CDSCO approves Form 11 in ONE DAY! – SUGAM Portal Magic

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Encouraged by the Union government’s initiatives towards facilitating regulatory-industry relations, the south zonal office of the Central Drugs Standard Control Organization (CDSCO) in Chennai has kicked off the online issuance of licences and approvals following the introduction of the CDSCO’s high-tech online application system, known as ‘Sugam’.

Dr S Manivannan, the deputy director of drugs control at Chennai CDSCO office has claimed that the high-tech system has operated first in Chennai zone.

“We received applications on June 15, which was the deadline given for online application, we processed the same on the next day, June 16, and issued approval for Form 11 on 17th itself. This is a major achievement as far as both the industry and the regulator’s office are concerned,” he told Pharmabiz.

Form 11 is for grant of licence to import drugs for the purpose of examination, test or analysis. The DCGI has made it mandatory with effect from 15.06.2016.  This is issued online by the DDC at the zonal offices. The first such operation was held in Chennai office.

He said the operation of ‘Sugam’ portal is part of the e-governance facility of CDSCO and it is an initiative for enhancement of services to high-tech facilities and Chennai office is the first one to start within the entire country.  Previously, a minimum of five days time would be taken for processing and issuing approvals or licences.

Prior to the introduction of the online solutions in south India, the DDC has called for a stakeholders meeting at his office in which all the Tamil Nadu based pharma manufacturers, especially importers and exporters, attended. R Chandrasekhar, deputy director at CDSCO headquarters in New Delhi was the chief guest. IDMA Tamil Nadu state board president J Jayaseelan and secretary T Satheesh were also present on the occasion.
While explaining the benefits of the Sugam portal, the DDC at the CDSCO, New Delhi said the online solution offers advantages for patient community, industry people and for the regulatory staff on various things.

Jayaseelan said this high-tech facility would provide better and quick services to the pharma manufacturing companies and other associating business firms. The people of the industry can reduce their travel cost, better use their time and speed up the operations. Earlier, a manufacturer has to go to the CDSCO office several times for submission of applications, tracking the status of submitted applications and receiving licences. The online facility is a onetime solution for all the problems.

Dr Manivannan said he received only one application from Tamil Nadu as the people are now getting to know about it. When asked whether his office has given information to the manufacturers in Kerala, he said there is no big manufacturing company in Kerala. When the DDC’s response was taken to Kerala Pharmaceutical Manufacturers Association (KPMA), Purushothaman Nampoothiri, its president, said the CDSCO office is not giving any attention to Kerala companies.

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Centre for Traditional Medicines and Research has new plans to strengthen Siddha

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As part of promoting and developing the traditional Siddha treatment system worldwide, especially among the Tamil diaspora, the Chennai-based Centre for Traditional Medicines and Research (CTMR) has made scores of proposals to the Sri Lankan government on Siddha system of treatment as part of implementing various health projects in the northern Tamil Province of the island nation.

The Minister for Health for Northern Province, Dr. P. Sathyalingam had recently invited the director of CTMR Dr. T. Thirunarayanan to Sri Lanka to explain in detail the proposals he made to the Lankan government to strengthen the system there. The proposal sought support from the Indian government as well as the state government of Tamil Nadu. In the meeting, he discussed with various health officials, medical officers and hospital authorities who are following the traditional system of treatment there.

While sharing details about his visit to Sri Lanka, Dr Thirunarayanan said manufacture and supply of traditional drugs, especially Siddha medicines, is always a difficult problem there, and there occurs a long gap in the supply system. The quantum of medicines manufactured is very less and often inadequate to cater to the needs of the patients.

In a proposal to develop production and marketing of Siddha drugs, CTMR has suggested that maintenance of quality standard is of prime importance, and for that there should be a testing methodology which should be followed in the analytical process. A well equipped laboratory is essential to address issues like adulteration, misbranding, spurious, not-of-standard quality, etc. Besides, government should ensure availability of good raw materials.

