Spectrum PHARM

Pharma Spectrum Organisation of Pharmaceutical Producers of India
Volume 6
Issue 10
October 2013
INDEX
INTERNATIONAL
1. 2. 3. 4. 5. 6. 7. 8. 9. IPR / Innovation Regulatory/ Medical / Biotech New Products R&D / Clinical Trials Mergers & Acquisitions / Collaborations Access & Pricing Trade Ethics & Compliance New Appointments 1 1 2 2 3 4 4 5 6
DOMESTIC
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. IPR / Innovation Regulatory / Medical / Biotech New Products R&D / Clinical Trials Mergers & Acquisitions / Collaborations Access & Pricing Trade Ethics & Compliance New Appointments OPPI Related News / Events 6 8 10 10 12 13 15 16 16 16
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
International
IPR / Innovation
September 24, 2013, Pharmabiz
The US District Court for the District of New Jersey has issued a favourable ruling in the Teva Pharmaceutical Industries' patent infringement lawsuit against Mylan regarding an Azilect (rasagiline tablets) patent which covers methods of treating Parkinsons disease (PD). The Court has upheld the validity of Tevas patent. Teva anticipates the Court will enter Judgment that prevents Mylan from launching its generic version of Azilect until Tevas patent expires in 2017. Teva filed a lawsuit suit against Mylan in October 2010. Similar lawsuits were filed against Watson and Orchid in October 2010, Apotex in May 2011 and Sandoz in April 2012.
to data released last week by the Indian Patent Office (IPO).
South Africa Writes IP Policy Making It Harder To Get Drug Patents

September 11, 2013, Fierce Pharma
Big Pharma has fought bruising battles in India over intellectual property. China has added compulsory licensing to its bag of tricks for dealing with costly drugs. Now drugmakers can add South Africa to the list of countries that are looking askance at unimpeded patents. The South African government is asking for comments by Oct. 4 on a proposed National Policy on Intellectual Property, PharmaTimes reports. It would raise the bar on innovation, striking a blow at what critics consider "evergreening" by drug companies to extend patent protection.
Teva Gets Favourable US Court Ruling In Azilect Patent Infringement Lawsuit Against Mylan
Watson Sends Patent Challenge Notice To Ranbaxy For Acne Drug

September 22, 2013, Hindu Business Line
Ranbaxy Laboratories has said its U.S. arm has received a notice from Watson Laboratories Inc, challenging the patent of acne treatment drug Absorica. The drug is licensed to Ranbaxy Laboratories from Cipher Pharmaceuticals Inc of Mississauga, Ontario. It is now protected by two issued patents listed in the U.S. Food and Drug Administrations (USFDA) approved drug products list, which expire in September, 2021, the company said in a statement. Ranbaxy Laboratories Inc, the wholly-owned subsidiary of the company, has received a Paragraph IV certification....
Regulatory / Medical / Biotech

GSK Gets Double Dose Of Good News For Breo Ellipta
GlaxoSmithKline got a double dose of good news today about its respiratory drug Breo Ellipta, known as Relvar Ellipta in other markets. Regulators in Europe recommended the potential blockbuster be approved there for COPD and asthma, while regulators in Japan gave it the OK for asthma. Breo was approved in May by the FDA for two uses in COPD. The respiratory drug is one that GSK is leaning heavily on to pick up some of the sales vacuum that will come when generics of Advair finally take on the nearly $8 billion a year powerhouse.
Foreign Drug Makers Won 77% Of All Patents Granted In Last 3 Years
September 16, 2013, Livemint
More than two-thirds of the pharmaceutical patents awarded by India in the last three years were granted to foreign drug makers such as Pfizer Inc., Novartis AG and F Hoffmann La Roche Ltd , which have been critical of Indias intellectual property rights (IPR) regime. The country issued 1,001 drug patents between April 2010 and March 2013, of which 771 were given to foreign drug makers, mainly from the US and Europe, according
FDA Approves Teva's Generic Of Roche Blockbuster Xeloda

Roche's blockbuster Xeloda went off patent in December, so it was inevitable that a generic would hit the market at some point. It just wasn't known when. Well, that when is now. The FDA Monday said it had approved a generic from Teva Pharmaceutical Industries.
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Teva has been approved to market generic capecitabine in 150 and 500 milligram strengths, the agency said. "Generic drugs are important options that allow greater access to healthcare for all Americans," said Dr. Kathleen Uhl, acting director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research. the contents could not be determined, according to a July 18 letter from the U.S. Food and Drug Administration to Wockhardt, which makes sterile injectable drugs and various forms of insulin.
US Import Alert On Ranbaxy; Mohali Unit Part Of Consent Decree

September 17, 2013, The Economic Times
Ranbaxy's regulatory ailments are threatening to become chronic. Months after it agreed to pay $500 million to settle charges, the US Food & Drug Administration issued an import alert against its factory in Mohali (Punjab), sending the stock tumbling 30%. While Ranbaxy doesn't export any drugs to the US from the plant, the move could delay plans to start selling several generics in the world's biggest drug market. "I think there are some 17 generic drug filings that Ranbaxy has done from the Mohali plant that might get delayed," said Surjit Pal, an analyst with brokerage firm Prabhudas Lilladher.
Bayer's Nexavar In FDA Fast Lane For Thyroid Cancer Use

August 27, 2013, Fierce Pharma
Bayer's Nexavar is one big step closer to a thyroid-cancer approval. The FDA put the drug on the priority-review fast track, which means Nexavar could have its new indication by February. It's a timely win for Bayer's development partner, Onyx Pharmaceuticals, which just agreed to a $10.4 billion buyout by Amgen. It's not a huge new market--analysts see $200 million in additional sales--but it's a needy one. Nexavar would be pointed toward patients whose cancer has returned after surgery and radiation--patients whose treatment options are limited, and prognosis poor.
FDA Turbocharges GlaxoSmithKline's Bids For New Cancer Drug Uses

With two back-to-back decisions, the FDA is revving up GlaxoSmithKline's cancer prospects. Friday, the agency dubbed Arzerra a "breakthrough therapy," a coveted designation that puts the leukemia drug into the fast lane for first-line use. And today, the FDA put GSK's new melanoma duo, Tafinlar and Mekinist, on its priority review track as a combination cocktail. Developed with Genmab, Arzerra is not a big seller; it brought in less than $100 million last year. But the breakthrough designation gives it a chance to do much better. The drug is now approved for chronic lymphocytic leukemia patients whose disease has progressed despite previous therapy.
New Products
Eisai Launches Halaven In Russia Anticancer Agent
Eisai Co., Ltd., a Japanese pharmaceutical company, has launched anticancer agent, Halaven (eribulin mesylate) in Russia, making it the first product to be marketed in Russia by the company. Halaven is a novel anticancer agent discovered and developed in-house by Eisai and is currently approved in more than 50 countries, including Japan, the United States and in Europe. In Russia, Halaven was approved in July 2012 for the treatment of locally advanced or metastatic breast cancer previously treated with at least two chemotherapy regimens including an anthracycline and a taxane. The Russian pharmaceutical market constitutes the 11th largest in the world and is expected to continue to achieve double-digit growth going forward.
Indian Pharma Draws More Scrutiny As US Exports Rise

