The life sciences sector had high expectations of the budget not only from the point of view of tax incentives, but also from a regulatory point of view. Expectations were based on the Government's vision of making India one of the top three pharmaceutical markets by 2020. This year too, no specific impetus was given to the sector.
Tuberculosis is without doubt a deadly disease that requires serious and constant attention. To address the growing incidence of drug-resistant tuberculosis, its survivors and various public health groups have written to the Department of Health for the incorporation of the patented drug Delamanid into the RNTCP(Revised National Tuberculosis Control Programme). Delamanid has been shown to be effective in the treatment of drug-resistant TB. In a letter to the Union Ministry of Health, the organizations urged the government to order Ostuka Pharmaceuticals Co. Ltd. (Otsuka), the company holding the drug monopoly, to register the delamanid in India without further delay.
The health ministry asked the Supreme Court to challenge an order of the Delhi High Court that had quashed its ban on more than 300 fixed-dose drugs. The health ministry last year had banned 344 FDCs, estimated to affect about 6,000 drug brands and shave over Rs 3,000 crore on the Indian pharmaceutical market, which is estimated to be over Rs 100,000 crore.
Union Minister for Chemicals & Fertilizers and Parliamentary Affairs, Shri Ananth Kumar presided over the signing of Memorandum of Understanding (MoU) between the Bureau of Pharma PSUs of India (BPPI) and National Yuva Cooperative Society Ltd. (NYCS) here today, with the objective to setup 1000 Pradhan Mantri Bhartiya Janaushadhi Kendras in both urban and rural places of the country, as a part of "Mission 3000" kendras by March 2017. Shri Mansukh L. Mandaviya, Minister of State for Road Transport & Highways, Shipping, Chemicals & Fertilizers, was also present on the occasion.
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.
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