000 for an offence under paragraph 1 schedule 3 of the Medicines for Human Use (Marketing Authorisations etc) Regulations 1994. Mr Hussein had previously entered a guilty plea following an Enforcement investigation which showed that he had acted as a broker in respect of the sale or supply of unlicensed medicines.

Regina v Shazia Amjad - 5 November 2007
The above named, who supplied counterfeit prescription drugs to the UK, was sentenced to two and a half years at Croydon Crown Court on 5 November 2007.

Shazia Amjad, 39, of Crowell Lane, Uxbridge, was arrested as part of a joint investigation between the MHRA  and City of London Police.

Enforcement officers from the MHRA, along with officers from City of London Police, found counterfeit prescription drugs worth over £250,000, including more than 50,000 units of Ephedrine and a selection of slimming pills, erectile dysfunction pills, painkillers and anabolic steroids, when they searched Amjad’s address in November 2006.

In addition, officers found twelve passports hidden inside a suitcase. A total of 30 bank and visa cards were also recovered during the search. Officers discovered that the drugs originated in Pakistan and were mailed over to Amjad, who was paid in cash.

The same day Amjad was charged with offences under the Identity Card Act. In July 2007 Amjad was subsequently charged with trademark offences, possession with intent to supply class C drugs and money laundering.

Mick Deats, Head of Enforcement at the MHRA said, “Today’s result sends out a very clear warning that dealing in counterfeit medicines doesn’t pay. The MHRA will continue to clamp down on those who flout the law and put the public’s health at risk. People should ensure that they only obtain their medicines from legitimate outlets, e.g. their doctor or pharmacist. If people do not, then there can be no guarantee to their safety, quality or indeed that they work. At best these medicines could be a waste of money, at worst they could be severely detrimental to your health.”

DC Wilson McQuitty, from the Force’s Economic Crime Department at City of London Police said, “Shazia Amjad was exploiting people who genuinely needed these drugs for her own personal gain. Together with colleagues from the MHRA we were able to take these drugs out of circulation and seize numerous fake documents and bank cards which were being used to launder the money she was making.”

Regina v Halai, Haywood, Patel & Mirza - 17 September 2007
An investigation by the MHRA has today led to the sentencing of a man to four and a half years' imprisonment at Kingston Crown Court. He was convicted of four offences under the Medicines Act and Trade Marks Act. Three other men have also been found guilty, one of whom was also convicted of money laundering offences. The offences concerned the conspiracy to smuggle and supply counterfeit medicines into and, in some cases, out of the UK

The men were charged with masterminding the industrial-scale supply of counterfeit medicine between 2002 and 2005, involving millions of pounds worth of counterfeit Viagra, Cialis and Propecia. These seizures resulted in the MHRA unravelling the biggest conspiracy of the supply of counterfeit medicines thus far in the UK. The seizure of over £1,500,000 of counterfeit medicines was intended to be supplied to customers through this conspiracy.

Ashish Halai  
Charged counts 1 to 9
Pleaded guilty 24/2/07 counts 1 to 4

Gary Haywood
Charged and found guilty on all 11 counts listed

Ashwin Patel
Charged counts 1 to 9
Found guilty counts 1, 2, 3, 4, 6, 7, 8
Found not guilty counts 5 and 9

Zahid Mirza
Charged counts 1, 2, 3, 4, 7, 8
Found guilty counts 1, 2, 3, 4, 8
Found not guilty count 7

COUNT 1
Conspiracy to evade the prohibition on the unauthorised use of a trade mark in relation to goods, contrary to section 92 (1) of the Trade Marks Act 1994 and section 1(1) of the Criminal Law Act 1977.

Between 1 January 2002 and 12 October 2005 conspired together with ASHISH HALAI and with other persons known and unknown to offer or expose for sale goods, namely medicinal products, which bore, or the packaging of which bore, the manufacturer’s trademark sign “Viagra” and with a view to gain for themselves or others, or with intent to cause loss to another, and without the consent of the proprietor,

COUNT 2
Conspiracy to place a medicinal product on the market, contrary to Schedule 3(1) of the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994 and section 1(1) of the Criminal Law Act 1977.

