Health ministry to amend Sch H of D&C Rules to curb misuse of certain steroid preparations

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The Union health ministry will soon amend Schedule H of the Drugs & Cosmetics Rules (D&C Rules), 1945 to include certain steroid preparations in Schedule H which are misused mainly as topical steroids leading to extensive Tinea infections.

A decision to this effect was taken by the Drugs Technical Advisory Board (DTAB) of the health ministry, which is considered the highest authority on technical matters under the Union health ministry. The DTAB, in its 77th meeting held on 16th June, 2017 considered a proposal of the ministry to amend Schedule H to include certain steroid preparations which are misused mainly as topical steroids leading to extensive Tinea infections.

After examining the issue in detail, the DTAB recommended for inclusion of several corticosteroids in Schedule H of the Drugs and Cosmetics Rules, 1945. They include alclometasone, beclomethasone, betamethasone, desonide, desoximetasone, dexamethasone, diflorasone diacetate, fluocinonide, fluocinolone acetonide, halobetasol propionate, halometasone, methylprednisone, prednicarbate and triamcinolone acetonide.

Besides, the DTAB also recommended to the ministry to constitute a Standing Committee under chairmanship of Director General of Health Services (DGHS) comprising some of members of DTAB for periodic review of the marketed drugs in respect of their inclusion/deletion in Schedule H of the Drugs and Cosmetics Rule, 1945 and submit the recommendation to DTAB for consideration. The other members of the Standing Committee are The Chair in Clinical Pharmacology, Indian Council of Medical Research (ICMR); The President, Pharmacy Council of India (PCI); The President, Medical Council of India (MCI); and one in-charge of Drugs Controller in the States nominated to be member of DTAB.

Dr. Jagdish Prasad, Director General of Health Services (chairman); C. Hariharan Director in-charge, CDL, Kolkata; Dr. A. K. Tahlan, Director, CRI, Kasauli; Dr. P. Dhar, Indian Veterinary Research Institute, Izatnagar, UP; OS Sadhwani, Joint Commissioner, FDA, Maharashtra; Dr. B.Suresh, President, PCI; Dr.H.G.Koshia, Commissioner, FDCA, Gujarat; Dr.Nilima Kshirasagar, Chair in Clinical Pharmacology, ICMR; Prof. MD Karvekar, Bangalore; Dr. Rao V. S. V. Vadlamudi, President, Indian Pharmaceutical Association Hyderabad; Sudhir Mehta, chairman, Torrent Pharmaceuticals, Dr. G. N. Singh, DCGI (Member Secretary); President, Medical Council of India; Director, CDRI, Lucknow; Shushma Saptarshi, Asst. Director & Government Analyst, Drugs Control Laboratory, Mumbai; Dr. G. B. Gupta, Prof. And Head, Department of Medicine, Raipur; Dr. A Marthanda Pillai, Ananthapuri Hospital and Res. Institute, Kerala; and Sheju Purushothaman, Government Analyst, Regional Drugs Testing Laboratory, Kerala are the members of the DTAB.

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FDA unveils plan to eliminate orphan designation backlog

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Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to all new requests for designation within 90 days of receipt during his testimony before a Senate subcommittee.

As authorized under the Orphan Drug Act, the Orphan Drug Designation Program provides orphan status to drugs and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases, which are generally defined as diseases that affect fewer than 200,000 people in the United States. Orphan designation qualifies the sponsor of the drug for various development incentives, including tax credits for clinical trial costs, relief from prescription drug user fee if the indication is for a rare disease or condition, and eligibility for seven years of marketing exclusivity upon approval. A request for orphan designation is one step that can be taken in the drug development process and is different than the filing of a marketing application with the FDA.

Currently, the FDA has about 200 orphan drug designation requests that are pending review. The number of orphan drug designation requests has steadily increased over the past five years. In 2016, the FDA’s Office of Orphan Products Development received 568 new requests for designation – more than double the number of requests received in 2012. The increased interest in the program is a positive development for those with rare diseases and under this new plan, the agency remains committed to advancing the program to ensure it can efficiently and adequately review these requests.

“People who suffer with rare diseases are too often faced with no, or limited, treatment options, and what treatment options they have may be quite expensive due in part to significant costs of developing therapies for smaller populations,” said FDA Commissioner Scott Gottlieb, M.D. “Congress gave us tools to incentivize the development of novel therapies for rare diseases and we intend to use these resources to their fullest extent in order to ensure Americans get the safe and effective medicines they need, and that the process for developing these innovations is as modern and efficient as possible.”

