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CII moots model cGMP facility with QCI support for drug sector

SSIs set for nationwide stir for not getting sops in budget

'The Recognition of New Systems of Medicines' Bill on cards

JIVAS gets Rs 1 cr from WDF, Denmark for 10 diabetic foot clinics, one mobile clinic

AxSys HealthTech to offer patient management system to hospitals across country

CII moots model cGMP facility with QCI support for drug sector
March 16, 2006, 0800 IST

The Confederation of Indian Industry (CII) is taking the lead to help establish a model cGMP facility having the approval of major drug regulatory agencies to facilitate easy entry for Indian drugs to the developed world markets. The proposal is to involve Quality Council of India (QCI) in developing a common facility to be used by the domestic drug industry for getting quicker approvals from agencies like US FDA and UK MHRA. The CII may approach the government seeking sufficient funds for establishing the facility.

According to sources, CII is looking at the creation of a nodal body to control and regulate policies in GMP for all pharmaceutical manufacturers with emphasis on SMEs. Creation of appropriate cGMP infrastructure for various dosage forms, establishment of pre-clinical research facility for SMEs and establishment of cGMP accredited process development facility for API are among the major objectives of the initiative. As per the initial estimates, an initial investment of about Rs 100 crore would be required to materialize the project.

The CII had recently organized an industry-government interaction to obtain necessary feedback on its proposal. The organization feels that the response from the office of the Drugs Controller General of India, Council for Scientific and Industrial Research (CSIR), QCI, industry associations and individual pharma companies was encouraging.

The CII has stated that the proposed facility would serve as a one-stop shop for testing of product to establish processes for drugs and pharmaceuticals. The agency thus created would aim at global partnerships with US FDA, WHO etc to assist Indian drug companies create cGMP infrastructure of world standards. The testing lab, part of the proposed facility, would include analytical, bio-chemical, micro-biological and chemical testing facility for laboratory analysis. The production facility would be of global standards and would facilitate small scale trial for feasibility testing, process evaluation and determination and establishment of parameters for commercial production. The facility could be used by the pharmaceutical companies to carry out small scale production for test marketing to establish market potential and credentials. Accreditation of GMP consultants is another objective of the programme.

QCI, an autonomous body promoted by the Ministry of Commerce & Industry, is mandated to establish and operate National Accreditation Structure for conformity assessment bodies. QCI is also assigned the task of monitoring and administering the National Board for Quality promotion and oversee effective functioning of the National Information and enquiry services. Indian Industry is represented on QCI by three premier industry associations ASSOCHAM, CII and FICCI.

SSIs set for nationwide stir for not getting sops in budget
March 16, 2006, 0800 IST

The small scale drug manufacturers in the country, upset over the Finance Minister's decision not to offer the much-discussed sops for survival in the Union Budget 2006, are planning to launch a series of protest actions in the coming days.

With this in mind, the SSI pharma manufacturers from various states under the umbrella association Confederation of Indian Pharmaceutical Industries (CIPI-ssi) are meeting in Chennai on 18th and 19th of this month to chalk out future survival strategies. About 30 representatives from various state associations are attending the meet. Apart from meeting the authorities, the meet is likely to chalk out a series of agitations to attract public attention towards the impending closure of SSIs.

CIPI is planning to have a meeting with Sonia Gandhi, United Progressive Alliance (UPA) chairperson and P Chidambaram, Union Finance Minister, as an attempt to salvage the SSIs. The association is likely to take up two issues, reduction of excise duty from 16% to 8% and increase in minimum turnover limit for SSIs from Rs One crore to Rs 5 crore.

Sources said that ministries concerned, including the Health, SSI and Chemicals & Petrochemicals, had recommended these two demands to the Ministry of Finance. Besides, senior officials with the Customs and Central Excise also had informed the CIPI leaders that they also were in favour of reducing the excise duty. With assurances from almost all authorities, the 5000 odd SSI units invested about Rs 300 to Rs 500 crore on modernisation during the last one to one and a half years. Now these units are in deep trouble, they said.

The SSIs also lament that other organisations representing the pharma industry did not take up the issue properly on behalf of the SSIs. While associations like IDMA supported CIPI on certain issues, the MNC backed OPPI and IPA "favoured closure of SSIs," alleged T S Jaishankar, Chairman, CIPI.

"The MNC lobby is not at all bothered about the excise duty issue as they can pass on the additional burden to the consumers. The SSIs, who operate on lean margins, are affected. On most of the platforms, fellow associations contradicted our views. This also would have worked against us. I feel the Finance Minister is still under the impression that the SSIs, who operate through the Propaganda Cum Distribution (PCD) route are reaping huge profits by offering big bonus schemes to doctors. Further, ministry views the increase in abatement given was a big generosity to improve the pharma sector," said Jaishankar.

'The Recognition of New Systems of Medicines' Bill on cards
March 16, 2006, 0800 IST

The Central Government has constituted a Standing Committee of Experts under the chairmanship of director general, Indian Council of Medical Research and members were drawn from various fields of medicine to consider and give its recommendations to the Government on the efficacy and merits of various streams of alternative medicine and also to examine the feasibility of making legislation as suggested by the High Court of Delhi.

