Health ministry to set up expert panel to re-examine issue of allowing trial in hospitals with less than 50 beds Ramesh Shankar, Mumbai Monday, September 01, 2014,

The Union health ministry will soon constitute an expert committee comprising of experts from various therapeutic areas to re-examine the issue as to whether clinical trials can be allowed to be conducted in hospitals having less than 50 beds with or without emergency facilities.  

A recommendation to this effect was given by the apex committee on clinical trials which was constituted by the Union health ministry in April this year on the directive of the Supreme Court to monitor the clinical trial sector in the country. 

“An expert committee comprising of experts from various therapeutic areas viz. two experts each from medicine, pharmacology, oncology, cardiology, nephrology and one expert each from ophthalmology, dermatology and endocrinology needs to be constituted to re-examine the issue as to whether, depending on nature of clinical trial in a particular therapeutic area, clinical trial can be allowed to be conducted in hospitals/institutes having less than 50 beds with/without emergency facilities”, the apex committee in its 16th meeting held on August 8 under the chairmanship of health secretary Lov Verma recommended, ratifying the recommendations of the technical committee, another high-level panel formed by the ministry on this purpose. 

The committee also opined that the proposed expert committee may co-opt suitable expert(s) from other discipline as per requirement.

The issue came up for discussion in the apex committee meeting on August 8 as Dr. Sunil M. Jain, managing director of TOTALL diabetes Hormone Institute, Indore, Madhya Pradesh had once again requested to revise the essential need of 50 bedded hospitals to conduct a clinical trial and to grant permission for the conduct of clinical trials at their 20 bedded facilities. 

The applications for inclusion of TOTALL was submitted by Novo Nordisk India Ltd (the sponsor) to CDSCO for two global clinical trials in subjects with type II diabetes i.e. CT/76/13: a trial comparing cardiovascular safety of insulin degludec versus insulin glargagine in subjects with type 2 diabetes at high risk of cardiovascular events; and CT/69/13: efficacy and safety of Semaglutide once weekly versus Sitagliptin once daily as add on to Metformin and/or TZD in subjects with type 2 diabetes. 

Early last year, Dr Sunil Jain had approached the CDSCO for the same.  The technical committee and apex committee in its meetings dated 23.08.2013 and 30.08.2013 had recommended that for all clinical trials the sites should be multi specialty hospitals with emergency services and having institutional ethics committees. 

In view of the representations made by Dr. Sunil Jain, the matter was again put forth to the technical committee experts in the 14th meeting dated 28.04.2014. The committee after due deliberation did not recommend for the addition of this site under the said studies as the site is having only 20 beds.  The committee further recommended that the clinical trial sites should have minimum 50 number of beds in the institute/hospital with emergency medical care facility. 

But, Dr Jain once again requested to reconsider the proposal. The apex committee in its latest meeting on August 8 recommended that under the present circumstances, the status quo shall be maintained with respect to the requirement of 50 bedded hospital with emergency medical care facilities for conducting clinical trial. 

However, the committee recommended that an expert committee comprising of experts from various therapeutic areas needs to be constituted to re-examine the issue.
http://www.pharmabiz.com/NewsDetails.aspx?aid=83821&sid=1

Indian pharmaceutical excipients cos get togeather to form IPEC India Our Bureau, Mumbai Monday, September 01, 2014,

Giving a much needed boost to the pharmaceutical excipients industry in India, the leading names in the industry have joined hands to set up its first ever excipients council in India, International Pharmaceutical Excipients Council (IPEC) India.

The founding members of IPEC India are Ajit Singh of ACG Worldwide and Subodh Priolkar of Colorcon Asia. Indchem International, Micro Labs, Dow Chemicals, Lubrizol India, BASF India, SPI Pharma, and Merck Group are the other founder-member companies.

The council will work actively to promote excipients safety and harmonization of regulatory standards and pharmacopoeial monographs. It will give advice and expertise on excipients and excipients-related regulations. The council will focus its attention on the law, regulations, science and business landscape of the Indian pharmaceutical industry for excipient manufacturers and suppliers. It aims to be a proactive colleague of the Indian pharmaceutical industry associations and federations.

IPEC India is the fifth member of the IPEC Federation (www.ipec.org), the others being the Americas, Europe, Japan and China. Internationally, the IPEC Federation is the leading federation of the pharmaceutical excipients industry and has over 250 members across all affiliates.  The IPEC Federation provides a unified voice which promotes the proper use of excipients in medicines as a means of improving patient treatment.

Says Subodh Priolkar, “This is something that the Indian pharma industry has been crying out for. India is one of the world’s largest manufacturers of pharmaceuticals and excipients, which are a critical part of any formulation. It is critically important that we have an industry association that works on these matters.”

According to Ajit Singh, IPEC India will have three main areas of activity. “ In the first place it will represent its members i.e. excipients manufacturers, distributors and finished drug makers to government. It aims to work with relevant authorities and help ensure that regulations are not just streamlined and useful for manufacturers, but also represent the best efforts in reaching and improving upon global GMP standards for both, the Indian market and exports.

“Secondly, via EXCiPACT and other initiatives, IPEC India will set and maintain standards for Indian excipient manufacturers and suppliers. From best practices in manufacturing, to audit guides and templates that will ensure not just a level playing field, but a high reliability quotient for pharmaceutical manufacturers when they use these excipients.

