Author: adminficci

High Court upholds packaging norms for curbing export of fake drugs

The Madras High Court has upheld packaging norms introduced by the government in 2011 for curbing the export of counterfeit pharmaceutical products and medical devices. The court agreed with the Centre’s stand that these were necessary to protect the country’s trade reputation. The Directorate-General of Foreign Trade issued notifications in January and June 2011 with regard to primary, secondary and tertiary levels of packaging of pharmaceutical products meant for export to foreign countries. In his order dismissing two petitions, which challenged a notification of June 30 modifying the notification dated January 1, 2011 and sought their quashing, Justice K. Venkataraman agreed with Additional Solicitor-General of India, P. Wilson, that the Centre thought it fit to impose certain conditions on the export of drugs and medicines in furtherance of the country’s trade reputation. Industry contention The Confederation of Indian Pharmaceutical Industry (SSI) and the Indian Drugs Manufacturers’ Association filed the writ petitions. The confederation, among other things, said that the notification would increase the cost of production. This would have to be thrust upon the foreign buyers, who may, due to higher price, opt out of purchasing Indian products and switch to countries such as China. The confederation members, who were registered small scale industries, would incur heavy loss because of the plant and machinery for the new packing line as per the GSI standard. Mr. Justice Venkataraman said that in the minutes of the meeting of the Commerce Secretary of June 2010 regarding the strategy to contain the campaign against fake drugs, it was notified that a concerted campaign against Indian pharma industry had been launched by MNCs whose interests were getting adversely impacted due to the increasing global presence of Indian pharma companies, especially in the generic segment. It was also been notified that news was appearing in the international press to malign the growing Indian generic drugs by labelling them as fake. It was felt that there could not be any laxity in enforcement as that also harmed the domestic industry’s interest and domestic consumers. The Judge noted that in the counter, it was stated that to protect Indian medicines in the international market and to fulfil the manufacturers’ obligations, the Centre had issued public notice imposing certain conditions. When such was the government’s motto, the court could not sit over the government’s decision. The petitioners had not established that the government’s decision and the public notice were arbitrary or a colourable exercise of power, Mr. Justice Venkataraman said.

http://www.thehindu.com/news/states/tamil-nadu/high-court-upholds-packaging-norms-for-curbing-export-of-fake-drugs/article4302591.ece

