Pharma News & Analysis

Biocon marketing head quits

2014-01-04T21:26:00.002+05:30

Biocon, a leading biotechnology company, has announced that its marketing head Rakesh Bamzai had quit the company. The company, in a filing to the Bombay Stock Exchange made on Wednesday evening said Mr. Bamzai, President, Marketing, who had been associated with the company for 19 years, “has decided to leave the organisation and accept a new leadership role”.

Biocon Chairperson and Managing Director Kiran Mazumdar-Shaw said Mr. Bamzai had played a “pivotal role in Biocon’s evolution from a leading enzymes company to a global biopharmaceutical enterprise”. She credited Mr. Bamzai as being “instrumental” in developing Biocon’s “global footprint”.

Ms. Shaw said Mr. Bamzai had decided to take up a “very senior and challenging assignment” after leaving Biocon. Despite his departure, Mr. Bamzai would remain a “strong brand ambassador for the company”, she said.

Mr. Bamzai said he hoped to “remain engaged with Biocon in the future”, and that he was confident that the team he leaves behind at the company would “ensure Biocon’s continued success”

-The Hindu

Free medicine and diagnostic services in West Bengal Government hospitals

2014-01-04T20:54:00.002+05:30

The West Bengal government on Saturday announced that it will provide free medicine and diagnostic services in its hospitals and health centres to benefit a large section of people dependent on state healthcare.

“Henceforth, all vital and essential medicines and all available diagnostic services (except those run on PPP mode) will be provided free to all patients in government-run health centres and hospitals,” Chief Minister Mamata Banerjee told reporters at the secretariat.

Free medicines and diagnostic services would also be provided to patients in free beds in block primary health centres and rural health centres run by the government, the Chief Minister said dubbing it a “landmark” decision.

“Moreover, all expecting mothers and all children up to one year of age will get all vital and essential medicines and all available diagnostic services free in all health centres and hospitals run by the government in the state,” she said.

The Chief Minister also announced the upgrade of three medical college and hospitals in the western and

northern parts of the state.

They would now have specialised facilities which will spare patients the hassle of coming down to Kolkata for treatment at a government facility, she said.

“Bankura Medical College and Hospital, Malda Medical College and Hospital and North Bengal Medical College and Hospital will be upgraded soon,” she said.

Trauma care, specialised services in areas like oncology, nephrology, endocrinology, paediatric surgery and more would be provided at these hospitals, she said.

The upgrade would cost the state exchequer Rs 450 crore, she said.

-The Hindu

Will India achieve pharma vision 2020?

2013-12-31T13:31:00.003+05:30

The government is committed to making India one of the world's leading destinations for end-to-end drug discovery and innovation by 2020. Although India has achieved the distinction of being the world's No. 1 supplier of low-cost generic medicines, in recent years, a toxic brew of misguided government policy and shortsighted business practices has crippled our efforts to become a drug discovery and innovation powerhouse, even while jeopardising our access to foreign markets due to quality issues ..

2013 has been a year with mixed blessings and some policy decisions taken this year are likely to have farreaching impact on the future of the pharmaceutical industry in India. In March this year, the Intellectual Property Appellate Board upheld the compulsory licence (CL) issued for the manufacture and sale of a generic version of Bayer's Nexavar in India citing affordability and product access as the reasons for the decision. While the grant of a CL is justified in a national emergency, broadening the scope to affordability can result in abuse of this provision and be counterproductive to pharmaceutical innovation in India. CL must remain the exception rather than the rule.

On the upside, after much deliberation, the government ruled in favour of 100% foreign direct investment in the pharmaceutical industry. This is a positive move and will allow India to invest in R&D, enhance local capabilities and find solutions to endemic health problems.

China halts imports of Pfizer drug on paperwork glitch

2013-12-31T13:27:00.002+05:30

China suspended imports of U.S. drugmaker Pfizer Inc's AIDS-related drug Diflucan on Tuesday, citing a problem with late paperwork, the country's food and drug watchdog said in a statement on its website.

Pfizer, the largest drugmaker in the United States, contravened Chinese law when one of its France-based factories failed to submit a supplementary application on time, the China Food and Drug Administration (FDA) said in the statement.

With the country's healthcare spending forecast to nearly triple to $1 trillion by 2020 from $357 billion in 2011, according to consulting firm McKinsey, China is a magnet for makers of medicines and medical equipment.

Pfizer has taken steps to resolve the issue and is working with China's FDA to ensure its products comply with Chinese law, it said in a statement on its Chinese-language website. The issue is not linked to quality or safety, it added.

Some analysts said the incident looked like a paperwork "glitch" and should be short-lived.

"It should not impact too much Pfizer's business in China and I am sure the imports will be resumed once the procedure is complete," said Simon Li, Shanghai-based general manager at Kantar Health China.

China has been cracking down this year on the healthcare sector, with investigations ranging from allegations of corporate bribery to how drugs are priced, as well as drives to increase quality and safety levels across the sector.

Diflucan, which treats fungal infections linked to AIDS, had worldwide sales of $259 million in 2012, according to Pfizer's latest annual financial statement, a small fraction of the firm's $59 billion revenue that year. Pfizer has more than 9,000 employees in China and operates in more than 250 Chinese cities

~Reuters

CDA Bill to be redrafted in line with Parliamentary panel recommendations

2013-12-30T22:16:00.001+05:30

The Central Drug Authority Bill, which was virtually rejected by the Parliamentary panel, will be redrafted in line with the recommendations of the panel pertaining to the exclusion of exports from its purview.

Sources in the health ministry said that the bill would be amended in accordance with the recommendations of the Parliamentary Standing Committee on Health and the suggestions from the stakeholders. The recommendations of the Prof Ranjit Roy Chaudhury expert panel on clinical trials will be taken into consideration while revamping the bill, sources said.

Commenting on the report of the Parliamentary panel report, Drug Controller General of India (DCGI) Dr G N Singh also felt that the bill had to be redrafted now.