September 12, 2013, Reuters
U.S. inspectors visiting a factory in India owned by drugmaker Wockhardt Ltd in March found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six meters from the entrance to a sterile manufacturing area. And when an inspector asked about the contents of unlabelled vials in the laboratory glassware washing area, a plant worker dumped them down a sink and said
R&D/Clinical Trials
Scientists Discover Blueprint For First Universal Flu Vaccine
September 24, 2013, The Times of India
A team led by a scientist of Indian origin has made a "blueprint" for a universal flu vaccine. The influenza
Pharma Spectrum
virus that causes flu is known to be one of the world's most rapidly changing organisms. Flu vaccines become redundant after every season and aren't effective against every strain causing cough, cold and other complications. So, scientists have to create new vaccines with new strains of the virus each year. Now, a team led by professor Ajit Lalvani from the National Heart and Lung Institute at Imperial College London has used a 2009 pandemic virus strain to study why some people seem to resist severe illness, thereby stumbling upon a recipe to create the world's first universal flu vaccine. Even the smallest biotech company can benefit when it thinks--and acts--globally. And a biotech startup that was able to grab a promising therapeutic asset from Pfizer as it shuttered much of its work in the U.K. has pieced together a global virtual organization that illustrates just how effective that can be.
UK Committee Urges Transparency In Clinical Trials

September 17, 2013, Pharma Letter
The UK Parliaments Science and Technology Committee has described the current lack of transparency of many clinical trials as unacceptable, adding t hat it has not been impressed with government efforts to tackle the problem to date. Committee chairman Andrew Miller MP said: Many of the trials taking place today are unregistered and unpublished, meaning that the information that they generate remains invisible to both the scientific community and the public.
Mergers & Acquisitions / Collaborations

Otsuka To Buy Astex Pharma For $886m
September 6, 2013, Financial Express
Japanese drugmaker Otsuka Holdings said on Thursday that it had agreed to buy Astex Pharmaceuticals for close to $900 million to tap cancer drugs under development by the US company. The move comes as Otsuka seeks to increase revenue streams as patents for its mainstay Abilify schizophrenia treatment will begin to expire. Otsuka said in a statement through the Tokyo Stock Exchange that it would launch a tender offer beginning within the next 10 days that would run for 20 days. The company has set aside $886 million to cover the purchase of Astex at $8.50 a share.
On A Roll, Boehringer Wins 'Breakthrough' Status For Pioneering Leukemia Drug

September 17, 2013, Fierce Biotech
When Boehringer Ingelheim took volasertib into a Phase III study for acute myeloid leukemia earlier this year, the pharma company claimed a pioneering role in advancing a promising cancer therapy that inhibits polo-like kinase-or Plk. Today, the company said that the FDA agreed, offering to help speed development with its "breakthrough" therapy designation. The BTD announcement marks another step forward in Boehringer's considerable effort to push a small group of late-stage cancer therapies into the market. In July the FDA approved afatinib for non-small cell lung cancer for patients with EGFR mutations.
India Receives Highest FDI Worth $1b In Pharma In Apr-Jun

September 1, 2013, Financial Chronicle
India's pharmaceuticals sector has received FDI of $ 1 billion, the highest among the top 10 segments, during the April-June period this year amid concerns over increasing acquisitions of domestic firms by multinationals. Foreign Direct Investment (FDI) in drugs and pharmaceuticals during April-June 2012 stood at $ 465 million, according to the latest data of Department of Industrial Policy and Promotion (DIPP). The DIPP is working on a cabinet note to include major changes in the FDI policy in the sector to protect domestic generic (off-patent) firms. "The DIPP is concerned that an overwhelming majority of foreign direct investment in pharma is coming only in existing (brownfield) units," an official said.
U.K. Biotech Startup Forges Close Ties To Eli Lilly's R&D Experts
September 10, 2013, Fierce Biotech
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Access & Pricing

Increase Of Japan's Medical Expenditure Slowed To 1.7% In 2012
September 16, 2013, Pharma Letter
The Japanese Ministry of Health, Labor and Welfare (MHLW) reported approximate medical expenditure (AME) for the fiscal year 2012 that ended in March. Although costs for work-place injuries and some out-ofpocket items are yet to be included, the AME accounting for 98% of the National Health Expenditure (NHE) - is a quick and accurate indicator of trends in the NHE, which takes a year and a half to be finalized, reports The Pharma Letters local analyst. The AME increased by 640 billion yen ($6.44 billion) or 1.7% to 38.4 trillion yen in 2012. Payments for elderly patients (aged above 70) accounted for 75% or 480 billion yen of the total increase. For the age bracket, daily medical cost per patient increased 2.6% to 14,800 yen in 2012 and annual medical.
corporations to bypass the Supreme Court and sue the government for millions of dollars in foreign tribunals. The 'investor-state dispute settlement', a key element of the bilateral investment pact, will arm foreign investors operating in India with a slew of rights. Biswajit Dhar, director general of the Research and Information System for Developing Countries told TOI:.....
Pfizer Rolls Out Digital Reps In U.K., Hoping For Access To Primary-Care Docs
Which sort of pharma rep would a doctor prefer to see--a live rep, in the flesh, possibly carrying an iPad? Or an electronic version, piped in via Skype at the physician's convenience? Pfizer aims to find out, with its latest foray into e-detailing. As Pharmafile reports, the U.S.-based pharma giant has been promoting a new service in the U.K. called Pfizerline, which allows primary care doctors to book time with reps. Ads in the BMJ (formerly the British Medical Journal) tout the convenience of anytime, anywhere contact with Pfizer reps bearing info about the company's products.
U.K. Groups Want Drugmakers To Guarantee Supplies When Prices Are Reduced
The Pharmaceutical Services Negotiating Committee (PSNC) in the U.K. is afraid impending price reductions will lead to drug shortages. It has asked the government to require drugmakers meet certain supply levels, according to PharmaTimes. The PSNC and the British Association of Pharmaceutical Wholesalers (BAPW) have said the price cuts slated for January might make it more attractive for some wholesalers to export drugs to countries with higher prices. They contend price cuts also might lead them to reduce stocks of some drugs.
Pharma Suffers In China As Widening Scandal Spooks Docs, Reps

There's no doubt the pharma bribery scandal has been bad for business in China. Just how bad? That remains to be seen. But in the meantime, Reuters reports that drugmakers are struggling to push their products--and explores how those problems might affect third-quarter results. Fearful doctors, who have grown more cautious with the widening scandal, pose a major hurdle to pharma sales efforts. As one former sales rep told Reuters, some doctors accustomed to seeing upwards of 10 sales staff per day have slashed visits altogether.
Trade
US Wants MNCs To Have Right To Sue India Abroad
There is growing pressure on the Indian government to incorporate a provision in an investment agreement with the US, which if invoked will have far-reaching implications in that it will allow multinational
India May Join Global Safeguard Drug Exports
Forum
To

