A novel molecule that will control not only diabetes but also prevent abnormalities in cholesterol levels - Latest Drug News

The Central Drug Research Institute (CDRI) has come up with a novel molecule that will control not only diabetes but also prevent abnormalities in cholesterol levels which lead to heart ailments in diabetics.

“Heart and kidney are the two main organs that get affected by diabetes,” said Dr Atul Kumar, a scientist at CDRI. Though kidney problems only occur after prolonged uncontrolled diabetes, heart problem arises with increase in level of triglyceride, a type of lipid. “We have got encouraging results with the molecule to control triglyceride and other lipids and hyperglycemia, the disorder of increased glucose in blood responsible for diabetes,” said Kumar. His research has found a place in December’s Nature India, one of the e-magazines of Nature Publishing Group.

“Research on the methodology of the new synthetic molecule is still on,” Kumar said. But test results on animals show a promising effect on both hyperglycemia and increased lipid levels. “We came up with this molecule by combining the structure of organic molecules known to have anti-hyperglycemic characters and anti-dyslipidemic characters.”

The synthetic molecule targets an enzyme found in body called PTP1B, which is responsible for non-activation of insulin.

Insulin, the enzyme responsible for glucose-related metabolism, is inhibited by PTP1B in Non-Insulin Dependent Diabetes (Type 2). “The PTP1B was known for some time as a target for diabetes but till now no drug was made to target it,” he said. The molecule, a polyhydroquinoline, was structured keeping in mind the enzyme so it inhibits the formation of PTP1B.

“The human body stores glucose in the form of glycogen. In Type 2 diabetes, another enzyme called glycogen phosphorylase inhibits this process of conversion of glucose to glycogen, because of which free glucose remains in blood, increasing the blood sugar level,” explained Kumar. “The new molecule also targets glycogen phosphorylase.”

Stressing the relevance of the molecule, Kumar said: “On the one hand diabetes is fast becoming an epidemic and on the other, drugs for it have been exhausted ¿ the reason why diabetics need to shift on multiple drugs.”

Source: www.drugscontrol.org

Strict label standards are in the offing for pharmaceutical products and medical devices - Latest Pharmaceutical News

Strict label standards are in the offing for pharmaceutical products and medical devices. Following this drug makers engaged in contract manufacturing for export purpose would face stringent scrutiny at the customs.

The Drug Controller General of India (DCGI) is in the process of tightening enforcement of export labeling norms, according to official sources. “We are instructing the port authorities to insist that the display of neutral code should be clear and with an English translation of the information, if it is in any other language so that it could be deciphered properly,” an official from the DCGI’s office said. The size of contract manufacturing pharma in India is pegged at about Rs 10,000 crore per annum.

The official said traders and exporters of drugs, who are not the actual manufacturers, cannot use their names under ‘manufacturer’ or ‘manufactured by’. All such cases violate provisions under Drug and Cosmetic Rules and fall under ‘spurious drugs’. After violations of norms, the DCGI had conveyed it to state drug regulators, port and zonal authorities in a letter late last year. The letter, signed by the DCGI Surinder Singh, stated, “...the matter is of serious nature, all concerned are requested to take necessary action in this regard under intimation to this directorate”.

Neutral code is a code given out to a manufacturer by the state licensing authorities that he can use in place of his name and address, which helps locate the coordinates of manufacturer. This provision of neutral code is actually an exemption to the manufacturer under Rule 94 of the Drug and Cosmetic Rules but ensures that information regarding every exported consignment can be traced back to the last detail.

“In many cases, we find that the information on the consignment is written out in a foreign language, in most cases the language of importing country. However, that creates problems for the officials at exit points who bear the responsibility of checking if the standard format of information is being displayed on the consignment. It is logical to ask for the information display in English,” the official said.

