Pharma cos & CROs opt for cloud computing to propel competence in data integration for clinical studies
Indian pharma and clinical research organisations (CROs) are adopting cloud technology solutions to accelerate drug development, enable data compilation, create efficiency and decrease the time-to market. Following changes on the global regulatory landscape, there is an increased dependence on reliable data which has led pharma companies and CROs opt for cloud computing to nurture innovation and improve productivity, according to industry experts.
A recently concluded DIA workshop on ‘Evolving landscape of clinical data management: Focus on technology and data standard’ indicated that in the current competitive landscape, pharma industry was looking to collaborate with the clinical data management service providers to garner regulatory compliance and improve efficiency.
“Clinical research business in the country is on a revival mode and is indicating signs of growth. But the momentum of growth is still found wanting even though change is evident and perceptible. The focus is not on just clinical data management (CDM) but a shift to value-added services like medical monitoring and safety data processes. Now this will see India play a big role in the space of clinical data management projects”, Suresh Ramu, chief executive officer, Cytespace told Pharmabiz on the sidelines of the DIA workshop.
“However, the growth in clinical research particularly human studies is not exponential but steady. The way forward is mergers and acquisitions with the industry moving to a consolidation mode”, noted the Cytespace chief executive officer, in his keynote address on the ‘Interplay of technology and data standards in CDM’.
There are clear signs that global majors have recognised the indispensability of India. This has led pharma and the CROs to move on to cloud computing and analytics platforms to reduce manual errors and help achieve better quality and patient safety. Since clinical trials are a critical component of drug development, there is need to achieve seamless integration across applications to diminish data duplication, highlighted experts at the DIA workshop.
The participants like clinical data managers, clinical database programmers, bio statisticians, besides related professionals were given a lucid angle on the role of cloud technology as an innovative tool for clinical data management.
Mandar Ghatnekar, senior manager, Life Sciences Practice, Accenture in his presentation on the recent innovations in technology solutions for clinical data management said that the focus of pharma industry and the CROs was to achieve speed, functionally and collaboration. Technology trends like social media, mobility, analytics and cloud computing (SMAC) are evolving in this space.
“Particularly, cloud computing and analytics have created a seamless and scalable environment. The industry be it pharma or CROs are now seen to increasingly invest in such technologies to achieve speed to market,” he added.
A few years ago, global pharma companies were reluctant to host any data of clinical trial on an external environment. But today, all these companies and those in India are looking to increase their presence on a private cloud environment. The focus of information technology majors including SAP and Oracle is to develop life sciences software powered by analytical tools and reporting applications to enhance knowledge management, said Ghatnekar.
In order to equip pharma manufacturing units for GMP compliance, Maharashtra Food and Drug Administration (FDA) is in the process of drafting a proforma to help 1703 existing manufacturers do self auditing of their units in accordance to global standards. The proforma will help generate a self inspection report of the unit for further review and recommendation from the state FDA for effective global compliance.
The proforma likely to be available soon to the manufacturers is the outcome of the fact that Indian pharma companies are of late being targeted in many importing countries and regulated markets. Regulatory regimes in the respective countries are being tightened by raising barriers to protect the domestic industry.
Says Maharashtra FDA Commissioner Mahesh Zagade, “With complaints received from countries like Vietnam very recently regarding supply of not of standard quality drugs, it becomes the responsibility of the Indian regulatory authorities to ensure that position of Indian pharma industry is not compromised in the international market. The objective is to account for what goes out of India.”
An FDA official further explains that generic drugs produced in the country have made inroads in both developing and developed markets of the world. Doing inspection through a set of procedures, therefore, is the need of the hour.
Audit readiness of pharma manufacturing units has also become a focus area following the US FDA’s workshops on GMP and CGMP compliance for the first time in four cities of India in partnership with Central Drugs Standard Control Organisation (CDSCO) last month. The US FDA –CDSCO workshops conducted recently covered relevant topics for Indian regulatory requirements like process validation, enforcements and computer system validation based on out of specific information. The workshops were held in Hyderabad, Goa, Chandigarh and Ahmedabad.
US-based online compliance and regulatory learning solutions company Underwriters Laboratories (UL) Eduneering, which trains drug regulators to ensure safety of FDA related pharma products is also planning to equip leading Indian pharma companies on maximizing compliances related to consent decree, Form 483, data integrity and quality management systems. This would entail maintenance of electronic records for inspection readiness of Indian companies.
A resolution passed by the general body of the Tamil Nadu branch of the Indian Pharmaceutical Association (IPA) has demanded that government of India should soon take steps to set up a national council for pharmaceutical research, which should be known as Indian Council for Pharmaceutical Research (ICPR).