“Finally, IPEC India aims to be a knowledge base and resource centre for the Indian excipients industry, conducting workshops and seminars, organising conferences where training can be given regarding best practices, as well as providing other suitable forums in which knowledge and best practices can be institutionalised in member companies.”

EXCiPACT (www.exipact.org) is a voluntary international scheme to provide independent third party certification of manufacturers, suppliers and distributors of pharmaceutical excipients. So the EXCiPACT scheme provides independent certification of manufacturers and suppliers of pharmaceutical excipients as a means of ensuring patient safety, through supplier quality, while minimising the overall supply chain costs.

The Board of Directors is responsible for the management of the EXCiPACT organization. The members of the Board are appointed by the General Assembly. The members consist of a representative of four of the five founding project consortium associations – FECC, IPEC-Europe, IPEC-Americas and PQG.

Given the involvement of IPEC in the development, and current corporate governance of EXCiPACT, IPEC India is keen to be in the vanguard of bringing this certification to India.

“It is natural for IPEC India to lead the way in introducing EXCiPACT Certification to India. It will be part of our programme to ensure that Indian excipient manufacturers and suppliers can independently verify the quality of their products, both for the internal market, and for export. We are currently working with IPEC Federation to decide on the best way forward, and hope to make further announcements about these exciting developments in the near future,”says Ajit Singh.
http://www.pharmabiz.com/NewsDetails.aspx?aid=83820&sid=1

Intl civil society groups call upon ICDRA participants to ensure access to affordable biotherapeutic products Ramesh Shankar, Mumbai Monday, September 01, 2014,

A group of international civil society organizations including All India Drug Action Network (AIDAN)  from India have called upon drug regulatory authorities, WHO, Member States and other participants of the ongoing Pre and International Conference on Drug Regulatory Authorities (Pre-ICDRA and ICDRA) to act to ensure access to affordable biotherapeutic products. They also called for a regulatory regime in the world which facilitates competition and price reduction.

While the Pre ICDRA was held from 24-25 of August, the ICDRA was organised from 26 to 29, August. 

Stating that it is time to act to ensure access to affordable bio-therapeutic products, the civil society organisations said that the access to bio-therapeutics can play an important role in the fulfillment of the human right to health and peoples’ right to enjoy the benefits of scientific progress and its applications. 

The exorbitant price of bio-therapeutic products places them beyond the reach of millions of people who need them. In addition, exorbitant price also makes it impossible for governments to include biotherapeutic products in the public health programme in a sustainable manner and without compromising the allocation of funds intended for other equally important health services and technologies, it said. 

The civil society organisations in their Pre-ICDRA and ICDRA statements called upon the participants to ensure enjoyment of right to health and right to enjoy the progress of science and technology through appropriate regulation of biotherapeutics and do not view regulation as an end in itself; to implement the directions provided in the WHA 67.21; to develop an appropriate regulatory framework for biotherapeutic products that ensure universal access to affordable, safe and efficacious biotherapeutic products; and to ensure a regulatory framework which facilitate effective competition in the biotherapeutic market instead of making the regulation an unnecessary technical barrier itself.

The civil society organisations also called upon the participants to review WHO Guidelines on biotherapeutic products/medicine based on the accumulated scientific and technology advancement, in a transparent manner with utmost care for avoidance of conflict of interest and including representative Governments in the setting and discussion process. Besides, they also called upon the participants to stop attempts for the creation of separate INN regime for bio-therapeutic products/medicine; to insist for the full disclosure of data and relevant information on clinical trials and manufacturing process by the originator companies; and to make sure that regulatory framework is guided by public health needs and to move away from the corporate driven regulatory norms and setting process.

Some of the signatories to the statement include Associação Brasileira Interdisciplinar de Aids (Brazil), Centro de Información de Medicamentos de la Universidad Nacional de Colombia (CIMUN) (Colombia), Fundación GEP (Argentina), Health Action International (HAI)Third World Network (TWN), etc.
http://www.pharmabiz.com/NewsDetails.aspx?aid=83817&sid=1

MMC serves notices to 11 doctors of top Mumbai hospital for practicing without registration Shardul Nautiyal, Mumbai Monday, September 01, 2014,

Maharashtra Medical Council (MMC) has served show cause notices to 11 Mumbai based doctors for getting engaged in medical practice in a hospital without MMC registrations. Section 33 of the Maharashtra Medical Practitioners Act, 1961 prohibits medical practice by unregistered and unlisted persons. 

The show cause notices served comes close on the heels of a Right to Information (RTI Act) application filed by a Mumbai based finance consultant in a medical negligence case. MMC in its reply on the RTI application revealed that 11 doctors of a reputed hospital are not registered with MMC. Explains an MMC Official, "The show cause notices served is intended to seek a satisfactory answer or explanation within 15 days from the doctors for practicing without registrations with the state medical council." 

An MMC official talking about the magnanimity of the problem related to unregistered doctors and quacks in the country also revealed that Maharashtra alone has over one lakh quacks whereas Delhi has 40,000 quacks as per a study done a few years back. 

In its RTI application filed this year by a healthcare advocacy group Chikitsasansar Trust has also contested that absence of any government regulation led to widespread quackery across the country. Explains Ashok Khandelwal from Chikitsasansar Trust," There are over 2 lakh electropaths working in an unregulated manner because there is no Act in place. As such it does not come under the purview of either of the central or state government's medical Act. This can have a bearing on the patient safety as quacks are practicing it in several villages of the country."

