Indian Patents Act promotes inventions

Concerns raised by US multinational corporations (MNCs) over the Indian Patents Act discouraging innovation have been refuted in a study released on Monday.

According to the study carried out by T.C. James, director, National Intellectual Property Organisation (NIPO), the number of patents issued for new pharma products in India have jumped more than three-fold from 765 in 2004-05 to 2,373 in 2008-09 after the patents act was introduced in the country. The total number of patents for companies across all segments have leaped from 1,911 to a whopping 18,230 during the period.

The study titled 'Patent Protection and Innovation' also points out that in 2004-05, as many as 40 per cent of the patents issued went to Indian companies and 60 per cent were given to foreign companies. In 2007-08, the number of patents issued to Indian companies fell to 21 per cent while those given to foreign companies went up to 79 per cent. James said this clearly shows that the Indian Patents Act is not discouraging innovation.

The study looks at the concerns expressed in a paper prepared by the US-India Business Council.

At the heart of the matter is Section 3 (d) of the Indian Patents Act, which has been put in place to prevent pharma companies from extending or "ever- greening" their patents by merely introducing some minor changes in a product to block Indian companies from launching cheaper generic versions of the drug.

US trade representative Ron Kirk had also expressed reservations over the Indian patent regime during his recent visit to New Delhi. Section 3(d) of the Act states that “the mere discovery of a new form of a known substance, which does not result in the enhancement of the known efficacy of that substance" shall not be treated as an invention within the meaning of the Act.

Companies are known to undertake a mere "tweaking" of the product to get an extension of the patent by claiming that the drug in question is a new product.

Pharma giant Novartis had first challenged the constitutional validity of this section in the high court but had lost the case.

It has now challenged the decision on its anti-cancer drug Gleevec, which was denied a patent on the ground that the company was resorting to ever- greening the patent without making any significant changes in the efficacy of the product. The case is now pending in the Supreme Court.

James pointed out that when India moved to the product patent regime in pharmaceuticals in 2005, it introduced modifications in Section 3( d) to guard against ' ever- greening' of patents.

This, he said, was done while withstanding pressure from many to restrict patenting of drugs to new chemical entities, since the government felt that it would not be TRIPS compatible. The section only sets a standard for inventiveness and does not debar incremental innovations which meet the criteria for patentability.

FICCI to organize a Roundtable Conference on the controversial Section 3(d) of Indian Patents Act

The Federation of Indian Chambers of Commerce and Industry (FICCI) is organizing a Roundtable Conference on the controversial Section 3(d) of Indian Patents Act in New Delhi on March 29. P H Kurian, Controller General of Patents, Designs & Trademarks and Arun Jha, Joint Secretary, Department of Pharmaceuticals, will address the conference. The Conference is expected to be attended by government officials, lawyers, industry representatives, academicians, NGO, etc.

Section 3(d) to the Patents Act, 1970, was introduced in 2005. The section provides that mere discovery of a new form of a known substance which does not result in enhancement of the known efficacy of that substance or mere discovery of new property or new use for a known substance or of the mere use of a known process, etc., are not patentable. There have been views expressed in favour and against this provision.

While the multinational pharma companies reason that Section 3(d) of India's Patents Act, (which prevents incremental pharmaceutical innovations from receiving patent protection), inhibits development of safer, more efficacious and more useful drugs for Indian patients, the public interest groups argue that this provision acts as a check on pharmaceutical companies obtaining patent monopolies for medicines that are not actual inventions, such as combinations or slightly modified formulation of existing medicines.

The public interest groups and patient groups in the country argue that Section 3(d) and other public health safeguards in India's patent law directly impact the lives of millions of patients not only in India but across the developing world who rely on access to safe, effective and affordable medicines from India.

Section 3(d) of India's patent law is a key public health safeguard introduced by the Indian Parliament in the 2005 amendments to the Patents Act, 1970. The Indian Parliament recognized public health concerns regarding 'evergreening' - a common practice of pharmaceutical companies to extend their patent monopolies on known medicines by making insignificant or minor changes and accordingly introduced Section 3(d), they argue.

Section 3(d) is being used by public interest and patients groups to ensure that frivolous patents are not granted in India. Moreover, the Indian government put up a strong defence of this provision in a legal challenge by a multinational pharmaceutical company before the Madras High Court. The challenge to Section 3(d) was rejected by the Court, which recognized the importance of the provision in light of the obligation on the Indian government to protect the right to life and health of all citizens.

Indian Society of Clinical Research calls for notification of Schedule Y-1 Amendment

According to Indian Society of Clinical Research, The Union Government should notify amendment to Schedule Y-1 without delay so as to make registration of clinical research organizations mandatory in the country.

Dr Arun Bhatt, president, Indian Society for Clinical Research and president, ClinInvent Research India Pvt Ltd, said that amendment to Schedule Y is the need of the hour and ISCR has worked on the revised guidelines and made a submission to the Drugs Controller General of India (DCGI) in September 2009. Only a speedy tabulation of the guidelines could provide the industry the much needed fillip.

"The Schedule Y 1988 was relevant to the generic industry. With the advent of the Good Clinical Practices (GCP) trials since 1995, and adoption of IPR regime in 2005, the country needed to integrate practices of global clinical development. There was also need for legal support to GCP guidelines to improve the quality of clinical trials and we amended Schedule Y in 2006," said Dr Bhatt. "We are now awaiting the revised guidelines which will strengthen the clinical trial sector," he said.

Currently, the clinical trial industry is in a phase of chaos as issues need to be addressed from an in-house perspective. That is why this industry is now insisting on compulsory regulatory inspections from DCGI. The inspection process will put the sector on the right track and on a global platform, he added.

The guidelines will also provide credible image to those who head the CROs. There will be standard operating procedures in place. Schedule Y1 will also insist on renewal of CROs every five years. The function of the Ethics Committees will also be scrutinized. There is also more clarity needed on the insurance of the subjects and the sites, Dr Arun Bhatt told.

According to Dr. Suresh Menon, past ISCR president and chief scientific officer at Novartis India, India needs to strengthen its regulatory framework in clinical trials. Although the country has a Schedule Y under the Drugs & Cosmetics Act, which deals with regulations relating to clinical trial requirements in India, the current regulatory framework not geared up to keep pace with the new requirements.

The Indian clinical trial industry is valued at US$ 500 million. Clinical trials constitute 60 per cent of the cost of the drug development process. There are around 800 human studies which are being conducted in the country at present with 200 Ethics Committees.

Special Courts to expedite spurious drug trials soon

For the expeditious disposal of cases related to manufacturing and marketing of spurious drugs in the country, the Union Health Ministry will soon set up special courts for trial of offenses falling under the D&C Act. In the first phase, the special courts will be set up at major cities and at the pharma clusters across the country.