One of the key changes in the bill can be the exclusion of exports from the the bill and also amendment to the definition of clinical trials. “The Committee has been informed that the exporter has to ensure that the pharma units whose drugs are proposed to be exported comply with the Good Manufacturing Practices (GMP) guidelines issued by the World Health Organisation (WHO). Hence, no further regulation on the export of such drugs would be necessary,” according to the report of the panel.

“The Committee is of the view that if export of drugs is brought within the ambit of Drugs and Cosmetics Act/Rules, it will severely affect exports of drugs and put domestic pharma manufacturing units/exporters at serious disadvantage. The Committee therefore decided that the word 'export' may be omitted from this clause and consequential amendments may be made to other clauses of the Bill,” it said.

“The Committee decided that in the definition of clinical trial provided in (af) (i) the words “any drug” should be substituted by “any new drug”, since generally Bioavailability/Bioequivalence studies of approved drugs are conducted in healthy volunteers with recommended doses,” the report said.

“As regards the definition of clinical trial in respect of cosmetics provided in (af) (ii) the words “of a cosmetic including a new cosmetic” should be substituted by the words “of any new cosmetic” as the cosmetics containing approved ingredients are generally considered safe. The Committee, therefore, recommends that clinical trials of all cosmetics may not be required to be regulated. Clinical trials of only cosmetics having new ingredients (new cosmetics) should be regulated,” the panel said.

“In the definition of clinical trial in respect of medical device provided in (af) (iii) line 2, after the words “study of a” the words “medical device” should be omitted as the medical devices are approved in the country after ensuring their safety and effectiveness. Clinical trials of all medical devices may not be required to be regulated. Therefore, Committee recommends that clinical trials of only new medical devices should be regulated,” it added.

Rajasthan Pharmacy Council to launch new industry based CEPs

2013-12-28T17:57:00.002+05:30

s a step towards updating the knowledge of pharmacists in line with pharma industry needs, Rajasthan Pharmacy Council (RPC) is planning to launch a new Continuing Educational Programmes (CEPs) from January.

Says Alok Bhargava, member, RPC, "We will be holding a meeting in the month of January 2014 to devise new industry based CEPs which will help pharmacists to update and follow standards in pharmacy practice existing globally."

The council had conducted five CEPs last year and has witnessed an overwhelming response from the community pharmacists. "The meeting will also discuss the budget for conducting CEPs so that it can cater to over 40,000 registered pharmacists in the state. Budget is not a constraint for us as we do a good number of registrations on an annual basis. With a total of 41,000 registrations till date, RPC does 3500 registrations on an annual basis," he informs.

Taking into consideration the pharmacist's role in serving the industry and trade in a professional and ethical manner, Pharmacy Council of India (PCI) is also looking into the quality assurance aspect in CEPs. As a part of the quality assurance programme, PCI is working on models to strengthen CEPs with certain variations to customize it according to the needs of pharmacists in various parts of the country based on the regions and their requirements.

These programmes will involve industry people and other stakeholders in the process of framing the curriculum to give the much required exposure to the pharmacists.

As a step towards value enhancement in the quality assurance programme, PCI is also planning to launch 'train the teachers programme' by next year for which Rs.1 crore has already been allocated.

CEPs bear importance in the current scenario as clinical services provided by pharmacists are fairly new to India and there is also a shortage of clinical pharmacy trainers. Besides this, expansion of pharmacy education in India marks an uneven distribution of colleges across states with quality of education being variable

Malarial drug resistance marker identified

2013-12-28T17:31:00.002+05:30

Scientists have uncovered mutations of a gene that make the most dangerous malarial parasite resistant to front line drug therapy.

More than half a million children die each year from malaria caused by Plasmodium falciparum. Drugs with artemisinin have led the fight against this single-celled parasite's depredations and contributed to a decline in the world's burden of malaria.

However, strains of P. falciparum that are resistant to artemisinin have been detected in Cambodia, Thailand, Myanmar and Vietnam, raising fears that these drug-resistant forms could spread to other parts of the world and put at risk the advances that have been made in combating malaria.

An international team of scientists have identified a parasite gene whose mutations are associated with artemisinin resistance. Such mutations could be “a useful molecular marker for tracking the emergence and spread” of resistance, noted Frédéric Ariey of the Institut Pasteur in France and his colleagues in a paper published last week in Nature.

These scientists “seem to have won the race to identify if not the gene, at the very least a key gene, responsible for artemisinin resistance,” remarked Christopher V. Plowe of the Howard Hughes Medical Institute in the U.S. in a commentary published in the same issue of the journal.

The team took a drug-sensitive P. falciparum parasite isolated from a malaria-sufferer in Tanzania and then cultured in it in the laboratory, subjecting it to 125 cycles of escalating doses of artemisinin over five years. Genome sequences of the resistant forms that emerged were compared to that of a sensitive strain cultured in parallel without being exposed to the drug. The analysis revealed that the resistant parasites had eight mutations in seven genes that the sensitive ones lacked.

With this information in hand, the scientists examined the genomes of 49 P. falciparum isolates from Cambodia with varying levels of artemisinin resistance. Mutations in a gene producing a protein called K13 stood out.

Dr. Ariey and his colleagues then analysed the K13 gene sequence from over 900 parasites isolated from patients in various Cambodian provinces. The K13 mutations were widespread in provinces where artemisinin resistance had been reported and hardly found elsewhere. They also showed that these mutations were a good molecular marker to identify patients with drug-resistant parasites.

Ruling on clinical trials is in national interest: Azad

2013-12-28T17:30:00.003+05:30

Union Health Minister Ghulam Nabi Azad on Wednesday admitted that the recent Supreme Court ruling on, and stringent regulations for, clinical trials had set drugs research back in India. But he was hopeful that the sector would gather pace again.

“We received a setback because not many pharmaceutical companies are coming forward for clinical trials now. There has been a 50 per cent drop in clinical trials after stringent regulations were put in place, but we are hopeful that they will pick up in the coming days,” he told The Hindu.

The changes were meant to protect the national interest and to do justice to those who participated in the trials, he said.

The Ministry has laid down tough rules to make companies liable for the death of, or injury to, any drug trial subject. Even permission for such trials is given after a rigorous process. Simultaneously, the Supreme Court suspended 157 previously approved trials pending review by new committees. This slowed down new trials, especially those by foreign companies or those being lined up with foreign collaboration.