India is considering joining a global forum that prescribes standards for medicine manufacturing to safeguard its drug exports to the member countries. Called the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), it currently comprises 43 drug importing countries.
Pharma Spectrum
The move assumes significance in the backdrop of Indian drugmaker Ranbaxy being recently penalised $500 million (aboutRs3,350 crore) by the US government for shoddy manufacturing practices. The United States and the European Union are among the key members. In 2012, the Russian market of drugs and dietary supplements totaled 818 billion roubles ($24.8 billion) by value, of which 80% was accounted for by imports. According to state plans, by 2020, the share of domestically produced drugs should be no less than 50%, and in the segment of essential drugs even 90%.
EU Leaders Slam China For Targeting Foreign Drugmakers

European business leaders are taking up Pharma's case in China. Foreign drugmakers have been singled out unfairly in Chinese investigations into bribery and anticompetitive pricing, the European Union Chamber of Commerce says. Fighting corruption is great--but the crackdown has to extend to domestic drugmakers, too. In fact, one official says, it's the very companies with the strongest compliance procedures that are attracting the most government scrutiny. Foreign multinationals have been "at large" very responsible, the chamber's top pharma official, Bruno Gensburger, told Reuters.
Ethics & Compliance

Novartis Begins Inquiry Against Chinese Graft Allegations
September 17, 2013, BioSpectrum Asia
With the Chinese getting tough on the pharmaceutical sector in the country, reports of both foreign multinationals and domestic companies making amends to their operations are coming to light. Swiss pharmaceutical major Novartis has now released a statement claiming that it has started an internal inquiry following Chinese press accusations of corruption at its Alcon eye care division. "Alcon does not tolerate activities that are not in compliance with the laws and regulations in the markets where we operate. When any inappropriate activities are identified, we take swift remedial action," Novartis said in a statement.
Novartis Can't Get Past Foul-Ups At Consumer Plant; Recalls 4.4 Million Bottles Of Maalox
August 29, 2013, Fierce Pharma
Novartis can't catch a break with its troubled U.S. OTC plant that has been a source of frustration for CEO Joseph Jimenez. The Swiss drugmaker has recalled 4.4 million bottles of its popular Maalox products due to manufacturing problems that predate Jimenez's recent decision to strip the facility down to the most basic operations. Several weeks ago, Novartis began recalling the Maalox products from the U.S. and Canada because of packaging issues. The recall encompasses 9 different types of its Maalox chewable tablets, including more than 3.4 million bottles of Maalox Advanced Maximum Strength Antacid & Antigas.
'Zorro' Claims Novartis' Alcon Unit Faked Trials To Bribe Chinese Docs
The bribery allegations in China just keep on coming. Novartis' Alcon eyecare division now says it will investigate claims it used fabricated clinical trials to bribe doctors. The news is none too welcome for Novartis, which has already faced a set of bribery accusations in China. China's 21st Century Business Herald publicized whistleblower allegations against Alcon on Tuesday, the Financial Times reports. Citing an Alcon employee codenamed Zorro, the Chinese newspaper reports that Alcon used a middleman to pay doctors for working on non-existent post-marketing clinical trials.
Russian Pharma Market Will Continue To Focus On Imports Over Next Few Years
August 27, 2013, Pharma Letter
The Russian pharmaceutical market will continue to focus on imports during the next several years, despite all the attempts of the state to improve the situation and to increase the share of domestic producers, according to results of a recent study conducted by Deloitte, titled Trends and practical aspects of the development of the Russian pharmaceutical market 2013."
Germany's Bayer Joins Crowd Of Companies Under Chinese Investigation

Add Bayer to the list of companies Chinese authorities are investigating. Friday, a Bayer spokeswoman told The Wall Street Journal China's probe has reached the German pharma for a "potential case of unfair
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competition" as the country's government continues its industry-wide crackdown. According to the Journal, a representative from China's corporate registry, the State Administration for Industry and Commerce (AIC), visited an unspecified Bayer office in China at the end of August, the spokeswoman says. "We are fully cooperating with the authority," she told the WSJ without providing further details.
Domestic
IPR / Innovation
Genzyme Corp Files Infringement Suit Against DRL Patent
September 22, 2013, Business Standard
Genzyme Corporation, a fully-owned subsidiary of drug major Sanofi-Aventis, has filed a suit against Dr. Reddy's Laboratories alleging that the Indian drug maker infringed patents of its blockbuster cancer drug Mozobil on three counts. Mozobil (plerixafor injection) is a hematopoietic stem cell mobiliser indicated to patients with non-Hodgkin's lymphoma (blood cancer) and multiple myeloma. In its petition filed in the District Court of Delaware, Genzyme alleged that DRL intimated though a letter that it had submitted.....
GlaxoSmithKline's China Probe Triggers U.S. Bribery Investigation

Once again, GlaxoSmithKline has the U.S. Justice Department on its tail. Prosecutors are investigating bribery allegations that Glaxo faces in China, trying to determine whether the drug maker violated U.S. law. First reported by Reuters, the news of the U.S. investigation illustrates the Justice Department's renewed zeal about Corporate America's operations overseas. Prosecutors have been eyeing pharma (and other industries) for violations of the Foreign Corrupt Practices Act (FCPA), and several drugmakers have paid millions of dollars to settle corruption probes. Though Glaxo is based in Britain, its shares are listed in the U.S., making it vulnerable to FCPA prosecution.
Bristol-Myers Misleading HC In Patent Case

The struggle for introducing an affordable version of an anti-cancer drug in the domestic market has taken an interesting turn. Even as the patent regulator is yet to allow BDR Pharma a licence to manufacture a generic version of cancer drug, dasatinib, drug MNC Bristol-Myers Squibb has told the Delhi high court that the generic company's application for compulsory licence has been rejected. BDR Pharma's application seeking compulsory licence on exorbitantly priced anti-cancer drug is still pending with the Patent Controller with the related hearings still on, a company official said. The innovator, BMS is believed to be "misleading" the court which may "influence the final order", a lawyer with the law firm, Gopakumar Nair Associates, which represents BDR Pharma, told TOI.
New Appointments
Roche Names Lufthansa CEO Franz to Replace Humer
September 16, 2013, Bloomberg.com
Roche Holding AG (ROG), the worlds biggest maker of cancer medicines, named Deutsche Lufthansa AG (LHA) Chief Executive Officer Christoph Franz to replace Chairman Franz Humer next year. Roche will propose his nomination to the annual shareholder meeting on March 4, the Basel-based company said today in a statement. Franzs term at Lufthansa expires May 31. Humer, who led Roche for more than a decade, is credited as an architect of Roche s strategy of yoking its diagnostics and drugs units together to create medicines targeted at individual patients. Humer, 67, was CEO when Roche bought a 30 percent stake in U.S. biotechnology company Genentech Inc. in 1999.
BDR Pharmaceutical's Plea For Compulsory Licence On Cancer Drug Rejected