"We will soon be taking up with the respective authorities for setting up of designated special courts for trial of offenses under the D&C Act. To begin with, special courts will be set up in cities and districts where there is a concentration of pharmaceutical industry," a senior health ministry official said. In the first phase, the courts may be set up in Mumbai, Ahmedabad, Chandigarh, Chennai, Hyderabad and Bangalore. The ministry has already started initiatives in this regard.

The Union Health Ministry had recently amended the D&C Act, 1940 to incorporate stringent penal provisions for various offenses including manufacturing and marketing of spurious drugs. Under the amendment, maximum penalty has been enhanced to life imprisonment for manufacturing and marketing spurious drugs. Besides, fine has also been enhanced to Rs 10 lakh or three times the value of the spurious drugs confiscated, whichever is more.

Ever since the amendment was notified by the ministry on August 10 last year, the pharma industry has been up in arms against several provisions in the Act, especially the powers vested in the hands of the drug inspectors. The industry fears that some provisions in the Act will be misused by the drug authorities to harass even the genuine drug manufacturers. Industry fears that since manufacturing and marketing of spurious drugs is a non-bailable and cognizable offense under the new amendments in the Act, there is a possibility of even genuine manufacturers getting arrested for no faults of theirs. And by the time they prove their innocence in the court, it may be years.

National Institute of Health creates new Genetic Testing Registry

The National Institutes of Health (NIH) announced that it is creating a public database that researchers, consumers, health care providers, and others can search for information submitted voluntarily by genetic test providers. The Genetic Testing Registry (GTR) aims to enhance access to information about the availability, validity, and usefulness of genetic tests.

Currently, more than 1,600 genetic tests are available to patients and consumers, but there is no single public resource that provides detailed information about them. GTR is intended to fill that gap.

The overarching goal of the GTR is to advance the public health and research into the genetic basis of health and disease. As such, the registry will have several key functions: Encourage providers of genetic tests to enhance transparency by publicly sharing information about the availability and utility of their tests; Provide an information resource for the public, including researchers, health care providers and patients, to locate laboratories that offer particular tests; Facilitate genomic data-sharing for research and new scientific discoveries

"The need for this database reflects how far we have come in the last 10 years," said NIH Director Francis S. Collins, M.D., Ph.D. "The registry will help consumers and health care providers determine the best options for genetic testing, which is becoming more and more common and accessible. Our combined expertise in biomedical research and managing such large databases makes NIH the ideal home for the registry."

The GTR project will be overseen by the NIH Office of the Director. The National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at NIH, will be responsible for developing the registry, which is expected to be available in 2011. GTR genetic test data will be integrated with information in other NIH/NCBI genetic, scientific, and medical databases to facilitate the research process. This integration will allow scientists to make, more easily and effectively, the kinds of connections that ultimately lead to discoveries and scientific advances.

During the development process, NIH will engage with stakeholders-such as genetic test developers, test kit manufacturers, health care providers, patients, and researchers-for their insights on the best way to collect and display test information. In addition, other federal agencies, including the Food and Drug Administration and the Centers for Medicare and Medicaid Services, will be consulted.

Several drugs to come under Regulatory Scanner as National Pharmacovigilance Programme to begin in April

Two H1N1 drugs - oseltamivir and zanamavir, the controversial sub-fertility drug letrozole, popular non-steroidal anti-inflammatory drug nimesulide, decongestant drug phenylpropanolamine (PPA), antibiotic drug gatifloxacine, chronic constipation drug tegaserod, type-2 diabetes drug pioglitazone and rosiglitazone have been selected for the first phase of national pharmacovigilance programme which will begin in selected 40 medical colleges across the country from April this year.

The much awaited pharmacovigliance programme for India has been designed by the central drugs standard control organisation (CDSCO), in collaboration with the Department of Pharmacology, AIIMS, for comprehensive drug safety monitoring with nationwide coverage. Inputs from scientific organizations like WHO and ICMR have been incorporated into this programme.

Dr Y K Gupta, professor and head, Department of Pharmacology, AIIMS, who heads the national programme, said that several criteria have been used for putting a drug on the watch list like restriction/withdrawal by any other regulatory agency in the world; reports in media; adverse reports published in WHO Newsletters; diseases of public health importance in relation to Indian population; drugs, vaccines for epidemics/pandemics; and signals generated from the spontaneous reports received under the NPV.

In the first phase, operative from April 2010, 40 medical colleges that have been identified as adverse drug reports (ADR) monitoring centres, will send ADR reports to the national coordinating centre at Department of Pharmacology, AIIMS, which will be involved in quality assurance, causality assessment and training. The programme also envisages to include all the medical colleges and corporate hospitals by 2012.

In addition to routine sponateous reporting, these ADR monitoring centres will also carry out focussed ADR monitoring on selected drugs of national importance, Dr Gupta said.

The 24 centres already identified for the pharmacovigilance programme are R G Kar Medical College, Kolkata; Postgraduate Institute of Medical Education & Research, Chandigarh; G.S.V.M. Medical College, Swaroop Nagar, Kanpur, U.P; C.S.M. Medical University (erstwhile KGMC), Lucknow, U.P; Pandit Bhagwat Dayal Sharma, Post Graduate Institute of Medical Sciences, Rohtak, Haryana; Gauhati Medical College and Hospital Guwahati, Assam; SMS Medical College, Jaipur; S.N. Medical College, Agra, U.P; Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P; Dayanand Medical College and Hospital, Ludhiana; Nizam's Institute of Medical Sciences, Hyderabad; Burdwan Medical College, Burdwan, West Bengal; LLRM Medical College, Meerut, U.P; Subharti Medical College, Subharti Nagar, Meerut, U.P; SGS Medical College and KEM Hospital, Mumbai; Govt Medical College, Srinagar, J&K; Santosh Medical College, Ghaziabad; V.P. Chest Institute, University of Delhi, Delhi; TN Medical College & BYL Nair Hospital, Dr. AL Nair Road, Mumbai; Seth G. S. Medical College & KEM Hospital, M. S. Building, Parel, Mumbai; Himalayan Institute of Medical Sciences, Jolly Grant, Dehra dun; RD Gardi Medical College, Ujjain (MP); KIMS University, Karad, Maharashtra; and National Institute of Malaria Research, Sec-8, Dwarka, New Delhi.
The remaining 16 centres will be identified soon.

Intas Pharma to introduce world’s first Interferon Lozenges in tablet form for flu in India

Following the recent license and supply agreement signed between Amarillo Biosciences Inc. (ABI), a US biotechnology firm, and Intas Pharmaceuticals, Intas will soon market world’s first Interferon Lozenges (tablet form) in India.

