12. December 2011 16:07
Myleofibrosis is a rare bone-marrow disease that leads to anemia and thrombocytopenia. As the disease progresses, bone marrow is replaced by scar tissue, which gets to be stored elsewhere in the body, notably, in the spleen and in the liver. Spleen and liver enlargement result as a consequence.
Myleofibrosis results from the ineffective regulation of two enzymes, namely, JAK-1 (Janus-Associated Kinase - 1) and JAK 2. Ruxolitinib, a new medicine to treat the disease, inhibits JAK-1 and JAK-2, and is the first JAK inhibitor to be approved by the US Food and Drug Administration (FDA). Designated an orphan drug (a drug to treat a disease that fewer than 200,000 people in the US suffer from), Ruxolitinib was cleared on a priority basis under a special review programme that provides for priority review of drugs that are (i) significantly superior to other existing therapies or (ii) provide treatment when other therapies are absent. Ruxolitinib has been approved for treating patients who have intermediate or high-risk myelofibrosis, according to its manufacturer, who says also that 80% to 90% of myelofibrosis patients fall in this category.
Reduction of spleen size by more than 35% occurred in a greater proportion of test subjects who were on Ruxolitnib as compared to those on placebos or on best-available therapies (hydroxyurea or glucocorticoids). A 50% abatement of other symptoms associated with the disease - abdominal discomfort, night sweats, itching or bone and muscle pain, was similarly more prevalent among the Ruxolitnib-ingesting test subjects.
In most cases of patients on Ruxolitnib, spleen size decreased and symptoms abated within a month of treatment. By contrast, most of those on placebos experienced worsening of symptoms and enlargement of the spleen, according to the principal investigator in one of the two trials - Srdan Verstovsek, MD, PhD, of the University of Texas M.D. Anderson Cancer Center in Houston. Another analyst, Richard Pazdur, M.D. - the FDA’s Director of Oncology, said that the drug represents an instance of how better scientific understanding makes possible a more focused intervention.
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
13. November 2011 23:05
In another move to remove dubious medical formulations from the market place, the Gujarat FDCA (Food and Drug Control Administration), in a first of its kind initiative in the country, has instituted an e-governance system by which Not of Standard Quality (NSQ) drugs are speedily recalled and procedural delays circumvented. Food & Drugs Control Administration (FDCA) Commissioner Dr H G Koshia explains how the system works. Once a drug is declared as NSQ, an online report is uploaded by the testing lab in Baroda. This in turn is automatically transferred to the FDCA commissioner’s regulatory system, from where, it is relayed by the Commmissioner, via bulk e-mail, to all stakeholders registered with his office, among them, doctors, chemists, wholesalers, retailers and companies. Earlier, on account of lengthy paperwork, dubious drugs were found in the market even up to six weeks after they were categorized as NSQ.
13. November 2011 23:03
The district administration of Gautam Budh Nagar has stepped up vigilance to prevent fake drugs infiltrating the markets following reports that manufacture of illicit medicines is thriving in western Uttar Pradesh. In a drive to check production of fake drugs, the district administration has cancelled licences of three non-functional drug-manufacturing units and sealed two chemist outlets operating without a licence, apart from checking 35 drug factories and nine private blood banks in Noida.
The administration has been constantly checking wholesale units and factories and claims to have not come across any instance of finding fake drugs till date. "We had conducted raids on some medicine shops following complaints and in the process sealed two chemist outlets that had been operating without a licence," said city magistrate Kanchal Saran. "The owners of these shops have been arrested. The district drug department has been carrying out raids to check illicit drugs," she added.
The district drug department has, meanwhile, conducted a thorough check to weed out manufacturing of fake drugs, if any, prevalent in the region. "Following reports, we conducted a night raid on a factory alleged to be involved in the production of fake drugs, but did not find anything there," said district drug inspector, Rajesh Srivastava. "We have, however, taken samples from the factory and sent them for tests. In adjoining Meerut, six shops alleged to be dealing in fake drugs have been sealed and samples have been sent for tests," added Srivastava.
The drug department has claimed that it has not found any gross violation of norms in the checks carried out on medicine factories and drug units in the district. "A team has checked all 35 drug manufacturing units and the nine private blood banks in Noida. No spurious drugs were found in any of them, but regular checks like this will help prevent circulation of fake drugs and improve the functioning of blood banks," said Srivastava.
The District Chemists' Association, meanwhile, has also taken measures to prevent spurious medicines from entering the markets in Noida. "We have asked all wholesalers to maintain a record of bills of the medicines that they purchase in bulk," said president of the association, Anoop Khanna. "A proper billing system for wholesalers can help nip the problem in the bud," added Khanna.
The association has also written to the Noida Authority to make provisions for a separate market for drug wholesalers under one roof. "This would aid the drug department to keep an easy tab on wholesalers," said Khanna.