Between 1 January 2002 and 12 October 2005 conspired together with ASHISH HALAI and with other persons known and unknown to place a relevant medicinal product, namely Sildenafil Citrate in tablet form, on the market without holding a Community or United Kingdom marketing authorisation in respect of that product.

COUNT 3
Conspiracy to evade the prohibition on the unauthorised use of a trade mark in relation to goods, contrary to section 92 (1) of the
Trade Marks Act 1994 and section 1(1) of the Criminal Law Act 1977.

Between 1 January 2002 and 12 October 2005 conspired together with ASHISH HALAI and with other persons known and unknown to offer or expose for sale goods, namely medicinal products, which bore, or the packaging of which bore, the manufacturer’s trademark sign “Cialis” and with a view to gain for themselves or others, or with intent to cause loss to another, and without the consent of the proprietor.

COUNT 4
Conspiracy to place a medicinal product on the market contrary to Schedule 3(1) of the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994 and section 1(1) of the Criminal Law Act 1977.

Between 1 January 2002 and 12 October 2005 conspired together with ASHISH HALAI and with other persons known and unknown to place a relevant medicinal product, namely Tadalafil in tablet form, on the market without holding a Community or United Kingdom marketing authorisation in respect of that product.

COUNT 5
Conspiracy to evade the prohibition on the unauthorised use of a trade mark in relation to goods, contrary to section 92 (1) of the Trade Marks Act 1994 and section 1(1) of the Criminal Law Act 1977.

Between 1 January 2002 and 12 October 2005 conspired together with ASHISH HALAI and with other persons known and unknown to offer or expose for sale goods, namely medicinal products, which bore, or the packaging of which bore, the manufacturer’s trademark sign “Propecia” and with a view to gain for themselves or others, or with intent to cause loss to another, and without the consent of the proprietor

COUNT 6
Conspiracy to place a medicinal product on the market contrary to Schedule 3(1) of the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994 and section 1(1) of the Criminal Law Act 1977.

Between 1 January 2002 and 12 October 2005 conspired together with ASHISH HALAI and with other persons known and unknown to place a relevant medicinal product, namely Finasteride in tablet form, on the market without holding a Community or United Kingdom marketing authorisation in respect of that product.

COUNT 7
Conspiracy to evade the prohibition on wholesale dealing, contrary to section 8 (3) (a) and section 45(1) of the Medicines Act 1968 and section 1(1) of the Criminal Law Act 1977

Between 1 January 2002 and 12 October 2005 in the course of a business conspired together with ASHISH HALAI and with other persons known and unknown to sell, or offer to sell, a medicinal product, namely a quantity of Sildenafil Citrate in tablet form, except than in accordance with a wholesale dealer’s licence.

COUNT 8
Conspiracy to evade the prohibition on wholesale dealing contrary, to section 8 (3) (a) and section 45(1) of the Medicines Act 1968 and section 1(1) of the Criminal Law Act 1977

Between 1 January 2002 and 12 October 2005 in the course of a business conspired together with ASHISH HALAI and with other persons known and unknown to sell, or offer to sell, a medicinal product, namely a quantity of Tadalafil in tablet form, except than in accordance with a wholesale dealer’s licence.

COUNT 9
Conspiracy to evade the prohibition on wholesale dealing, contrary to section 8 (3) (a) and section 45(1) of the Medicines Act 1968 and section 1(1) of the Criminal Law Act 1977
Between 1 January 2002 and 12 October 2005 in the course of a business conspired together with ASHISH HALAI and with other persons known and unknown to sell, or offer to sell, a medicinal product, namely a quantity of Finasteride in tablet form, except than in accordance with a wholesale dealer’s licence.

COUNT 10
Concealing, disguising, converting, transferring or removing the proceeds of criminal conduct, contrary to section 93C of the Criminal Justice Act 1988

Between 1 January 2002 and 24 February 2003 knowing or having reasonable grounds to suspect that property, in whole or in part, represented the proceeds of his criminal conduct did conceal, disguise, covert, transfer or remove such property from the jurisdiction for the purpose of avoiding prosecution for an offence to which this Part of this Act applies or the making or enforcement in his case of a confiscation order.

