28. November 2011 16:45
Russia, France, Germany and other European countries signed the first ever international treaty to combat the counterfeit medicine industry.
Developed in 2010, the Council of Europe created a binding international instrument based upon the Right to Life provision in the European Convention on Human Rights and Fundamental Freedoms. Signatories of the treaty agree to criminalize activities that produce or promote the sale of counterfeit drugs that are harmful to patients. Said Tatyana Golkova, Health and Social Development Minister of Russia, "The global trend has been that these crimes were often not considered as serious enough to merit criminal law measures," she said. "In some countries, these activities have already been criminalized. In others, the governments will have to introduce new measures." Austria, Finland, Italy, Israel, Iceland, Portugal, Switzerland, Ukraine, Russia, France and Germany have signed the treaty.
SOURCE: Safe Medicines
28. November 2011 10:34
The Food and Drugs Administration, Pune, has banned six formulations touted to be effective in increasing height or treating sexual health problems, breast enlargement, and obesity. The products that have attracted the ban: Japani oil, Ratan’s Pursharth massage oil, and Safed Musli Power Plus, all sold as remedies of sexual health problems; SpeedHeight capsules, which supposedly makes you grow taller; Medora oil and gel, sold as remedies for obesity and fat reduction; and breast care capsule and oil for breast enlargement.
The ban has been implemented on the ground that the claims made on behalf of these products in newspaper advertisements run foul of sections 3 and 4 of the Drugs and Magic Remedies (Objectionable Advertisements) Act of 1954. The Act disallows advertisements for certain categories of disease and disorders, including diabetes, obesity and sexual problems.
The manufacturers of the controversial products, most of them based in Haridwar, have been sent legal notices under the provisions of the Act, requiring them to henceforth desist from advertising their products in newspapers. The recipients have also been directed, by these legal notices, to withdraw promotional material in the form of leaflets, literature, banners and stickers. Failure to comply will make them liable to prosecution, leading to imprisonment for up to six months and a fine for first time offenders, Joint commissioner S.T. Patil said.
The newspapers in which the ads appeared too have been sent legal notices, on the ground that some ads did not provide the addresses of the advertisers. If they do not provide these addresses, they too will be liable for legal action, Joint Commissioner Patil indicated. The Joint Commissioner alleged that the cures attributed to the advertised products are not backed by scientific evidence, and that the claimed benefits are misleading. He wanted the media to refrain from publishing such advertisements.
28. November 2011 10:32
A sub-zonal office of the Central Drugs Standard Control Organisation (CDSCO) was set up at Mormugao Port Trust (MPT), Goa, on 16 November, 2011, making Goa one of the seven Indian port cities from where pharmaceutical products can be exported from the country - the other six being Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva and Kandla. The new sub-zonal office at Goa, which falls under the jurisdiction of the West Zone of the Drug Controller General of India (DCGI), will also provide pharmaceuticals exporters product certification (WHO-GMP, including CoPP). Consequently, exporters from the region no longer need go all the way to Mumbai for this purpose.
28. November 2011 10:29
Officials of Maharashtra’s Food and Drug Administration have found that out of more than 100 investigated advertisements on billboards and in the print and electronic media, some - advertisements of aphrodisiacs, were in violation of the Drugs and Magic Remedies (Objectional Advertisments) Act of 1954, which stipulates that aphrodisiacs cannot be advertised unless they are prescribed by a medical practitioner. First time offenders are liable to a six month term of imprisonment or a fine, or both, and for repeat offenders, the law prescribes, as penalty, a fine or a one year imprisonment, or both. Apart from the action against the advertisers, Rs. 5 lakhs worth of aphrodisiacal drugs have been confiscated and 14 companies asked to reformulate their ad campaigns.
SOURCE: Hindustan Times
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.
28. November 2011 10:19
Judge Nityanand Singh of a CBI Special Court has remanded two medical suppliers to a couple of weeks judicial custody in a case relating to alleged irregularities in the purchase of medicines and medical equipment. The supposed scam, which made the headlines in 2009, is believed to have resulted in an estimated 130 crore rupees loss to the State exchequer. The irregularities alleged in the case are believed to have occurred under the watch of the Madhu Koda regime in Jharkhand. Of the persons charge sheeted,three had been earlier remanded to judicial custody - former health minister, Bhanu Pratap Sahi, and ex-health secretaries Pradeep Kumar and Siyaram Prasad. All of these five accused had surrendered before the court. Three persons were earlier given bail, and four are absconding.