This is the first element of several efforts the FDA will undertake under its new “Medical Innovation Development Plan,” which is aimed at ensuring that the FDA’s regulatory tools and policies are modern, risk based, and efficient. The goal of the plan is to seek ways the FDA can help facilitate the development of safe, effective and transformative medical innovations that have the potential to significantly impact disease and reduce overall health care costs.

Among the elements of the plan to eliminate the backlog, the FDA will deploy a Backlog SWAT team comprised of senior, experienced reviewers with significant expertise in orphan drug designation. The team will focus solely on the backlogged applications, starting with the oldest requests. The agency will also employ a new streamlined Designation Review Template to increase consistency and efficiency of its reviews. The program will also look to collaborate within the agency’s medical product centers to create greater efficiency, including conducting joint reviews with the Office of Pediatric Therapeutics to review rare pediatric disease designation requests.

To ensure all future requests receive a response within 90 days of receipt, the agency will take a multifaceted approach. These efforts include, among other new steps: reorganizing the review staff to maximize expertise and improve workload efficiencies; better leveraging the expertise across the FDA’s medical product centers; and establishing a new FDA Orphan Products Council that will help address scientific and regulatory issues to ensure the agency is applying a consistent approach to regulating orphan drug products and reviewing designation requests.

The agency intends to communicate around the successful elimination of the backlog by mid-September and will soon provide more information about the Medical Innovation Development Plan.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Indian Pharma market posts 7.5% growth in June 2017 at Rs.9,463 cr

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Indian Pharmaceutical market has registered satisfactory growth of 7.5 per cent during June 2017 to Rs.9,463 crore as major chronic therapy like anti-diabetic segments achieved double digit growth of 18.3 per cent. However, monthly growth has been pulled down by the volumes of the established products. FDC related market show a de-growth of 10.9 per cent on account of lower volumes, while the non FDC market moved up by 7.9 per cent. Total 222 brands & 414 SKUs launched in June 2017 and Sertaspor, Xpreza, Aptamil, ShelcalXT, Otriving fast and Itraget remained top.

As per AIOCD Pharmasofttech AWACS report, Indian companies showed a positive growth of 2 per cent while MNC showed a degrowth of 36.1 per cent in the FDC segment in the months of June 2017.

Amongst the top 10 corporate, Zydus has the highest growth of 19.4 per cent followed by Lupin at 16.4 per cent and Macleods at 12.5 per cent. Glaxo is showing signs of recovery by posting monthly growth of 9.2 per cent.

Amongst the top 50 corporate, Bharat Serum has the highest growth of 21.8 per cent followed by Novartis growth at 21 per cent and Zydus at 19.4 per cent. 22 corporate have crossed the growth of IPM for June 2017 and 12 companies showed growth of more than 10 per cent as compared to 16 companies in the previous month.

During the last three years, total 43 companies launched in which 4 companies cross Rs.10 crore in revenue. Indian companies grew by 6.9 per cent while MNC grew by 10.1 per cent in last 3 years. Novartis grew at 21 per cent followed by Sanofi growing at 18.3 per cent and Boehringer Ingelheim which grew at 16 per cent. In the non NLEM category Indian companies grew at 8.2 per cent whereas MNCs grew at 11.8 per cent. The NLEM 2013 containing molecules market degrowth at 3.5 per cent whereas the non NLEM market grew by 8.9 per cent resulting in an overall growth of 7.5 per cent for the June 2017.

From therapy perspective 9 therapies have outgrown the IPM growth during June 2017. Respiratory market grew at 3 per cent, gastro intestinal market grew at 6.2 per cent, pain & Analgesics market grew at 5.3 per cent and anti infective posted a positive growth of 3 per cent. Anti-malarials degrew at 12 3 per cent & VMS market was stagnant at 1.6 per cent. Derma moved up by 8.1 per cent which is slightly slower that May 2017.

From regional perspective 11 regions have outgrown the IPM growth and 9 regions had negative growth in June 2017. South Rajasthan market grew the highest at 53.9 per cent followed by North Rajasthan at 43.7 per cent and Jarkand at 36.5 per cent.

Among the brands, Mixtard leads the pack with Rs.43 crore followed by Glycomet GP at Rs.37 crore, spasmoproxyvon plus at Rs.42 crore, lantus at Rs.33 crore, galvus met at 40 crore, liv 52 Rs.26 crore and Janumet at Rs.32 crore during June 2017. Azilsartan is a recently launched molecule now valued at 24 crore. With in antidiabetic category there are 7 brands launched in the month and with the VMS category there have been 10 brands launched.