COUNT 11
Concealing, disguising, converting, transferring or removing the proceeds of criminal conduct, contrary to section 327 of the Proceeds of Crime Act 2002

Between 25 February 2003 and 21 March 2006 knowing or suspecting that property, in whole or in part, represented the proceeds of his criminal conduct did conceal, disguise, convert, transfer or remove criminal property from England and Wales.

Regina V Christopher John Hill & Graeme Trevor Carlton
On 18  September 2007 at Hartlepool Magistrates Court, Christopher John HILL pleaded guilty to two offences. He was fined £150 for each and ordered to pay an additional £1025 towards MHRA Costs.

Hill was found guilty of one offence in relation to the illegal sale of Kamagra under Section 52 of the Medicines Act of 1968 and one offence under regulation 23 (1) and 3 (1) of  the Medicines (Advertising) Regulations 1994

Graeme Trevor Carlton also pleaded guilty to eight offences in relation to the illegal sale and supply of Kamagra. More information on this will follow when a date for sentencing at Teesside Crown Court has been advised

Products had been sold via two websites www.kamagra-online.co.uk and www.viagra-global.com (external links)

Regina v Sabina Hair & Cosmetics (Tooting) Ltd
On the 17 May at South Western Magistrates Court, the above named company and the defendant ( Company Director Wasim RABBANI) were sentenced to a total of £24,400 in fines and £2,500 in costs,

The offences related to the illegal sale of creams containing Cortciosteroids and Hydroquinone. In total, there were five offences under Section 52 of the Medicines Act 1968, one offence under the Cosmetics Safety Regulations and a labelling offence under the Consumer protection Act.

This case was a joint prosecution with Wandsworth Trading Standards.

MHRA v Martin Hickman
On Wednesday 25 April, at the High Court, Martin Hickman was given a three month prison sentence for contempt of court following his failure to comply with terms of an Injunction secured in September. His company MSH World Traders Limited was fined £20,000.

The Injunction against Hickman rel ates to sections 3(1) and 7 of the Medicines (Advertising) Regul ations 1994 and other retail sale offences.

Hickman had been ordered to cease advertising medicinal products including Viagra and Kamagra on the internet and to cease trading in other unlicensed and Prescription Only Medicines.

The Right Honourable Justice Saunders described Hickman as a “wholly unbelievable witness”.

Regina v Neil Johnson
On 11 April at Bourne Magistrates Court Neil Graham Johnson was fined £500 and MHRA were awarded £500 costs.

This case concerned the illegal sale of unlicensed medicine via the internet under section 52 of the Medicines Act 1968.

This prosecution follows one of MHRA’s recent Internet “day of action” initiatives where following intelligence and evidence gathering, co-ordinated visits to addresses suspected of engaging in such illegal activity are made.

In this case, following entry to the address, 3000 Kamagra tablets were seized. Analysis revealed the presence of the active pharmaceutical ingredient Sildenafil Citrate, found in the licensed product Viagra.

Regina v David Watkins
At Lowestoft Magistrates Court, on the Thursday 15 March, David Watkins pleaded guilty and was sentenced as follows:

£250 for each of the four offences concerned and £500 costs to MHRA.

The case involved the illegal sale and supply of medicine (Kamagra) via the internet.

Watkins pleaded guilty to one offence under S52 of the Medicines Act and three offences under Regulation 3(1) & 23(1) of the Medicines Advertising Regulations 1994.

Regina v Qurban Hussain & Mohammed llyas Khan (African Dreams Cosmetics limited)
Mr Qurban Hussain and Mr Mohammed Ilyas Khan were sentenced on 07 February 2007 at Tower Bridge Magistrates Court for illegally selling and supplying unlicensed creams containing corticosteroids. The medicines were being sold for as skin lightening products.

This was a joint prosecution with Trading Standards. Offences were brought:

• under section 52 of the Medicines Act 1968 for illegally selling and supplying unlicensed medicines
• under the Cosmetic Product (Safety) Regulations 2004 and Consumer Protection Act 1987 for supplying cosmetics which do not comply with cosmetic regulations.

Both defendants were fined £6,500 and £2,263 costs each. The company, African Dream Cosmetics Ltd, was also fined £13,000 and £2,263 costs.

Regina v Michael Crook
On Tuesday 23 January 2007 at Wigan Magistrates Court, Michael Crook was sentenced to a community order of 18 months duration, with a requirement to complete 200 hours unpaid work. Additionally MHRA were awarded £2000 costs.