To increase the availability of Siddha medicine in the island country, Dr. Thirunarayanan made a major suggestion that a government owned manufacturing unit with state-of-the-art facilities should be set up. The facilities should be in compliance with WHO-GMP standards. For the availability of raw drugs including herbs, medicinal plants, the government was advised to encourage founding herbal gardens at schools, colleges, homes, public parks, etc and planting of medicinal saplings as much as possible everywhere involving NGOs.

Further, he suggested to digitize the palm leaf manuscripts of Siddha available with traditional healers there and also with the libraries. CTMR will give training in the digitization of palm leaves. He said the government of Sri Lanka can approach the ministry of Ayush in India through ministry of external affairs for financial assistance to train the graduates in Siddha and to conduct continuous medical education programmes and skill development schemes.

For strengthening the potential and skill of traditional medicine practitioners in Sri Lanka, he said the Siddha practitioners in the Northern Province have to undergone specialized training in various treatment methods of Siddha like Varmam, Thokkanam, Kayakalpam, Balar maruthuvam, skin diseases, non-communicable diseases and mental health.

Source : Pharmabiz

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Telemedicine needs to be expanded to rural areas: Dr K Kasturirangan

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Accessing the potential of specialist doctors, the method of telemedicine has to be expanded to the rural areas in order to bridge the urban-rural divide in medicare, according to Dr K Kasturirangan, Member (Science), Planning Commission and former chairman of the ISRO.

This method can be applied in the continuing medical education of the rural doctors and in introducing miniaturized bioinstrumentation to monitor patients and later transfer it to the specialists, he said.

While delivering the convocation address at Sri Ramachandra University  in Chennai, he said there is shortage of specialist doctors and hospital beds in the country.  While there is an urgent need to rapidly implement Vision 2015 of the Medical Council of India to enable every Indian medical graduate to pursue post-graduate education to multiply the availability of specialists, telemedicine could connect these specialists available mostly in urban centres with rural doctors, he added.

According to him ISRO launched telemedicine programme that has now been enhanced to multi-point systems and has a network of 400 centres across the country. The scope of telemedicine can transform the future with miniaturized bioinstrumentation that can monitor a patient’s biological parameters to a finer level and transmit relevant data to specialists.  This can provide sophisticated treatment by specialists even to patients in remote areas. He lauded Sri Ramachandra University for establishing the state of the art telemedicine network connecting India and Africa.

Turning to space medicine Dr Kasturirangan said micro-gravity condition of astronauts affects body mass and  causes bone loss. To study this and cure the related problems, specialized medical courses are required. Referring to space technology as a source of innovative ideas for medical research, he said NASA Bio-capsule made of inert subcutaneous implant that is designed to diagnose a medical problem and administer treatment could revolutionise cancer treatment targeting cancer cells and avoid side effects. He said  space centres and medical institutions should engage in joint medical research.

The former ISRO head said in the next few decades medical sciences are expected to witness several breakthroughs like fabrication of organs through tissue construction and  development of cells acceptable to immune systems.

Source: PharmaBiz

CPCSEA wants DCGI to end use of dogs in regulatory testing following new scientific evidence

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The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) urged the Drug Controller General of India (DCGI) to end the use of dogs in regulatory testing following new scientific evidence from the BUAV and People For Animals. CPCSEA which regulates the use of animals in experiments in India, has urged Dr G N Singh who is the DCGI to examine the country’s use of dogs in regulatory testing and consider switching to humane alternative approaches instead.

The move has come after Dr Shiranee Pereira Tettamanti of People For Animals placed a proposal before the committee in 2013 to consider a ban on the use of dogs in research.  This was followed by a presentation from Michelle Thew, chief executive of the BUAV and Cruelty Free International, on the results of a ground-breaking new analysis carried out by the BUAV, in conjunction with FRAME, which shows that using dogs in experiments to predict toxic responses in humans is not scientifically justifiable.