While contesting the issue of recognition of electro homoeopathy which has come up before various high courts, its practitioners say that no law has banned its practice and they are entitled to engage in a profession as guaranteed by the Constitution. The right of electro homoeopathic practitioners are well protected under Article 19(1)(g) of Constitution of India.

For practicing modern medicine or any other forms of Indian system of medicine like Ayurveda/Unani systems of medicine, registration is required under Medical Council Act. For getting these registrations, the applicants should also possess the prescribed qualifications. But electro homoeopathy is an entirely different system of medicine. Its practice is not controlled by any state in India. It is not prohibited by any law also. 

Therefore, the practitioners have a fundamental right under Article (19) (1) (g) of the constitution of India to proceed with the practice of the electro homoeopathy. Doctors can practice electro homoeopathy by settled law of the Government of India which means law allowed.

http://www.pharmabiz.com/NewsDetails.aspx?aid=83819&sid=1

Kerala's first pancreas-kidney transplant performed in Kochi

KOCHI: It was 19 years after he was confirmed as a Type-1 diabetic patient that Syed Yunus Shahir (35) ate an ice cream without a pang of fear. "I can eat normal food and I'm no more a diabetic. I can't express how it feels," said the civil engineer from Palakkad, while leaving Amrita Institute of Medical Sciences here after a combined pancreas-kidney transplant.

His wife Sunitha Shahir was busy packing their things to move out of the hospital. "Ours was a love marriage. She married me, knowing that I am insulin-dependent and today I am free from all diabetes-related complications, including retinopathy and end-stage kidney failure."

The 12-hour surgery was the state's first combined pancreas-kidney transplant, and the third in India. Juvenile Diabetes Mellitus is a relatively rare health disorder, wherein insulin-producing Beta cells in pancreas face destruction. The situation could lead to damage of organs like kidney, heart, nervous system, blood vessels and eyes.

The donor was a brain-dead patient, 38-year-old Thomas Varghese, whose organs were donated through the Kerala Network for Organ Sharing (KNOS).

Doctors said transplant was not a solution for all those suffering from Type-1 diabetes.

"This could be a solution for those suffering from juvenile diabetes, kidney failure and damage to other organs," said Dr Ramachandra Menon, gastrointestinal surgeon who performed the surgery. "In Shahir's case, despite using an insulin pump, he had erratic control of blood sugar." Transplant surgeon Dr Unnikrishnan G said Shahir's pancreas had an endocrinal defect, which meant that his body was not producing insulin.

The combined procedure is particularly effective for those with Type 1 diabetes and chronic kidney failure. Even a transplanted kidney could be affected by the high blood sugar levels if the kidney alone is transplanted.

Doctors said the procedure could improve the quality of life and bring freedom from diabetes-related complications.

http://timesofindia.indiatimes.com/city/kochi/Keralas-first-pancreas-kidney-transplant-performed-in-Kochi/articleshow/41310572.cms

'Set up day-care centres for the mental challenged in all districts'

MYSORE: Karnataka state mental health task force chairman K A Ashok Pai on Saturday said that the task force would press for the opening of day-care centres in all district headquarters to treat and rehabilitate mentally challenged people.

"As per norms, each district should have a minimum 20-bed facility, including 10 for de-addiction programme. This apart, the districts should have the required number of psychiatrists, psychologists, social workers and nurses. But many districts do not have psychiatrists to treat the mentally challenged patients, the number of whom is growing up. Around 75 lakh people in Karnataka are in need of mental healthcare services. Due to lack of facilities, many depressed people are taking drastic steps of ending their lives," he claimed.

The members of the task force, set up a year ago, have toured different parts of the state and prepared a list of recommendations to be submitted to Karnataka Mental Health Authority on September 5.

Their top priority is the creation of adequate facilities in each district headquarters to treat mental challenged people. Secondly, they want the government to recruit required number of supporting staff members along with psychiatrists. "Also, a mentally ill person requires continuous medication for 2-3 years for a permanent cure. However, (s)he becomes normal after initial treatment. A day-care centre would help such patients," Ashok explained.

District health officer H T Puttaswamy claimed that many patients are being treated and sent back home due to lack of facility. "The proposed day-care centre would enable patients to stay there for three weeks for adequate treatment and food. It requires additional funding," he said.

KR Hospital psychiatric department head B N Raveesh said that the primary objective of the task force is to create awareness about mental health. "It also wants to ensure treatment, and implement the provisions of national mental health programme," he added.
http://timesofindia.indiatimes.com/city/mysore/Set-up-day-care-centres-for-the-mental-challenged-in-all-districts/articleshow/41328963.cms

Cord blood bank under FDA lens for operating without licence Sumitra Deb Roy,TNN | Aug 31, 2014,

MUMBAI: An ISO-certified cord blood bank in Sangli was found to be grossly negligent in labelling, testing and storing of stem cells. The Food and Drug Administration (FDA), which uncovered the violation last week, is now contemplating police action against the centre and a crackdown on more such set-ups across state.