The case concerned the illegal supply of products containing Ephedrine. Crook had supplied a product referred to as “Heat Seeker” to a Bernard Long who had been prosecuted previously by the MHRA for illegal sale and supply of a medicinal product.

Offences were brought under the Schedule 3(2) of the Medicines for Human Use (Marketing Authorisations etc) Regulations of 1994, and section 8 of the Medicines Act 1968.

Regina V Michael & Yinka Oluyemi (Yinka Bodyline)
On 4 January 2007 at Inner London Crown Court, in a joint prosecution with Trading Standards, the above named defendants were sentenced for selling unlicensed medicines containing corticosteroids. The products were sold as skin lightening creams.

Michael and Yinka Oluyemi were each given a nine month prison sentence suspended for two years. They were also fined £35,000 each and ordered to pay £22,267 in costs – a total of £92,267.

They were also banned from holding company directorships for five years.

Charges were brought under section 52 of the Medicines Act 1968 and Trading Standards brought offences under cosmetic regulations.

Regina v Harminder Johal
On 18 December 2006 at Halesowen Magistrate’s Court Harminder Johal was fined £5,000 and ordered to pay £2,000 costs.

Mr Johal pleaded guilty to 2 charges under Schedule 3(2) of Statutory Instrument 3144/1994 of the Medicines for Human Use (Marketing Authorisations etc) Regulations for supplying and possessing with a view to supply, a cream which contained the corticosteroid Clobetasol Propionate.

The product was supplied as having “spiritual qualities” by Mr Johal to a parent who had sought his help with their child’s skin condition.

Regina v Walter (Jim) Wright
On 14 December 2006 at Swansea Crown Court Walter Wright received 120 hours Community Service and was ordered to pay £1,000 costs.

Mr Wright pleaded guilty to selling B17 tablets, he was found guilty of 5 further charges of selling unlicensed medicines including Quickheal Green, Omega UR Tonic, AO Heart Drops, Eczema and Myco+.

Charges were brought under Section 58(2) of the Medicines Act 1968 and Schedule 3(2) of Statutory Instrument 3144/1994 of the Medicines for Human Use (Marketing Authorisations etc) Regulations.

These products were advertised by Mr Wright through mail order and a website, they were distributed from his home address. The website claimed they treated medical conditions such as strokes and heart disease.

Regina v Philip Brocklehurst
On 14 December 2006 at Glasgow Sheriff Court Philip Brocklehurst received a 6 month Restriction of Liberty Order. He has been electronically tagged and must remain at his home address between the hours of 7am and 7pm.

Mr Brocklehurst pleaded guilty to 2 charges of supplying erectile dysfunction products contrary to section 52 of the Medicines Act 1968.

The products were supplied by Mr Brocklehurst through a website he ran from his home address advertising Kamagra for sale. MHRA Investigators visited the address where Kamagra tablets and oral sachets were seized together with evidence of their sale.

Regina v Michael Shaw Roberts (Alpha Marketing)
On 13 December 2006, at Brighton Magistrates Court, Michael Roberts pleaded guilty to the illegal sale of medicines for the treatment of erectile dysfunction and was fined £3000

Roberts pleaded guilty to three counts brought under Section 52 of the Medicines Act 1968 and one count under Schedule 3(2) of Statutory Instrument 3144/1994 of the Medicines for Human Use (Marketing Authorisations etc) Regulations.

The products concerned were Kamagra, and Viagra derivatives including a product named “Erectalis”.

Regina v Richard Underhill
On 8 December 2006 at Guildford Crown Court Richard Underhill was fined £500 and the MHRA were awarded £1000 costs.

This case concerns the illegal sale and supply of Kamagra, an unlicensed medicine containing the active ingredient found in the licensed medicine Viagra, via the internet.

The defendant had set up a website in order to undertake this illegal activity. Underhill came to the attention of MHRA Investigators following a previous prosecution of Christopher Wayne Davies. It transpired that Underhill had supplied Davies.

Underhill was prosecuted for offences under the Medicines Act.