Unlike vaccines, Lozenges (tablet form) has outstanding safety profile with minimal side effects at a much affordable price. Lozenges, being orally administered, offer treatment of Influenza which have unique advantages of less frequent visit to doctors and efficacy at low dose. In a breakthrough achievement, Australian scientists have also studied this drug that prepares the immune system to effectively resist flu infections. The drug contains interferon, a protein, which is produced by the body naturally to fight infections. When lozenge releases the protein, the immune system is stimulated to protect against infection caused by different viruses. Interferon placed in mouth binds to receptors in the mucosal lining and stimulates immune system to protect against viral invasion.

Elaborating on the development, Kirti Maheshwari, senior vice president, Corporate, Quality & Regulatory affairs, Intas, informed that after approval, Intas is planning to conduct clinical trial with Amarillo Biosciences’ patented orally administered interferon-alfa lozenges. This will be a multi-centre study on 500 patients and would take approximately three months to complete. Intas has submitted the required technical documents to Drug Controller General of India (DCGI) for authorisation of conducting clinical trials.

Intas will undertake clinical study which will be randomised and double blind in nature. It will conduct clinical trial on ambulatory patients who are clinically diagnosed with influenza. The objective of the clinical trial planned in India is to determine the safety and efficacy of low dose oral interferon in reducing the severity of infection with influenza viruses such as H1N1. Intas will pay ABI a royalty on net sales in India and Nepal after marketing approval is obtained

Dr Rajendra Rane, senior vice president (Medical Affairs), Intas, said, “Our collaboration with Amarillo Biosciences ensures that we have the best available technological expertise of oral Interferon that offers superior safety and efficacy profile than the conventional vaccines. If things work out as per plans, we will be producing the drug at our Ahmedabad facility.”

Giving further details about the launch, Maheshwari informed that if Government of India supports this low dose, cost effective drug with minimal side-effects in fast review and approves it, then they will be able to bring the product much sooner than expected. "We would be able to bring the product to Indian market before 2011," added Maheshwari.

Amarillo Biosciences has already completed preclinical studies in US and rest of the world and in a phase-II clinical trial recently completed in Perth, Australia demonstrated that ABI’s interferon-alpha lozenges were safe and beneficial when given as prevention against respiratory viruses, including influenza. The experience in Australian clinical study is a well-timed development, which will help Intas deal with the next wave of swine flu or any other viral respiratory infections efficiently.

India ready to move WTO against EU Customs laws

India is ready to file a case against the EU’s Customs regulations at the World Trade Organisation, as talks have failed to resolve the issue of wrongful confiscation of Indian generic medicines at European airports, a government official has said. India has all its documents required for filing the case ready and is now awaiting approval from the Brazilian authorities before it jointly approaches the WTO.

“Earlier this year, we felt that the EU was serious about bringing about some changes in its regulations, which could address our problem. But we are disappointed,” the official said.

EU’s former trade commissioner Katherine Ashton, during her visits to India last year, had given assurances that the EU would sort out the issue bilaterally with India. Following on the promise, in January this year, the EU had said that it would make alterations in its customs regulations or its application in a way that shipments of generics from India on the way to third countries would not get confiscated at European ports for violation of patent laws of the European countries.

Once Brazil, which had jointly raised its voice with India against EU’s customs regulations, gets the required approval domestically for filing the case, both countries would request the WTO for setting up of a panel to hear the dispute. India has appointed intellectual property experts to prepare the case against the EU and is confident of a favourable verdict at the WTO. “We are very clear that customs officials in the EU countries bent WTO rules when they seized good quality off patent medicines being shipped from India. We won’t have a problem proving our case,” the official said.

Over the past one year, a number of reputed Indian drug producers including Dr Reddy’s Laboratories Ltd and Aurobindo Pharma Ltd had their consignments seized in countries like Netherlands and France, following complaints made by European pharmaceutical companies that hold European patents to these medicines.

“Such seizures violate the provisions of Trips (international intellectual property law) agreement,” the official said pointing out that while the European countries had granted patents for those medicines to global pharma companies, they were off-patent in India.

Moreover, the drugs that were confiscated were life-saving medicines being exported to countries in Latin America and Africa, which did not have enough capacities to manufacture these and such transactions are permitted under the Trips and public health agreement.

Africa and Latin America are major markets for India’s low cost drugs used for treatment of diseases like HIV/AIDS, tuberculosis and malaria. The two continents account for around 15% of India’s total pharmaceutical exports of nearly Rs 40,000 crore.

Clinical Research Industry in India to touch USD600m by 2010

Over the past few years, Indian Clinical research (CR) organization has garnered bulk of the outsourced clinical research revenue share of the pharma market globally. Till 1990, India was not the preferred destination for major global pharmaceutical companies, even though some of them were conducting clinical trials here.

Clinical Research (CR) organization is one that manages a research or an investigation to assess and/or verify the clinical, pharmacological or other pharmacodynamics effects, safety and/or efficacy, and adverse reactions of an investigational product. Clinical Research (CR) organizations were primarily organized as outsourcing service companies that provided only clinical trial management. However, in recent times, most of them have expanded their scope of services to provide comprehensive management of complex drug trial processes for their client companies as well as to facilitate access to vast areas of expertise, which many not exist in the client’s internal organization.

In the last 10 years however, there has been a steep rise in the global demand for world-class clinical trial management capacity and productivity.

With the average R&D expenditure growing at more than 15% per year, biopharmaceutical majors worldwide are realizing that the time-consuming and expensive affair of drug discovery and development can be done easier and better in India, given its rich technical resource pool, the relative ease and attractive economics of recruiting large number of patients and the sheer diversity inherent in the country’s genetic texture.

The international biopharmaceutical sector now finds India’s pool of highly skilled doctor’s trained medical personnel, investigators, and the support research infrastructure to be highly attractive and as a result, large numbers of international companies are now viewing India as a potential center of knowledge, skills and resources, and are hoping to derive expertise-based synergies from Indian partners.

The global clinical trials market is expected to be worth USD 16 billion by 2008, up from USD 10 billion in 2005 and is growing at 15-18%. The clinical research industry in India touched USD140 million in 2006, up from USD70-80 million in 2001-02 and has been estimated to touch USD200 million by 2007 and USD500-600m by 2010.

Asian Clinical Trials Market to Grow 31% during 2010-2012

A clinical trial is a research study, comprising human volunteers, to test the effectiveness of a new drug. In other words, clinical trials are carried out to find out if proposed treatments work on human beings. A clinical trial for a specific drug takes nearly 9 to 10 years to reach the completion stage.