The Supreme Court’s order came in response to a public interest litigation petition by a health rights group, Swasthya Adhikar Manch, which said trials in India had exploited poor patients, who were not even aware that the drugs were still being tested.

India made sweeping changes to the rules of the Drugs and Cosmetics Act, 1940, which governs clinical trials, making it mandatory for the principal investigator of the pharmaceutical company to reveal the contract between the subject and the company to the Drugs Controller-General of India. “Earlier, the informed consent of the persons on which the trials had been conducted was often manipulated by the companies to the disadvantage of the subjects,” Mr. Azad said.

Videography of the process of informed consent, with the full knowledge of the participant, had been made mandatory, and any death during a trial would have to be reported to the DCGI within 24 hours, he said.

The Drug Testing Advisory Board was the only body for granting permission for trials.

GSK launches $1 b open offer for Indian arm

2013-12-20T22:33:00.004+05:30

UK-headquartered multinational GlaxoSmithKline (GSK) has announced a voluntary open offer to hike its stake in its Indian pharmaceutical operations, GlaxoSmithKline Pharmaceuticals Ltd. (GSK Pharma), from 50.7 per cent to 75 per cent at Rs. 3,100 per share.

A statement from GSK said the offer is to acquire up to 20.6 million shares, representing 24.3 per cent of the total outstanding shares of the Indian company.

The offer price of Rs. 3,100 per share represents a premium of about 26 per cent to the company’s closing price on the National Stock Exchange (NSE) on December 13, 2013. The potential value of the transaction at the offer price is about Rs. 6,400 crore ($1 billion or 629 million pounds). The transaction will be funded through GSK’s existing cash resources, will be earnings neutral for the first year and accretive thereafter and will not impact expectations for the Group’s long-term share buyback programme, GSK said in a statement.

GSK Pharma makes and distributes pharmaceuticals and vaccines across multiple therapeutic areas . It employs more than 5,000 people and reported a Rs. 2,600 crore-plus turnover in calendar 2012. David Redfern, Chief Strategy Officer, GSK said, “For GSK, this transaction will increase exposure to a strategically important market and for our Indian pharmaceuticals subsidiary’s shareholders, we believe it offers a good liquidity opportunity at an attractive premium.”

“GSK has a proud heritage in India,” said Mr. Redfern, adding, “Today’s announcement is a further demonstration of our long-term commitment to the country, having increased our holding in our consumer business earlier this year and more recently committed to a significant manufacturing investment.”

Gaurang Shah, VP – Research, Geojit BNP Paribas Financial Services felt the offer price was a very good one. “It reflects the confidence of the parent company in the long-term India growth story. Even though the Indian pharmaceutical market is fragmented, GSK has the multinational edge and a very strong balance sheet.”

With this deal, GSK would spend almost $2 billion in hiking its shareholding in its Indian subsidiaries in the span of a year. In February 2013, GSK hiked its stake in its other listed Indian subsidiary GSK Consumer Healthcare to 72.5 per cent from 43 per cent at around Rs. 4,800 crore ($ 900 million). Exactly a month ago, GSK said it would invest Rs. 864 crore in GSK Pharma’s manufacturing facility. On the BSE, the shares of GSK Pharmaceuticals scaled a 52-week high of Rs. 2,952 before closing up Rs. 459 (18.6 per cent) at Rs. 2,927.4.

Biocon inks licensing pact with Quark Pharma

2013-12-20T22:33:00.002+05:30

Biotechnology major Biocon on Wednesday said it has inked a pact with Quark Pharmaceuticals, Inc to develop a range of siRNA (small interfering RNA) based novel therapeutics.

The companies have entered into a licensing and collaboration agreement for the development of a range of siRNA (small interfering RNA) based novel therapeutics, Biocon Ltd said in a statement.

“This collaboration will enable Biocon to co-develop, manufacture and commercialise QPI-1007, a novel siRNA drug candidate for ophthalmic conditions, for India and other key markets,” it added.

As part of the agreement, Biocon will have access to Quark’s innovative and proprietary siRNA technology platform that can be leveraged for the development of novel therapeutics for various unmet medical needs.

The company, however, did not disclose financial details.

Commenting on the development, Biocon Chairperson and Managing Director Kiran Mazumdar Shaw said Quark is the world leader in this technology and their joint development efforts on QPI—1007, targeting ocular neuroprotection, aims at providing relief to several patients suffering from serious ophthalmic conditions.

“This collaboration reinforces our commitment to develop and introduce innovative therapeutics to India to meet the unmet medical needs. We hope to use this technology for developing several other novel therapeutics,” she added.

QuarkPharma CEO Daniel Zurr said the collaboration will position Biocon as the leading siRNA company in India and as an international player in this new drug category.

Shares of Biocon were trading at Rs 427.30 apiece on the BSE in late afternoon trade, up 8.82 per cent from its previous close.

Nobel winner boycotts top science journals

2013-12-20T22:32:00.000+05:30

Leading academic journals are distorting the scientific process and represent a "tyranny" that must be broken, according to a Nobel prize winner who has declared a boycott on the publications.

Randy Schekman, a US biologist who won the Nobel prize in physiology or medicine this year and receives his prize in Stockholm on Tuesday, said his lab would no longer send research papers to the top-tier journals, Nature, Cell and Science.

Dr. Schekman said pressure to publish in "luxury" journals encouraged researchers to cut corners and pursue trendy fields of science instead of doing more important work. The problem was exacerbated, he said, by editors who were not active scientists but professionals who favoured studies that were likely to make a splash.

The prestige of appearing in the major journals has led the Chinese Academy of Sciences to pay successful authors the equivalent of $30,000. Some researchers made half of their income through such "bribes", Dr. Schekman said in an interview.

Writing in the Guardian, Dr. Schekman raises serious concerns over the journals' practices and calls on others in the scientific community to take action.

"I have published in the big brands, including papers that won me a Nobel Prize. But no longer," he writes. "Just as Wall Street needs to break the hold of bonus culture, so science must break the tyranny of the luxury journals."