The Indian Patent Office has rejected Mumbai-based BDR Pharmaceutical's application for compulsory licence on cancer drug Dasatinib, according to an affidavit filed by Bristol Myers Squibb, the patent holder for the drug. Compulsory licensing is a provision provided by international intellectual property protection
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agreements under which governments can allow companies to produce generic versions of patentprotected drugs under certain conditions, including if they are found to be out of reach of the public. Dasatinib, which Bristol-Myers Squibb sells as Sprycel, is used in the treatment of chronic myeloid leukaemia. In India, a month's dose of this drug costs about Rs 1 lakh. BDR Pharmaceutical had applied for a compulsory licence (CL) on this drug in March and said its version will cost Rs 8,100/month. The recent crises highlight the weaknesses of the global economic model. As former Federal Reserve chairman Paul Volcker observed on December 11, 2009, "We have another economic problem which is mixed up in this of too much consumption, too much spending relative to our capacity to invest and to export." Traditional sources of growth include increasing population, sustainable and affordable resources, new markets as well as improved productivity and innovation. Environmental and resource constraints limit the potential for large increases in population. The population in more affluent developed nations is shrinking, with birth rates falling below replacement levels.
Mylan Will Not Shy Away From Pursuing Frivolous Patents

Multinational drug-maker Mylan has hinted that it is willing to get its hands dirty in India, even if this meant pursuing frivolous or invalid patents to bring in lessexpensive generic medicines. There is a clear distinction between large brand pharmaceutical multinationals and Mylan, said President Rajiv Malik. Mylan is a multinational, but it is also a generic and specialty company focused on improving access to quality, affordable medicines, he clarifies. And to enhance access, we will pursue patents we believe are frivolous or invalid in order to bring generic versions of products to market sooner and create more affordable access to these products, he said, adding that Mylans generic Herceptin programme is a case in point.
Govt Refutes Novartis' Allegations On Patents

August 29, 2013, Indian Express
Tearing into the allegations made by Novartis on India's 'discriminatory' patent practices, the government has said global firms, including the Swiss drug major, have benefited more from the country's rules cornering over 80 per cent of the patents granted. "You would appreciate that more than 80 per cent of patents registered in India are attributed to nonIndians," Commerce Secretary S R Rao has said in a letter to Novartis AG CEO Joseph Jimenez. Responding to a letter sent by Jimenez to Commerce and Industry Minister Anand Sharma, Rao further....
Panel Backs Compulsory Licence On Cancer Drug

September 11, 2013, Mint
An expert committee on compulsory licensing has recommended that the department of industrial policy and promotion (DIPP) issue a compulsory licence for the manufacture of Bristol-Myers Squibb Co.s anti-cancer drug Dasatinib to two companies. If the department approves the recommendation, it will be Indias second compulsory licence and a significant blow to the New York-based drug maker. A compulsory licence would allow the government to produce a generic version of the patented medicine and sell it at a cheaper price.
Indian Patent Regime A Thorn In The Flesh Of Global Drug Makers: Arun Narasani
August 29, 2013, Pharmabiz, Nandita Vijay
Brain League IP Services and Origiin IP Solutions LLP have expressed that India needs to be taken seriously by global pharma majors when it comes to revoking of patents. This goes by the developments in the last few months proving that process of getting patent is tough in India and those granted are extremely prone to revocation. These included the recent Roches Herceptin application. In 2012, India retracted patents granted to Roche's hepatitis C drug Pegasys, Pfizer Inc.'s cancer drug Sutent and Merck's asthma aerosol suspension formulation. While Roches Pegasys invention was seen to be not efficient compared to non-pegylated version,....
Innovation, Productivity, New Markets Essential For Sustainable Growth

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Regulatory / Medical / Biotech

DCGI May Look Into Fresh Quality Complaints Against Ranbaxy
September 24, 2013, Pharmabiz, Joseph Alexander
Ranbaxy Laboratories, which is facing heat from the US Food and Drug Administration (FDA) over the quality of products from its Mohali plant, is still under the scanner of Indian regulatory authorities also and the Drug Control General of India (DCGI) said his office will look into the fresh complaints, if required. The investigation is still going on, DCGI Dr G N Singh informed about the status of the review of GMP compliance of Ranbaxy facilities as ordered by the Health Ministry. It is an ongoing process as we want to ensure the safety and efficacy of drugs marketed in the domestic market, he added.
Ranbaxy's newest facility at Mohali was put under an import alert by US FDA earlier this month after the company had failed to correct violations from prescribed good manufacturing practices noted by US drug regulatory investigators in September 2012 and December 2012.
No Major Violations At Ranbaxys Mohali Plant: Indias Drug Regulator

Indias drug regulator on Thursday said it found no major discrepancies at Ranbaxy Laboratories Ltds manufacturing plant in Mohali, after the US drug regulator earlier this week banned imports from the facility citing irregularities. We had carried out inspections of products and services in the concerned manufacturing units of Ranbaxy, and have found no major discrepancies. Hence there are no violations by the company under the Drugs and Cosmetics Act and Ranbaxy operations will continue in India as usual, said G.N. Singh, Indias Drugs Controller General of India (DGCI).
Indian Drug Regulator Reaches Out To Other Countries As Issues Mount

The top drug regulator in India has decided it is time to confer with some of his peers around the world after a run of tough regulatory actions by Western countries against Indian drugmakers. Just last week the FDA issued a new import ban against yet another plant of the country's largest generic drugmaker, Ranbaxy Laboratories. According to the Business Standard, with problems for its drugmakers mounting, Drug Controller General of India G. N. Singh is confabbing with regulators in Europe this week about the cGMP standards that they expect. His agency might invite officials from the U.S. for discussions as well.
46 Habit-Forming Drugs To Be Sold Only On Doc's Prescription

Habit-forming anti-biotics, anti -TB and other such drugs like diazepam sleeping pills will not be freely available at chemists from March 1 next year, as government has notified a list of 46 such medicines to regulate their use. They will no longer be over-the-counter drugs and will be sold only through a doctor's prescription. Chemists will have to record the names and addresses of prescriber and buyer of all such drugs in a separate register. As per the notification, such records will have to be maintained for a period of three years.
UK, Australia Regulators Seek Details Of US Findings On Ranbaxys Mohali Plant

