12. December 2011 15:49
The Indian Pharmaceutical Summit 2011 was meant to prepare a road map on the challenges and opportunities facing the country as it gears to assume global leadership in generic medicine manufacture.
The India Pharmaceutical Summit 2011 was held in New Delhi on 29 November. Its objective: to prepare a road map on the opportunities and challenges facing the country as it seeks to assume global leadership in generic medicine manufacture. Regulatory issues and the fostering of global industry-institutional-academic linkages in a partnership mode were integral to the vision for the summit as articulated by the Press Information Bureau of the Government of India’s Ministry of Chemicals and Fertilisers. Participants at the summit included senior government officials, representatives of the pharmaceutical industry, and members of academia.
In his inaugural address, Mr. Srikant Kumar Jena, Minister of State for Chemicals and Fertilizers, spoke of the country’s potential to play a leading role in the field of generic medicines. He stressed the need for research and development and said the summit would help stakeholders come together to evolve new ideas and plans. Mr. Jena spoke also of the government’s commitment to providing quality medicines at affordable prices. In pursuance of that objective, the government had initiated the Jan Aushadi scheme for providing generic medicines to the maximum number of people, the minister said.
12. December 2011 15:47
A racket involving the sale of counterfeit cosmetics has been busted in Nagpur by the city’s Crime Branch.
Acting on a tip off, the social service department of Nagpur city’s Crime Branch has seized misbranded cosmetics worth Rs. 1.80 lakhs. The products carried the names of leading brands and were meant for sale to unwary rural consumers. One Rajesh Sachdeo, believed to be the kingpin in the racket, was arrested from a godown. His aide managed to flee the police net.
28. November 2011 10:26
In a police crackdown on an illicit medicines racket in China, over 65 million fake pills have been confiscated and 114 suspects arrested. The counterfeit products were being sold through websites and advertisements. 117 locales from where the fake products were sold have been busted by the police.
China’s Ministry of Public Security says that criminals operating across eight provinces had been manufacturing fake medicines using ingredients such as starch and corn powder, as well as substances that were harmful to humans, like animal feed, chemical pigments and other ingredients. The racketeers had also been repackaging drugs whose use-by dates had been exceeded.
The police had been tipped off by the case of a woman in central Henan province who had been substituting genuine medicines with fake ones in pharmacy stocks.
28. November 2011 10:22
Sub-standard counterfeits the anti-HIV drug Zidolam-N have been tracked down in Kenya. The genuine product marked with the same batch numbers as the counterfeited versions, was however found to be of an acceptable grade. READ MORE.
Anti-HIV medicine Zidolam-N, manufactured by Indian drug maker Hetero Drugs Ltd., had made it to the list of WHO prequalified products in 2006 after its product dossier was assessed and its manufacturing site inspected. Additional WHO inspections too vindicated Zidolam-N’s authenticity - the manufacturing site was inspected afresh and given the thumbs up, first in 2007 and again, in 2009.
Subsequently, in September 2011, WHO’s Prequalification of Medicines (PQM) programme, discovered counterfeit Zidolam-N in Kenya. PSM reports that the tablet pakages marked “Batch E110766” were ascertained to be fake, while tablets with the batch number labels E110467, A9351, A9357 and A9366 were suspect. The counterfeited products, which were found to be sub-standard or in a deteriorated state, have been confiscated by Kenya’s Pharmacy and Poisons Board. Genuine Hetero products with the same batch numbers as the counterfeits were however found to be of an acceptable grade, WHO affirmed, adding that indiscriminate termination of treatment was hence not called for.
13. November 2011 23:01
Dr. Paul B. Orhii, Director General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), in an interview with Ruth Choji of Leadership Weekend, said that NASDAC had been able to eliminate about 5% of the imported fake drugs from the market in the country’s big cities. He contended that NASDAC had put up a good fight, especially considering that with crackdown on narcotics, drugs barons had begun to make their presence felt in the less risky and more profitable business of counterfeit medicine. He underscored the inadequacy of infrastructural and funding constraints in NAFDAC’s policing activities.
