DCGI drive to push generics and phase-out brand names.

The Drug Controller General of India on Friday barred the state drug regulators from granting manufacturing licenses to pharma companies under brand names of the drugs, directing them to strictly issue licenses under generic name of the molecule. Additionally the central drug regulator asked the state licensing authorities not to grant licenses to combination drugs, which are technically new drugs. Under the drugs Cosmetics Act, only the central drug regulator has the remit to grant licens more

DCGI bars state drug regulators from granting combination drug license The Drug Controller General of India on Friday barred the state drug regulators from granting manufacturing licenses to pharma companies under brand names of the drugs, directing them to strictly issue licenses under generic name of the molecule. Additionally the central drug regulator asked the state licensing authorities not to grant licenses to combination drugs, which are technically new drugs. Under the drugs Cosmetics Act, only the central drug regulator has the remit to grant license more AstraZeneca launches heart drug Brilinta in India AstraZeneca Pharma India today launched its patented antiplatelet drug Brilinta, used to prevent heart attack, after receiving approval from the Drug Controller General of India (DCGI). Based on the New Drug Advisory Committee's (NDAC) recommendations, the DCGI granted approval on May 2012 for marketing Brilinta (Ticagrelor) tablets in India, the company said in a statement. Brilinta, an oral antiplatelet treatment for Acute Coronary Syndromes (ACS) in adult patients, is competitively priced to more 348 vital drugs to come under price control The Group of Ministers (GoM), headed by Agriculture Minister Sharad Pawar, on Thursday, gave its approval to the final pharma pricing policy, bringing 348 essential drugs under the governments price control regime. The GoM, at its last meeting, had agreed to study how emerging countries such as Mexico, South Africa, Bangladesh and Sri Lanka fixed the prices of essential medicines, before finalising the drug pricing policy in India. After the meeting, Mr. Pawar told reporters that the GoM would more Mylan sues USFDA for permiting Ranbaxy to market Diovan's Generic Mylan Inc has sued the US drug regulator for not allowing it to market a generic version of the Novartis' hypertension medicine Diovan, saying that Ranbaxy has lost its exclusivity for the drug as it has failed to get the tentative approval to sell the drug in the US within the specified period. If Mylan succeeds in its appeal, it could wipe off potential one-time revenue of 350-450 crore windfall for Ranbaxy. India's largest drugmaker has the exclusive rights to market the generic for 180 days more Generic Drug User fees and its impact in pharmaceutical industry: All generic pharmaceutical companies, including Ranbaxy Laboratories, Cipla, Dr Reddys Laboratories, Lupin, Glenmark and Torrent Pharma, might soon have to pay a fee to the US drug regulator when they seek its permission to sell their products there. America is the worlds largest drug market. A Generic Drug User Fee Act is on the way, to enable the US Food and Drugs Administration (FDA) to levy a user fee of around $100,000 on each generic drug application filed for approval, it is learnt. The new norms are likely to be introduced from October. The regulator might also impose a fee for re-inspection of FDA-approved facilities abroad and on Drug Master Files

(DMFs) that are generally filed by pharmaceutical companies with detailed information about facilities, products and processes, according to an industry representative Currently, the FDA does not charge any fee for generic drug applications, also known as Abbreviated New Drug Applications (ANDAs). However, under the present law or the Prescription Drug User Fee Act (PDUFA), the regulator collects a fee from companies for any newly innovated medicine. While the move is expected to have a financial impact on generic drug makers, analysts suggest it would also benefit companies, with faster approvals. Our preliminary calculations suggest the levy is likely to cause a fairly nominal financial impact (less than $100,000 per ANDA filing) for generics filers. However, generics players will benefit greatly by significantly accelerated review of filings in the medium term, analysts from IDFC Securities said. The proposed generic user fee is expected to give FDA the additional resources required to expedite and improve the review of drugs. Currently, it takes the regulator an average of 30 months to review an application; it aims to reduce the review time to 10 months by 2017, a source said. According to estimates of IDFC Securities, once the proposed law goes through, it could earn the FDA an additional $299 million per annum from generic makers. Of this, 30 per cent is likely to come from processing of ANDAs and DMFs, and the rest from its inspection of various facilities. However, some other sources said the user fee for generic drug applications might vary, depending on the products market size. Once in place, the new law is also likely to increase the frequency of re-inspections and audits of facilities abroad by the FDA. India has, outside the US, the largest number of FDA-approved manufacturing units. The development is also significant as a large number of Indian companies are targeting various generic launches in the US, in the wake of expiring patents. The US generic market, 70-75 per cent of the total US pharmaceutical market, is currently estimated to be at $350 billion and seen to grow at three to five per cent yearly. Sales by Indian companies make up around 10 per cent of the US market. Around 1,000 generic applications are filed in the US market every year by Indian drug companies. In 2011, the ANDA fillings in the US went up to 946, against 793 in 2006. This led to a sharp increase in the backlog of processing ANDAs. Analyst estimates show 2,696 generic drug applications were pending with the FDA as of December 2011, as compared to 1,216 in December 2006. NCK Pharma Solution Private Limited has created a iconic training brand "Knowledge Proess Enhancer" which is approved by International Assocoation of Distance Learning (IADL) registered under the Trademark Registry of India under section 42. KPE is conceptualized with a vision to spearhead innovation in the field of Pharmaceutical, Biotechnology, Medical Devices learinng with the technological advances. The mission is to provide "Best On the go" training services across those industries to create, develop, train tomorrows leaders. All courses are designed by the industry mentors keeping industry working in mind. Mode: 1. Lecture Pack - Interactive online access to classroom lectures. 2. Secure access to e-module. 3. Practical Training classes. 4. Access to industry case study files. 5. Self Assessment Tests. 6. Flexible online final examination (Computer Based Test by secure mode) KPE courses can be accessed anytime from anywhere KPE Courses Drug Regulatory Affairs

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