15. December 2011 13:17
Hyderabad: Drugs of 9 pharmaceutical companies were found to be substandard and have been blacklisted by the Andhra Pradesh Medical Services and Infrastructure Development Corporation ( APMSIDC) .
The following drugs meant for common ailments have failed the quality test. They are
Karnataka Antibiotics and Pharmaceuticals Ltd
Injection Verclov 1.2gm (Amoxycillin+Clavulanic Acid), Batch no. 3401410
* Cipco Pharmaceuticals
Tablet Dicyclomine HCL 10mg, Batch No. CT-91201
* Hindustan Pharmaceu-ticals
Etophylline and Theophylline injection, Batch No. 426
* Vital Health Care (P) Ltd.
Prednisolone Acetate Opthalmic Suspension USP Batch No. V9094
* Jackson Laboratories (P) Ltd.
Pentasol Injection, Batch No. I.P.B NO.1-3236
* Bengal Chemicals
Ciprofolxacin Tablet 250mg, Batch No. 0578002
* The Swastik Pharmaceuticals
Povidone Iodine Solution, Batch No. 2667
* Eurokem Laboratories (P) Ltd.
Nifidifine Tablet I.P 10mg Batch No. F62
* Agron Remedies (P) Ltd.
Diclofenac Sodium Tablet, Batch No. DDF-35
SOURCE: DECCAN CHRONICLE
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.
12. December 2011 16:03
A drug used to treat breast cancer in post-menopausal women – Letrozol, has been banned by the Government of India because its use as a fertility drug is believed to have resulted in babies with bone malformations and other complications.
The Government of India has banned the manufacture, sale and distribution of Letrozol, a drug meant for treating breast cancer in post-menopausal women. The drug had become controversial because it was being used to treat infertility in women unable to ovulate, i.e., these women were unable to produce the ovum or the reproductive cell that divides and forms into an embryo after fertilization by the spermatozoa. When it was discovered that babies born to mothers using Letrozol to treat infertility had bone malformations and other complications, the government stepped in to ban the drug in the public interest, taking recourse to the powers conferred on it by the Drugs and Cosmetic Act, 1940. The government was satisfied that safer alternatives to the drug were available, according to a Ministry of Health and Welfare press release.
SOURCE: FIRST POST
12. December 2011 16:01
A professional fund-raising agency – the Canadian Organisation for International Philanthrophy, has been under the scanner for linking up with two charities in a supposed campaign to provide AIDS medicines in Africa.
The charities told donors they were buying AIDS medicines for $12 a dose, whereas other charities had been buying them from abroad for a fraction of the cost, at 30 to 40 cents a dose, according to investigative journalists from the Star. The Star’s revelations were news to Robert Steen, a senior executive with the fundraising agency. Steen informed the Star’s scribes also that the medicines in question were bought from Globe Lending Group - a Costa Rican company. The Star however wasn’t able to find the group’s head office. Reporters from the Star smelt something fishy also in a picture in the fundraising agency’s boardroom showing one of the agency’s executives in the company of Canadian AIDS activist Stephen Lewis, who was formerly the United Nations HIV/AIDS envoy to Africa. It turned out that Lewis had nothing to do with the group; he was in a conference when he was accosted and the picture taken. Also fishy was the fact that the fundraisers were not able to say where the Africa pictures in their glossy brochures were clicked.
12. December 2011 15:57
A scientific investigation team headed by Cleveland Clinic’s Stephen J. Nicholls, M.B.B.S., Ph.D., has found that the use of the drug Evacetrapib is associated with a large increase in “good cholesterol”, i.e., high-density lipoprotein cholesterol, or HDL-C, a substance that is known to be associated with a lower incidence of cardiovascular disease. Evacetrapib acted also to decrease“bad cholesterol” or low-density lipoprotein cholesterol, also known as LDL-C. 398 individuals who had sub-optimal levels of cholesterol – either abnormally low HDL-C or abnormally high LDL-C, were the subjects of the investigation.
Evacetrapib belongs to a class of substances that act to increase HDL-C and in some cases, reduce LDL-C, by means of inhibiting Cholesterol Ester Transfer Proteins, or CTEPs. The Nicholls study found that over the course of twelve weeks of treatment, HDL-C levels in the test subjects who were given doses of Evacetrapib shot up by dramatically, from 53.6% to 128.8% (from 30 mg/dL to 66 mg/dL). LDL-C levels dropped by -13.6% to -35.9%. The HDL-C boost was even more impressive in the test subjects who had lowerlevels of HDL-C to begin with. Placebos were found todecrease HDL-C by -3% in test subjects, and to either reduce LDL-C by -3.0% or increase it by 3.9%.
The study also looked at the effect of Evacetrapib when taken in conjunction with statins (cholesterol reducing drugs). When 100 mg/d of Evaceptrapib was taken along with statins, HDL-C levels increased by 78.5% to 88.5%, and LDL-C got reduced by -11.2% to -13.9%. Compared to exclusive statin therapy, (i) Evaceptrapib plus statins resulted in greater decrease of LDL-C and (ii) Evaceptrapib plus statins did not produce greater increase in HDL-C. These results are consistent with well known findings from other studies.