Dr. Schekman is the editor of eLife, an online journal set up by the Wellcome Trust. Articles submitted to the journal - a competitor to Nature, Cell and Science - are discussed by reviewers who are working scientists and accepted if all agree. The papers are free for anyone to read.

Dr. Schekman criticises Nature, Cell and Science for artificially restricting the number of papers they accept, a policy he says stokes demand "like fashion designers who create limited-edition handbags." He also attacks a widespread metric called an "impact factor", used by many top-tier journals in their marketing.

A journal's impact factor is a measure of how often its papers are cited, and is used as a proxy for quality. But Schekman said it was "toxic influence" on science that "introduced a distortion". He writes: "A paper can become highly cited because it is good science - or because it is eye-catching, provocative, or wrong."

Daniel Sirkis, a post doctoral researcher in Schekman's lab, said many scientists wasted a lot of time trying to get their work into Cell, Science and Nature. "It's true I could have a harder time getting my foot in the door of certain elite institutions without papers in these journals during my post doctoral researcher, but I don't think I'd want to do science at a place that had this as one of their most important criteria for hiring anyway," he told the Guardian.

Sebastian Springer, a biochemist at Jacobs University in Bremen, who worked with Dr. Schekman at the University of California, Berkeley, said he agreed there were major problems in scientific publishing, but no better model yet existed. "The system is not meritocratic. You don't necessarily see the best papers published in those journals. The editors are not professional scientists, they are journalists, which isn't necessarily the greatest problem, but they emphasise novelty over solid work," he said.

Mr. Springer said it was not enough for individual scientists to take a stand. Scientists are hired and awarded grants and fellowships on the basis of which journals they publish in. "The hiring committees all around the world need to acknowledge this issue," he said.

Philip Campbell, editor-in-chief at Nature, said the journal had worked with the scientific community for more than 140 years and the support it had from authors and reviewers was validation that it served their needs.

"We select research for publication in Nature on the basis of scientific significance. That in turn may lead to citation impact and media coverage, but Nature editors aren't driven by those considerations, and couldn't predict them even if they wished to do so," he said.

"The research community tends towards an over-reliance in assessing research by the journal in which it appears, or the impact factor of that journal. In a survey Nature Publishing Group conducted this year of over 20,000 scientists, the three most important factors in choosing a journal to submit to were: the reputation of the journal; the relevance of the journal content to their discipline; and the journal's impact factor. My colleagues and I have expressed concerns about over-reliance on impact factors many times over the years, both in the pages of Nature and elsewhere."

Monica Bradford, executive editor at Science, said: "We have a large circulation and printing additional papers has a real economic cost . . . Our editorial staff is dedicated to ensuring a thorough and professional peer review upon which they determine which papers to select for inclusion in our journal. There is nothing artificial about the acceptance rate. It reflects the scope and mission of our journal."

~The Hindu

Chennai hospital gets approval for clinical trials

2013-12-20T22:23:00.002+05:30

The drug controller general of India has granted approval to Dr. K.M. Cherian’s Heart Foundation and Frontier Lifeline Hospital to conduct clinical trials of their tissue-engineered porcine pulmonary artery, tissue-engineered bovine jugular vein and tissue-engineered bovine pericardium.

Heart Foundation has been given permission to carry out clinical trials on human beings.

In a release, Dr. Cherian said, “Now that we have got approval, the trial will be done and manufactured tissues will be sent to leading medical colleges for clinical tests.” Following the trials, Heart Foun- dation will start manufacturing and supplying the tissues.

Central Drugs Administration in India

2013-12-20T22:21:00.000+05:30

Rejecting the proposal of the Ministry of Health and Family Welfare to set up a Central Drugs Authority, to check malpractices in drug manufacturing, a Parliamentary panel has, instead, recommended creation of a professionally-managed Central Drugs Administration under the amended Drugs and Cosmetics Act.

In its 79th report on the Drugs and Cosmetics (Amendment) Bill, 2013, the Parliamentary Standing Committee on Health and Family Welfare has said that there was a need for effective discharge of enforcement activities, which requires a strong, professionally-managed administration that can take action against unscrupulous manufacturing companies.

The panel pointed out that neither the Mashelkar Committee report nor the Committee on Health and Family Welfare had recommended constitution of a Central Drugs Authority as proposed in the Bill, but had instead recommended strengthening of the existing Drugs Regulatory body (Central Drugs Standard Control Organisation).

"The proposed Central Drugs Authority is studded with bureaucratic heads of seven central ministries and four secretary and additional secretary/joint secretary-level bureaucrats as ex-officio members with the Health Secretary as its chairperson. Its composition is unprecedented as no other regulatory body in the country or outside has such a composition and it is not acceptable to the Committee," it said.

The Committee said that the central drugs administration should be headed by a chief drug controller general of India of the rank of secretary/special secretary who possesses the requisite technical and professional expertise for the role.

The panel also said that the chief controller general should be selected by a committee headed by the Cabinet Secretary with the review of the functioning of CDA to be done by a panel of independent experts under the Act.

There should be three separate sections dealing with clinical trials, cosmetics and medical technologies, the

panel noted.

The panel also raised the issue of the flooding of markets with food supplements making claims of possessing medicinal properties and pointed out that the current drug regulating authorities had no control over them.

"The Committee recommends that if any such food supplement claims to have medicinal properties (and) effectiveness in curing disease, they should also be brought under the purview of the proposed Central Drugs Administration for the purpose of their import, sale and distribution," it said.

As regards compensation for injury or death due to clinical trial, the committee has recommended that Principal Investigator appointed by the Chief Drug Controller of India (as recommended by Committee) and the Ethics Committee should be given responsibility for determining the cause of injury or death. The Chief Drug Controller of India should act as Appellate Authority for both, the ``subject’’ and the ``sponsor’’.

The Chief Drug Controller should refer such appeals to the Serious Adverse Event Panel of experts, which will give the final decision, the committee said.