In rural Nigeria, where the fake drugs situation is far worse than in the cities, a massive educational campaign is needed to disabuse villagers of the notion that fake drugs peddlers, who sell medicines at a cheap price, are the saviours of the people. NAFDAC has, in this context, had sought to reach out to the people by associating traditional rulers in rural areas with the campaign to educate people about fake drugs, Dr. Orhii said. Another strategy has been that of educating youth, by holding competitions across the country under the aegis of NAFDAC consumer safety clubs. Apart from this, NAFDAC also airs educational TV and radio programmes, and people call in with tip offs from remote corners of the country, Director-General Orhii went on to say. The Director-General also emphasised the efficacy of SMS messaging system in the fight against counterfeit medicine, given that more than 80 million Nigerians use cell phones.
At a governmental level, NAFDAC was working with local council chairmen, who were invited to a stakeholder meeting where they were asked to set up NAFDAC desks to police illegal drug hawking and illegal advertisements of fake drugs. The response was encouraging, according to Dr. Orhii. Part of the problem lies beyond Nigeria, for the country was dependent on imported medicines, originating mostly from India and China. Both countries were taking stringent steps to ensure that fake drugs were not sent to Nigeria from within their borders, Dr. Orhii maintained. The Director General felt also that rather than being dependent on imports, Nigeria’s should build up its own pharmaceutical industry.
13. November 2011 22:56
A number of steps taken by the Chinese government suggest that it is demonstrating political will to contain the counterfeit medicines racket in the country (Taylor 2011). One of these relates to what has come to be known as the third shift (also known as the midnight shift or the ghost shift) - terms that refer to the phenomenon of the licensed manufacturer of a product clandestinely manufacturing some of it for sale on the sly. Or it can refer to the manufacture of a product by a producer who is no longer licensed or contracted to do so. The roots of the phenomenon lie in the extensive outsourcing by Western companies to manufacturers overseas, which has entailed transfer of intellectual property in the form of designs, specifications, moulds, and trade secrets. The outsourced producer has the hands on knowhow to manufacture and market the product illegally, policing is problematic for the outsourcers, and “ … IP is leaking out through 1000 cracks” (Parloff 2006). There appear to be signs of change in the air, however, with the recent August 2011 move by the Chinese government to curb counterfeit drugs manufactured in “third shifts” (Taylor 2011) suggesting an intent on the part of the Chinese that is all the more noteworthy in the light of the other steps they have taken to tackle the counterfeit drug menace in China in the recent past.
Earlier in the year, China’s new Criminal Law Amendment bill advocated a removal of three year cap on jail sentences and an increase in the maximum fines, apart from increasing other penalties. The bill also abolishes a clause in criminal law requiring counterfeit medicines to be “harmful enough to seriously endanger human health” in order to attract punishments. Furthermore, the country’s track and trace system to identify authentic medicines manufactured in the country is to be extended to cover additional pharmaceutical formulations. Coming on the heels of these developments is a major crackdown on a counterfeit racket in Henan province, in which 114 people were arrested and $ 30 million worth of pharmaceuticals confiscated (Taylor 2011).
13. November 2011 22:55
Arturo Godinez, who formerly ran two assisted living facilities in Florida, and his accomplice, Joel de la Osa, both of Miami, USA, have been convicted of selling counterfeit, stolen and mis-labeled medicines through a wholesale pharmaceutical business whose illegal trading in pharmaceutical products is believed to have garnered profits worth $ 20 million. The conviction of the two men was the most recent of over a dozen convictions of those involved in the racket. The list includes the infamous Michael Carlow, who was in the limelight in 2007 when he was convicted of conspiring to sell fake, misbranded and illegally imported medicines to the tune of $ 42 million.
SOURCE: SECURING PHARMA