A clinical trial is a long-drawn out process, globally costing anywhere between USD350 and USD500 million. Not surprisingly, a significant share (30%) of clinical trials is now outsourced to Contract Research Organizatins (CROs). At a given time, over 3,500 drugs are under development and about 4,000 clinical trial projects are in progress of new drug applications.

Asia, as a whole is witnessing a rapid growth of R&D spending, driven by increasing globalization of the pharmaceuticals and biotechnology markets and strong cost advantages. This signifies the increasing penetration of CROs as well as the emergence of newer markets like China, India, and Aisa Pacific, as hotspots for clinical trials and other areas of outsourcing services.

One of the biggest reasons attracting drug manufacturers and CROs to India is that the clinical trial market in India looks very lucrative. India promises to be one of the hottest destinations for conducting global clinical trials, owing toa huge patient pool representing both chronic and infectious diseases, easy recruitment of patients, and high cost savings. Moreover, the market is getting a boost from improved IPR protection with changed rules and also from reduced taxes and duties, Clinical trials for drugs related to central nervous system and cancer have been mainly outsourced to Indian in recent years.

According to the report on new research study on the sector called “Booming Clinical Trials Market in India”, the clinical trial outsourced market in India is forecasted to grow at a CAGR of around 31% during 2010-2012. Presently, the market is characterized by the dominance of phase III and phase II trials, which currently hold more than 80% of the market. This scenario is expected to remain intact in future as well. In terms of competitive landscape, the market is characterized by many CROs like MakroCare, with certain companies like Syngene, Pfizer Quintiles, Lambda Therapeutics, Vimta labs doing better in comparison of the rest.

DoP to set up GLP compliant animal testing facility for clinical trial

The Department of Pharmaceuticals (DoP) has initiated efforts to set up a Good Laboratory Practices (GLP) Compliant large animal facility for clinical trials in the country in public private partnership mode. This is in line with its promise of building up adequate infrastructure for the pharmaceutical industry to flourish.

As part of its capacity building exercise, the DoP has called for expression of interest from public-funded institutes, public sector units and private organizations with experience in drugs and pharmaceutical sector to set up the facility in one of the major pharma hub. The facility, in compliance with the latest GLP norms, is estimated to come up with an investment support will be of Rs. 5 crore, according to a DoP notification.

Evan though the pharma industry needs large animal trials for testing new drugs, the country at present has a very few number of large animal facilities. The industry, which is involved in New Chemical Entity (NCE) research, are currently going abroad to carry out their studies which cause delay and loss of foreign exchange to the country.

Setting up of the facility will help the country to save foreign exchange and further, being a favourite outsourcing destination for global multi national companies, India can also earn foreign exchange through conducting large animal trials, expects the government. “Carrying out of the regulatory research for the large animals in India will decrease the drug discovery cycle time which is an intangible benefit. By carrying out these tests in India the brand image of the Indian Pharma industries or CROs will increase and thereby the profit will also increase”, explains the DoP letter.

The Department will release the fund in two phases of Rs. 2.5 crore each. Initially, 50 per cent of the money will be provided on production of installation report and remaining 50 per cent on production of GLP certification or accreditation by the competent authority. The Scheme is proposed to continue initially for three year (remaining period of 11th Five Year Plan) with total requirement of Rs. 15 crore and after the period, assessment would be made for the outcome for further development of the project.

As a partner, the DoP has not proposed return from the laboratory in the form of revenue, except putting forward conditions for conducting training of analysts and testing of samples from government organizations and public sector undertakings on concessional rate, details the DoP.

The facility will also be the first GLP compliant large animal house for the government. Even though primate animal experimentation is carried out by few organizations like Central Drug Research Laboratory (CDRL), Lucknow, National Institute of Immunology (NII), Indian Institute of Science (IISc) and recently by National Brain Research Centre (NBRC) and National Institute for Research Reproductive Health (NIRRH), with the stringent CPCSEA Act, there are no GLP compliant large animal facilities under the government sector.

The department as part of its Indian Pharma Vision 2020 has earlier declared capacity building projects including setting up two world class animal houses, three pre-clinical drug discovery centres and three world class drug testing and analytical laboratories in the country, in a set timeline. The DoP, earlier in December 2009, has initiated efforts to set up the drug testing laboratories, one for chemical testing and two separate facilities for biological drugs testing.

Delhi drug control dept alerts newspapers against publishing ads making excessive claims of drugs

Concerned over the growing instances of violation of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954, the Delhi Drug Control Administration has written letters to the editors of English and vernacular newspapers in the National Capital Territory not to accept and publish advertisements about drugs which are claiming magical properties, it is learnt.

Recently the Indian Medical Association (IMA) has complained to the Delhi drug control administration against the exaggerated claims being made by certain pharmaceutical companies while marketing their products. P K Jaggi, assistant drugs controller, NCT of Delhi said even before the Association approached DCA, the department had initiated steps to control such unethical activities. Letters were sent to English, Hindi, Urdu and Punjabi newspapers.

When asked whether any action was taken against any media in the capital, he said it is too early to say something on this matter. The decision of the department is part of an initiative to strengthen the Act in the National Capital Territory. Jaggi said the Drug Controller has also set up a four-member committee to keep a vigil on the advertisements appearing in the media.

ADC said that many pharmaceutical companies in North India were carrying advertisements claiming they could cure common lifestyle and other diseases like diabetes, blood pressure, cancer, cataract and epilepsy. According to him, the department will scrutinize various advertisements published in newspapers and periodicals under Drugs & Magic Remedies Act and strict action will be initiated against all kinds of contraventions.

He said that there are provisions for prosecution under the Act against the persons found publishing objectionable advertisements. The electronic media in the capital is releasing relatively less number of objectionable advertisements in violation of DMRA, he added.

Dr. Farhan Jalees Ahmad elected as new IPA-Delhi branch President

Dr. Farhan Jalees Ahmad, Associate Professor, Faculty of Pharmacy, Jamia Hamdard, Hamdard University, New Delhi has been elected as the new President of the Indian Pharmaceutical Association (IPA), Delhi branch.

The IPA, Delhi branch announced its new office bearers and new executive council for 2009-11 for which elections were held recently. Prafull D Sheth, past president of IPA, was the returning officer for conduct of the election process.

Dr Praveen Khullar, director of Sanofi-Synthelabo (I) Ltd, Goa is the Immediate Past president. Other office-bearers are: Vice-Presidents, Dr Sunil Kumar Jain, chief pharmacist at AIIMS and Sanjay Talwar; honorary general secretary, Kalhan Bazaz, editor of The Indian Pharmacist; honorary treasurer, Dr Rajesh Khanna, Associate Director-Formulations, Fresenius Kabi, Sahibabad, UP; and joint secretary, Naresh Sharma, drugs inspector, Central Drug Standards Control Organization, Ghaziabad, UP.