-The Hindu

Indian Pharma market grows at 6.9% in Nov 2013

2013-12-14T19:26:00.003+05:30

The Indian Pharmaceutical Market (IPM) has registered a growth of 6.9 per cent during November 2013 and reached at Rs. 6,291 crore as per 'AIOCD AWACS', a pharmaceutical market research organisation that has evolved into an IT infrastructure player in Pharma Distribution & Retail, monthly figures. Sun Pharmaceuticals, which reported consolidated net sales of Rs. 11,200 crore plus in 2012-13, has grabbed highest position with sales of Rs. 357 crore during November 2013, followed by Cipla at Rs. 328 crore and Zydus Cadila at Rs. 262 crore. The sales of Sun Pharmaceuticals increased by 17.1 per cent and that of Cipla moved up by 12.2 per cent. Glenmark, Ipca Laboratories, Emcure, Alembic Cadila, Eris and Meyer Organics have registered growth of over 25 per cent during November 2013.

After three continuous months of volume degrowths, the IPM market witnessed a seasonal change with once again the numbers coming to positive for the months of November 2013. The price growth component was at 0.8 per cent thereby signifying the impact of price cuts witnessed due to the implementation of the pricing policy. The leading brands like Phensedyl clocked a growth of 63 per cent followed by Glycomet-GP 62 per cent, Moxikind -VC 33 per cent and Clavam 29 per cent.

However, the volume growths that was seen in the last years is still far off. The growth driver split shows positive on the parameter of volume & new introductions leading to overall positive growths over October 2012.

The DPCO 2013 containing molecules market was negative at 8.6 per cent whereas the non DPCO market grew by 9.5 per cent resulting in an overall growth of 6.9 per cent. The DPCO 2013 portfolio for GlaxoSmithKline Pharma declined by 31.8 per cent and that of Ranbaxy Laboratories declined by 20.7 per cent. However, Sun Pharma had the least impact with its DPCO 2013 portfolio degrowing at 6.8 per cent.

As per the report, eight therapies have outgrown the IPM growth. Gastrointestinal market grew at 8.4 per cent, anti-infective market had a growth of 2.6 per cent, whereas respiratory market had a 15.1 per cent growth. Anti-diabetic market moved up by 6.1 per cent and cardiac at 7.2 per cent in chronic business. Anti-malarials increased by 21.2 per cent and Derma market up by 15.2 per cent.

Total eleven regions have outgrown in IPM growth and Bihar growth was up by 16.6 per cent and Delhi by 16.4 per cent. However, biggest region Tamil Nadu degrew at 7.5 per cent and AP Rest degrew by 5.2 per cent. The biggest molecule amozycillin and clavulanic increased by 9.7 per cent and cefixime also moved up at 2.3 per cent. Paracetamol and azithromycin grew at 5.1 per cent and 2.7 per cent respectively. The market of vitamin-D increased sharply by 49.5 per cent and that of glimepiride and metformin improved by 40.8 per cent. Rosuvastain, levocetirizine and montelukast & telmisartan up by 22 per cent.

Source: PharmaBiz

IPSCON 2013 to be held in Bengaluru from Dec 16 to 18

2013-12-14T19:24:00.002+05:30

The Indian Pharmacological Society (IPS), Bengaluru Chapter and the Karnataka College of Pharmacy (KCP), Bengaluru are jointly organising the three-day 46th Annual Conference of Indian Pharmacological Society referred to as the IPSCON – Bengaluru 2013 between December 16 and 18, 2013. The venue is the NIMHANS Convention Centre. The event is known as the International Conference On Translational Pharmacology with the theme as ‘Translating Research to Therapy’.

The conference comes to Bengaluru after 25 years when it was held in 1987 at the St John’s Medical College.

Over 2500 delegates from India and overseas are expected to attend the event. Dr Jagdish Prasad, director general of health services, Government of India, Dr Sharanprakash Patil, Karnataka Minister for Medical Education and SR Patil, Karnataka Minister for Planning & Statistics, IT & BT and Science & Technology will be inaugurating the conference.

Pharmacologists play a key role in all the aspects of drug like drug design, drug development, drug research, drug safety, etc. With the theme of the conference as 'Translating Research to Therapy', there is already considerable ongoing drug discovery research in India. However, rarely research outcome is commercialized for the benefit of the population. Hence, the conference aims at guiding the pharmacologists to carry on research that benefits mankind in treatment, stated Dr Raju Koneri, professor of Pharmacology- dean, Karnataka College of Pharmacy, president, Indian Pharmacological Society, Bengaluru Chapter and organising secretary of IPSCON2013.

The conference will be a platform for senior faculty from India and overseas to discuss the recent advances in drug development and advances in pharmacotherapy.

Specific to drug development, there would be symposia on innovative therapies and challenges to pharmacology, preclinical evaluations in developing clinical acceptance, drug discovery current aspects and advances in traditional, natural system of medicine.

There will be extensive deliberations on the current issues in clinical research and the aspiration and vision for pharmacovigilance in India

CDSCO to have staff strength of 5000 in next 5 years, recruitment plan submitted to centre

2013-12-13T00:40:00.002+05:30

The Central Drugs Standard Control Organisation (CDSCO) may soon commence a major recruitment drive to strengthen the regulatory machinery at the Centre as the current strength of staff is highly inadequate according to, Dr G N Singh, Drugs Controller General of India.

Responding to a query from Pharmabiz, Dr Singh said CDSCO has made a detailed proposal for recruiting sufficient staff and submitted to the government of India. Response of the government is awaited. Once the proposal is cleared, the appointments will be undertaken on a fast-track basis. With that the staff crunch will be solved and the total strength should be going up to 5000 in next five years. Currently CDSCO has only 340 sanctioned posts including administrative personnel. But not all of them are recruited.

“Compared to US FDA, the manpower strength of CDSCO is far less, but we are still not weak. US FDA has 13000 posts of technical and administrative staff. We are facing the staff crunch for some time and hopefully it will be solved in five years with the recruitment programme envisaged now. Until a few years ago, the situation was worse,” Dr Singh told Pharmabiz.

Crippled with staff shortage, the central regulatory office is struggling to manage the daily operations now. The number of deputy drug controllers and ADCs is less than ten and the posts of drug inspectors have not been filled up fully. With these limited staff CDSCO is handling 20,000 applications, attend over 200 meetings and more than 11000 industry and public representatives. The institution has to respond to around 150 court cases annually, sources from the central agency informed.