In a letter to Dr Singh, the CPSCSEA acknowledges the paper and stated, “It appears that the dog test provides essentially no additional confidence in the outcome for humans, but is at great ethical and financial cost. Thus we hope that the DCGI will look into the matter and consider the use of other alternatives.”

People for Animals India, the BUAV and Cruelty Free International have been working with the CPCSEA on the issue since 2013. The news comes on the day of a meeting between the Drug Controller General and founder and chairperson of People For Animals, Maneka Sanjay Gandhi.  It is understood that Gandhi will be reiterating the committee’s call to end the use of dogs in experiments in India.

Michelle Thew, chief executive of the BUAV and Cruelty Free International said, “The CPCSEA decision to push for alternative approaches instead of the use of dogs in cruel experiments is a hugely significant milestone. We have always known that using dogs in research is ethically unacceptable, and our ground-breaking research provides proven evidence that it is not scientifically justifiable either.  I congratulate the CPCSEA for having the vision to recognise and act on this and I call on regulators around the world to follow their lead and end the use of dogs in research.”

Dr Shiranee Tettamanti, co-founder of People for Animals (Chennai) added, “Dogs are our companion animals and it is heartening that the CPCSEA has taken this giant step forward to promote science that rests on scientific reason and ethical values. This decision is not just a milestone for the welfare of animals in laboratories where dogs have been recognised as companion animals, but a milestone wherein a nation has recognised the need to promote humane science. I urge the Drug Controller of India to back these scientific findings and the recommendations of the CPCSEA so that India leads the world by becoming the first country to end the use of dogs in regulatory testing.”

Source: PharmaBiz

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Urgent need to integrate traditional and modern medicine to provide best healthcare :Shekhar Dutt

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Research efforts taking place in traditional medicines in different parts of the world should be integrated through a global coordination network in order to get better outcome in the modern age, according to Shekhar Dutt, Governor of Chattisgarh.

While delivering the keynote address at the two day seminar on traditional medicines held at Ramachandra University in Chennai, he said that there is an urgent need to integrate traditional medicine with modern system to provide the best healthcare to people. The Governor said that no medicine, whether it is traditional or modern, could be fully effective independently, so there is need for integration.  Tomorrow’s medicine would require improving human body’s ability to develop better immune system,  he said.

The Governor pointed out that  parts of several herbs have different molecules capable of yielding newer drugs and India has a huge biological wealth and a large academic community engaged in research.  Giving examples, he said turmeric has 16 active ingredients and Indian ginger has 17 ingredients, whereas Brazilian ginger is known to have 21 active ingredients.  “We need to integrate our research with those in other parts of the world so that we get better outcome for modern health care”, Dutt said.

Earlier, inaugurating the seminar, Prof H Devaraj, vice chairman, UGC, said, “ apart from integration of traditional systems with modern system of medicine there should be accountability in medical research so that along with horizontal development we have vertical development with concrete results and new drugs discovered in India”.

Prof  R S Ramaswamy, director general, Central Council for Research in Siddha, said, Siddha medicines are being rigorously subjected to regular pharmacological studies to certify non-toxicity for global acceptance and use. Referring to recent uproar regarding toxicity in Siddha medicines, he said constant researches are undertaken to identify if any content of toxicity is there in the drugs. He said one drug, a medicated oil, developed under the system has been found to be very effective for psoriasis, and presently people from many parts of the world are coming to Chennai for treatment. Similarly, another one drug has been found effective for reducing the size of fibroid in the uterus, and its clinical trials are going on.

Dr S P Thyagarajan, Professor of Eminence and Dean Research, Sri Ramachandra University, Chennai stressed the need for standardization of Indian formulations of medicinal plants.

Prof  S S Handa, former director, Indian Institute of Integrative Medicines, CSIR and Professor of Head of Institute of Pharmaceutical Sciences, Punjab University was conferred with the Life time Achievement Award by the Governor.

Source: PharmaBiz