Regina v Ace Afro Hair and Beauty Cosmetics
On 27 November 2006, at Inner London Crown Court, Hassan Akhtar, Nasira Akhtar and Mubashir Akhtar were fined a total of £56,000 for Medicines Act and Trading Standard offences. The defendants were fined £500 for Trading Standard offences, a total of £50,500 for Medicines Act offences and £5,000 was awarded towards MHRA prosecution costs.

This case involved the illegal sale and supply of skin lightening creams containing corticosteroids. Offences were brought under Section 52 of the Medicines Act.

This was an MHRA led joint prosecution with Lambeth Trading Standards.

On sentencing, His Honour Judge Quentin Campbell said “Public safety is more important than filling up your private purses”

This company had previously been fined in November 2005 in another joint prosecution led by Southwark Trading Standards for similar offences.

Regina v Peter Kaul (Mens Health Matters)  -  conclusion 10 October 2006
On 14 January 2004, at Croydon Crown Court, Judge Tanzer sentenced Peter Kaul to six months' imprisonment, suspended for two years, for conspiracy and for offences under section 52 and 58 of the Medicines Act 1968.

The offences relate to the illegal sale and supply of Viagra (a prescription only medicine - POM).

On 14 May at Croydon Crown Court a confiscation order for £170,000 and MHRA costs of £15,000 were awarded.

Since this date Kaul has appeared in court several times regarding  non-payment of the confiscation order.

This matter was concluded on Tuesday 10 October 2006. at Marylebone Magistrates Court.

District Judge Arbuthnot stated:

"Mr Kaul has had over two years. No payment has been made. In my view he has not made any efforts to pay. He has had lots of opportunities including an asset he has failed to realise. He didn't sign the consent order, then he filed for bankruptCy,giving the same day's notice. I think I should issue the warrant for commitment."

Kaul was sent to prison for three years.

Regina v Ming Xia Xie
On 4 October 2006, at Coventry Crown Court, Ms Ming Xia Xie was fined £10,000 (£4000 & £6000 MHRA prosecution costs)

This case concerned the illegal sale and supply of Shubao, a traditional Chinese Medicine used for slimming.

Following a complaint form a pharmacist at the Queen Elizabeth hospital in Birmingham, a visit was made to a Chinese Herbal Clinic in Dudley where two pots of product were seized. Following analysis, the products were found to contain a toxic derivative of the banned substance fenfluramine.

After further investigation the supplier was found to be the defendant in this case.

Offences were brought under the Medicines Act.

Regina v Malcolm Derek Thouless
At Worthing Magistrates Court on 17 May 2006, Malcolm Derek Thouless pleaded guilty to two Medicines Act offences in relation to the illegal sale and supply of Kamagra, a product designed to treat erectile dysfunction.

Thouless was given a conditional discharge and was ordered to pay £1000 costs.

This investigation had been instigated following an advertisement for Viagra in a local paper. A visit to the home address of the defendant resulted in a significant seizure of tablets.

Regina v Spencer Henry Brosch
On 5 May 2006, at Guildford crown Court, Spencer Henry Brosch was sentenced to 30 weeks imprisonment suspended for 12 months. He also received 110 hours community service and ordered to pay £800 MHRA prosecution costs.

Brosch had pleaded guilty to three offences under the Medicines Act involving the illegal sale and supply of Kamagra and Lovegra over the internet and offences under the Trademarks Act.

This was a joint investigation with Surrey Trading Standards.

Regina v Chistopher Wayne Davies
On 6 March 2006, at West Berkshire Magistrates Court, Christopher Wayne Davies was fined £800 for the illegal sale and supply of Medicines over the internet.

Mr Davies, who was serving as a soldier with the Royal Engineers at the time the offences were committed, had set up a website through which transactions had taken place.

During a search of his room Kamagra tablets, Kamagra Jelly and Lovegra tablets were found along with correspondence, cheques and receipts. These medicines were sold to treat erectile dysfunction.

Davies pleaded guilty to all Medicines Act offences.

Regina v Nigel John Keenan & Ebrahim Chunara
On 2 March 2005 at Leeds Crown Court, Nigel Keenan and Ebrahim Chunara pleaded guilty to Medicines Act offences (Keenan for 8 offences and Chunara for 4 offences) in relation to the illegal sale and supply of very significant amounts of Kamagra, an unlicensed version of the licensed Prescription Only Medicine Viagra

Keenan was sentenced to 12 months imprisonment for each count to run concurrently and a £140,940 confiscation order was made. Chunara was sentenced to 12 months imprisonment on each count, to run concurrently and a £109,207 confiscation order was also made.