According to Dr Singh, the central organisation is also planning to set up a CDSCO Estate in Chennai for its regional office. The present laboratory functioning near Egmore in Chennai will be developed into a modern drug testing lab with all facilities. After demolishing the present building, a new one will be constructed on the site. The estate will contain, apart from the modern lab, a training academy and administrative office.

DCGI said a proposal has been given to the central government to acquire five acres of land in Chennai for the purpose.

IMS introduces AppScript, an mHealth app prescribing solution designed to help healthcare providers

2013-12-13T00:03:00.004+05:30

IMS Health, a leading worldwide provider of information, technology and services dedicated to making healthcare perform better, has launched AppScript, an mHealth app prescribing solution designed to help healthcare providers and health plans create proprietary formularies based on an objective assessment of healthcare app functionality and value.

The company also announced the launch of AppNucleus, its customizable, cloud-based hosting platform that will enable developers to build secure, industry-compliant healthcare apps at very low cost. Both new products will leverage IMS Health’s comprehensive data on diseases, treatments, costs and outcomes. The solutions address the growing demand for secure mobile apps that drive patient engagement and enhance the delivery of care.

The AppScript Software-as-a-Service solution classifies and evaluates more than 40,000 mobile healthcare apps currently available for download on iOS and Android platforms, categorized by stage of the patient journey. Each app is assessed using the company’s proprietary IMS Health AppScore, which ranks apps based on functionality, peer and patient reviews, certifications, and their potential to improve outcomes and lower the cost of care. As part of wellness, prevention and treatment regimens, physicians can organize these apps into formularies based on their specific patient population and practice preferences. In addition, AppScript enables them to securely prescribe, reconcile and track app use by patients from any mobile interface.

AppNucleus is the company’s innovative healthcare app development and hosting platform that makes it easier for app developers to offer HIPAA- and HITECH-compliant solutions. The platform, compatible with all mobile operating systems, uniquely integrates IMS Health information and analytics at every stage of app development to support design and performance evaluation decisions. AppNucleus features a suite of plug-and-play solutions, enabling patients and physicians to exchange health information on mobile devices via a secure, encrypted channel to protect patient information. It also offers app developers a highly economical way to build security into their apps and protect patient information.

“Today, there is growing recognition of mobile health’s potential to transform healthcare – to advance doctor/patient engagement and empower consumers to better monitor and manage their own health,” said Stefan Linn, senior vice president, Strategy & Global Pharma Solutions, IMS Health. “That potential can only be realized through a systematic evaluation of the clinical benefits of healthcare apps, clear professional guidelines around their use, and effective integration of apps with other aspects of patient care. With these game-changing solutions, IMS Health is establishing an intelligent, secure infrastructure for mobile health, backed by our market-leading real-world evidence capabilities and the most advanced technology platform in healthcare.”

The launch of AppScript and AppNucleus is a key step in IMS Health’s efforts to deliver connected healthcare solutions that leverage the company’s intelligent cloud and extensive information assets to inform strategic decisions, reduce costs and improve the quality of care.

Nearly 5000 delegates expected to take part in 65th IPC starting from Dec 20 in Delhi

2013-12-13T00:03:00.000+05:30

As the preparations nearing completion for the 65th edition of the Indian Pharmaceutical Congress (IPC), the organisers are looking for a large turnout of delegates and strong presence of regulatory officials in the mega event that brings together all stakeholders of pharma and allied industries.

Around 5000 delegates are expected and there was a huge response to the call for papers and posters already. The presence of top officials from the Union Government and the States will be a major attraction of the event, said A K Nasa, president of the Indian Pharmaceutical Congress Association (IPCA) which is organising the meet.

IPC, the biggest gathering of the pharma and pharmacy segments in the country, is being held at Amity University, Noida, near here from December 20 to 22, 2013. Delhi is hosting the event for the eighth time. The organisers, including Indian Pharmacy Graduates Association (IPGA) which is the host organisation, have made elaborate arrangements for the event.

“The theme for the conference is “Pharma Vision 2020: Empowering Pharmacist”. The event will also have a dedicated expo involving over 200 stalls and job fair for the students community,” he added.

Prominent scientific personalities and intellectuals from the pharmaceutical industry, research and development, regulatory departments, quality control, hospitals, community pharmacy, academic fields, marketing, pharmaceutical consultants, policy makers, state and central agencies will be attending the event.

The organisers said they had received more 1750 presentations and posters, indicating the interest it could generate in the field. Among the 100 odd speakers, 25 are going to be from abroad, making it a strongest platform of idea-sharing at the global level.

“The focus of the event will be in-depth panel discussions on industry, regulatory and educational aspects. The event will come out with strong recommendations in these areas,” said organizing secretary Dr Arun Garg.

“The Delhi edition of the IPC will make a difference from the earlier editions in many ways. The theme of the conference is chosen to bring out the excellence in pharmacy education and practices,” according to Nasa.

The meet is also expected to give a much-wanted boost to the North Indian pharma industry which has been fighting for survival in the recent times, after the attraction of excise free zones lost sheen. Besides,participation of large number of officials from the government will be a major spur to the event.

“Hosting the conference in Delhi, being the capital and also the seat of all Ministries and major Authorities would surely play a significant role as representatives from various Authorities and regulatory forums are also expected to participate in the conference,” Nasa added.

An innovative Indian R&D proposal may get WHO funding for development

2013-12-12T01:20:00.003+05:30

An innovative research and development proposal by Translational Health Science and Technology Institute (THSTI) of India is likely to be one of the few projects to be selected by the World Health Organisation (WHO) for funding and thereby addressing the diseases affecting the developing countries.

This is one of the eight proposals shortlisted for the final selection by the WHO executive board in January and then ratification by the World Health Assembly in May. The initiative is in line with the decision by the Assembly in May this year to 'facilitate the implementation of a few health research and development demonstration projects to address identified gaps that disproportionately affect developing countries, particularly the poor, and for which immediate action can be taken'.

