Drug Information Bulletin (electronic)

Drug Information Centre (DIC) Indian Pharmaceutical Association, Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291 Volume: 3 Number: 46

Content
DTAB constituted expert Group to examine definitions of Spurious, Adulterated and Misbranded Drugs etc. under the Drugs and Cosmetics Act Drug Companies Target Indias Patent Law...Again Group Of UK Health Professionals Warn Against Automatic Generic Substitution. Doctor Pleads Guilty to Research Fraud In Story Of Genetically-Targeted Melanoma Drug, Results Look Promising. DTAB asks Sun to submit safety, efficacy profile of letrozole for its use as fertility drug British Pain Society to Publish New Recommendations On Opioid Prescribing. Lilly Is Fined By Mexico for Collusion

DTAB constituted expert Group to examine definitions of Spurious, Adulterated and Misbranded Drugs etc. under the Drugs and Cosmetics Act DTAB in its 58th meeting recommended for setting up of the following Expert Group to

examine definitions of Spurious, Adulterated and Misbranded Drugs etc. under the Drugs and Cosmetics Act, 1940 and give its recommendations. Composition of the Expert Group

2 1. Dr. K. Satyanarayana, Scientist G, Head P & P, ICMR, Ansari Nagar, New Delhi Chairman Members 2. Shri H.G.Khosia, Commissioner, FDCA, Gujarat, Gandhi Nagar 3. Dr. B.R. Jagashetty, Drugs Controller, Karnataka, Bangalore 4. Director, Dept. of Industrial Policy and Promotion, or his representatives, Ministry of Commerce and Industry, New Delhi 5. Ms. Leena Menghaney, C-236, Defence Colony, new Delhi 6. Shri D. G. Shah, Secretary General, Indian Pharmaceutical Alliance, Mumbai 7. President, IDMA Mumbai or his representative 8. President, OPPI, Mumbai or his representative 9. DCH (I) Drug Companies Target Indias Patent Law...Again After Indian courts throw out Bayers case, the company says it intends to appeal to the Supreme Court -- which is also poised to rule on another case brought by Novartis, targeting the public safeguards in Indias patent law. These are the latest in a series of legal moves by pharmaceutical companies to shut down generic production in India. Read more and listen to an interview with Leena Menghaney MSF Access Campaigner in India Group Of UK Health Professionals Warn Against Automatic Generic Substitution The London Times (UK) reports, "Patients' health could be put at serious risk by plans to make pharmacies offer the cheapest version of any drug prescribed by a doctor, a group of health professionals warns today." According to a group of 17 doctors, nurses, pharmacologists and patient representatives, a "push by ministers to have the generic version of medications automatically substituted for more expensive brands could confuse patients, worsen disease management and increase the chance of hospital admission." The Times adds, "A consultation on automatic generic substitution (AGS) is due to finish at the end of next month." Doctor Pleads Guilty to Research Fraud A doctor accused of faking research for a dozen years in published studies that suggested after-surgery benefits from painkillers including Vioxx and Celebrex pleaded guilty yesterday to one count of federal health care fraud. His attorney said the anesthesiologist will have to repay $361,932 in research grants and forfeit assets worth at least $50,000 as penalty for his conduct following a plea hearing in U.S. District Court. Prosecutors alleged the doctor sought and received research grants from pharmaceutical companies but never performed the studies. In Story of Genetically-Targeted Melanoma Drug, Results Look Promising In the second of three articles, the New York Times recounts in a front-page story on the trials for PLX4032, a genetically targeted drug for melanoma patients. Dr. Keith Flaherty, University of Pennsylvania oncologist, sees "impressive" results in the Phase 1 trial, and sought FDA approval for a Phase 2 trial. "The trial of PLX4032 offers a glimpse at how doctors, patients and drug developers