Spurious drug menace unearthed

The sorry state of affairs in the State Health Department came to light on Friday with the detection of preparation and supply of spurious medicines for infants. On receipt of information regarding illegal and unhygienic manufacture of medicines at the industrial unit of Induscreed Pharmaceuticals situated at the Industrial Estate at Lawmali, the Civil Society Women’s Organization (CSWO) carried out an inspection where they discovered the same and found out from an assistant drugs controller, D Swer, that the license which was issued earlier to the company was cancelled in 2003 due to alleged malpractices. There are reports that the company did not adhere to the laid down norms and conditions regarding the manufacture of medicines like Albendazole Suspension (de-worming medicine), Paracetamol (mild analgesic), liver tonic, furazolidone oral suspension (antibiotic used to treat infectious diarrhea) and Povidone Iodine Solution (stable chemical complex of povidone and elemental iodine possessing anti-bacterial activity. It is generally used for determining the skin pre and post operatively for all surgical procedures and for the antiseptic treatment of superficial wounds, burns and injuries). CSWO president Agnes Kharshiing, after carrying out an inspection at the industry site, told reporters on Friday that the officer, D Swer, was under pressure from the Government to revoke the cancellation but he stuck to his duty for the sake of the people.According to Kharshiing, the official confirmed that the medicines manufactured by Induscreed were not as per the prescribed standards after a test was conducted in this regard.“We found out that the medicines are being supplied to government-run hospitals including, Shillong Civil Hospital, Ganesh Das Hospital, PHCs and CHCs in rural areas,” Kharshiing said. Earlier, the Medical Superintendent of Ganesh Das Hospital, in a letter dated October 4, 2012, had asked for a clarification from DHS (MI), on the quality of Albendazole Suspension supplied from the central store of Director of Health Services (MI) procured from Induscreed Pharmaceuticals. According to the Medical Superintendent, as per the IP (Indian Pharmacopoeia), “the standard strength of Albendazole suspension is supposed to be 400mg for 10ml. But the medicine being supplied was found to be having 200mg for 10ml which is far below the standard set by the IP for Albendazole suspension”. The CSWO leader stressed on the severe health hazards that may come about if Induscreed was allowed to supply the illegal and unhygienic medicines to the Health department. “We feel that there can be a connivance of some officials from the Health and Excise departments in facilitating the supply of spurious medicines to kill our children,” Kharshiing alleged. Induscreed Pharmaceuticals has also got the nod from the Excise department to import methyl alcohol for manufacturing chemicals. The CSWO alleged that there is a suspicion regarding the use of methyl alcohol. Citing the CAG report for the year ended March 31, 2009, Kharshiing said that the test check of records revealed that a commercial firm located at Shillong imported 28,000 bulk litres of spirit, 24,000 bulk litres of absolute alcohol and 4,000 bulk litres of methylated spirit in four consignments between April 28, 2006 and May 27, 2008 on which import fee of Rs 1.92 lakh, though realizable, was not realised by the Department although the rules do not permit such exemptions. The CAG report for the year ended March 31, 2010 further stated that during test check of the records in May 2009 it was found that the commercial firm imported 2,667 cases of absolute alcohol between October 2007 and February 2009 for use in manufacture of drugs and medicine. For import of the spirit, two import permits were issued without realization of import pass fee. Since import pass fee is exempted for the purpose of import of denatured spirit only, the grant of exemption was irregular; and resulted in loss of revenue of Rs 2.88 lakh, the CAG observed. However, the CAG did not mention the name of the company in its reports. As per norms, each licensee should have Good Manufacturing Practices (GMP) to manufacture medicines. The Schedule M of GMP states that each licensee has to evolve appropriate methodology, systems and procedures which will be documented and maintained for inspection and the manufacturing premises will be used exclusively for production of drugs. “Since the medicines are meant to improve the health of all sections of people, we think that the High Court will take a sou moto action regarding the case,” Kharshiing said, adding that CSWO will continue to pursue the matter. Kharshiing also asked the Government to shut down Induscreed immediately. The CSWO also raised concerns on the delay in the appointment for the post of DHS (MI). “The Government is playing with the life of the people especially children and it is unfortunate that the Government did not take into confidence experienced doctors as most of the procurement was made at the whims and fancies of certain officials,” Kharshiing added.

http://www.theshillongtimes.com/2013/01/12/spurious-drug-menace-unearthed/

Feds seize suspected counterfeit sports gear at Meridian Mall

·A team of federal agents made a “significant seizure” of suspected counterfeit sports merchandise and apparel in a raid on the Sportz R Us store in Meridian Mall, a U.S. Customs Enforcement spokesman confirmed Thursday. The agents, accompanied by a uniformed police officer from Meridian Township, executed a search warrant Monday morning, according to witnesses, police and Khaalid Walls, a Detroit-based spokesman for the federal agency that operates within the Department of Homeland Security. No arrests were made, but Walls said sports merchandise and apparel were “boxed and hauled off.” “We’ll review the items we have and confirm whether or not they’re authentic,” Walls said. He said documents from the investigation are under seal in federal court, preventing him from commenting on what led agents to believe the merchandise associated with teams from the NFL, NBA, NHL and Major League Baseball was manufactured without payment of the licensing fees the leagues collect. He also declined to quantify the amount of merchandise seized or to speculate on its retail value. “It’s an ongoing investigation,” Walls said. “We’re still in the early stages.” Sportz R Us was incorporated by Terry Harrison in 2007, one year before he incorporated Goin Deep Collectibles in Saginaw, according to state business registration records. The Okemos store was open on Tuesday and Wednesday, but at mid-day Thursday, it was closed and a metal drop-down security gate was in place. Phone calls went unanswered during the morning and early afternoon. An employee who identified himself as Joe Oliver was working alone in the store around 5 p.m. He said he opened for business around 3 p.m. and was not expecting Harrison to join him before closing. He said he came to work Monday afternoon to find much of the store’s merchandise was gone but no one told him it had been confiscated. “I’ve just been told maybe we’re moving,” he said. An employee who answered a call at the Saginaw store Thursday afternoon said Harrison was not there either. The square footage of the Okemos store could not be determined Thursday, but the remaining merchandise appeared to consist primarily of collectibles from toys to banners to sports cards and to be sparsely distributed across the available space. Claudia Bleil, marketing director for the mall, declined to comment on the raid.