The global technical consultative meeting recently selected eight proposals from 22 submitted by different countries. The Indian proposal selected is about ‘Multiplexed Point-of-Care test for acute febrile illness,’ sources at THSTI said here.

Acute fever or acute febrile illness (a rapid onset of fever and symptoms such as headache, chills or muscle and joint pains) is common in the tropics and sub-tropics and can be caused by very diverse pathogens.

“We have decided to use simple field deployable lateral flow formats, which with some innovation, can be used for the generation of multiplex test for at least five to six major high-burden pathogens responsible for AFI in tropical and subtropical regions of the world especially SEARO region,” said the proposal.

“Based on literature search, infectious diseases which cause major burden of AFI and also amenable to multiplexing include malaria, dengue, typhoid/ paratyphoid, chikungunya, leptospirosis and scrub typhus. These are the diseases that are proposed to be targeted by multiplex POCT. Despite the strong need, no multiplex POCT is available in market which can be used in resource limited settings for the detection of multiple etiologies of AFI. Although, individual (singleplex) POCTs for the chosen infections are commercially available, most of these tests are of poor quality,” it said.

The POCTs for infectious diseases developed in developed countries are often imported by developing countries but these tests are generally very expensive and also do not perform to the mark in the developing countries, according to the proposal.

Evaluation of assay using clinical samples from developing world/SEARO region is prerequisite as regional background must be determined to tune the cut-off value. The whole project will be guided by the WHO, and THSTI, India will play role of coordinator (nodal point) for this project.

54 deaths reported during clinical trials in three years from 2010 in India

2013-12-12T01:20:00.000+05:30

The Union health ministry has said that total number of deaths related to clinical trials during three years from 2010 were 54 while the casualties and injuries during the year of 2013 were still to be assessed.

In a written reply in the Lok Sabah recently, Health Minister Ghulam Nabi Azad said the number of deaths related to clinical trials in the year 2010, 2011 and 2012 were 22, 16 and 16 respectively as per the available data. “The reports of Serious Adverse Events (SAEs) of injuries and deaths, received in the current year 2013 are under examination. Compensations have been paid in 21 cases of deaths related to clinical trial in 2010 and in all cases in 2011 and 2012. In one case of 2010, the compensation remained unpaid as whereabouts of the legal heir could not be traced by the investigator and his team in spite of their best efforts,” he said

The Minister also gave details of the steps taken by the government to strengthen the approval procedure for clinical trials, monitoring mechanism and payment of compensation to ensure that safety, rights and well-being of clinical trial subjects are protected.

“In light of the Supreme Court Order dated 21.10.2013, it has been decided that for all clinical trials, in addition to the requirement of obtaining written informed consent, audio-visual recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent, is also required to be done while adhering to the principle of confidentiality. This is applicable to the new subjects to be enrolled in all clinical trials including Global Clinical Trials,” the Minister said.

“The Drugs and Cosmetics Rules, 1945 have been amended vide Gazette Notification G.S.R. 53 (E) dated 30-01-2013 specifying procedures to analyze the reports of Serious Adverse Events occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death as per prescribed timelines. . The Drugs and Cosmetics Rules, 1945 have been amended vide Gazette Notification G.S.R. 63(E) dated 01-02-2013 specifying various conditions for conduct of clinical trials, authority for conducting clinical trial inspections and actions in case of non-compliance. Another amendment was done vide Gazette Notification G.S.R No. 72(E) Dated 08.02.13 making registration of the Ethics Committees mandatory and specifying requirements and guidelines for registration of Ethics Committee,” he added.

Source: Pharmabiz

Pondicherry accounts for highest number of FDCs approved without prior permission from DCGI

2013-12-12T01:19:00.000+05:30

Pondicherry, which has been recently in the news regarding violation of 122E Drug & Cosmetic Rules, was found to have approved the highest number of fixed dose combinations without the prior approval of the Drug Controller General of India (DCGI) in the past.

According to the information gathered by the Union Health Ministry, of the total 23 such cases of approvals to FDCs, Pondicherry has reported as many as 8 cases. The Centre had fixed October 1, 2012 as the cut-off date for implementing the rule to get prior permission by the state authorities from the DCGI for approving FDCs.

After Pondicherry, Uttarakhand was found to have sanctioned five FDCs while Maharashtra, Madhya Pradesh and Himachal Pradesh reported two each cases. Goa, Tamil Nadu, Haryana and Union Territory of Daman and Diu sanctioned one FDC each. Out of these, 11 were approved during 2011 and the rest during 2012, as per the information.

“As many as 23 cases of new FDCs , considered as new drugs, were also found to be licenced by State Licensing Authorities (SLAs) without approval of the DCGI . In all such cases, the office of DCG (I) took up the matter with respective SLAs for necessary action,” according to official sources.

“The State Drug Controllers have been requested in the Drugs Consultative Committee meeting to ensure that new drugs and FDCs are not permitted without approval from the office of DCG (I) and the drugs prohibited by the Central Government are withdrawn from the market with immediate effect. States have also been advised to strengthen their infrastructure for better enforcement and develop vigilance mechanism over the drugs moving in the market,” sources added.

On October 1, 2012, the Central Government issued statutory directions under Section 33 P of the Drugs and Cosmetics Act, 1940 to all State/UT Governments to instruct their respective drug licensing authorities to abide by the provisions prescribed under the Drugs and Cosmetics Rules for grant of manufacturing licenses for the drugs falling under the definition of the term “new drug” and not to grant licenses for manufacture for sale or for distribution or for export of such new drugs, except in accordance with the procedure laid down under the said rules without prior approval of the DCG (I).

Recently, the health secretary to the government of Pondicherry had issued show-cause notices to 20 pharmaceutical manufacturing companies operating in region for violation of provision of 122E of the Drugs & Cosmetics Rules following a probe by the Government on the alleged nexus between a former official and a section of the manufacturers.

Source: Pharmabiz

IPR Yatra reiterates rationale use of medicines through govt intervention

2013-12-01T10:54:00.002+05:30

Aimed at creating awareness about the proper functioning of pharmacies in private and public sector and the need for rational use of medicines, India Pharma Revolution (IPR), a Delhi-based Group of Pharmacists reached Goa and met state government health officials on November 18 after touring 25 states.