3 navigate a medical frontier as more drugs tailored to the genetic profile of a cancer are being widely tested on humans for the first time," according to the Times. In the trials, researchers find side effects at the 1,120milligram dose, but at lower doses, patients seem to be improving. DTAB asks Sun to submit safety, efficacy profile of letrozole for its use as fertility drug The Drug Technical Advisory Board (DTAB) sub-committee of the Union Health Ministry, which is re-examining the issue of whether the controversial drug letrozole should be allowed to be marketed for sub-fertility in young menstruating women in the country, has asked the promoter of the drug, Mumbaibased Sun Pharmaceuticals, to make a detailed presentation on the safety and efficacy drug. Besides, the sub-committee has asked for technical support from the Indian Council for Medical Research (ICMR). According to sources, the sub-committee, headed by Dr Lakhbir Dhaliwal, head obstetrics & gynaecology, PGI Chandigarh, held another meeting in the first week of this month to discuss the issue. The meeting, attended by experts, company representatives and Drug Controller General of India (DCGI) Dr Surinder Singh, asked the Sun Pharmaceuticals to present a detailed presentation on the safety and efficacy drug. It may be recalled that ever since the drug was given marketing approval by the DCGI, health experts have been raising eyebrows over the safety and efficacy of the drug in young menstruating women as its use in women of child bearing age is strictly prohibited elsewhere in the world due to severe side effects such as estrogen deprivation, ovarian atrophy, uterine atrophy, increased incidence of foetal malformations, foetal resorption and foetal death. The drug, a product of Novartis, was originally indicated for use in cases of breast cancer in postmenopausal women all over the world. Besides, there was criticism from the medical fraternity that the DCGI has approved the drug on the basis of the phase-III trials conducted by Sun Pharmaceuticals on a mere 55 patients that too conducted by private practitioners in personal clinics. They opine that these studies should have been conducted on more number of patients by independent, experienced investigators in large, research hospitals attached to medical college to avoid any bias results. Experts are of the view that as per Drugs and Cosmetics Rules, even an old drug when used for a new indication is deemed to be a 'New drug' and must undergo a series of safety and efficacy studies both in animals and humans before its use in general public is allowed. If the drug is intended for use in young women of child bearing age, reproductive studies including fertility studies, teratogenicity studies and pre natal studies must have been performed in two female animals such as mouse, dog or rabbit. Besides, the drug must also undergo phase I clinical trial in about 10 healthy volunteers (pre-menopausal women over 18 years of age) to determine the maximum tolerated dose and document preliminary side effects. Exploratory phase II studies to determine the therapeutic use, dose and safety of the drug are to be conducted in 10-12 patients in each of three to four research hospitals. Experts regretted that none of the above studies were conducted by Novartis or any other company anywhere in the world since the drug was never intended to be used in women of childbearing age British Pain Society to Publish New Recommendations on Opioid Prescribing

4 The UK's Telegraph reports on the nearly four-fold rise in prescriptions for opioids in Great Britain, and this month, "the British Pain Society is publishing new recommendations on good practice in opioid prescribing." The Telegraph adds, "In Britain, some doctors are worried. They welcome the fact that chronic pain, long ignored, is at last being taken seriously. But they fear that more generous prescribing is releasing ever-greater quantities of addictive drugs into the population." Lilly Is Fined By Mexico for Collusion Mexicos antitrust watchdog fined Lilly and three Mexican drugmakers for colluding to inflate prices in government tenders for medicine. The drugmakers allegedly took turns placing winning bids to buy insulin from 2003 to 2006, eliminating competition and ensuring artificially high prices, Reuters writes. A Lilly spokeswoman denied the charges and plans to appeal. The companies that have been fined conspired for years to make badly needed medicine artificially expensive, commission head Eduardo Perez-Motta said in a statement. The drugmakers, as well as unit of Baxter International, were each fined $1.7 million, the maximum allowed prior to 2006, when Mexicos competition laws were beefed up, Reuters adds. Separately, the US Department of Justice and the Securities and Exchange Commission expanded a probe into Lillys compliance with the Foreign Corrupt Practices Act, which prohibits bribery of foreign officials. The SEC notified Lilly in 2003 it was investigating whether overseas units of various drugmakers in Poland violated the law; the probe is now focusing on other countries (see page 15 of this SEC filing). Recently, the head of the Justice Departments Criminal Division warned drugmakers there will be more criminal enforcement against interactions with foreign officials (see here).
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