Following this sentencing, in the summer of 2005, Keenan was charged with further offences and pleaded guilty to three of these counts. Keenan was sentenced to six months imprisonment for each count to run concurrently but consecutive to the previous 12 months imprisonment. Subsequent to this, a further confiscation order for £225,000 has been made against Nigel Keenan.

Regina v Allan Valentine, David Pattni and Paul Austin
In an example of joint working with the Metropolitan Police and other agencies the above defendants were found guilty of those counts detailed below.

The case was a police-led prosecution and involved the discovery by the Metropolitan Police of an illegal manufacturing site in the Wembley area. The site was being used for the illegal manufacture of illegitimate medicinal products including controlled drugs.

Legislative breaches ranged form the illegal supply of controlled drugs to trademark offences and illegal manufacture of medicinal products contrary to the Medicines Act.

MHRA investigators, inspectors and medical assessors assisted the police in a thorough examination of the site, its equipment, products, raw materials and licensing requirements.

Products involved included controlled drugs (diazepam), derivatives of Viagra and steroids. It was estimated that the site had a capacity to produce approximately a half a million tablets per day.

The defendants were sentenced on 19 November 2004 at Harrow Crown Court by His Honour Judge Barrington Black as follows:

Valentine

Count 1. Conspiracy to supply Class C Drugs. (diazepam and nitrazepam). Three years' imprisonment (concurrent).

Count 2. Conspiracy to contravene Section 92 of the Trade Marks Act 1994. (Pfizer Viagra.) Five years' imprisonment (concurrent).

Count 3. Conspiracy to contravene Section 8 of the Medicines Act 1968, (manufacture or assemble) (steroids) - one year's imprisonment (concurrent).

For breach of the sentence of six months' imprisonment suspended for two years imposed at Harrow Crown Court on 3 November 2000, he was sentenced to six months' imprisonment (consecutive).

Total: five years and six months

Pattni

Count 1. Conspiracy to supply Class C Drugs. (diazepam and nitrazepam). Two years' imprisonment (concurrent).

Count 2. Conspiracy to contravene Section 92 of the Trade Marks Act 1994. (Pfizer Viagra.) Three years' imprisonment (concurrent).

Count 3. Conspiracy to contravene Section 8 of the Medicines Act 1968, (manufacture or assemble) (steroids) - one year's imprisonment (concurrent).

Total: three years

Austin

Count 5. Conspiracy to contravene Section 8 of the Medicines Act 1968, (manufacture or assemble) (sildenafil) - 18 months' imprisonment suspended for two years.

On passing sentence, Judge Barrington Black told Valentine that it was a serious matter. He had traded on people's need for a normal life. He said considerable sums were invested by pharmaceutical companies to develop products in a controlled and safe way. It is a serious matter when the public are hoodwinked to the extent that such products, although structurally akin to the correct ones, are being produced in an environment without the necessary precautions, in a makeshift and potentially dangerous manner.

Regina v Bernard Long
On 3 June 2004 at Wigan Magistrates court, Bernard Long pleaded guilty to one offence under section 58 of the Medicines Act 1968 and three offences under section 52 of the Medicines Act 1968.

One of the offences concerned the illegal sale of a product called "Heat Seeker" which was found to contain Ephedrine.

One aspect of the case involved the consumption of a product containing Ephedrine by a professional rugby player who later tested positive for a banned substance.

Bernard Long was given a two year conditional discharge and ordered to pay costs of £2600.

Regina v Dr Duo Gao (Chinese Herbal Medicine & Healthcare Ltd / Trading as Herbal King)
Dr Gao pleaded guilty on 8 March 2004 at Leeds Crown Court to four offences under section 52 of the Medicines Act 1968 and was sentenced on 10 March 2004. The offences related to the offering or exposing for sale the following four medicinal products in shops based either in Leeds and/ or Eastbourne:

• Guan Xin Su He - found to contain the banned ingredient Aristolochia (aristolochic acids).
• Tian Wang Bu Xin wan - found to contain mercuric sulphide.
  • Fang Feng Tong Sheng wan - found to contain ephedrine.
• She Dan - product label specifying presence of several medicinal ingredients (also containing snake bile).

