Videorecording of consent for clinical trials mandatory

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

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

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

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

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

Source: The Hindu

5th Annual Biosimilars Evolution Congress

Day 1 – 10^th April, 2014

Meet : Key note on Future of biosimilar industry

Sessions :

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

R&D Sessions:

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

Day 2 – 11^th April, 2014

Meet: Opening remarks from the Chair

Sessions:

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

Manufacturing Sessions:

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

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

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

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

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

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

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

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

Pfizer to stop using Blackberry phones

AllThingsD reports that pharmaceutical company Pfizer has advised all of its BlackBerry-using employees to move on to iOS or Android smartphones for work due to BlackBerry’s current “volatile state.” A Pfizer spokesperson explained to AllThingsD that it was recommending that employees continue to ”use their BlackBerry devices and… migrate to a new device at normal contract expiration.” Pfizer employs around 90,000 people and AllThingsD’s sources say the company’s BlackBerry deployment is “huge.” There is a silver lining for Pfizer workers who don’t want to give up their BlackBerrys, however — they’ll at least be able to get BBM on their new iPhones and Android phones

Source: BGR

Indian biotech aiming to be $100-bn sector by 2025: Shaw

 Indian biotechnology sector is looking to be a $100 billion sector by 2025, Biocon Chief Kiran Mazumdar-Shaw said on Saturday.

“We want to make Indian biotechnology a $100 billion sector by 2025. I really believe this can be done if we have right policies in place, right resources and right investments,” Biocon Chairman and Managing Director Kiran Mazumdar-Shaw told PTI.

She was speaking on the sidelines of the third convocation and fifth annual lecture of NIIT University.

Taking this road map is about delivering security like food security, health security and energy security and environment security, she added.

“Agri bio can itself provide a $40 billion sector, Already BT Cotton is a $7.5 billion sector for the country.

If you allow other genetically modified crops it could be much bigger,” Ms. Shaw said.

The government should allow the genetically modified crops. Without that the country cannot be food sufficient, she added.

“Moreover this would also lead to less use of pesticides which are very harmful. You need to reduce pests and pesticides and that can only be done with technology,” Ms. Mazumdar-Shaw said.

If farmers are to become prosperous you need technology, she added.

“This can happen when you have investments in agri-bio, pharma-bio among others,” Ms. Mazumdar-Shaw said, adding that “for this, we need enabling policies by the government.”

Private sector needs the ease to conduct its business, she said.

Source: The Hindu 

Indian Pharmacist Revolution Yatra

The Indian Pharmacist Revolution Yatra has reached Andhra Pradesh and has raised various issues pertaining to pharmacy profession and demanded amendments in various aspects of Pharmacy Act in the country. The main aim of the yatra is to create awareness about the role of pharmacists among the people across the country. The yatra reached Hyderabad on October 20, 2013.

According to Convenor of the yatra, Amitav Joyprakash Choudhury, the main objective of this country wide yatra is to create awareness among the people of this country about the role of pharmacist in healthcare sector. Today the pharmacists have a major role to play in the community pharmacy, manufacturing of pharmaceuticals and research.

The Udyog Development Foundation which began the yatra on January 04, 2013 at Jantar Mantar in New Delhi has planned to tour entire country from Kashmir to Kanyakurmari. As part of this yatra, the Foundation is raising various issues concerning the pharmacy professionals and seeking amendments to Food Safety & Standards Act 2011, Drug and Cosmetics Rules - 1945 (rule 64, 65, 71 and 76, Pharmacy Act-1948, NIPER Act (National Institute of Pharmaceutical Education and Research) and demanded formation of a separate Ministry of Pharmaceuticals, and formation Indian Pharmaceutical Services in the country.

The Indian Pharmacist Revolution has also demanded employment generation for pharmacists in NRHM/Primary Health Centre (PHC), Community Health Centre (CHC), Head Quarters Hospitals and teaching Hospitals. It has also demanded formation of Central Register of pharmacist done by Pharmacy Council of India (PCI).

Till date the foundation has already completed its tour visiting almost all the Northern and Northeaster states. Starting from Jammu & Kashmir in the North, the members of Udyog development foundation have travelled to Punjab, Himachal, Uttarakhand, Uttarapradesh, Haryana, Rajasthan, Gujarat, Bihar, Jharkhand, Chhatisgarh, Odisha, WestBengal, Sikkim, Tripura, Mizoram, Manipur, Nagaland, Arunchal Pradesh, Assam, Madhya Pradesh and now it has begun its tour in the south beginning with Andhra Pradesh.