In order to sensitise patients towards health safety, pharmacists through the IPR yatra advocated the need of common man to access knowledge on Adverse Drug Reactions (ADR), rationale use of medicines, drug interactions, side effects and toxicity through the establishment of drug information centres and pharmacovigilance centre in the Goa state.

Among the other demands IPR yatra pursued were setting up of warehouses for stocking all lifesaving drugs and creation of medical supply depot for storage of generic drugs. "State government should take the initiative on this front as central government will readily support such a system. Besides this, quacks should also not be allowed to practice medicine and the state government should take this aspect seriously," members of the yatra said. Other demands included creation of separate directorate of pharmacy in the state and also restructuring of pharmacists cadre.

Reiterating the fact that pharmacy sector at the government level needs a revamp to provide better services to the public, Yatra convenor Amitav Joyprakash Choudhury pointed that modernization of drug testing labs in the state, appointment of drug analysts and technical manpower need to be met urgently by the concerned authorities for better patient safety.

As per the agenda of IPR, the pharmacists from across the country have also demanded that the government should recognise professionals with Doctor of Pharmacy (Pharm. D) as primary healthcare providers in the state. Professionals holding Pharm D degrees are not recognised as primary healthcare providers, while they have all the knowledge about the drug information and can treat basic illness.

Among other demands, the pharmacists have proposed the state government to create a separate Directorate of Pharmacy in the medical and health department and designate Pharmacists as Director Pharmacy, Deputy Director (Admin), Deputy Director (purchase), officer in charge pharmacy and chief pharmacists in each hospital in every district.

Source: PharmaBiz

Videorecording of consent for clinical trials mandatory

2013-11-28T21:49:00.003+05:30

The Union Health Ministry has made audio-visual recording of the informed consent of each subject mandatory in a clinical trial. This is in addition to obtaining his/her written consent.

This decision comes in the wake of the Supreme Court pulling up the Ministry for lack of transparency in clinical trials.In its October 21, 2013, order on a writ petition filed by an NGO, the Swasthya Adhikar Manch, Indore, the court said with respect to five global clinical trials, which was approved by the Drugs Controller-General of India (DCGI) office from January 1, 2013, to August 31, 2013, an appropriate provision should be made or administrative direction issued, ensuring that audio-visual recording of the informed consent process was done and the documentation preserved, adhering to confidentiality principles.

In his order, DCGI G.N. Singh said all sponsors/investigators/institutes/organisations and other stakeholders involved in clinical trials should adhere to this requirement with immediate effect.

Reacting to this, the Indian Society for Clinical Research — an association of professionals involved in clinical trials — said lack of guidance and direction on operational and logistical issues of managing the audio-visual recording process like the kind of equipment to be used, and where and how information should be stored could leave room for ambiguity and inconsistencies in execution.

More clarity was required on how confidentiality of patients should be protected and maintained in an ‘audio-visual’ context and what processes needed to be followed in instances where, for religious and socio-cultural reasons, patients might not want to be videographed, the association said.

Source: The Hindu

5th Annual Biosimilars Evolution Congress

2013-11-26T23:23:00.000+05:30

Day 1 – 10^th April, 2014

Meet : Key note on Future of biosimilar industry

Sessions :

Master class: Indian regulatory landscape
Comparative study of regulatory guidelines between Developed and Emerging markets
White Paper Submission: Examining the benefits of Product specific guidelines to have a single regulatory guideline across the globe
Understanding Regulations and challenges in developing countries to device a proper entrance strategy

R&D Sessions:

Face Off: R&D in India is not as per international levels, what is required to bring it to that level
Understanding the future of QbD in biologics to make sure your companies processes and technologies are refined for Qbd implementation
Case study: Approach of big companies in terms of R&D
Understanding the aspects of tech transfer to develop a proper process for the same in your organisation.

Day 2 – 11^th April, 2014

Meet: Opening remarks from the Chair

Sessions:

Panel Discussion: Ensuring the use of non infringing formulations to ease out the process of regulatory approval
Studying the patent landscape carefully to get a better understanding of its effect on your organisation
Panel Discussion: Changes required for a creating talent pool with university tie-ups for biosimilar R&D in India

Manufacturing Sessions:

Understanding how to create a quality biosimilar at par with innovator molecules to build a strong product portfolio for your company.
Learning about the outsourcing options available for manufacturing to choose the best fit for your organisation
Panel discussion: Why is the manufacturing of biosimilars slow in India, Evaluating how to implement best practices to fast track drug production in India
Building ways of tackling multiple product manufacturing to make sure your organisation has the right environment for each product
Outsource it to us: 4 vendor presentation of 15 mins each from manufacturing facilities that do outsourced work

Who Should Attend!
R&D heads, Manufacturing Heads, Regulatory Heads, Biosimilar heads, VPs and General managers Chief Scientific officers

Sanofi close to acquiring Elder Pharma for Rs 2,200 cr

2013-11-17T20:54:00.002+05:30

French drug maker Sanofi SA is close to acquiring city-based Elder Pharmaceuticals, valuing the pharmaceuticals company at about Rs 2,200 crore. The transaction is expected to be closed in the next few weeks, said a banker close to the development.

The Indian company’s recent default on interest payments of Rs 10 crore to debenture holders had expedited the talks for the sale, said a banker, on condition of anonymity. Its liabilities were close to the deal size and the company’s bankers were pushing for the deal so that it could repay the loans, the banker added.

When contacted, an Elder Pharma spokesperson declined to comment. A Sanofi spokesperson, too, refused to comment on what he termed “market speculation”.

Bankers say Sanofi has sent details of the deal and legal agreements to Elder Pharma and the Indian company is now vetting the legal papers.

While the sale will give the promoters of the Indian company an opportunity to cash out, it will help Sanofi deepen its penetration into the $13-billion Indian pharmaceuticals market. Sanofi earned a third of its revenues from emerging markets, including India, and was looking for acquisition opportunities in emerging markets, its chief executive Chris Viehbacher had told reporters here on September 30 this year.