Cops bust fake printer ink syndicate

KUALA LUMPUR: Police busted an international syndicate that been raking in millions of ringgit by supplying fake Hewlett Packard printer ink to Middle East and African countries with the arrest of a Singaporean. Federal Commercial Crime Department director Datuk Syed Ismail Syed Azizan said police made their move following information from HP representatives in the United States.“HP made a statutory declaration (SD) on the case and we launched our investigation after we receiving the SD,” Syed Ismail said.It was understood that the SD was necessary in investigations involving copyright issues.He said police moved in on the main suspect, a 38-year-old Singaporean, and seized two boxes of ink cartridges from him. The suspect who is married to a local, then took police to his condominium unit in Brickfields.“There we seized several documents and a computer,” Syed Ismail said.He said the suspect then led police to an industrial area in Bukit Permai Utama, Ampang where the fake ink was produced and packed using HP packaging.Police arrested a 48-year-old local woman believed to be the man’s business partner and 11 Myanmar workers at the premises.“We also seized 252 boxes of of ink cartridges, computers and documents,” he said.He said initial investigations, based on the seized documents, revealed that the syndicate had been operating for two years. Their main clients were in Bahrain and Tunisia.“We also believe that they used re-cycled ink cartridges to distribute their products,” Syed Ismail said.He said the Singaporean was arrested last year for the same offence. It was a joint operation between police and the Ministry of Domestic Trade and Consumers Affairs.“They handled the investigations. We do not know what happened to that case,” he said, adding that police will be working closely with HP on this case.All those arrested are being investigated for infringement under the Section 41(1) of Copyright Act 1987. They can be fined a maximum RM20,000 for each copy seized, a maximum of five years’ imprisonment, or both.

Chinese man pleads guilty in $100 mln stolen software sting

In a case U.S. officials say is the first of its kind, a Chinese businessman pleaded guilty Monday to selling stolen American software used in defense, space technology and engineering – programs prosecutors said held a retail value of more than $100 million.The sophisticated software was stolen from an estimated 200 American manufacturers and sold to 325 black market buyers in 61 countries from 2008 to 2011, prosecutors said in court filings. U.S. buyers in 28 states included a NASA engineer and the chief scientist for a defense and law-enforcement contractor, prosecutors said.Corporate victims in the case included Microsoft, Oracle, Rockwell Automation, Agilent Technolgoies, Siemens, Delcam, Altera Corp and SAP, a government spokesman said.U.S. officials and the Chinese man’s lawyer, Mingli Chen, said the case was the first in which a businessman involved in pirating industrial software was lured from China by undercover agents and arrested.The businessman, Xiang Li, of Chengdu, China, was arrested in June 2011, during an undercover sting by U.S. Department of Homeland Security agents on the Pacific island of Saipan, an American territory near Guam.Video from the undercover meeting in Saipan, filed as evidence in court, is expected to be made public during a press conference Tuesday by John Morton, director of U.S. Immigration and Customs Enforcement, and Charles M. Oberly III, the U.S. Attorney for Delaware.Li, 36, originally charged in a 46-count indictment, pleaded guilty late Monday to single counts of conspiracy to commit criminal copyright violations and wire fraud.”I want to tell the court that what I did was wrong and illegal and I want to say I’m sorry,” Li told U.S. District Judge Leonard P. Stark during a 90-minute hearing in federal court. The Chinese citizen spoke through a translator.In a court filing, prosecutors David Hall and Edward McAndrew said the retail value of the programs Li sold on the black market exceeded $100 million. During the hearing, Li told U.S. District Judge Leonard Stark that he disputes that figure. After the hearing, his lawyer said Li did not realize the retail value of what he was selling until he was caught and plans to present his own estimate at sentencing, which is set for May 3, he said.In recent years, U.S. officials have targeted software pirates overseas but bringing them to the United States has proved difficult.In one of the largest copyright cases, U.S. prosecutors last year charged seven people, including Megaupload founder Kim Dotcom, with racketeering conspiracy and copyright violations. The indictment alleges that Dotcom, who lives in New Zealand, ran an organization that earned $175 million selling an estimated $500 billion worth of pirated movies, TV shows and other entertainment media. Dotcom is fighting extradition from New Zealand.