After the US Food and Drug Administration barred products from Ranbaxy Labs' Mohali plant earlier this month, other global drug regulators from the UK and Australia said that they are seeking information from the US regulator to check the impact on the company's drugs marketed in their respective countries.
Expert Panel On FDC Issues Draft Policy Guidelines For Approval Of FDCs In India
September 16, 2013, Pharmabiz, Ramesh Shankar
The Prof C K Kokate-headed expert committee, constituted by the Union health ministry in February this year, to formulate policy guidelines and procedures for approval of fixed dose combinations (FDCs) has issued draft policy guidelines for approval of FDCs in India. The guidelines apply to the manufacture/ import and marketing approval of any FDCs in the country. As per the guidelines, a clear justification with a valid
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therapeutic rationale of the particular combination of active substances proposed along with the appropriate data will be the basis for approval. and includes DNA vaccines and vaccines containing living genetically engineered organisms, toxins, antigens and anti-toxins, antibiotics....
Govt Asks Pharma Industry Not To Ignore Drugs For Neglected Tropical Diseases
Pointing out that the pharmaceutical industry was ignoring the neglected tropical diseases (NTDs), the Centre has asked the industry to chip in by manufacturing required drugs to combat these NTDs which impact millions of 'faceless and nameless' downtrodden people in India. Pharmaceutical industry has been neglecting the NTDs and there is not sufficient number of drugs and enough supply to treat these diseases impacting the millions. For Kala-azar, there is only one company that supplies drugs for our national programme.
Health Min Plans To Amend Rules To Increase Period Of Retaining Seized Documents, Samples
September Alexander 2, 2013, Pharmabiz, Joseph
Union Health Ministry is planning to make amendment to the Drugs and Cosmetics (D&C) Rules to increase the period of retention of documents from the manufacturers and also the control of samples for a greater time as part of tightening the monitoring quality of drugs. The proposal, which is now under the consideration of an expert panel, is to amend the rule 65 (7) of the D&C Rules to increase the period of retention of documents, registers etc., for a period from two years to five years in line with the provision for maintaining manufacturing records.
DCGI Asks Clinical Trial Sponsors To Furnish Details Of Payments To Investigators Along With Applications
Industry Urges DCGI To Give Deadline Of March 2014 For Submitting Efficacy Data Of FDCs Approved By SLAs
August 30, 2013, Pharmabiz, Ramesh Shankar
Even as the last date for submitting the efficacy data of FDC drugs approved by the state drug controllers before October 1, 2012 to the Drug Controller General of India (DCGI) ends on August 30, the pharma industry in the country has urged the DCGI to extend the last date of submission till March 31, 2014 as proposed earlier. The industry has pointed out that the extension of last date for submission of safety and efficacy data for SLAapproved FDCs is necessary in view of the extensive nature of effort and time required in compiling and submitting the necessary details.
The Drugs Control General of India (DCGI) has asked the sponsors of clinical trials to furnish details of the contracts with the investigators with regard to the financial support, fees and payments in kind, while making the applications for trial permissions. The DCGI, in an order, pointed out that good clinical practice guidelines provide that the sponsor should enter into a formal and legal agreement/ contract with the investigators and the institutions before the start of the trial on various terms of the trial.
Central Drug Authority To Centralise Licensing In 17 Critical Categories

Govt Moves Bill To Regulate Drugs, Cosmetics

August 30, 2013, The Times of India
The government on Thursday introduced a bill in Rajya Sabha that provides for setting up of a Central Drugs Authority as an overarching body for regulation of drugs and cosmetics and seeks to bring 17 critical drugs under central licencing. The bill also contains a separate chapter for regulatory provisions for medical devices and for regulating clinical trials and export of drugs and cosmetics. While no person can conduct any clinical trial for a new drug or medical
The proposed Central Drug Authority (CDA), though with diluted powers as compared to the original proposal and recommendations, will centralise the licensing in respect of 17 categories of very critical drugs, as per the Drugs and Cosmetics (amendment) Bill, 2013 recently introduced in Parliament. The categories of drugs which the central licensing authority is empowered to issue licenses will be sera, solutions serum proteins intended for injection vaccines;
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device or cosmetic, the bill contains severe penal provisions for its violations that include imprisonment of maximum 10 years and penalty of up to Rs 30 lakh. We are through with clinical trials and have received the necessary approvals. We hope to launch it by the end of this year," Novo Nordisk India Managing Director Melvin D'souza told reporters here. Tresiba is a once-daily basal insulin with a duration of action beyond 42 hours, allowing for flexibility....
DCGI Allows Cos To Submit Applications For FDCs At Zonal Or Sub Zonal Offices Before Aug 31
August 28, 2013, Pharmabiz, Suja Nair Shirodkar
Understanding woes of the pharma manufacturers in travelling all the way to Delhi to submit the applications for the FDCs to prove their safety and efficacy, the Drug Controller General of India (DCGI) informed the manufacturers that they can file application for the same, before the deadline, in the nearest zonal or sub zonal offices. Through this initiative, the DCGI hopes to encourage more manufacturers to follow the mandate passed by the Centre which requires all the companies to submit, Form 44 along with other requisite supporting documents to prove the safety and efficacy of the FDC on or before August 31.
R&D/Clinical Trials
DBT Invites Applications From Indian Biotech Cos For Funding R&D
The Department of Biotechnology (DBT), under its Small Business Innovation Research Initiative (SBIRI) scheme, has invited proposals from Indian biotech companies for funding of research and development in the field of biotechnology. Under this SBIRI scheme, the DBT will provide support for innovation research in biotech companies including start-ups and small and medium enterprises. Under this flagship public-private partnership programme, the DBT will support early stage and proofof-concept for innovations based on valid hypothesis, R&D aimed at affordable product development, lab-scale technology refinement, validation of a technology at pilot scale, platform technologies/ prototype development, etc.
New Products
Zydus Launches Diabetes Treatment Drug Lipaglyn
Pharmaceutical entity Zydus group on Monday said it has launched Lipaglyn, its patented new drug for treatment of diabetes. Lipaglyn will be available across India and is priced at Rs 25.90 per tablet. It is recommended for once administration of once day as a 4mg tablet, the company said in a statement. Commenting on the launch of the drug, Zydus Cadila Chairman and Managing Director Pankaj R Patel said: "It's a great milestone for Indian pharmaceutical research today as Lipaglyn completes its journey from the lab to the market."
BA/BE Studies Of New Drugs Discovered Abroad & Not Marketed In India Should Not Be Approved To Be Conducted In India: Panel
The Prof. Ranjit Roy Chaudhury expert committee, constituted by the union health ministry to formulate policy, guidelines and SOPs for approval of new drugs including biologicals, clinical trials and banning of drugs, has recommended that bioavailability (BA) and bioequivalence (BE) studies of new drug substances discovered abroad and not marketed in India should not be approved to be conducted in India. If new chemical entities (NCEs), new drug substances or their generic drugs are to be introduced in India, BA/BE studies in patients should be done as a part of the clinical trials, the panel in its recommendations said. However, the expert committee recommended that a generic drug produced in India for the first time should
Novo Nordisk To Launch Injection Tresiba In India
Insulin

World's largest insulin player Novo Nordisk today said it is launching long-lasting insulin injection Tresiba in the country soon. "Tresiba (insulin degludec)-- a new basal insulin for adult patients with type 1 and type 2 diabetes to be available in India as a new treatment option.
10
Pharma Spectrum
undergo BE studies in comparison with the innovator molecule. ministry will present details of the new regulatory regime for clinical trials.
CSIR Pushes For TB, Malaria Drug Finds

Giving crowd sourcing a whole new meaning, scientists at the Council for Scientific and Industrial Research (CSIR) have initiated a country-wide venture to build a chemical library with diverse compounds that will successfully drive drug discovery programmes, particularly for neglected diseases like tuberculosis and malaria. CSIR had launched the Open Source Drug Discovery (OSDD) in 2008 with the objective of discovering drugs for neglected diseases like TB, malaria and others through open innovation and sharing of research that has been lauded across the globe.
Clinical Trial Victims May Get Minimum Rs 2 Lakh

An expert panel set up by the drug regulator has recommended a minimum compensation of Rs 2 lakh for the family of 'most serious, terminally ill' patients who die because of drug study-related injuries. The recommendation is part of a government move to address concerns raised by health activists that pharmaceutical companies do not always adequately compensate volunteers for clinical trials who end up with injuries. The expert committee, set up by the Drug Controller General of India (DCGI), has also set a range of Rs 4 lakh to Rs 74 lakh as payout, depending on age and health risks of volunteers at the time of enrollment. These figures are significantly higher than what some drug makers pay to trial victims in India.
New Law To Regulate Biomedical, Health Research