With this country wide yatra, the foundation is aiming to spread the message of professional ethics and responsibility of the pharmacists towards the society and strengthen the unity among the Pharma professionals. “Today, there are lakhs of pharma professionals spread across the country holding  professional degrees such as D. Pharm, B. Pharm, M. Pharm, M.S. Pharm, Pharm D, Ph.D. and working in different organizations. Many more are freshly graduated every year, but still there is lack of proper awareness about the profession among the common people. Our aim is to highlight the national and state issues relevant to the pharmacy profession and create awareness among the common public,” says Amitav Joyproakash Choudhury.

State of Pharmacy Colleges in India

Last month Pharmabiz carried a report stating that 8345 seats for B Pharm course are going vacant in Andhra Pradesh for the academic year 2013-14. In the previous year, Andhra faced the same situation of not having students for 8150 seats in the state’s 280 pharmacy colleges spread across in 28 districts. And five to ten pharmacy colleges reported zero admissions for B Pharm course during the current year. The report further says that despite a sharp rise in number of vacant seats in the state, some pharmacy colleges are adding more seats every year. If this is the status of Andhra, one can very well imagine what is happening in 2000 other pharmacy colleges in the country. Exact number of vacant seats in all pharmacy colleges in the country for the current academic year is not available. But, Andhra case is indicative of the state of affairs of pharmacy education in the country today. According to an estimate, there should be at least 30,000 B Pharm seats lying vacant in pharmacy colleges in the country in the current academic year. In Gujarat, a few pharmacy colleges already shut down early this year for want of students. Many more pharmacy colleges may face the same fate in southern and northern  states soon as they all are not able to get adequate number of students for the last two years.

One of the main reasons for the steady increase in the number of vacant seats for B Pharm course is the drop in quality of educational facilities in pharmacy colleges. Many of them do not have required lab infrastructure and competent faculty members to teach the students. Wherever the standard facilities are provided, managements have no difficulty in getting students for the pharmacy course. Moreover the students are also selecting colleges based on their track record in job placements. As per norms laid down by the Pharmacy Council of India, all pharmacy colleges need to have 10 labs with required equipments, four class rooms and 24 qualified faculty members. The fact is that most of the country’s pharmacy colleges do not have these basic facilities. Quality of faculty in pharmacy colleges has been a matter of serious concern for PCI with the increasing number of colleges over the years. Many college managements are found to be taking even fresh graduates for the teaching assignments because of increasing demand for qualified and experienced faculty. What the PCI and AICTE have done to address this matter so far is a big question. PCI has to keep track of these basic facilities in pharmacy colleges if it has to be the guardian of quality of pharmacy education in the country. Apart from this, there is a need to harmonize pharmacy education in the country with global standards so as to make it a well recognised, critical and indispensable clinical profession. For this, the current curricula for the pharmacy courses including the one for diploma course needs to be drastically changed. 

Related posts:

More Pharmacy colleges to be started in Tamilnadu in 2014

source: Pharmabiz

Novo Nordisk India teams up with Dept of Posts, Karnataka for diabetes awareness campaign

Novo Nordisk India has partnered with Karnataka’s Postal Department to create mass awareness and reaching out to maximum number of people in the State. Around 9800 network post offices of the Karnataka postal department delivered the booklet on treatment and management of diabetes at the recipient’s doorstep. Coinciding with this year’s World Diabetic day theme, “millions of steps to change diabetes”, Novo Nordisk India along with the postal department to create awareness amongst the public distributed one lakh booklets containing information about the treatment and management of diabetes to individuals through the network of post offices across Karnataka on World Diabetes Day on November 14.  The informative booklet published in the regional language was well packed with information and illustrations on how to manage diabetes effectively and aimed at addressing the requirements of both those affected as well as their family members. Minister of Health and Family Welfare, Government of Karnataka, U.T Khader said, “Good health of its citizens is critical for a State to prosper and therefore it is imperative that we all unite in this cause to make Karnataka a healthy state. We need such large scale initiatives to create awareness and to educate people about diabetes and its management in the state.” “The recent diabetes trend in India reflects the shifting demographics of the disease nationwide. The Novo Nordisk Education Foundation (NNEF) through its multiple national and state level programmes has long been at the forefront for creating mass awareness amongst people in the urban and rural areas in India,” said Melvin D’souza, managing director, Novo Nordisk India. “We are happy to partner with the Postal department which incidentally is one of the largest networks of postal offices in the world. The sheer number has helped us take the message on diabetes awareness to the most remote corners of the state,” added the Novo Nordisk India chief. As part of this unique partnership, posters on diabetes awareness have been put up in all 9800 post offices across the state in English and Kannada to further create awareness amongst people. In addition, a diabetes management video has also been developed, and is being beamed across 70 nodal post offices in Karnataka. To mark the occasion Minister Khader also unveiled a ‘Special Cover’ and ‘My Stamp’ emphasizing on diabetes prevention, detection and management. Arundhaty Ghosh, Postmaster General, South Karnataka Region said that the  sheer size and scale of this entire campaign was to create awareness and educate people about prevention, detection and control of diabetes. We are happy to have contributed in creating this mass awareness and there could not have been a better platform than the postal department to send out the message. In addition to this, over 2000 people were screened for diabetes at the event that included postal department staff and the public at large. A unique ‘Diabetes Village’ was also created to educate people about the condition, its implications and treatment. People in large numbers visited the village and underwent a comprehensive diabetes programme.