Stem Plus Biotech was found to be operating without a valid licence since its inception two years back. Among the serious laxities, the FDA officials found that the mandatory tests to rule out infections, including HIV, hepatitis B and C, syphilis, malaria, etc, in the maternal blood were not carried out at all. There were also question marks on whether or not the stem cells from the umbilical cord were processed within the stipulated 72 hours. Stem cells are master cells that can transform into any type of cell creating blood, kidneys, bones, etc.

Acting on a tip-off, officers from Mumbai FDA visited the centre last week, presenting themselves as clients willing to invest in cord blood banking. On reaching the centre, which was housed in a commercial complex again in violation of the Drug and Cosmetics Act, the officers were ushered in with professional elan. They were explained the various schemes following which the undercover officers demanded a visit to the storage facility.

"The violations were clear once we went inside. There were no reports to show that maternal blood was being tested. The bar-coding was incomplete, which is a serious violation. There was no clarity on how much of the freezing agent was being used to preserve the cells and these errors can be potentially hazardous," said Dr Madhuri Pawar, assistant commissioner (vigilance), FDA. "They did not have a quality control in-charge or a technical supervisor, who are supposed to ensure all the protocols of banking are followed," added Pawar.

Dr Rohit Kulkarni, member of the Association of the Stem Cell Banks of India, said that the licensing rules were laid down only in 2012. "It may be an inadvertent mistake. But, two years is a long time to get all permissions in place," he added.

Pawar said that FDA will lodge an FIR at Sangli against the centre.

http://timesofindia.indiatimes.com/City/Mumbai/Cord-blood-bank-under-FDA-lens-for-operating-without-licence/articleshow/41376565.cms

India, Japan to fight Sickle Cell Anaemia together

Kyoto: Japan on Sunday agreed to work with India in inventing treatment for  Sickle Cell Anaemia after PM Narendra Modi sought help for finding remedy to the deadly disease common among tribals in India.

Mr Modi, who has been keenly looking for a remedy to the disease since his days as Chief Minister of Gujarat, discussed the issue with Nobel Prize winner for medicine (2012) S Yamanaka when he visited the Kyoto University.

The Prime Minister, raised the issue during his visit to the Stem Cell Research facility of the University.

http://www.deccanchronicle.com/140901/nation-current-affairs/article/india-japan-fight-sickle-cell-anaemia-together

Work in Rural Areas on Holidays, Doctors and Specialists Told

NEW DELHI: As part of the efforts to strengthen the medical facilities in far-flung villages and areas, Union Health Minister Dr Harshvardhan on Sunday appealed to the doctors and specialists to adopt the ‘Work on Holiday’ package to serve the people in these areas.

Speaking at the Annual conference of the Society of Cardiac Anaesthesiology, Vardhan urged the doctors to serve the patients in the hilly areas,  where the respective state governments were finding it terribly difficult to provide secondary and tertiary healthcare.

He cited the example of his recent visit to Mussoorie-- where he had confronted the critical lapses in the public health system of hilly terrain-- which had only two small government hospitals with very few trained doctors which resulted in many preventable deaths.

“The mismatch between the natural beauty of the region stretching from Dehradun to Jaunsaar-Bawar tribal belt, and, the ugly reality of people dying for want of even the basic primary care is a problem we must address with an out-of-the-box approach,” he said.

Dr Vardhan exhorted the specialist doctors to visit the hill stations as guests of the state government. And they could also offer their services as cardiologists, gynaecologists, neurologists and anaesthetists, while simultaneously enjoying the state government’s hospitality with their families. According to the minister, the medics should consider this as an extension of their service. Harshvardhan said he would soon circulate this suggestion among the state governments.

“Even after 67 years of Independence, health for every Indian is still a distant dream. But, I believe if we can put our heart and soul to it, we can achieve it...And, therefore I appeal to all doctors, in every specialty to devote at least some time in small villages, where access to specialised medical services is not easy,” he said.

He also added that though the county faced  a shortage of medical experts, they could still serve patients in a better way. He urged the doctors to find ways to decrease the death rate.

“The deficit in specialist medical practitioners has resulted in patients being  deprived of treatment,” Vardhan added.

He said the medical practitioners should come up with innovative ideas to extend healthcare to the people and asked them to find new ways to cut down on the death rate.

http://www.newindianexpress.com/nation/Work-in-Rural-Areas-on-Holidays-Doctors-and-Specialists-Told/2014/09/01/article2408915.ece

Karnataka wary of losing investments in pharma to AP, Telangana, and Tamil Nadu Nandita Vijay, Bengaluru Saturday, August 30, 2014,

As the newly formed Telangana and the residual state of Andhra Pradesh are competing with each other to attract investments now, Karnataka fears that it would much lose some of its major projects in the drug manufacturing space. 

Though no companies have confirmed their investments into Andhra Pradesh, Telangana and Tamil Nadu, industry sources are of the view that there is every possibility that investments into Karnataka may get diverted to its neighbouring states.

In March this, Karnataka Udyog Mitra, the single window agency which facilitates investments into the state cleared the GlaxoSmithKline Pharmaceuticals formulation production plant project. The MNC has now been allocated 50 acres of Karnataka Industrial Area Development Board (KIADB) land at the Vemgal Industrial Area in Kolar for the manufacture of tablets and capsules. The production plant will require 2600 KVA power. The company is slating a Rs. 994 crore investment and is slated to provide employment to 232 personnel. However sources have indicated that the GSK is yet to confirm this investment.