The DCGI’s office is taking up the issue with the health ministry. It may also put up a directive related to export labeling norms on its website in near future. Drug exporters engaged in contract manufacturing told that their clients abroad insist on having the label in native languages for regulatory clearances in their countries. “The English translation is not so much of a problem but the government recognizes it only if it is translated by official translators, and that causes delay”, said a Delhi-based drug exporter.

Source: www.drugscontrol.org

Use of erythropoiesis-stimulating agents is associated with an increased risk of venous thromboembolism - Latest Drug News

A study published online November 10 in the Journal of the National Cancer Institute says that use of erythropoiesis-stimulating agents is associated with an increased risk of venous thromboembolism.

Erythropoiesis-stimulating agents (i.e., erythropoietin and darbopoietin) stimulate red blood cell production and therefore were approved to reduce the number of blood transfusions required during chemotherapy; however, concerns about the risks of venous thromboembolism (the disease that includes deep vein thrombosis and pulmonary embolism) and mortality exist.

Dawn L. Hershman, M.D., of Columbia University Medical Center in New York, and colleagues analyzed the association between agent use and venous thromboembolism and overall survival in patients who were 65 years or older and diagnosed with colon, non-small cell lung, or breast cancer or diffuse large B-cell lymphoma in 1991-2002. Patients were identified in the Surveillance, Epidemiology, and End Results–Medicare database.

More patients who received an erythropoiesis-stimulating agent than patients who did not developed venous thromboembolism. Overall survival was similar in both groups. The number of patients receiving erythropoiesis-stimulating agents increased approximately 10-fold from 1991 through 2002. The rate of blood transfusion per year during the same time period, however, remained constant at 22%.

"Further efforts at monitoring use and long-term toxicity of expensive oncology drugs should be put in place to ensure that for any drug the benefits outweigh the risks in community practice," the authors write.

Source: www.drugscontrol.org

Fake tablet manufacturers are making merry as the demand for contraceptive - Latest Pharmaceutical News

If the emergency contraceptive pill you have popped to tide over an “accident” fails to provide the desired result, don’t be surprised: the market is being flooded with fake pills.

Fake tablet manufacturers are making merry as the demand for contraceptive and slimming pills across the country increased in the past few years, speakers at a workshop on Counterfeiting and Piracy said here on Friday.

“Every fifth contraceptive pill or one for weight reduction available in the market is either of sub-standard quality or fake,” said Sajan Poovayya, an advocate and chairman of the Federation of Indian Chambers of Commerce and Industry.

“When there is a huge demand for one particular type of product that product is on high risk as there are chances of it being of a lower quality or faked,” he added while speaking at the workshop organised by the Federation of Karnataka Chambers of Commerce and Industry.

According to a 2009 study, women aged between 16 and 35 are mostly the consumers of contraceptive or slimming pills, the second-most pirated products in the country.

Manufacturers of duplicate cosmetics market their wares at bus terminals in city suburbs and rural areas. About 23%-30% of cosmetics are not original.

The speakers at the workshop also pointed out that aggressive marketing strategies of manufacturers had led to an increase in demand, which in turn, encouraged fraudsters to market duplicate products.

According to YG Muralidharan, managing trustee of Consumer Rights Education and Awareness Trust, utter lack of awareness on differentiating fakes from originals among consumers has helped fraudsters.

Source: www.drugscontrol.org

NABP now lists more than 5,000 Internet drug outlets as Not Recommended - Latest Pharmaceutical News

On December 11, 2009, the National Association of Boards of Pharmacy(R) (NABP(R)) reached a bitter-sweet milestone in its ongoing review of Web sites selling prescription medications. NABP now lists more than 5,000 Internet drug outlets as Not Recommended. These sites -- 96% of the total number of sites reviewed -- have been found to be out of compliance with pharmacy laws and practice standards established in the United States to protect the public health.