EXPENSIVE SOFTWAREThe Li case involves sophisticated business software, not entertainment software, and thus small quantities of higher-priced products. The retail value of the products Li pirated ranged from several hundred dollars to more than $1 million apiece. He sold them online for as little as $20 to $1,200, according to government court filings.At one point, Crack99.com and Li’s other sites offered more than 2,000 pirated software titles, prosecutors said.Li trolled black market Internet forums in search of hacked software, and people with the know-how to crack the passwords needed to run the program. Then he advertised them for sale on his websites. Li transferred the pirated programs to customers by sending compressed files via Gmail, or sent them hyperlinks to download servers, officials said.”He was pretty proud of himself,” Chen said of his client’s business acumen. “He did not realize it was such a big crime.”

Agents from Immigration and Customs Enforcement/Homeland Security Investigations learned of Li’s enterprise after an unidentified U.S. manufacturer noticed his company’s software for sale on crack99.com.Working undercover for 18 months beginning in early 2010, the U.S. agents made at least five purchases from Li. These included pirated versions of “Satellite Tool Kit” by Analytical Graphics Inc. of Exton, Penn., a product prosecutors said is “designed to assist the military, aerospace and intelligence industries through scenario-based modules that simulate real-world situations, such as missile launches, warfare simulations and flight trajectories.” Agents bought software worth $150,000 retail for several thousand dollars.Agents lured Li from China to the U.S. territory of Saipan under the premise of discussing a joint illicit business venture. At an island hotel, Li delivered counterfeit packaging and, prosecutors said, “Twenty gigabytes of proprietary data obtained unlawfully from an American software company.” Officials did not identify the company in court documents.

Credit card fraud busted;gang of 14 arrested in Bangalore

The police have busted a fake credit card racket and arrested a gang of 14 in this connection. The police named the kingpin as Jayakumar, (44), a resident of Binny Mills area, who used to create fake identity cards of his associates to get them credit cards from MNC banks. Using these cards, the accused made purchases in showrooms and malls before selling the goods at other shops cheap. The merchandise purchased through these credit cards included gold jewellery, branded clothes, footwear, expensive watches and mobile phones. Jayakumar was earlier arrested by the police for a similar offence but came out on bail. The gang used to make purchases during weekends to avoid undue attention during the heavy rush and swiped the cards before trashing them for fresh ones. Jayakumar also used to allegedly clone international credit cards from his contact, identified as Gunashekhar who lives abroad. The contact used to procure the credit card details of various people through skimming, clone the cards and send them to Jayakumar for use in Bangalore.Though the amount thus siphoned off is believed to be large, the police are trying to arrive at the exact figure, according to Assistant Commissioner of Police Babu Rajendra Prasad. Most of the gang members are college dropouts working in private firms who fell in with Jayakumar to earn an extra buck.The police named them as Maharaj (27), Satyanarayana (37), Mohammed Imran (28), Nagaraj (30), Amit Sharma (26), Girish (22), Mohammed Masiuddin (23), Syed Kaleem (21), Sheikh Fayaz (21), Pradeep (31), Raja Manikyam (45), Krishna Naidu (23) and Mohammed Ayaz.The police are also on the lookout for other suspects.The police recovered 27 cloned credit cards of various banks, two sports utility vehicles, a car, 11 two-wheelers, 150 gm gold jewellery, a Rado watch, laptops and mobile phones worth Rs. 33 lakh, all purchased by the gang.