Industry observers said that GSK is set to seriously contemplate whether to set up the facility in Karnataka. This is primarily because of the Telangana government's new initiatives unveiled by governor E S L Narashimhan to establish a Pharma City to give a further fillip for the development of pharmaceutical industry in the region. There are sops like tax rebates, slashing of excise duty, uninterrupted power and water supply. With the presence of Ramagundam, the City of Energy situated on the banks of river Godavari, off 250 kilometres from Hyderabad is a key factor favoring investors with regular and quality power.

According to the Governor of Telangana, the region contributes one third of the pharma production in India and to sustain this growth it would look to woo Greenfield and Brownfield projects in pharma and biotechnology.

In the case of Karnataka, there have been no any major Greenfield pharma investments for over a decade. The government which unveiled a Karnataka Pharmaceutical Policy primarily to spur investments are yet to be implemented. Therefore there are clear signs that that the state lacks the assertiveness to woo and retain investments, expressed sources.

“We are waiting for GSK to finalize and cannot comment on the issue,” M Maheshwar Rao, Commissioner for Industrial Development and Director of Industries and Commerce told Pharmabiz.

It is gathered that GSK is making its second time entry into Karnataka. Over a decade ago, the global drug company had a full-fledged manufacturing facility but later went on to shut down operations. However, it has over five pharma companies in Bengaluru undertaking contract manufacture for its range of capsules and tablets. These are Kemwell, Medreich now acquired by Meiji Pharma, Remidex, Geltec and Tejkamal Pharmaceuticals.

Former employees of GSK do see that the global drug major would see Karnataka as a favorable location to kick off its dedicated production plans which could be driven by climatic conditions, access to qualified workforce and presence of leading research institutes like NCBS, JNCASR and IISc. 

http://www.pharmabiz.com/NewsDetails.aspx?aid=83805&sid=1

Pharma cos look up to solar power to stall power crisis impacting production plants Nandita Vijay, Bengaluru Saturday, August 30, 2014,

Bogged down by staggering power supply, pharma units across India and primarily in Karnataka are looking at renewable energy solutions like solar power to solve the crisis. The cancellation of the coal block allocation is another blow to power generation as 54 per cent of electricity in India is produced with coal.

A few weeks ago, Karnataka, indicated its inability to provide 24/7 power supply owing to daily shortage of 1,000 MW. With the Union government’s focus on renewable energy and the allocation of Rs. 1,000 crore to develop ultra large solar power plants and solar parks has made pharma companies to look at the sun to solve its power crisis.

According to Jatish N Sheth, president, Karnataka Drugs & Pharmaceutical Manufacturers Association (KDPMA), solar could be the answer to prevent the power crisis in future.

In India, the big names in the space include ACME Group, Azure Power, Tata BP Solar, Schneider Electric India Solar Business Unit and Vikram Solar are engaged in discussions with the pharma industry for the effective implementation of solar-power generation solutions and working closely to contribute to the sector through its efficient green-energy solutions.

Solar power is the saviour and this source replaces diesel generators, reduces carbon footprint. Therefore solar power is the best suited for any manufacturing units including pharma as the sun-lit hours match the time-slot for most of the industries, Manoj Kumar Upadhyay, chairman & managing director, ACME Group told Pharmabiz in an email.

Reduction of excise duty to promote domestic manufacturing of solar cells, modules and batteries, allocation of Rs. 100 crore to replicate the solar power project commissioned on Narmada canal would enable India to enhance its solar power production share in the overall electricity generation from existing 1 per cent to 3 per cent , he added.

“There is need for dedicated Pharma Park which has solar power installation to ensure uninterrupted manufacturing operations, said Harish K Jain, treasurer, KDPMA and director, Embiotic Laboratories (P) Ltd.

According to Sunil Attavar, secretary, KDPMA and managing director, Group Pharmaceuticals, solar power installations would help considerably help non manufacturing operations in a plant and it was high time that the industry looked up to the sun for power.

Solar power is cost effective in the long-run and adopting a green energy path should be a bench mark for pharma industry which is a power guzzler, said solar panel manufacturers who stated that there is an overwhelming response for solar-led power generation for captive and grid utilisation.

A few states have net-metering policy enabling retail power users to feed in the surplus energy generated back to the grid, which in turn reduces cost and carbon footprint. “As an industry leader, we propose that states not having access to 300 sun-lit days should invest in solar parks. Several industrial parks are opting for solar power and seeking LEED certification too”, said the ACME Group chief.

A handful of small and medium enterprises(SMEs) in pharma viewed that that solar power was ideal for R&D labs and not for large scale manufacturing. But ACME along with other solar companies beg to differ. “This perception has changed with advances in technology. Solar is the future in power generation. Its short panel construction time, modular design and easy maintenance are its success factors,” said the ACME CMD.

However, a challenge is to convince pharma SMEs to accept the higher upfront which follows with the minimal operation cost after installation. There is also an issue of space constraint, as the roof-top solar power unit stalls the option future high rise construction on the same building, said Upadhyay.

http://www.pharmabiz.com/NewsDetails.aspx?aid=83803&sid=1

DICs need to be effective to generate awareness about ADRs among patients to avoid tragedies: Experts Shardul Nautiyal, Mumbai Saturday, August 30, 2014

In the wake of rampant incidents of adverse drug reactions (ADR) in 38 women at BMC run Bhabha Hospital, Kurla and at Rajawadi Hospital in Vidyavihar East after being administered a variant combination of two Schedule H1 antibacterial antibiotics - ceftriaxone and cefotaxime recently, pharma experts advocate that the concept of Drug Information Centres (DICs) need to be embraced by healthcare institutions to address the menace. 