In sentencing Dr Gao was fined a total of £2700 and ordered to pay £4000 costs.

Regina v Mr Patrick Donkor (Kumasi Market Peckham)
On 22 January 2004 at Tower Bridge Magistrates Court, District Judge Zani sentenced Mr Patrick Donkor for offences under the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994.

Mr Donkor was sentenced in respect of six offences relating to the illegal sale of skin lightening creams containing corticosteroids and consequently fined a total of £1650 and ordered to pay £2800 costs.

The offences related to the sale of products labelled as "Wau Wa cream", "Dark and Lovely"; and "Fair and Lovely Super Cream".

This prosecution was the result of Joint working between the MHRA and Southwark Trading Standards. The MHRA was the lead authority in this prosecution.

Regina v Paul Bowditch
On 3 June 2003, at Daventry Magistrates Court, Paul Bowditch pleaded guilty to the sale by retail of a medicinal product being a prescription only medicine, namely sildenafil citrate in tablet form, supplied to him, other than in accordance with a prescription given by an appropriate practitioner, contrary to Section 58(2) (a) of the Medicines Act 1968.

Subsequently, the defendant was fined £800 and ordered to pay £250 costs payable at £40 per week.

Result of appeal hearing in Regina v Mark Groombridge (Menscare UK Ltd)
In a successful prosecution, brought by this Agency (see report on this website), Mark Groombridge was sentenced in November and December of last year, to twelve months imprisonment with six months suspended and a confiscation order for £630,000 was imposed.

An appeal by the defendant was heard in the Royal Courts of Justice on 8 May 2003.

The appeal was unsuccessful and the sentence (including the confiscation order) has been upheld.

More specific information surrounding this appeal will follow.

Regina v Andrew Whitehead
On 20 January 2003, at Preston Crown Court, Judge Badley sentenced Andrew Whitehead to 21 months' imprisonment.

The offences centred around activity being conducted in a body building gym (Body Masters) in Blackpool.

The offences related to the sale and supply of anabolic steroids and gamma hydroxy butyrate (GHB). In a joint operation with Blackpool Police Officers, MHRA (medicines) investigators seized 18 Gallons of liquid GHB and 43 full pots containing GHB crystals (the largest MHRA seizure of GHB to date).

Additionally, the following products were discovered and seized: Kamagra(a derivative of Viagra) nandrolone, diazepam, testosterone, clenbuterol, stanozolol, lorazepam, Pregnyl, Nubain and ephedrine (13,000 tablets).

Of the 21 months sentence, nine months of the sentence is attributable to six offences included by the MHRA under Section 3 (2) of the Medicines for Human Use (Marketing Authorisations etc.) Regulations. Six months imprisonment was attributed to four of these offences and three months attributed to the remaining two, all to run concurrently and consecutive to the other Crown Prosecution Service offences.

In addition to the 21 months imprisonment, a benefit order of £176,000 and a Confiscation Order of £176,000 was made with two years imprisonment in default of payment. Judge Badley congratulated all those involved in bringing this prosecution.

This case was brought by the Crown Prosecution Service and serves as a fine example of the MHRA (medicines) working closely with the Police to protect public health.

Regina v Mark Groombridge (Menscare UK Ltd)
On 12 November 2002, at Stafford Crown Court, Recorder John Maxwell sentenced Mark Groombridge to 12 months' imprisonment with six months suspended.

In sentencing the Judge stated that Groombridge had flouted the law and made substantial profits.

Groombridge had been found guilty of supplying a Prescription only medicine (Viagra) by way of his company, Menscare (UK) Ltd, on the Internet , other than in accordance with a prescription from an appropriate practitioner, contrary to Section 58 of the Medicines Act 1968.

Additionally, a confiscation order for £258,000 was imposed and Groombridge was banned from holding the office of Company Director for seven years.

At a review hearing on 3 December 2002 at Stafford Crown Court a restraint order was put in place and the original confiscation order was increased to £630,000. Prosecution costs of £12,500 were also awarded to the MHRA.

The above is subject to appeal.