Drugs Controller General India (DCGI) urges stakeholders to follow strict requirements of Schedule H and H1 for sale of medicines. Recently it has reported by the media that antimicrobial resistance has resulted in the death of a patient in India, followed by which DCGI asked all chemists, druggists and related professionals in supply chain to tight the sale of schedule H and H1 medicines.
The National Cancer Institute (NCI) launched a new drug formulary (the "NCI Formulary") that will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials. The NCI Formulary could ultimately translate into speeding the availability of more-effective treatment options to patients with cancer.
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The NCI Formulary is a public-private partnership between NCI, part of the National Institutes of Health, and pharmaceutical and biotechnology companies. It is also one of NCI's efforts in support of the Cancer Moonshot, answering Vice President Biden's call for greater collaboration and faster development of new therapies for patients. The availability of agents through the NCI Formulary will expedite the start of clinical trials by alleviating the lengthy negotiation process--sometimes up to 18 months--that has been required for investigators to access such agents on their own.
"The NCI Formulary will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner," said NCI Acting Director Douglas Lowy, M.D. "Rather than spending time negotiating agreements, investigators will be able to focus on the important research that can ultimately lead to improved cancer care."
The NCI Formulary launched today with fifteen targeted agents from six pharmaceutical companies:
"The agreements with these companies demonstrate our shared commitment to expedite cancer clinical trials and improve outcomes for patients," said James Doroshow, M.D., NCI Deputy Director for Clinical and Translational Research. "It represents a new drug development paradigm that will enhance the efficiency with which new treatments are discovered."
The establishment of the NCI Formulary will enable NCI to act as an intermediary between investigators at NCI-designated Cancer Centers and participating pharmaceutical companies, facilitating and streamlining the arrangements for access to and use of pharmaceutical agents. Following company approval, investigators will be able to obtain agents from the available formulary list and test them in new preclinical or clinical studies, including combination studies of formulary agents from different companies.
The NCI Formulary leverages lessons learned through NCI's Cancer Therapy Evaluation Program (CTEP) and the NCI-MATCH trial, a study in which targeted agents from different companies are being tested alone or in combination in patients with genetic mutations that are targeted by these drugs. As the use of genomic sequencing data becomes more common in selecting cancer therapies, requests for access to multiple targeted agents for the conduct of clinical trials are becoming more common.
"We are very pleased that several additional pharmaceutical companies have already pledged a willingness to participate and are in various stages of negotiation with NCI," said Dr. Doroshow, who is also director of NCI's Division of Cancer Treatment and Diagnosis. "By the end of 2017, we expect to have doubled the number of partnerships and drugs available in the NCI Formulary."
CTEP staff continue to discuss the NCI Formulary with pharmaceutical companies to make additional proprietary agents available for studies initiated by investigators at NCI-designated Cancer Centers.
The Formulary will complement NIH's plans for another new public-private partnership in oncology, the Partnership to Accelerate Cancer Therapies (PACT). Through PACT, the NIH, U.S. Food and Drug Administration, biopharmaceutical groups in the private sector, foundations, and cancer advocacy organizations will come together to support new research projects to accelerate progress in cancer research as part of the Cancer Moonshot. PACT research will center on the identification and validation of biomarkers of response and resistance to cancer therapies, with special emphasis on immunotherapies. PACT will also establish a platform for selecting and testing combination therapies. PACT is expected to launch in 2017.
National Pharmaceutical Pricing Authority (NPPA) is not in a position to set ceiling price of Coronary Stents due to lack of data and difference in stent pricing. Though NPPA notified that they have initiated the exercise of determination of ceiling price of Coronary Stents after they received notice from department of pharmaceuticals.
The Union Cabinet chaired by the Prime Minister Shri Narendra Modi has approved the sale of surplus land of Hindustan Antibiotics Limited (HAL), Indian Drugs & Pharmaceuticals Limited (IDPL), Rajasthan Drugs & Pharmaceuticals Limited (RDPL) and Bengal Chemicals & Pharmaceuticals Limited (BCPL), as would be required, to meet their outstanding liabilities. In this way, the national assets would be utilized in the best national interest.
Indian Pharmacopoiea commission (IPC) informed that there will be no legal action taken on Adverse drug reaction (ADR) reporter. And active participation in ADR reporting is needed from all healthcare professionals, as IPC concern.
With an aim to promote patient safety by ensuring presence of pharmacists in healthcare delivery of the state, the Maharashtra Registered Pharmacists Association (MRPA) has demanded the implementation of Pharmacy Practice Regulations (PPR) 2015. MRPA submitted a memorandum to Maharashtra Department of Medical Education and Research (DMER) Minister Girish Mahajan in this regards governing Maharashtra State Pharmacy Council (MSPC) which is responsible for implementation of PPR 2015.
By protesting the decision of Department of Pharmaceuticals (DoP) to consider Coronary stents in DPCO 2013, Medical Technology Association of India (MtaI) has requested the government to have a holistic view on the decision by involving all the concerned stakeholders i.e. hospitals, physicians, companies in the discussion on price regulations to arrive at a decision which is best for patient health. MTaI also requested to create a vibrant environment for the medical device sector to make innovative therapies accessible to patients and uphold & strengthen the state of healthcare already achieved in the country.
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Department of Pharmaceuticals (DoP) notified that "Coronary Stents" will be included in Drugs Price Control Order (DPCO), soon. This Order may be called the Drugs (Prices Control) third amendment Order, 2016.
Government is aware of the sale and advertisement of Ayurvedic medicines through TV channels which are required to adhere to the Advertising Code prescribed under the Cable TV Networks (Regulation) Act, 1995 and Rules framed thereunder. Presently, there are no regulatory provisions for pre-censorship on advertisements. Action is taken whenever violation of Advertisement Code is brought to the notice of the Ministry of Information and Broadcasting or the advertisement is found to be in contravention of the provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder.
As a step-up to the ongoing probe by the anti-trust department of the US Department of Justice (DoJ), initiated in October 2014, on the sharp increases in prices of certain generic drugs in the US and the possibility of cartelisation among the drug makers, 20 US States filed a lawsuit on December 15, 2016 against six pharmaceutical companies – Aurobindo Pharmaceuticals Limited, Citron Pharma LLC, Heritage Pharmaceuticals Inc., Mayne Pharma, Mylan NV and Teva Pharmaceuticals. The lawsuit alleges these companies for conspiring the prices of two generic drugs –Doxycycline Hyclate (an anti-biotic) and Glyburide (an anti-diabetic drug).
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