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FDA approves new treatment for sickle cell disease

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The U.S. Food and Drug Administration today approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder.

“Endari is the first treatment approved for patients with sickle cell disease in almost 20 years,” said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “Until now, only one other drug was approved for patients living with this serious, debilitating condition.”

Sickle cell disease is an inherited blood disorder in which the red blood cells are abnormally shaped (in a crescent, or “sickle,” shape). This restricts the flow in blood vessels and limits oxygen delivery to the body’s tissues, leading to severe pain and organ damage. According to the National Institutes of Health, approximately 100,000 people in the United States have sickle cell disease. The disease occurs most often in African-Americans, Latinos and other minority groups. The average life expectancy for patients with sickle cell disease in the United States is approximately 40 to 60 years.

The safety and efficacy of Endari were studied in a randomized trial of patients ages five to 58 years old with sickle cell disease who had two or more painful crises within the 12 months prior to enrollment in the trial. Patients were assigned randomly to treatment with Endari or placebo, and the effect of treatment was evaluated over 48 weeks. Patients who were treated with Endari experienced fewer hospital visits for pain treated with a parenterally administered narcotic or ketorolac (sickle cell crises), on average, compared to patients who received a placebo (median 3 vs. median 4), fewer hospitalizations for sickle cell pain (median 2 vs. median 3), and fewer days in the hospital (median 6.5 days vs. median 11 days).  Patients who received Endari also had fewer occurrences of acute chest syndrome (a life-threatening complication of sickle cell disease) compared with patients who received a placebo (8.6 percent vs. 23.1 percent).

Common side effects of Endari include constipation, nausea, headache, abdominal pain, cough, pain in the extremities, back pain and chest pain.

Endari received Orphan Drug designation for this use, which provides incentives to assist and encourage the development of drugs for rare diseases.  In addition, development of this drug was in part supported by the FDA Orphan Products Grants Program, which provides grants for clinical studies on safety and/or effectiveness of products for use in rare diseases or conditions.

The FDA granted the approval of Endari to Emmaus Medical Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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India and Sri Lanka to sign MoU for cooperation in traditional medicine & homoeopathy

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The Central government has given its approval for signing an Memorandum of Understanding (MoU) for cooperation in traditional systems of medicine and homoeopathy between India and Sri Lanka.

The signing of the proposed MoU will enhance bilateral cooperation between the two countries in the areas of traditional medicine and homoeopathy. This will be of immense importance to both countries considering their shared cultural heritage. There will be no additional financial implications involved. The financial resources necessary to conduct research, training courses, conferences/meetings will be met from the existing allocated budget and existing plan schemes of the Ministry of Ayush.

The activities between the two sides will start immediately after the signing of the MoU by the two countries. The initiatives taken between the two countries will be as per the terms of reference of the MoU signed and will be a continuing process till the MoU remains in operation.

India is blessed with well-developed systems of traditional medicine including medicinal plants, which hold tremendous potential in the global health scenario. Sri Lanka also has a long history of traditional medicine. Ayurveda, Siddha, Unani, Yoga & Naturopathy and Homoeopathy are the important traditional healthcare systems existing in Sri Lanka. Both countries share a common culture with respect to Ayurveda, Siddha and Unani systems of medicine. Moreover, there are a large number of medicinal plants, particularly those found in tropical region which are common to the two countries given similar geo-climatic factors.

The Ministry of Ayush, as a part of its mandate to propagate Indian systems of Medicine globally has taken effective steps by entering into MoUs with 11 countries.

They are the State Administration of Traditional Chinese Medicine (SATCM), People’s Republic of China; the Government of Malaysia; the Ministry of Health of the Government of the Republic of Trinidad & Tobago; Ministry of Human Resources, Government of Hungary; Ministry of Health & Family Welfare, Government of the People’s Republic of Bangladesh; Ministry of Health and Population, Government of Nepal; Ministry of Health and Quality of Life, Government of Mauritius; Ministry of Health and Sports, Government of Mongolia; Ministry of Health and Medical Industry, Government of Turkmenistan, Ministry of Health & Sports, Government of Myanmar and Joint Declaration of Intent with the Federal Ministry of Health of the Federal Republic of Germany for Cooperation in the field Traditional Medicine.

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