In the absence of any law to deal with biomedical and health research, government has decided to regulate all such activities in medical colleges, universities, hospitals and public and private organisations. The Ministry of Health has proposed the Biomedical and Health Research Bill to ensure ethical research in all institutions with proper care and compensation policy for human participants in such task. The proposed law will ensure compulsory registration and evaluation of ethics committees set up in all kinds of research institutions and provide for penal provisions against those engaged in unauthorised research, officials told. The law will also cover institutions and sponsors undertaking unethical biomedical research at places with inadequate facilities.
Health Panel Wants Against US Agency
Legal
Action

The Standing Committee on Health and Family Welfare has instructed the Centre to take legal action against a US agency, Programme for Appropriate Technology in Health (PATH), for violating clinical trial norms in India. In its report about the deaths of some female children and adolescents in Khammam district of Andhra Pradesh after being administered Human Papilloma Virus (HPV) vaccines by PATH in 2010, the committee observed that the agency showed gross violation of the concept and legal requirement of consent from study subjects for clinical trials.
Clinical Trials Of New Drugs Get Fresh Impetus As Govt Clears 55 Proposals
In a move that will provide a big impetus to India's $500million clinical trial industry, which has of late seen stunted growth, the government on Thursday cleared around 55 trials proposed by pharma firms and clinical research organisations, including Dr Reddy's, Eli Lilly, MSD Pharma, Cadila Healthcare, Quintiles. The approvals (including new combinations. ministrys apex 24 hearing by are for trials regarding new drugs chemical entities) and new fixed dose The approvals, given by the health committee, come ahead of a September the Supreme Court where the health
DNA Editorial: Interests
Safeguard
Patients
September 2, 2013, DNA

The current problems affecting clinical trials in the country a critical component of the $18 billion pharma sector and essential for developing affordable medication are following a familiar pattern. There are certain commonalities in the manner in which regulatory oversight functions in various sectors in the Indian economy. The guidelines that seem adequate on paper turn out to be lacking in practice not because there is something fundamentally wrong with them but because of flawed implementation. This could be due to corruption,
11
Pharma Spectrum
inefficiency or a lack of resources. In an effort to plug the gaps, harsher guidelines are instituted. circulated a draft Cabinet note that seeks to bring down FDI limit in brownfield pharma and calls for putting foreign investment in drug facilities defined as "critical" on the approval route, industry experts advocate the need to clear ambiguities in the current FDI policy to give the much required boost to the Indian pharma industry. Experts argue that there is a need for a sustainable policy as dilly dallying in terms of Greenfield and Brownfield projects makes the investment climate unpredictable.
Panel Raps Government Over Clinical Trials, Lapses

August 31, 2013, The Times of India
In a further indication of the rot in the country's healthcare system, a parliamentary panel has rapped the government for gross irregularities in drug trials, underreporting and lapses in monitoring serious adverse events and lethargy in safeguarding health, in studies on cervical cancer prevention vaccine by a US-based nongovernmental agency. Charging the government for inaction, the parliamentary committee on health says in a report that the issue has been diluted with no accountability fixed on erring officials for serious violations committed in the studies which led to the death of hapless tribal children three years back.
Govt May Have To Rethink Stand On FDI In Pharma

September 16, 2013, Indian Express
The Health Ministry may have to reconsider its stand that all foreign direct investment (FDI) in existing pharmaceutical companies should continue to be routed through the Foreign Investment Promotion Board (FIPB). Both the Prime Minister's Office and the Planning Commission are inclined towards opening up FDI across sectors. The Health Ministry has been opposed to the idea of including pharmaceutical companies in the automatic FDI list since its inception. In fact, the Parliamentary standing committee in a report tabled in the recentlyconcluded Monsoon Session called for a blanket ban on FDI in brownfield pharma companies.
Mergers & Acquisitions / Collaborations

Cap On FDI: Health Ministry To Identify Critical Pharma Sectors
Restrictions on Foreign Direct Investment (FDI) in existing pharmaceutical projects will apply on drugs that are identified as critical by the Health Ministry. The Industry Department, in its draft Cabinet note, has placed the responsibility of identifying the sectors where takeovers would not be permitted on the Health Ministry. It has also proposed that foreign investors be mandated to create at least 25 per cent additional capacity and generate additional employment in the critical pharma projects they are investing in, a Department of Industrial Policy and Promotion (DIPP) official told Business Line.
DIPP Seeks To Restrict Brownfield Pharma Projects
FDI
In

The Department of Industrial Policy & Promotion (DIPP) has floated a Cabinet note seeking restrictions on foreign direct investment (FDI) in existing pharmaceutical projects in specific areas, such as vaccines, injectibles and oncology medicines. Once we have incorporated the comments of all ministries (Finance and Health) and departments in the note, we will send it to the Cabinet for approval, a DIPP official told Business Line. The Government allows 100 per cent FDI in pharmaceuticals, but while investments in new projects are allowed automatically, investments in brownfield or existing pharmaceutical companies are required to be routed through the Foreign Investment Promotion Board (FIPB) since late last year.
Need For Sustainable FDI Policy In Pharma: Experts

September 19, 2013, Pharmabiz, Shardul Nautiyal
Even as the Department of Industrial Policy and Promotion (DIPP), the nodal body for FDI policy, has
SC Slaps Notice On Sanofi Over CrossBorder Deal

In a case similar to the Vodafone groups $2 -billion tax dispute, the Supreme Court on Wednesday asked French drug major Sanofi SA to explain why it should not pay tax
12
Pharma Spectrum
to the tune of around R1,058.07 crore on a cross-border merger involving Indian assets of Hyderabad-based Shantha Biotechnics (SBL). A bench headed by Justice AR Dave sought reply from the French firm after the income-tax department challenged the Andhra Pradesh high court's February 15 order that ruled in favour of Sanofi Pasteur Holding SA. It also posted the matter for further hearing on January 14 and asked the parties to file short notes. Mukherjee today said there is a need to increase spending in the key sector to provide better health and nutritional security to the people. "Public expenditure on health in India is 1.2 per cent of GDP. This is much lower than the 4 per cent plus levels in countries like US, UK, Australia, Norway and Brazil," Mukherjee said after inaugurating the new hospital building of Jagadguru Sri Shiva-rathreeshwara (JSS) Maha-vidya-peetha here.
Govt Clears Mylan's Rs 5,168-Cr Deal To Acquire Agila Specialties

The government today cleared the Rs 5,168-crore deal of the US-based Mylan Inc for acquiring Bangalore-based pharma firm Agila Specialties, a subsidiary of Strides Arcolab. The decision was taken at a meeting of the Cabinet Committee of Economic Affairs (CCEA) held here, Information and Broadcasting Minister Manish Tiwari told reporters. The acquisition, however, is subject to certain conditions. After the completion of acquisition process, Mylan has to maintain the investment level in R&D in value terms for five years at absolute quantitative level at the time of induction of FDI, according to sources.
Supply Essential Drugs: Govt To Drug Companies, Stockists