"There is a common misconception that prescription medications purchased from any Web site calling itself a pharmacy are safe," says NABP President Gary A. Schnabel, RN, RPh. "Patients have grown to trust prescription medications in the US because the manufacturing and supply systems are tightly regulated to ensure safety. What many patients fail to realize, however, is that when buying medications from unknown sources online, those safeguards vanish, and the odds of getting counterfeit or substandard medication rise substantially." Of the 5,231 Internet drug outlets NABP had assessed since the May 2008 launch of its Internet drug outlet review program, 5,008 (96%) of the sites were found to be out of compliance with basic criteria for legitimate pharmacy practice and were posted as Not Recommended on the NABP Web site. Of the 5,008 sites listed as Not Recommended:

• More than 75% (4,029) dispense drugs without a valid prescription.
• More than half (2,762) accept a brief online questionnaire in place of a prescription. To be valid, and to ensure patient safety, a prescription must be based on a legitimate patient-practitioner relationship that has included a face-to-face physical examination.
• Nearly 25% (1,327) post a physical address located outside the US.
• Nearly half (2,436) do not provide any physical address. According to the World Health Organization, more than 50% of medicines purchased over the Internet from sites that conceal their physical address are counterfeit.
• Nearly half (2,216) offer foreign or unapproved drugs. Because these drugs are not subject to the quality and safety requirements of those approved for sale in the US -- or even of those approved for sale in other developed countries -- their safety and efficacy are unknown.
• Nearly 20% (956) do not have secure sites that protect patients' personal and financial information.
• Internet pharmacies listed as Recommended on the NABP Web site have been accredited by the VIPPS(R) (Verified Internet Pharmacy Practice Sites) program or, for veterinary sites, the Vet-VIPPS program. These Internet pharmacies have successfully completed NABP's rigorous 19-point criteria evaluation and on-site inspection to ensure they adhere to the highest standards for pharmacy practice and patient safety.

"Patients looking to purchase medications over the Internet would be well-advised to consider who is on the other end of the transaction," President Schnabel says. "Virtually anyone with a computer and a bank account can sign on to become an affiliate of a rogue network, set up a Web site using a template, and start selling drugs online. Bearing in mind that these affiliate network programs are behind thousands of Web sites selling prescription drugs, it follows that the operators of most Internet drug outlets have no knowledge of or concern for patient safety."

Knowledge is key to protecting the public from these high-tech drug dealers. NABP continues to research Web sites selling prescription drugs and report its findings to state and federal regulators, and to educate health care professionals and the public on the dangers of buying prescription drugs online, thereby empowering patients to make informed choices. More information is available in the Internet Pharmacies section of the NABP Web site, www.nabp.net.

Source: www.drugscontrol.org

Clinical use of Omeprazole (OMIVA) - Product Manual

Use in Helicobacter pylori eradication

Omeprazole (OMIVA) is combined with the antibiotics clarithromycin and amoxicillin (or metronidazole in penicillin-hypersensitive patients) in the 7-14 day eradication triple therapy for Helicobacter pylori. Infection by H. pylori is the causative factor in the majority of peptic and duodenal ulcers.

Omeprazole is available as

OMIVA CAP (Omeprazole-20mg) and

OMIVA-D CAP (Omeprazole-20mg + Domperidone-10mg)

Pharmacology of Omeprazole -

Omeprazole is a racemate. It contains a tricoordinated sulfur atom in a pyramidal structure and therefore can exist in equal amounts of both the S and R enantiomers. In the acidic conditions of the stomach, both are converted to achiral products, which reacts with a cysteine group in H+/K+ ATPase, thereby inhibiting the ability of the parietal cells to produce gastric acid.

What is Omeprazole - Product Manual

Omeprazole (OMIVA CAP) is a proton pump inhibitor used in the treatment of dyspepsia, peptic ulcer disease (PUD), gastroesophageal reflux disease (GORD/GERD) and Zollinger-Ellison syndrome. Omeprazole is one of the most widely prescribed drugs internationally and is available over the counter in some countries.

OMIVA CAP (Omeprazole-20mg) and OMIVA-D CAP (Omeprazole-20mg + Domperidone-10mg)