The Committee developed essential and desirable criteria for grant of recognition to a new system of medicine and analysed the different streams of alternative medicine including electro-homoeopathy. The Committee did not recommend recognition to any of the alternative medicines except the already recognised traditional systems of medicines viz. Ayurveda, Siddha, Unani, Homoeopahty and Yoga and Naturopathy which were found to fulfil the essential and desirable criteria developed by the Committee for recognition of a system of medicine.

It is learnt, "The Recognition of New Systems of Medicines Bill - 2005" has been drafted in pursuance of the directions of the Supreme Court in a case for regulating such systems / therapies of medicines which are not extended recognition by the Government.

The new Bill will help in addressing various issues related to recognition of different new systems of medicines (including electro-homoeopathy) and penalising those who indulge in undertaking unauthorized practice and teaching these systems. It is learnt that the government has already received some representations against the proposed Bill.

JIVAS gets Rs 1 cr from WDF, Denmark for 10 diabetic foot clinics, one mobile clinic
March 16, 2006, 0800 IST

Jain Institute of Vascular Sciences (JIVAS), a unit of Bhagwan Mahaveer Jain Hospital has received Rs 1 crore from the World Diabetes Foundation, Denmark to set-up 10 Diabetic Foot Clinics in the state under its novel Project 'Padasamrakshane' which means preserve and protect the feet.

The clinics are expected to come up at Hubli, Belgaum, Kolar, Hoskote, Kanakapura and Mandya among others and will be operational by June this year. JIVAS is also talking with the Karnataka Government for the participation of Primary Health Centres (PHCs) to be associated in the Project.

The initiative is a part of the JIVAS Diabetic Foot Care Division. Through this project, JIVAS proposes to train 44 healthcare workers across the country in basic to advance diabetic foot care over two years beginning from April 2006.

As part of the Project, a Mobile Diabetic clinic has been introduced, which is equipped with modern gadgets to go around rural areas within 100 to 150 kilometre radius of Bangalore every day. "This could be the only such clinic for diabetic foot in the world, though there are other speciality offering like eye," claimed Dr. KR Suresh, director, JIVAS.

Two years ago, JIVAS introduced Project LEAP (Limb Evaluation & Education for Amputation Prevention) funded by the Society for Biomedical Technology at Mandya and KGF where 700 patients have received treatment. Plans are underway to train the local volunteers in KGF and Doddaballapur to reach patients in surrounding villages.

Under the 'Project Padasamrakshane,' consultation is free but a nominal charge will be levied for the tests since most of the equipments used are quite expensive. In addition to the World Diabetic Foundation aid, JIVAS has also approached the non-governmental organisations and philanthropists to fund part of the project to keep the operational costs low.

The magnitude of diabetic foot disorders is evident from the estimated 40,000 annual amputations. In the US, it is around 1,00,000 amputations of which 50 percent are among the diabetic patients. In India, over 30 million population suffer from diabetes. Around 5 percent of urban and 3.5 per cent of rural population have diabetes mellitus and 10 percent of these develop foot problems because of bare foot walking. 'The problem could be prevented with simple measures and that is where the Mobile diabetic Foot Clinic will help patients or public undergo examinations to prevent the threat of amputations," explained Dr. Suresh.

A large percentage of amputations in India, are done among patients in the lower income groups. The reason for the negligence is lack of awareness and affordability for treatment. "Hence, we felt to check the increasing number of cases and it would be better to move out to rural areas and help the people to prevent or treat the conditions which is looming as a serious threat in the rural areas, explained," Dr. Suresh.

AxSys HealthTech to offer patient management system to hospitals across country
March 16, 2006, 0800 IST

The Hyderabad-based AxSys HealthTech is planning to offer its advanced electronic patient record and patient management system, Excelicare, across the country. The company is spreading its operations to six cities in India in near future and is targeting a turnover of Rs 20 crore by 2007, Dr Gurmeet Singh, CEO, Axsys HealthTech, told Pharmabiz.

HIPAA / HL7 compliant Excelicare offers several benefits that include clinician friendly, patient-centred electronic patient record, built in telemedicine and home healthcare management, ability to email patient data and merge it directly into the record, uses international care plans and pathways.

Excelicare is a clinical system that allows capture, storage, review, distribution and reporting of all patient information in a consistent format, familiar to all clinicians.

AxSys HealthTech was formed following an injection of equity finance from Morgan Stanley Dean Witter. AxSys HealthTech and AxSys Technology form the AxSys Group and are under control of a common management team.

AxSys Technology Ltd., based at Glasgow, Scotland, aims at exploiting Information and Communications Technology (ICT) to improve the delivery of healthcare. All AxSys solutions are patient-centric and are designed with a clinical perspective to directly benefit patients and healthcare providers, Dr Singh added.

The Glasgow facility is responsible for the design, development and delivery of dedicated software services, including Technical Support, Clinical Support, On-site Project Management and User Education Services.

The Hyderabad facility is responsible for core product development and 'cutting-edge' R&D to specifications drawn up in Glasgow. It has a specialised hardware R&D environment for the development of embedded systems for healthcare.