Perturbed by reports of shortage of essential medicines on retail shelves after the implementation of new pharma policy, the government has sent out a sharp message to drug companies and trade channels to ensure their availability across the country. Supplies of widely used medicines such as pain relievers paracetamol and diclofenac, treatment for worms albendazole and those used in chronic ailments like cholesterol-lowering drug atorvastatin, diabetes drug metformin and blood pressure drug enalapril have been affected.
Access & Pricing

NPPA Fixes Prices Of 43 More Formulation Packs As Per New DPCO
The National Pharmaceutical Pricing Authority (NPPA), continuing its exercise of revising the prices of essential medicines under the new Drug Price Control Order, 2013, has fixed the prices of 43 more formulation packs. The formulations are based on the bulk drugs of allopurinol, dexchlorpheniramine maleate, promethazine, phenobarbitone, piperazine, dapsone, ethambutol, isoniazid, acyclovir, didanosine, stavudine, diltiazem, nifedipine beclomethasone dipropionate, hydrocortisone sodium succinate, ipratropium bromide,....
Recovery Of Overcharging Momentum
Arrears Cases
By NPPA In Picks Up

Spurred by intensive efforts like defending the court cases and issue of revenue attachment notices, the recovery of overcharging amount by the National Pharmaceutical Pricing Authority (NPPA) from defaulting companies has picked up momentum this year, after a sluggish phase in the last few years. In the first eight months of this year, the total recovered amount stood at Rs.19.17 crore whereas the total recovery during 2012-13 was Rs.14.97 crore. After Rs.51.41 crore collected during 2008-09 and Rs.35.41 crore during 2009-10, the recovery had gone slow. During 2010-11, the total amount stood at Rs.17.26 crore....
Need To Increase Spending In Health Sector: President

Observing that the country's public expenditure on health is only 1.2 per cent of GDP, President Pranab
President Pranab Mukherjee Concerned Over Low Expenditure On Health

With government spending on health less than two per cent of GDP, President Pranab Mukherjee today expressed concern over the low expenditure and
13
Pharma Spectrum
advocated universal healthcare as a plausible solution. Inaugurating a meeting of Ministers of Health and a Session of WHO Regional Committee for South-East Asia at Rashtrapati Bhavan, Mukherjee noted with concern that 46 per cent people in the region lived below poverty line and asked nations to build an environment for quality health. led to de-stocking by companies and retailers which was compounded by the retail traders strike in Maharashtra. In terms of overall performance, multi-national drug companies were more severely hurt in the quarter compared to their Indian peers. That is because unlike Indian companies which earn a bulk of their revenues from exports, much of the revenues of multinational drug companies are accounted....
Govt Plans Medical Records Network For Villages

Agrowing number of private companies are trying to tap Big Dataanalysing large amounts of information to detect and forecast trends and patternsto serve healthcare, as the government moves to set up an electronic medical record system that will hook up 25,000 villages across the country. How to put Big Data to its fruitful logical conclusion is the challenge that is faced by the country today, N.K. Dhamija, deputy commissioner and nodal officer of tele medicines at the health ministry, told a conference of government health officials and private sector entrepreneurs looking to utilize Big Data in healthcare.
Delhi HC Extends Relief Period For Pharma Cos In Drug Pricing Case
August 28, 2013, The Economic Times
The Delhi High Court on Tuesday extended relief for pharma firms, including Sun Pharma and Cipla, on relabeling of their existing stock under the new drug pricing regime on the condition that they comply with the interim order and posted the case for next hearing on September 23. The two companies along with a dozen other drug firms had challenged the government on specific provision under Drug Price Control Order 2013 which makes it mandatory upon the companies to label revised prices within 45 days of the price notification.
Panel Asks DoP To Identify Pharma Cos Changing Compositions To Dodge Price Control Provisions
August 29, Alexander 2013, Pharmabiz, Joseph
NPPA Revises Price Formulation Packs

August 28, 2013, Pharmabiz
Of
Nine
The Parliamentary Standing Committee attached to the Chemicals Ministry has asked the Department of Pharmaceuticals (DoP) to identify the pharmaceutical companies which are circumventing price control mechanism by changing the composition and strength of their formulations. The panel also asked the DoP to take up the matter with the ministry of health and family welfare for further action. In its recent recommendation, the Committee once again took up the issue of pharma companies dodging the provisions of the price control mechanism and asked the Department to follow up the matter.
The National Pharmaceutical Pricing Authority (NPPA) has fixed/ revised the prices in respect of nine formulation packs, in accordance with the provisions of the new Drug Price Control Order (DPCO), 2013. The formulations are based on the bulk drugs including pyrazinamide, propranolol hydrochloride, cyclophosphamid, oxaliplatin, diazepam, cefixime trihydrate with ofloxacin, according to a notification by the agency. The NPPA also issued correction orders with regard to its earlier three orders.
Health Ministry Launches Rs. 2550-Cr NACSP To Accelerate AIDS Prevention Programme
August 28, 2013, Pharmabiz
The Union health ministry has launched the Rs.2,550crore National AIDS Control Support Project (NACSP) which is aimed to help and accelerate the countrys AIDS prevention programme by targeting high risk groups like Female Sex Workers, men who have sex with men and Injecting Drug Users. The World Bank is supporting this project with an interest-free loan of Rs.1,275 crore. The project would
New Policy To Take A Toll On Pharma Cos Health In Near Term

August 28, 2013, (epaper page 7) The Economic Times
The quarter to June was a bad one for most pharma companies with a slowdown in growth for over a year now, weighing heavily on their performance. To add to their woes, the implementation of the new drug policy
14
Pharma Spectrum
also support the planned expansion and consolidation of tailored interventions for other at-risk populations, including migrant workers and truckers, which play a critical role in the transmission dynamics of HIV in the country. However, the move which was keenly awaited by the small and medium scale units for long, will not do any good to the very small generic manufacturers as the government will buy medicines from firms which have an average annual turnover of Rs.10 crores in the last three years.
Trade
Drug Market Growth At Eight-Month Low
Sales of drugs in India grew at a tepid 4.9% in August, the slowest pace in at least eight months, mainly due to lower stock intake by distributors and retailers, favourable weather conditions and weakening of the rupee against the US dollar. The Rs.75,933-crore local drug market grew at an average 12-13% pace in January-July, according to the latest data by pharma market researcher IMS Health India. August also saw dramatic changes in the rankings of leading drugmakers and their top-selling brands, IMS Health said.
FMCGs Come Together To Take On Counterfeit Brands

To curb the growing menace of counterfeit brands, FMCG companies ITC and Coca-Cola India, along with the Federation of Indian Chambers of Commerce and Industry (Ficci), are planning to take stringent steps in the next few months. To start with, Ficcis committee against smuggling and counterfeiting activities destroying the economy (CASCADE) has initiated a pan-India movement against smuggling and counterfeiting amongst youth and consumers.
Medicine Shortage Being Felt Across The Country

Shubas father-in-law had carried only a limited stock of his asthma medicine when he travelled from Payyanur (Kerala) to Mumbai to spend time with his children. After all, the medicine could be bought at pharmacies anywhere in the country. But that was not to be, as the family found out when he exhausted his stock. The medicine was not available with chemists in Mumbai, Payyanur or Chennai and Shuba had to call the doctor in Kerala to get an alternative to this asthma medicine.
Drug Companies Margins
To
Raise
Trade