Out of the 38 women who suffered drug reaction, a 47-year-old woman died a week ago, after 24 hours of suffering an ADR due to the administration of antibiotic injections at BMC run Bhabha Hospital.  

DICs according to experts will not only dispel a lot of misconceptions with regards to medical prescription but help address issues pertaining adverse drug reactions, drug usage, dosage and time schedule for patient safety. 

Experts rue that the concept is old but not very popular in India because of low awareness levels. In developed countries, pharmacists running medical shops are supposed to provide drug information through DICs. Informs Dr Atmaram Pawar, dean, pharmaceutical sciences, Bharati Vidyapeeth Deemed University, Pune, “DICs are important because drug information helps minimise death due to adverse effect of drugs. This is more relevant because India practically lacks a system to identify the reason of deaths due to drug side effects.”

First DIC in India started at JJ Hospital and KEM Hospital, Mumbai in 1968. There were around 21 DICs till 2008. Only government hospitals like All India Institute of Medical Sciences (AIIMS), New Delhi, Victoria Hospital, Bengaluru and few state pharmacy councils were equipped with DICs a few years back. 

"After launching of Pharm D courses in India during 2008-09, each college in India started gearing up towards setting up DIC and the number of DICs in the country gradually reached the figure of around 100 or so. But very few of them are working effectively today. Reason being that they are inclined more towards academic information and not into delivering clinically relevant information and details," he informs.

Taking cue from the developed countries where running a DIC is the main job of a pharmacist, DICs should ideally be promoted in the country, Dr Pawar advocates.

http://www.pharmabiz.com/NewsDetails.aspx?aid=83804&sid=1

Wholesalers in UP complains against Torrent to CCI for withholding supplies Peethaambaran Kunnathoor, Chennai Saturday, August 30, 2014,

Following a complaint raised by the All India Chemists & Distributors Federation (AICDF) against pharma major Torrent Pharmaceuticals for withholding supplies to the erstwhile stockists of Elder Pharmaceuticals, wholesalers from Uttar Pradesh have written to the director general of the Competition Commission of India (CCI) stating that the Ahmadabad-based pharma company is violating all the laws of pharma trade and indulging in illegal trade practice.

The Uttar Pradesh chemists & distributors Association (UPCDA) also approached the CCI with the same complaint and sought justice for good trade practice. 

The traders have alleged that the pharma company has stopped supplies to a certain number of wholesalers nationwide because of strict instruction from all India Organisation of Chemists & Druggists (AIOCD). The wholesalers who were previously the stockists of Elder Pharmaceuticals, whose branded domestic formulations were acquired by Torrent last year, are members of AICDF. They are now not getting products from Torrent.

The president of UPCDA, Vibha Shankar Singh,  says that AIOCD wanted Torrent to obtain NOC from the state unit of the all India trade body to effect supplies. He told Pharmabiz that there was an agreement between Torrent and UPCDA in June this year, followed by it, it resumed supply for a few days. Immediately AIOCD has intervened and stopped supplies.

Seeking justice for good trade practice, the UPCDA president wrote to the CCI that Torrent is violating provisions of Drugs and Cosmetics Act and the Clause 28a of the Drugs Price Control Order (DPCO). The D&C Act 1940 and Rules framed there regulate the manufacture, sale and distribution of drugs in the country. The drugs control administration (DCA) is solely responsible for the enforcement of the Act. No other private body can regulate or intervene in this sector. Violating this rule, AIOCD is controlling the whole pharma trade in the country.

The West Bengal branch of AICDF had filed a case in this connection with the competition commission last month. Since there are several manufacturing companies accepting the dictates of AIOCD, the Federation has apprised the matter to the department of pharmaceuticals and to the union health ministry for immediate action.

http://www.pharmabiz.com/NewsDetails.aspx?aid=83802&sid=1

Lack of food behind half of TB cases

Lack of food behind half of TB cases

Womans body is a temple: Harsh Vardhan, Union Health Minister

Womans body is a temple: Harsh Vardhan, Union Health Minister

Now, all senior citizens can visit CGHS wellness centres for free consultation - The Hindu

Now, all senior citizens can visit CGHS wellness centres for free consultation - The Hindu

Hyderabad to emerge as new biotechnology capital of India: Experts Our Bureau, Hyderabad Thursday, August 28, 2014

Hyderabad, the capital city of Telangana and Andhra Pradesh has the potential to become the biotechnology capital of India in the coming years, opined experts at broacher unveiling ceremony organised by OMICS group in the city. “Though many have projected Bengaluru as the biotech capital of India, in fact it is Hyderabad which has the potential. With numerous research institutes like CCMB, IICT along with private biotech players like GVK Bio, Bharat Biotech, Shanta Biotech, Dr Reddy’s, Mylan etc, the city of Hyderabad is a favourite destination for investments in the bio similar segment,” said Srinubabu, managing director of OMICS International Inc. 