More Pharmacy colleges to be started in Tamilnadu in 2014

The situation of the pharmacy colleges in Tamil Nadu is hugely improving and more colleges may come up in the next academic year. No college in the state is facing any crisis with regard to admission or faculty problem or infrastructure facilities, according to information received from the association of private pharmacy colleges in the state. 

The office of the secretary of the private professional colleges association to which the pharmacy colleges association is affiliated, informed Pharmabiz that unlike other states, Tamil Nadu is providing good and quality education in pharmacy, dentistry, nursing and medicine. So, all the 39 pharmacy colleges in the state are getting sufficient number of students and the colleges are running the courses in a full-fledged manner. 

A veteran pharmacy teacher and guide, Dr V Ravichandran, director of the School of Pharmacy at Vels University in Chennai said there is no unemployed pharmacy graduate anywhere in Tamil Nadu as the colleges are producing pharmacy graduates as per the requirement of the state. There are job opportunities for B Pharm and M Pharm graduates in clinical research organizations, manufacturing companies, and in the areas of pharmacovigilance and haemovigilance programmes. The graduates of the speciality oriented course, Pharm D, will be appointed in multi speciality hospitals with special responsibility on drugs as the drugs and cosmetics act demands the role of specialist pharmacists to monitor the action and reactions of medicines. 

He said only one college in Kancheepuram district was closed down in all these years and it was because of internal feud in the management.

“In the last five years only five new colleges were started in the state, whereas in Andhra Pradesh around three hundred colleges have come up during this period. It is more than the requirement of the state and it is because of that many unemployed pharmacy graduates are looking for jobs there. The regulatory bodies should not give approvals for starting colleges without assessing actual requirements. Here, in Tamil Nadu there is scope for a few more colleges. In the last twenty years we have produced graduates as per true demand”, said Dr Ravichandran, who is also the vice president of the Indian Pharmaceutical Association. 

While commenting on the private universities conducting the pharmacy courses, he said all the five deemed universities conducting pharmacy education and awarding certificates are affiliated to Dr MGR Medical University. Sri Ramachandra University, Chennai, Vels University, Chennai, SRM University, Chennai, Vinayaga Mission University, Salem and JSS University, Ootty are controlling the 39 pharmacy colleges in the state. Dr Ravichandran is a former syndicate member of Dr MGR Medical University

Biocon Academy, an initiative of Biocon Ltd.

Biotechnology company Biocon Ltd. has entered the arena of education by setting up a new centre of advanced learning for biosciences students.

The new arm, Biocon Academy, will start 16-week certificate courses in applied biosciences for engineering and science graduates from January 2014.

A large number of biotechnology graduates did not have the skills necessary to be employed in the industry. The initiative was aimed at making them employable through advanced and industry-relevant training.

Ms. Mazumdar-Shaw said the biotechnology industry grew at over 20 per cent in the last decade; each year, 40,000 biotech students pass out of 725 institutions in the country. However, 2,000 of them or barely 5 per cent are readily employable.

According to Ms. Mazumdar-Shaw, the academy has tied up with California-based Keck Graduate Institute to offer the Biocon KGI certificate programme in nine modules or study areas in biosciences based on the Keck model. Enrolments for the first batch of 25 opened on Monday. The academy will operate from Biocon’s second campus in Bommasandra and have faculty drawn from Keck, Biocon and industry. Each course costs Rs. 1.5 lakh. Biocon would offer merit scholarships and enable students to get employed with it or other leading companies, she said. Karnataka IT and BT secretary Srivatsa Krishna said the State had also initiated an advanced biotechnology institute to bridge the talent gap.

Source: The Hindu