In addition, the executive committee members elected to the branch are: Professor Roop K Khar, Department of Pharmaceutics, faculty of Pharmacy, Jamia Hamdard, Hamdard University, New Delhi; S L Nasa, Registrar, Delhi Pharmacy Council; Professor S. H. Ansari, Dean, Faculty of Pharmacy, Jamia Hamdard, Hamdard University, New Delhi; Manish Narang; Dr Sushma Talegaonkar, Assistant Professor, Faculty of Pharmacy, Jamia Hamdard, Hamdard University, New Delhi; Dr Sayeed Ahmad Khan, Lecturer at Department of Pharmacognosy & Phytochemistry, Faculty of Pharmacy, Jamia Hamdard, Hamdard University, New Delhi; Dr Mohd Aqil, Assistant Professor, Faculty of Pharmacy, Jamia Hamdard, Hamdard University, New Delhi; Pankaj Jain, senior lecturer, Vaish Institute of Pharmaceutical Education and Research, Rohtak, Haryana; and Dr Tanveer Naved, Assistant Professor, Amity Institute of Pharmacy, Amity University, Noida, UP.

BII EXAM NOTIFICATION

BII's Exams would be held on 24th & 25th April 2010 at the following cities Ahemdabad, Kottayam, Chennai, Hyderabad, Bangalore, Mumbai, Pune, Kolkata, Patna, Lucknow, Noida, Chandigarh.

Sanofi-Aventis planning a dedicated set-up in India for research

Sanofi, which spends €4-5 billion (Rs. 24,920-31,150 crore) on research and development (R&D) annually, is expected to invest some €650 million over the next five years in India

French pharmaceutical firm Sanofi-Aventis SA, the world’s third largest drug maker by sales, is looking to India to expand its scientific capabilities and tap new business opportunities. That’s a path being taken by other international drug makers as well, as they come under pressure in their home markets in developed economies.

Marc Cluzel, who became Sanofi’s global research head in November, was in India last week to meet at least a dozen scientific institutions and drug research firms and domestic drug makers in the public and private sectors. Cluzel, who is executive vice-president (research and development), met officials at scientific institutions such as the Indian Council of Medical Research, Indian Institute of Science, Bangalore, and regulatory agencies including the department of biotechnology and department of pharmaceuticals.

Sanofi, which spends €4-5 billion (Rs24,920-31,150 crore) on research and development (R&D) annually, is expected to invest some €650 million over the next five years in India. In an interview, Cluzel said Sanofi plans to have a “dedicated set-up in India for discovery research”.

Kaushik Desai to join as Chairman, Industrial Pharmacy Division and Vice President, IPA

Kaushik Suryakant Desai, Chief Executive Officer & Director, Global Pharmatech has been elected as Chairman, Industrial Pharmacy Division and vice president of Indian Pharmaceutical Association (IPA) for the period 2010-12.

Desai who holds a post-graduate degree in Pharmaceutical Technology from the University of Mumbai is armed with over 26 years of service in multinational companies including Johnson & Johnson, Wyeth, Hoechst India (Sanofi Aventis), May & Baker (Rhone-Poulenc). He has been responsible for commissioning the liquid, oral and tablet facilities at Baddi, in addition to bagging successful quality audits, ISO 9001: 2000 & WHO certification for the facilities during his reign in some of these companies.

Prior to his current service at Global Pharmatech, he was Vice President, Operations & Business Development with Sarvotham Care based at Baddi, Himachal Pradesh. Between February 2001 to May 2005, he was vice president, Operations with Charak Pharma, based at Mumbai and looked after activities of three manufacturing locations, Corporate Q.A., R&D, Contract manufacturing & Projects.

Career in the New Decade

Biomedical Informatics is an academic discipline that bridges medicine and information sciences. With the increasing popularity of IT biomedical informatics is making its presence felt in a big way.  


"The role of IT in healthcare has become increasingly necessary for modern practices in medicine, efficient and effective management of healthcare and professional health education. Health professionals recognize an urgent need for skilled scientists who are knowledgeable about both medical environment and information technologies," says Dr. Kumud Sarin, head of the department, Biotechnology and Bioinformatics, Bioinformatics Institute of India (BII), Noida.

For the uninitiated, Biomedical Informatics is the combination of theoretical foundations and the current range of applications within contemporary delivery system. It focuses on structure, algorithms and design of efficient logic necessar2y to organize, store and retrieve as well as analyses the data. It is emphasizing to produce knowledge and under-standing about cognition and representation of biomedical knowledge, management of health care systems, clinical decision making, research, design and development of interactive multimedia systems.

Talking about the program offered by BII, Dr. Sarin says: "The purpose of the program in Biomedical Informatics is to prepare students in the applications of computer and information sciences to support and manage and healthcare activities." These can range from those pertaining to the care of the sick to health promotion and disease prevention, medical and health education, health sciences research and management efforts directed towards solutions of problems in the delivery of health care, including resource optimization and cost-effectiveness.

Those interested in making a career out of a degree in Biomedical Informatics would be delighted to know that its applications are rapidly increasing in healthcare and hospital management systems, laboratory automation, quality assurance, financial management and resource allocation, health services and biomedical research. They can also find placements in clinical decision making, treatment monitoring, networking and registration systems, information storage, retrieval and database management systems, simulation and modeling, pattern recognition, biomedical signal and image processing, and health education, research and support systems.

In terms of a professional career, there are several areas within the field where a qualified person can find opportunities. Data management and information analysis apart, there is scope for placement in medical imaging, enabling telemedicine, genomic mapping, systems and software development, and knowledge management. With respect to those with a professional degree in healthcare, job opportunities are available as consultants with management consulting firms, hospital record managers, data analysts, librarians, and positions with the state health departments.

Careers abound in professional companies that offer end-to-end solutions in Biomedical Informatics for medical facilities including setting up systems for IT-enabled clinical practices, medical/diagnostics decision support systems, multimedia healthcare solutions, healthcare content management, clinical knowledge architecture and sharing of healthcare knowledge between different healthcare groups.

The subject also involves the design and statistical analysis of drug trials. Professionals in this field are much in demand at pharmaceutical companies and research labs to work in the areas of modeling, simulations, gene expression control, clinical databases and medical statistics.

The typical starting salary in the sector ranges from Rs. 25,000 to 30,000. Sarin has a positive picture to paint about the future for those pursuing the course. "Our students do immensely well after the completion of the course as we have 100 per cent placement," she adds.