To put the Nicholls study in perspective: Evaceptrapib therapy is only one among many approaches to treating patients with low HDL-C. Christopher P. Cannon, M.D., of Brigham and Women's Hospital, Boston, notes that while lifestyle change with respect to diet, exercise, and cigarette smoking are known to deliver the desired result, i.e., higher HDL-C, existing guidelines counsel lowering LDL-C. This has benefits regardless of HDL levels. The use of Niacin to increase HDL-C is yet another approach, though the jury is still out on this one. Meanwhile, trials involving Niacin and CTEP inhibitors like Dalcetrapib, Anacetrapib and Evacetrapib are on the anvil.
12. December 2011 15:54
China, which has demonstrated its vaccine manufacturing prowess globally, is poised to enter the international vaccine market in a big way in the coming years. However, more may be required than just the stern regulatory steps that the Chinese authorities have fashioned.
When the World Health Organisation attested last March to the efficacy of the Chinese drug regulatory authorities in ensuring international standards, a window of opportunity opened up for China’s vaccine manufacturers, who now stand poised to enter the international market for vaccines in a big way over the coming few years. This augurs well for the new competition that Western pharmaceutical companies will have to face, and consequently, for lower costs of life saving immunisations that can benefit the world’s poor. Once WHO gives the thumbs up, a given vaccine can be cleared for sale to big buyers like UNICEF, the United Nations, or the GAVI alliance – an alliance that purchases fifty million vaccine doses for children annually. Nina Schwalbe, GAVI’s head of policy, says China’s entry into the international market for vaccines can be a “game changer”, and UNICEF’s supply director, Shanelle Hall, says her organization has been in touch with Chinese companies.
Indeed, China’s clout as a vaccine manufacturer is enormous. 30 plus companies in the country have what it takes to manufacture some one billion vaccine doses, according to China’s State Food and Drug Administration.The country had already demonstrated its arrival on the scene as a vaccine maker in 2009 when, within the short space of eighty-seven days, a Chinese concern became the first to manufacture a vaccine against the swine flu raging across the world. China now has its sights set on entering the international market with, among other products, its vaccine for Japanese encephalitis, which the State-owned China National Biotec Group (CNBG) has been manufacturing since 1989. CNBG, which will be investing $ 1.5 billion by 2015 in a bid to bring its facilities and systems up to WHO standards, also plans to seek WHO approval for its vaccines for polio. Another CNBG product that will be submitted for WHO approval is a vaccine for a disease called rotavirus, which is responsible for half a million child deaths annually. Private players in China, operating on a smaller scale, too are getting ready to join the fray with their products. On the anvil is a new vaccine for enterovirus 71, which the company Sinovac is testing. (Enterovirus 71 causes acute hand, foot and mouth disease among children in China and elsewhere in Asia). Sinovac is also carrying out clinical trials on a vaccine for pneumococcal disease, which causes meningitis, pneumonia and ear infection.
Alas, notwithstanding all the favourable signs, it appears that “Made in China” is still a stumbling block, given the country’s murky track record in standards enforcement. An effective regulatory agency by itself will not do the trick, either; also crucial, according to one analyst, are supporting institutions such as those present in the US but lacking in China - the market economy, democracy, media monitoring, civil society and a business code of ethics.
12. December 2011 15:51
Armeina’s Director of Scientific Centre of Drug and Medical Technology says his country’s pharmaceuticals, mostly imported from India and China, are practically free of counterfeit products.
Armenia, which imports most of its pharmaceuticals from India and China and checks all drug imports at the border, is practically free of counterfeit medicines, according to Hakob Topchyan, Director of the country’s Scientific Centre of Drug and Medical Technology. In the decade 2001-2011, only 43 counterfeits were found, Mr. Topchyan said at a press conference on 29 November, 2011. Armenian medicines do not compromise on quality, Mr. Topchyan affirmed, adding that like other countries that have to compete in the drug market, Armenia relies on relatively inexpensive pharmaceutical raw material imports from India and China. Mr. Topchyan was against introducing e-pharmacies in Armenia, as he felt this could lead to the spread of counterfeit products.
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.
12. December 2011 15:45
Most of the private blood banks in the country do not comply with the provisions of the Drugs and Cosmetics Act of 1940, a survey shows.
Most of the private blood banks in the country do not comply with the provisions of the Drugs and Cosmetics Act of 1940, as per the findings of a survey conducted by a Chennai-based group that provides professional services to the pharmaceutical, blood bank, and medical devices industries. N. Selvaraju, Managing Director of the group (Gaja Consultation Services (GCS) Private Ltd.) alleges, among other things, that while blood banks are required by law to appoint full time medical officers to carry out QBTS (Quality Blood Transfusion System) operations, in most cases, the medical officers are part-time employees. In some instances, lab technicians substitute for medical officers to carry out functions like selection of donors, blood transfusions etc. Subsequently, to cover up their tracks, the former get the latter to sign on the dotted line. Mr. Selvaraju alleges also that in small hospitals run by private medical practitioners, blood is acquired even in the absence of adequate facilities for collection, testing and storage. A/B/O compatibility tests are done on these blood samples but communicable diseases tests are not, according to Mr. Selvaraju. Citing another dubious practice, he said that blood bags whose contents are not authenticated were being sold by unscrupulous elements to doctors and unlicensed blood banks. Considering that complex medical and surgical procedures depend on the services of blood banks, there is a need for NGOs to take up this matter, Mr. Selvaraju opines.