Shortage of essential medicines on retail shelves may be over soon with major companies like Cipla, Mankind Pharma and Torrent deciding to give in to the demand of higher trade margins and hoping to end the stalemate between the industry and chemists. Drug major Cipla and Mankind Pharma decided on Friday to increase the trade margins to 10% to stockists and 20% to retailers on the price-controlled basket of drugs, as against the earlier offered 8% and 16% respectively, while others like Torrent and Eris Lifesciences are doling out a 5% special discount'' on these medicines to stockists.
Drug Price Order Gain For Patients, Pain For Retailers

Some 350 drugs are set to become cheaper in the weeks ahead thanks to the Drug Price Control Order 2013. The Order mandated reduction of prices of the medicines within 45 days of the notification being issued and that the reduced prices apply to drugs already being sold in the market. Manufacturers were to replace existing stocks with the new price mentioned on labels. The Order officially came into effect from end July. This move will bring relief to lakhs of patients. But pharma manufacturers and the 7.5 lakh chemists and druggists in the country are unhappy as this order will erode their margins.
DoP Initiates Steps To Source Drugs For Jan Aushadi Stores From Private Firms
After toying with the idea for several years, the department of pharmaceuticals (DoP) has finally decided to source generic drugs from private sector manufacturers and initiated the steps in this regard, as part of the new attempt to revive the Jan Aushadhi programme with a new business plan.
15
Pharma Spectrum Number Of Spurious Drugs Comes Down Significantly During 2012-13
August 29, 2013, Pharmabiz, Ramesh Shankar
There has been a remarkable reduction in the number of drug samples declared spurious or adulterated by the drug control authorities in the country during the year 2012-2013 compared to the previous year. The number of drug samples declared spurious or adulterated has come down drastically from 133 in 2011-12 to just 70 in 2012-13. According to official data, the drug control authorities in different states in the country had collected and tested a total 57,351 random drug samples during the year 2012-2013 in which 2327 samples were declared not-ofstandard quality drugs while a total of 70 drug samples were declared spurious or adulterated. As the Regional Director, Dr Khetrapal Singh brings a vast repertoire of experience, having worked in the health sector for over three decades at both national and international levels. She served with WHO for the past 15 years. She is the first woman to be nominated to this post in the Region, according to a release here on Thursday.
OPPI Related News / Events

Targeting Neglected Diseases
September 11, 2013, Indian Express
International experts and representatives of the Indian government, along with global health organisations, recently gathered in Delhi for a conference titled "Partnering for Success Reducing India's Burden of Neglected Diseases." Experts from various fields of medicine comprised panels that examined the need to understand the economic and social burden of neglected disease, how to reach the poorest and most marginalised, and how to increase research and development capacity. In 2012, the World Health Organisation established targets for the control and elimination of 10 neglected tropical diseases by 2020. Governments around the world working in partnership with civil society organisations and the pharmaceutical industry have joined in a global coordinated effort to meet this challenge. The conference on Reducing India's Burden of Neglected Diseases is being convened by Global Health Progress (GHP), Organisation of Pharmaceutical Producers of India (OPPI) and International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).
Ethics & Compliance

No Relevant News
New Appointments / Transfers

Dr Poonam Khetrapal Singh Nominated WHO Regional Director
Dr Poonam Khetrapal Singh has been nominated as Regional Director for the WHO South-East Asia Region, involving 11 countries. She will become the first woman to hold this post. The 32-member Executive Board of the World Health Organisation (WHO) is expected to appoint Dr Khetrapal Singh as Regional Director in January 2014, in Geneva for a five-year period and she will assume charge in February at the regional office in New Delhi.
16

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Pharma Spectrum Organisation of Pharmaceutical Producers of India

Organisation of Pharmaceutical Producers of India

to data released last week by the Indian Patent Office (IPO).

South Africa Writes IP Policy Making It Harder To Get Drug Patents

Watson Sends Patent Challenge Notice To Ranbaxy For Acne Drug

Regulatory / Medical / Biotech

FDA Approves Teva's Generic Of Roche Blockbuster Xeloda

Organisation of Pharmaceutical Producers of India

US Import Alert On Ranbaxy; Mohali Unit Part Of Consent Decree

Bayer's Nexavar In FDA Fast Lane For Thyroid Cancer Use

FDA Turbocharges GlaxoSmithKline's Bids For New Cancer Drug Uses

Indian Pharma Draws More Scrutiny As US Exports Rise

Organisation of Pharmaceutical Producers of India

UK Committee Urges Transparency In Clinical Trials

Mergers & Acquisitions / Collaborations

On A Roll, Boehringer Wins 'Breakthrough' Status For Pioneering Leukemia Drug

India Receives Highest FDI Worth $1b In Pharma In Apr-Jun

Organisation of Pharmaceutical Producers of India

Access & Pricing

Pharma Suffers In China As Widening Scandal Spooks Docs, Reps

India May Join Global Safeguard Drug Exports

September 5, 2013, The Economic Times

Organisation of Pharmaceutical Producers of India

EU Leaders Slam China For Targeting Foreign Drugmakers

Ethics & Compliance

Germany's Bayer Joins Crowd Of Companies Under Chinese Investigation

Organisation of Pharmaceutical Producers of India

GlaxoSmithKline's China Probe Triggers U.S. Bribery Investigation

Bristol-Myers Misleading HC In Patent Case

BDR Pharmaceutical's Plea For Compulsory Licence On Cancer Drug Rejected

Organisation of Pharmaceutical Producers of India

Mylan Will Not Shy Away From Pursuing Frivolous Patents

Govt Refutes Novartis' Allegations On Patents

Panel Backs Compulsory Licence On Cancer Drug

Innovation, Productivity, New Markets Essential For Sustainable Growth

Organisation of Pharmaceutical Producers of India

Regulatory / Medical / Biotech

No Major Violations At Ranbaxys Mohali Plant: Indias Drug Regulator

Indian Drug Regulator Reaches Out To Other Countries As Issues Mount

46 Habit-Forming Drugs To Be Sold Only On Doc's Prescription

UK, Australia Regulators Seek Details Of US Findings On Ranbaxys Mohali Plant

Organisation of Pharmaceutical Producers of India

Central Drug Authority To Centralise Licensing In 17 Critical Categories

Govt Moves Bill To Regulate Drugs, Cosmetics

Organisation of Pharmaceutical Producers of India

Novo Nordisk To Launch Injection Tresiba In India

September 3, 2013, The Economic Times

Organisation of Pharmaceutical Producers of India

CSIR Pushes For TB, Malaria Drug Finds

Clinical Trial Victims May Get Minimum Rs 2 Lakh

New Law To Regulate Biomedical, Health Research

Health Panel Wants Against US Agency

September 3, 2013, Hindu Business Line

DNA Editorial: Interests

September 2, 2013, DNA

Organisation of Pharmaceutical Producers of India

Panel Raps Government Over Clinical Trials, Lapses

Govt May Have To Rethink Stand On FDI In Pharma

Mergers & Acquisitions / Collaborations

DIPP Seeks To Restrict Brownfield Pharma Projects

September 12, 2013, Hindu Business Line

Need For Sustainable FDI Policy In Pharma: Experts