Drug patents worth $60bn to expire in 4 years

Nearly $60 billion worth of patents for drugs is set to expire in the next four years across the world and Indian pharmaceutical companies are now in a position to take a major share of this pie, industry members said.

Already, India is the No. 1 exporter of generic drugs in the world with exports to the tune of $8 billion in 2008-09.

"The Indian pharma industry is the third largest in the world with strength in the value chain and constitutes 40% of the world's exports of bulk drugs," said S V Veerramani, vice-president, Indian Drug Manufacturers' Association.

Veerramani said the Indian pharma industry was expected to reach $30 billion by 2020.

"Out of every fifth generic drug produced in the world, three are from Indian companies. While we are not too much into new drug inventions, we are quite strong in manufacturing formulations and bulk drugs. When the $60 billion worth of patents expire in the next three to four years, Indian companies will be able to capture a major chunk of the market with our strength in generic drug manufacturing," said J Jayaseelan, honarary secretary, Indian Pharmaceutical Association (IPA). The IPA is organising a three-day convention in Chennai between March 12 and 14 that will discuss India's 'surge forward as the global pharma destination'.

"Many Indian companies are concentrating on manufacturing generic drugs. The US, Europe and Japan continue to be lucrative markets as they are the largest spenders in healthcare. Any company with good integration, can surely move up the chain," Raghavendra Rao, chairman and managing director, Orchid Chemicals, told.

There are over 9,000 formulations companies in India in the small, medium and large sectors, and they export to over 200 countries. "Companies like Pfizer, AstraZeneca have set up operations in India as the cost is low. New drug development is also happening along with a growing focus on R&D," Jayaseelan said.

Local pharma can and should step up outsourcing play

In the late nineties, when big pharmaceutical companies starting feeling the burden of over-sized research units in the face of a dwindling pipeline of molecules, they started looking at ways to source manufacturing at lower costs and to farm out semi-skilled chemistry work to Indian companies.

Back then, Indian firms, soaked in the success of generic drugs business, were hesitant and looked down on the prospects of aligning with multinational companies for vanilla manufacturing pacts.

But over the decade, inhibitions were shed and companies started working in tandem.

The earliest to take the plunge were the likes of Dishman, Divi’s Labs, Cadila Healthcare and Shasun.

The lure of having strong, assured revenue flows over long-term contracts attracted attention from large companies like Piramal and Dr Reddy’s.

Jubilant Organosys, earlier known as Vam Organics, completely transitioned to a pharmaceutical services company in a span of five years.

Dozens of other smaller units sprouted on the horizon and the outsourced manufacturing industry stands at $1.5 billion today. With growth upwards of 40% annually, more and more players are getting magnetised.

The latest to announce an entry is Aurobindo Pharma. Aurosource, the new division of Aurobindo, endeavours to capture business from large drug makers across the entire chain of business from pre-clinical data work to helping with know-how for regulatory filings. It put forth a simple logic.

The worldwide outsourcing business is over $50 billion and Indian companies have not cornered even 4% of that large pie. With nearly a dozen big and small manufacturing bases and expertise in developing hundreds of generic drugs, there could be a big opportunity waiting to be tapped by Aurosource.

The secret to succeed will, however, be in getting the cost-efficiency and ensuring good, enduring relationships. A few companies may have gone for ambitious delivery targets and come almost close to spoiling future business prospects. Bad word in business spreads faster. At the lower end, again, there could be many who may not be passing the global quality standards. Also important will be to scale higher into sharper value added technology platforms.

In the US, companies like Codexis have developed platform technologies that have helped companies reduce the number of stages needed to get the final yield. This gives two advantages: lesser time to arrive at the final product and lesser costs.

For contract manufacturers, it will be important to look at full-fledged contracts than work on smaller piecemeal projects. For large companies, managing too many vendors is seen as a big drain on resources and they are looking at fewer companies to deal with, essentially those who have large manpower in the labs and large manufacturing capacity. Remember, Pfizer, as part of its cost-saving exercise, had gone on a vendor pruning programme about a year ago.

WuXi of China has set an example in large-scale manufacturing, but being too commoditised has not worked in its favour.

Indian companies are confronted with one other mighty problem. Most go out in the market to offer similar services. Though there could be a range of sub-sects to work on, they replicate the same expertise, undercut and ultimately kill each other.

One good example of distinguishing itself is Cadila Healthcare. Years ago, the company set up a joint venture with Byk Gulden, which later became Altana and is presently called Nycomed, for manufacturing large volumes of pantoprazole. The success of this joint venture led Cadila to forge its next deal with Hospira, a large injectables company. Injectables is considered to be higher up in the value chain and the margins are stronger.

At a time when big companies are cutting thousands of jobs but do not want to let up on it pipeline, Indian companies can look at developing a strong bonding with foreign companies who are showing increasing appetite to come to India. Also Lonza, one of the best known contract manufacturers, has developed tremendous skill sets, which brings to it great companies like Teva.

Biologics could be another area waiting to be grabbed but quality will play a key role here.

HarNeedi.com to organise job fair for healthcare & pharma in Mumbai

HarNeedi.com, India’s No. 1 job portal for Healthcare and Pharma industry, will be organizing an exclusive ‘Healthi Job Fair 2010’ for Healthcare and Pharma 'Healthi Job Fair 2010' at the Bombay Exhibition Center, Western Express Highway, Goregaon East, Mumbai on March 20 and 21, 2010.

‘Healthi Job Fair 2010’ will be the first of its kind event, with innovative approach in fulfilling your manpower requirements of all categories in Healthcare and Pharma sectors. This job is expected to bring in more than 5000 walk-ins for candidates with Healthcare and Pharma experience, in different industrial and non-industrial clusters all over from Maharashtra including Mumbai as well as Pune.

‘Healthi Job Fair 2010’ is a new direction for healthcare, pharma, biotech and life sciences domain. This job fair is a bit different from other job fairs; it includes free career sessions where thousands of jobseekers / participants seek a suitable solution for their career related questions, so as to add additional value to their profiles. This job fair will have booths of renowned employers from Healthcare and Pharma industry. The very purpose behind organizing this job fair is to create a platform for employers and job aspirants in these industries.

Healthy Job Fair 2009 at Hyderabad was held on October 10 and 11, 2009 and has witnessed a large pool of prospective employees from health care and Pharma domain. Fifteen top employers from the industry participated in the Job fair and recorded approximately 7,000 job seekers during the fair.