According to Dr Kaiser Jamil, Director of Centre for Biotechnology and Bioinformatics, Jawaharlal Nehru Institute of Advanced Studies (JNIAS), there are lots of areas that are left unexplored in the biotechnology segment, with hundreds of biotech drugs coming off patent regime, very soon a large number of national and international companies are expected to focus in this segment and particularly Hyderabad is a favourite destination for new investments in biosimilar, biologics and biowaivers.

“Similar to generic medicines, biosimilars are imitation of patented biotech products.  Use of biosimilar products has fewer side effects as they can target only the infected areas in the body. With numerous educational and research institutions, the city of Hyderabad is already well equipped with the required infrastructure along with availability of affordable skilled and qualified manpower. Already renowned research institutes and biotechnology companies are working in the biosimilar segment. Majority of the companies are ready with their ground work and waiting for the right time to grab the opportunities,” opined Dr Kaiser.

At present Europe, China, Vietnam, Korea, India and Brazil are leading takers of biosimilar products in the world, while USA, Europe and Japan are leading in biologics segment. According to experts, the global biosimilars market is expected to reach $20 billion by the end of year 2015 and is largely driven by patent expiries. The segment is growing at an annual growth rate (CAGR) of 89.1 per cent from 2009. By 2020, the global market for biosimilars will be reaching $55 billion. More than 80 biosimilars are in the process of development worldwide currently and this market could potentially become the fastest growing biologics sector by 2020.

Having learned this, the OMICS group is planning to organise an international conference on biowaivers, biologics and biosimilars from October 27 to 29 at Hyderabad international convention centre, where about 300 biotechnology companies are expected to participate to discuss on challenges and regulatory approaches for biosimilars in the emerging markets. Experts like Krishna Menon of Cellceutix Corporation from USA, Daniel Galbraith of Bio Outsource Ltd from United Kingdom, Rodeina Challand of PRA Health Sciences from UK and Kamali Chance of Quintiles from UK are expected to focus on areas of emerging biosimilars in therapeutics and clinical studies.

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Separate counters for generics opened in medical stores in all districts of Haryana Peethaambaran Kunnathoor, Chennai Thursday, August 28, 2014

Under a strong initiative taken by the Haryana drugs control administration, the Gurgaon Chemists & Druggists Association (GCDA) has decided to open separate counters for generic medicines in all their pharmacies.

The move to popularise generic drugs through private medical stores will be expanded to all the 21 districts in the state within two years. Separate counters will be opened in all the medical stores exclusively for generics. Special instructions will be given to all the manufacturing companies to print separate labels with the actual prices of the generic medicines rather than pasting a higher MRP label, said Dr G L Singhal, director of state drugs control administration.

With this Haryana state DCA will become the first enforcement authority in India to advocate for generic medicines dispensing through private pharmacies, he claimed. According to him, generic medicines are as good as branded ones as far as quality is concerned. Besides they are available at reasonable prices compared to branded drugs. Dr Singhal added that all the government healthcare institutions in Haryana are dispensing only generic versions.

With the support of Gurgaon Chemists and Druggists Association, the zonal drugs control officer, Lalit Kumar Goel, has called a meeting of retail chemists and doctors working in government hospitals and members of IMA to discuss the supply scheme. In the meeting twenty five retail chemists assured that they would promote generic products through their retail outlets. The vice-president of GCDA, Charanjit Arora said he would soon open a full-fledged generic medicine shop in the city to dispense only generic drugs. The association has requested the civil hospital authorities in the city for a space to start a generic store.

While inaugurating the meeting, Dr. Singal said although India is the largest supplier of generic medicines to the world and every third tablet used in other countries of the world is from India, the poor patients of India are forced to take costly branded drugs.

“In Haryana we are advocating for generic medicines to the poor patients. Doctors are also cooperating with the department and supporting our efforts. They will prescribe only the name of the molecules. A happy thing is that the chemists association is also cooperating with the move and ready to provide medicines at reasonable prices”, said Dr Singhal.

Dr Singal had done Ph.D on a research project of branded generic medicines and launched campaign for propagation of generics in the country last year, said Lalit Kumar Goel, Gurgaon DCO.

Dr. Suman Dahiya, president of Gurgaon unit of I.M.A said they will ensure that generic medicines are prescribed to patients by the members of IMA.

Dr.Pushpa Bishnoi, civil surgeon of Gurgaon government hospital, G.S. Pasricha, president of chemist association Gurgaon zone, Manmohan Taneja, Amandeep, Rakesh Dahiya, Parjinder Singh and Gurcharn have addressed the audience.

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IPC to work with NACO to monitor safety of ARV drugs as part of PvPI programme Suja Nair Shirodkar, Mumbai Thursday, August 28, 2014

With a view to have a tab on the antiretroviral (ARV) drugs available in the market, the Indian Pharmacopoeia Commission (IPC), the national coordinating centre for the pharmacovigilance programme of India, recently agreed to work closely with the National AIDS Control Organisation (NACO) for reporting ADRs on ARV drugs. Under this ambitious project, both the organisation will work to generate data all the ARV drugs used under the national AIDS control programme (NACP).

It is understood that the outcome of the long term use of many of the ARV drugs that are currently running in the market is still not known, which experts feel is a matter of serious concern. With anti-retroviral therapy now available free of cost to all those who need it through the ART centres located in every medical colleges, district hospitals, regulators feel that it is high time to concentrate on having an an efficient ADR reporting system for ARV drugs as well.