Presenting the resolution in the meeting, Dr Thirumalai Elango, the Registrar of Tamil Nadu Pharmacy Council said there are several significant national councils for various industrial and medical researches. Indian Council for Agricultural Research (ICAR), Indian Council for Medical Research (ICMR), Indian Council for Ayurvedic Research (ICAR), Indian Council for Siddha Research (ICSR), Indian Council of Unani Research (ICUR), Indian Council for Naturopathy Research (ICNR), Indian Council for Scientific Research (ICSR)..etc are some examples. Unfortunately, the government of India has so far not created a Council for Pharmaceutical Research, he said in his resolution.
Citing examples, Dr Elango said the only industry in the country which is recession proof is the pharmaceutical industry and is growing at a rate of 15 per cent every year. With the dynamic growth of the industry, India is called the ‘pharmacy for the rest of the world’. Our country exports medicines to more than 220 countries. Other than medicine no other product is exported like this. Even then, the government has so far not given due recognition to the pharmaceutical industry, he added.
Later the meeting passed another resolution that like medical, engineering and agricultural subjects, pharmacy subjects like pharmaceutics, pharmaceutical chemistry, pharmacognosy and forensic pharmacy should be included in the Group 1 Examinations conducted by the Union Public Services Commission (UPSC). Inclusion of pharmacy subjects will enable the pharmacy graduates to appear for the national competitive examinations and to get into public administration on par with medical, engineering and agricultural graduates.
A third resolution presented in the meeting demanded the creation of a separate ministry for pharmacy and pharmaceuticals. It said that at present the pharmacy profession is controlled by many ministries like health ministry, ministry of petroleum & chemicals, ministry of commerce, ministry of forests, etc. The pharmacy education is under health ministry and under the higher education ministry (PCI & AICTE). The drugs control administration comes under ministry of health. Pharmaceutical industry comes under ministry of industry & commerce. Pollution control is controlled by ministry of environment & forests. Too many ministries to control a single pharmacy profession is not advisable and helpful for development. So the government should create a Ministry of Pharmacy and Pharmaceuticals, demanded the resolution.
All the three resolutions were passed unanimously by the general body.
The event will once again be co-locating to provide an all-round experience, creating a pivotal meeting-point for all sectors of the pharmaceutical industry. The full line-up of events includes ICSE Japan, a dedicated outsourcing event designed to connect the pharmaceutical community with contract service providers; P-MEC Japan, delivering innovative pharmaceutical technology, machinery and equipment; BioPh Japan, showcasing the biopharma sector, and a further two events- Pharmatec, providing a pharmaceutical packaging focus and MEDTEC Japan, specialising in medical devices.
Last year the event hosted over 14,000 attendees and more than 500 exhibitors A major highlight for this year’s event is the 150 free seminars covering current industry trends and providing invaluable insights into the Japanese pharmaceutical industry.
Industry wants health ministry to come out with rejoinder clarification to protect image of Indian generic industry
Concerned over the disturbing media reports published recently, questioning the quality of Indian generic drugs exported worldwide, Indian drug manufacturers across the country have demanded to the Indian government to immediately issue a rejoinder clarification on this matter, clearing the air. The industry fears that failing to take any requisite action, in time, may impact the reputation of the Indian pharma industry as majority of the companies thrive on exports.
Industry insiders pointed out that it has become a hackneyed pattern for the media to keep on attacking the authenticity and reliability of the Indian generic industry, without having any proof of the same, acting on the vested interest of the foreign MNC lobbies. Making matters worse is the lacklustre attitude of the Indian government, which seldom takes up any responsibility to demand clarification on such maligning reports which further thwarts the interests of the industry.
A reliable source from the industry stressed that, it is high time for the health ministry to come out with a rejoinder clarification, elucidating its stand on the issue of quality parameters adopted in the country, to protect the image of Indian generic industry. Many in the industry feels that only a stern intervention from the government will ensure that no one gets a free reign to play with the interest of the Indian pharma industry.
“Ironically such reports are not only a threat to the Indian pharma industry alone, but also an insult to the Indian drug regulators as well. Indian drug regulatory system is one of the strongest in the world and Indian drug manufacturers make sure that we follow all the drug regulations properly. That is why today we are one of the top exporters in the world, then why suddenly should we go on spree to harm the reputation of our industry which we took years to build on,” questioned a disgruntled industry expert.
Dr H G Koshia, commissioner, Food & Drugs Control Administration (FDCA) pointed out that as a regulator he is also concerned by such reports as it may impact the business interest of the Indian manufacturers and the reputation of the Indian regulators, globally. He added, “When such incidence happens in the state of Gujarat, we make it a point to demand clarification from the concerned department on this issue, to ensure that no one is indicted wrongly. Considering that Gujarat is one of the major exporters of pharma products in the country, it is a matter of huge concern for us as well and all steps will be taken by us to ensure that the issues of our manufacturers are well represented at the centre.”