28. November 2011 10:14
Alarmed by reports of a flourishing spurious drugs market in Kashmir, world-renowned cardio-thoracic surgeon Dr Naresh Trehan urged governmental action while addressing a school function in Srinagar. Echoing Dr. Trehan’s alarm, Dr. Surinder Bazaz, a cardiologist who also participated in the function, said on the occasion that Kashmir had become “ … a den of spurious and substandard drugs”. The importance of a healthy life style was another issue that was underscored, with Dr. Trehan counseling proper diet and exercise as a way of keeping heart ailments at bay. Dr. Trehan went on to add that Medanta, a Delhi based multi-specialty hospital, was preparing to set up a facility in Kashmir in the coming months.
SOURCE: Greater Kashmir
28. November 2011 10:08
Eleven persons contracted meningitis in three government run hospitals in Mumbai after being administered Bupivacaine, according to a report in Mid Day. Reacting to the story, the Food and Drug Administration undertook an inspection of the manufacturing plant of Ciron Pharmaceuticals, from where the hospitals received the drug.
Doctors at the hospitals said had reservations about administering the anesthetic and did so against their better judgment, they claimed. They claimed they had received a notification from a higher authority asking them to dispense the drug from hospital stocks instead of procuring them from pharmacies elsewhere.
The story goes back further, to two cases of meningitis in Sion hospital, suspected to be linked to Bupivacaine. Doctors alerted the FDA, which tested the drug and gave it a clean chit. However, following this, Sion, Bhabha and KEM hospitals reported cases of post spinal meningitis. In the light of such a development, the use of the drug should have been immediately stopped, notwithstanding the clean chit from the FDA, doctors interviewed opined.
In addition to its investigation of Ciron Pharmaceuticals, the FDA is collecting samples of Bupivacaine from the concerned hospitals for testing. K. B. Shende, joint commissioner, FDA (drugs), said a fresh enquiry has begun to investigate “… all possible causes of infection as well as contamination."
13. November 2011 23:06
Over 28 pharmaceutical manufacturing facilities in India are in the process of complying with the bar coding requirement for exports which came into effect from Oct 1, 2011 in partnership with PharmaSecure, Inc.
The most difficult challenge in implementing the DGFT serialization is putting unique numbers on packages in high speed, high volume and sterile pharmaceutical manufacturing facilities in a way that does not disrupt production.
PharmaSecure -- a global innovator in drug authentication technologies and software, had deployed a specialized team of engineers from the United States and India to help Indian companies meet the regulatory requirement.
As per the notification of Directorate General of Foreign Trade, every tertiary package (or shipping package) of drugs exported from India need to be serialized uniquely beginning October 1st 2011. All secondary packages (the box typically in the chemist's shop) need to be serialized uniquely beginning January 1st, 2012, and primary packages (blister packs and vials) need to be uniquely serialized by July 1st 2012.
The regulation allows pharmaceutical companies to track and ensure that their drugs are reaching the destination without the influx of counterfeits and diversion of valuable, life-saving products.
“This serialization to comply with DGFT mandate is just the beginning. We look forward to working with our clients to activate SMS authentication and data analytics in the over 60 different countries to which these drugs are being exported.” – Kishore Kar, VP Sales and Marketing for India and Southeast Asia, PharmaSecure.
PharmaSecure's DGFT serialization not only conforms to the regulations, but also allows consumers to confirm the authenticity of their medicines by sending the serial number by SMS and receiving confirmation of authenticity.
“India is leading the way in a global movement toward serialization which has the potential to transform the way drugs are distributed globally. I believe we will see other countries follow. We're seeing our focus on service excellence and cost effectiveness resonate with the Indian market right now. We plan to invest in more applications that can ride on the serialization to increase the reach and distribution of our clients' products.” - Nathan Sigworth, CEO PharmaSecure Inc.
India, which accounts for the 3rd Largest Drug production globally by volume and 14th by value, has increasingly witnessed Spurious and Counterfeit Drugs made in China for African Countries, under the brand name of Indian drug companies. The $20 Billion (Rs 90,000 Crore) Indian pharmaceutical industry constitutes 40% exports.