NACO, NCC-PvPI and WHO will be henceforth monitoring the possible recognition of new adverse reactions due to ARV drugs, while they will also be working to bridge the gap between ART centres and ADRs monitoring centre in monitoring and reporting. Dr Kalaiselvan, principal scientific officer, Indian Pharmacopoeia Commission informed that they also plan to have a standardised definitions in reporting system (software) for ARV drugs, while at the same time the NCC-PvPI and WHO will be providing training for the ART team in ADRs monitoring, reporting and causality assessment.

According to Dr Kalaiselvan this alliance is a part of the IPCs ongoing efforts to strengthen the PvPI programme further by specifically focusing on the adverse drug reactions from the ARV drugs, which are now easily available through scores of ART centres across the country. He further stressed that it is important to initiate this move as lack of data on this front can impact the confidence of the patients, leading to suboptimal levels of adherence to the treatment.

He added, “This initiative stands up as an important milestone towards streamlining the PvPI programme further, especially since there is hardly any data available on the effects of the ARV drugs on the patients across the country. In the light of better accessibility of ARV drugs throughout the country it is high time to build in a monitoring system that is specialised in identifying ADRs specifically arising out of ARV drugs.”

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MMC refers case of 'cut practice' followed by top Mumbai hospital to state govt Shardul Nautiyal, Mumbai Thursday, August 28, 2014

Following an apology from a Mumbai based leading private hospital over the cut practice, Maharashtra Medical Council (MMC) has recently referred the case for further action to the state government as healthcare institutions are not governed by the Maharashtra Medical Practitioners Act, 1961. Cut practice is the term given to exchange of commission for referring patients. 

MMC had sent a show-cause notice recently to this Hospital asking why action shouldn't be taken against it for reportedly paying a commission to doctors for referring patients for hospitalisation.

MMC is a quasi-judicial body that oversees functioning of the medical community. The complaint against the Andheri corporate hospital, too, came up during a core committee meeting to take up complaints filed against doctors. MMC is in receipt of papers with details of the scheme of awards for the referring doctor from this hospital. 

The hospital has allegedly been sending out a prescribed format to various doctors exhibiting 'rewards' for the number of admissions done by the respective doctor. This is nothing but offering a cut for doctors to refer patients for admission to the hospital. The 'reward' as per the prescribed format ranges from Rs. 1 lakh for 40 admissions per annum to Rs. 2.5 lakh per annum for 75 admissions.

The format needs doctors to sign and stamp a statement that reads: "I am very happy to know that the said hospital has introduced a scheme for membership by invitation to senior doctors, for partnering with the hospital, and jointly help bring about unique patient experience in line with the best of global hospitals."

MMC has been cracking down on the 'cut practice' ever since a Mahad-based doctor, Dr Himmatrao Bawaskar, petitioned it after receiving a "commission" from a well-known diagnostic chain for referring a patient for Magnetic Resonance Imaging (MRI). 

As per MMC version, soliciting and receiving any gift, gratuity, commission or bonus in consideration of or return for the referring recommending or procuring of any patient for medical, surgical or other treatment amounts to violation of the (MMC) code of conduct.

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Boehringer Ingelheim, Eli Lilly launch type 2 diabetes drug Jardiance in US market Ridgefield, Connecticut Thursday, August 28, 2014

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company have announced that Jardiance (empagliflozin) tablets are now available by prescription in pharmacies across the United States, including Walgreens, Rite Aid, Kroger and many other leading chain and independent retailers. 

The US Food and Drug Administration (US FDA) approved Jardiance on August 1, 2014 as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes (T2D). Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

"As a testament to the joint commitment by Boehringer Ingelheim and Lilly to improve care for people with diabetes, our alliance is proud to make Jardiance available so quickly following its approval by the FDA," said Kathleen Dowd, senior vice president, marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "We believe Jardiance is an exciting new treatment option with the potential to help many of the millions of adults with type 2 diabetes who have difficulty controlling their blood sugar levels."

Jardiance, a once-daily, 10 mg or 25 mg tablet, is a sodium glucose co-transporter-2 (SGLT2) inhibitor. Jardiance works by blocking the reabsorption of glucose in the kidney, increasing glucose excretion and lowering blood glucose levels in adults with type 2 diabetes who have elevated blood glucose levels.

Patients should not take Jardiance if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any ingredient in Jardiance. Jardiance can cause some people to have dehydration (the loss of body water and salt), which may lead to a drop in blood pressure, and may cause patients to feel dizzy or faint.

The Jardiance Simple Savings co-pay support programme is available online and in many doctors' offices for patients who qualify.

The FDA approval of Jardiance was based on results from a large clinical programme comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D. phase III studies showed Jardiance significantly reduced hemoglobin A1C (a measure of average blood glucose over the past two to three months) after 24 weeks as a stand-alone treatment or in combination with a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone. Although Jardiance is not approved for lowering weight or blood pressure, modest reductions in both weight and systolic blood pressure were observed in clinical trials.

The most common adverse reactions associated with Jardiance were urinary tract infections and vaginal yeast infections. Hypoglycemia was more commonly reported in patients treated with the combination of Jardiance and sulfonylurea or insulin.

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of people with diabetes and stand together to focus on patient needs.

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