Quality by Design seminars in Mumbai & Hyderabad

International Business Conferences (IBC) will be organizing two Quality by Design (QbD) seminars in Mumbai and Hyderabad respectively. In Mumbai ,the seminar will be held at Le Royal Meridian Hotel from March 8 to 10 and in Hyderabad from March 10 to 12.The speakers at the seminar include Dr Line Lundsberg, Senior Consultant, Quality by Design , Lundsberg Consulting, UK and Dhaval Trivedi, Asst Manager , Regulatory Affairs , Intas Bio pharmaceuticals.

Line Lundsberg PhD (Experimental Physics) is a scientist with many years practical experience in the pharma industry. She is one of the pioneers in PAT and QbD. She now works as an Independent Consultant and is an internal consultant for NNE Pharmaplan. She is also membership secretary of ASTM E55. Dhaval Trivedi is a regulatory affairs professional with experience of biosimilar product development. Currently he is leading regulated market and domestic market submissions. He has played a key role in preparation and submission of marketing authorisation applications with special focus on CMC.He is an M.Tech.in bioprocess technology from the University Institute of Chemical Technology.

 The QbD course will be focusing on : framework for QbD,1CHQ8/Q9/Q10/Q11, key concepts of QbD including practical understanding of CQAs, CPPs, material attributes, design space arid control strategy, Real Time Release,brief introduction to QbD enabling tools, pharmaceutical quality system,how the outcome of QbD can be used lor making qualification and validation easier and more efficient,science and risk based verification,practical examples and exercises,introduction and understanding of key elements of QbD, biopharrna product development,practical understanding for implementation of tools of QbD,various methodologies of risk analysis,DOE practical understanding with case study,design space creation,regulatory expectations and QbD.

DoP to launch PTUAS from July 1 to upgrade MSEs as per WHO-GMP, US FDA norms

To assist the medium pharma enterprises in the country for the technological upgradation of their units to comply with WHO-GMP, US FDA and other international norms, the department of pharmaceuticals (DoP) has launched an ambitious scheme, Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) which will come into effect from July 1 this year. Under the scheme, the DoP will provide an interest subsidy of five per cent on loans availed for such purposes, amounting upto a project cost or loan amount of Rs 10 crore.

The PTUAS is to be made operational for the pharma medium enterprises (ME) initially for a period of two years with effect from the July 1, 2010 to June 30, 2012 and to be extended for a further period of two years at the discretion of the government.

The interest will be reimbursed by the DoP through its nodal agency, SIDBI or IDBI. For this part of the interest, the ME units will have to approach the nodal agency and an MoU/tripartite agreement has to be signed by them with the nodal agency and the lending banker (scheduled banks).

Under the scheme, technology up-gradation would primarily aim at complying with the Good Manufacturing Practices (GMP) as per WHO GMP/ other international GMP norms and requirements of premises, plant and equipment for pharmaceutical products for this purpose. The list of well established and improved technologies include quite a few important components of equipments that are relevant and essential for upgradation of MEs so as to comply with WHO GMP/ other international norms.

The list of eligible machinery will be upgraded by the ministry on a periodic basis by a Technical Committee which will be set up by the ministry.Under the scheme, only new machinery will be permitted. Benchmarking of the cost of machinery will be done by a committee. This committee shall also look into all possible disagreements between lending institutions, units and SIDBI regarding eligibility and the cost of equipments/machinery.

A medium enterprise can undertake one or more activities under technology upgradation. However, multiple activities can be undertaken only in an integral manner, i.e., by way of forward or backward integration. For formulation activities packing in various forms shall be considered as integral activities. The upgradation includes laboratory (both instrumentation and microbiological), pollution treatment devices, controls, training, documentation, information technology, energy generation (DG), energy saving equipments and automation in production activities.

PTUAS will be totally independent of other similar schemes. ME units are permitted to avail of benefits of other schemes, in addition to PTUAS unless specifically provided otherwise.

The lending period is restricted to five years with a moratorium of one year, the interest incentive would be available during the currency of loan subject to a maximum period of six years. The unit should be in operation during the period of availment of incentives and if the unit closes down/becomes NPA, the unit would not be eligible for interest incentive.

Dept of Pharma wants review of FDI rules

The department of pharmaceuticals (DoP) under the ministry of chemicals and fertilisers has proposed that the government set up an expert group to assess the impact of foreign direct investment (FDI) in this sector. The move follows complaints from Indian companies that they were being forced to sell out to foreign companies for lack of long-term funding for R&D and market development.

DoP’s proposal comes after a suggestion by the National Security Council (NSC) that the sector be put on a “sensitive list” requiring approval by the Foreign Investment Promotion Board (FIPB).

Currently, FDI up to 100 per cent is allowed in the drugs and pharmaceuticals on the automatic route.

The department was responding to a note prepared by the NSC in February for the 20-member committee of secretaries (CoS) set up to suggest changes in FDI policy in sectors that involve security concerns. Cabinet Secretary K M Chandrasekhar heads the CoS.

In its letter to the NSC, the DoP said it had already raised concerns with the commerce ministry that acquisitions of Indian companies in this sector could increase, and this trend would impact the pricing and availability of medicines in India. It has suggested that an appropriate assessment be made on this issue by a small group and a study commissioned quickly. The DoP has proposed that the recommendations could be placed before the Prime Minister’s Economic Advisory Council or any other competent authority.

It has said the study should consider the views of the department of biotechnology, under the ministry of science and technology, and the ministry of family health and family welfare before the CoS takes a final call on changes in FDI for this sector.

In response to NSC’s February note, the commerce ministry has suggested that FDI levels in the sector on the automatic route should be cut from 100 to 49 per cent, meaning all proposals for foreign investment above 49 per cent would need FIPB approval.

The Indian Pharmaceutical Alliance – an association of Indian pharma companies -has been lobbying the government on the serious funding problems the sector faces, pointing out that companies like Ranbaxy, which was recently acquired by foreign companies, was involved in R&D and was striving for development of international business. However both these activities required significant infusion of funds from time to time with long-gestation periods.

The Alliance has also pointed out that there are serious new entry barriers in the international market such as seizure in transit, ever-growing intellectual property rights enforcement and protection and attacks on India’s brand equity.The Alliance has suggested that government should consider appropriate funding mechanism to protect and promote the domestic pharma industry.

FDA Approves New Somatropin Injection Pen for Growth Hormone Disorders

The US Food and Drug Administration (FDA) has approved a prefilled somatropin (rDNA origin) injection pen (Norditropin FlexPro, Novo Nordisk, Inc) for the treatment of growth hormone disorders in adult and pediatric patients. The product, an updated version of the company's NordiFlex pen introduced in 2004, is expected to be available in the second quarter of 2010.

According to a company news release, the pen was designed to facilitate use by pediatric patients. Advantages include a user-friendly design that makes it easy to learn and use, and an audible click that confirms each dose dispensed; no drug reconstitution or loading of cartridges is needed. Once started, the 5-, 10-, and 15-mg/mL pens may be left at room temperature for up to 3 weeks without spoiling.

In a usability study, 100% of patients found the device easy to master, and 99% of patients responded that they found it easy to push the dose button and administer the subcutaneous injection, respectively.

"Easy to use, growth hormone delivery devices allow patients and health care professionals alike to benefit from the convenience of these pens," noted Pinchas Cohen, MD, professor of pediatrics at the David Geffen School of Medicine at the University of California–Los Angeles and chief of endocrinology at the Mattel Children's Hospital at the University of California–Los Angeles in the news release.

Pediatric indications for recombinant somatropin (Norditropin) include the long-term treatment of growth failure resulting from growth hormone deficiency, short stature associated with Noonan and Turner syndromes, and short stature in small-for-gestational-age children with no catch-up growth by age 2 to 4 years. It also may be used to treat adults with adult- or childhood-onset growth hormone deficiency.

Somatropin therapy is contraindicated in patients with acute critical illness following open-heart surgery, abdominal surgery, or multiple accidental traumas; acute respiratory failure; active malignancy; diabetic retinopathy; hypersensitivity to any product components; and children with Prader-Willi syndrome who are severely obese, have sleep apnea, or have severe respiratory impairment.

Adverse effects most commonly reported with somatropin therapy include headaches, myalgia, joint stiffness, hyperglycemia, glucosuria, peripheral edema, injection-site reactions/rashes, and lipoatrophy.

Other potential adverse events may include impaired glucose tolerance and unmasking of diabetes mellitus; intracranial hypertension; new-onset or worsening hypothyroidism; and slipped capital femoral epiphysis and progression of existing scoliosis in children. Somatropin also increases the risk for otitis media in children with Turner syndrome.

Patients with Noonan or Turner syndrome should be closely monitored because of an increased risk for congenital heart disease.

Clinicians should be aware of patients taking glucocorticoid medication, thyroid hormones, insulin or other antidiabetic medications, oral estrogen replacement therapy, or drugs that undergo hepatic metabolism such as corticosteroids, sex steroids, anticonvulsants, and cyclosporine.

Budget could push R&D spend by 25-50%: pharma players

The R&D spend of drug companies could increase to the tune of 25 to 50 per cent thanks to the Budget push, feel Gujarat based pharma majors. This year's Union Budget has increased the weighted deduction for research and development (R&D) expenditure to 200 per cent from 150 per cent, thereby enabling an improved cash flow by reducing the tax burden.

As I A Modi, chairman of Ahmedabad based Cadila Pharmaceuticals explained, "If a company is spending Rs 100 crore on R&D, it will now be eligible for a Rs 200 crore deduction from its taxable income that will directly impact its profit after tax. If we consider a 33 per cent tax on income together with surcharge, that amount is saved directly." This would definitely boost companies to direct more money into research, he added.

"This was a long pending demand of the pharma industry", said a senior official in Intas Biopharmaceuticals Ltd a research oriented pharma major in Gujarat.

Welcoming the move, Ketan Patel, managing director Troikaa Pharmaceuticals said, "Many research based companies that are constantly striving to develop authentic, innovative products to survive in the market, will now get a filip. Research is essential for growth." He felt that the R&D spend could, therefore, rise by 25 to 50 percent.

Troikaa Pharma is in the process of getting patent approvals for its novel drug delivery system for Diclofenac injections, Dynapar AQ from several countries.

It has received patent approvals for Dynapar AQ from nine countries in Eurasia besides 31 countries in Africa and had originally applied for patent approvals in 99 countries.

While Pankaj R Patel, chairman and managing director, Zydus Cadila said that the move will provide much needed support for initiatives in research, he, however, added that "Reduction in state excise duty on products to 10 per cent from 16 per cent is a positive step but this is offset by the overall tax burden increasing on account of minimum alternative tax (MAT) rate being raised from 15 per cent to 18 per cent, when industry was demanding a cut down to 10 per cent".

Echoing the same concern, Sunil Parekh, advisor to Crisil and Zydus Cadila said, "The unexpected increase in MAT to 18 per cent is a dampener. This could habe a negative impact on industry in general and serious R&D establishments." He, however, added that the raising the weighted deduction on R&D will, however, not only boost pharma companies but also many chemical and engineering companies that invest in R&D.

Upbeat from the move, Gujarat wing of the Indian Drug Manufacturers' Association (IDMA) said that now small and medium enterprises could also take interest in R&D. "Currently, the SMEs are not involved in R&D activities, but this move could act as an encouragement.” said Kamlesh Patel, chairman,IDMA, Gujarat State Board. He also welcomed the Union government's move to not increase excise on pharma from a current 4 per cent. IDMA-Gujarat wing had earlier told Business Standard that total abolition of excise on pharma products could attract Rs 5000 crore worth fresh investments in the state.

Zydus applies for Phase II & III H1N1 vaccine trials

AHMEDABAD: The race amongst Indian swine flu vaccine-makers seems to be moving to the next level with Cadila Healthcare Ltd, the Rs 2,900-crore Zydus Group's listed entity, filing for the next phase of clinical trials after completing the first phase.

Talking to ET, Zydus Cadila CMD, Pankaj Patel said: "We have successfully completed our phase I trials and last week we have filed application with DCGI for phase II & III clinical trials". He said, he was hopeful of getting the requisite permission this month. Zydus conducted the first phase of trials for six weeks within Ahmedabad. "The vaccine was found to be effective, safe and well tolerated," said Mr. Patel.

Last month, Serum Institute of India (SII) become the first Indian company to announce the success of phase–I human clinical trials for its swine flu (H1N1) vaccine. SII too will begin the next phase of clinical trials after obtaining the necessary permission from the DCGI.

Amongst the other players working on the development of indigenous H1N1 vaccines are Bharat Biotech and Panacea Biotech. Cadila Pharmaceuticals Ltd, another Ahmedabad-based pharma major, too is working on developing H1N1 vaccine using Virus Like Particles (VLP) technology.

Zydus now plans to conduct the Phase-II and Phase-III clinical trials in Ahmedabad, Bangalore, Jaipur and Pune. The company will be manufacturing the vaccine at its vaccine manufacturing facility at Moraiya, Gujarat. "We will initially be producing 5-6 lakh doses per month which will be doubled to 10 lakh doses per month in the next 6 months." He said.

The company earlier made an announcement during the third quarter in this fiscal year that it planned to launch the H1N1 vaccine in the Indian market by April 2010.