PHARMA LITERATI

Glenmark Pharmaceuticals on Tuesday said it has initiated Phase 3 clinical trials on antiviral drug Favipiravir to check its efficacy on COVID-19 patients in India. The Mumbai-based company had received approval from Drug Controller General of India (DCGI) last month to conduct clinical trials of Favipiravir antiviral tablets for the treatment of COVID-19 patients. Glenmark Pharmaceuticals is the first company in the country to initiate Phase 3 clinical trials on Favipiravir for COVID-19 patients in India, it said in a statement. Clinical trials have commenced and over ten leading government and private hospitals are being enrolled for the study, it added. Glenmark estimates study completion by July/August 2020, it said. As per the approved clinical trial protocol, 150 subjects with mild to moderate COVID-19 symptoms will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. Treatment dura...

Global pandemics like Covid-19 require a coordinated global response. And yet what the world is witnessing is quite the opposite. The pandemic has provided new fuel to the US-China squabble, with the two sides engaged in endless mutual recrimination. President Donald Trump’s reported attempt to secure exclusive rights to German biopharma major CureVac’s vaccine reflects a continuing preoccupation with his ‘America First’ approach. China’s authoritarian model and lack of transparency in handling the crisis have dented its global leadership credentials. The G7 meeting last month failed to agree on a statement on the pandemic, accentuating the group’s continuing slide into irrelevance. The G20 Leaders Summit on March 26 called for “a transparent, robust, coordinated, large scale and science based global response in the spirit of solidarity”. However, the ground reality is that more than 75 countries have imposed trade restrictions on Covid-19 related supplies since the beginning of ...

The Gujarat State Pharmacy Council (GSPC) has wanted the Pharmacy Council of India (PCI) to develop a strategic plan towards achieving recognition of professional status of pharmacists at national level as trusted healthcare providers after medical professionals, in the entire healthcare system. In the background of upswing in COVID-19 infections in western countries, the respective government in each country in the west has recognized the various roles of pharmacists and their services were given deserving importance. They are considered as one of the frontline healthcare providers. But in India, their status is underrated, says a letter written to the president of the PCI by Montu Kumar Patel, president of GSPC. GSPC has put forth this demand to the PCI by considering the increasing demand for Indian medicines by US, Russia and other western countries which are experiencing escalation in COVID-19 infections. Including western nations, many countries in the world make appeal...

Union health ministry’s latest telemedicine practice guideline has not only given boost to telemedicine sector but has also given clarity in its implementation, says Dr Shankar Narang, COO, Paras Healthcare. Dr Narang added that lack of clarity on telemedicine was often recognized as a hindrance in the growth of the sector and more so lack of guidelines did not instill confidence in healthcare providers to use patient-friendly technology to reach out in a major way. With increasing number of people seeking medical help through advanced technological means such as video consultations or voice chat, telemedicine has helped reduce the spread of the virus by reducing hospital footfalls. “We strongly believe that these guidelines will serve to institutionalize and mainstream the role of telemedicine in healthcare. We are already witnessing a surge in the use of telemedicine facilities across the world to deal with the COVID-19 pandemic at hand,” added Dr Narang. The purpose of...

The Modi government is working on a contingency plan for the higher education sector as the academic calendar has been disrupted because of the ongoing Covid-19 pandemic.   The plan, which is likely to be announced after 14 April, will include an alternate academic calendar, ways to conduct exams for colleges and universities, a new schedule for vacations and announcement of results.   Apart from this, the plan will also include suggestions to improve the career prospects of students.   The University Grants Commission (UGC) had on 6 April constituted a seven-member committee to look into a contingency plan.   The committee is headed by the vice-chancellor of the Central University of Haryana, R.C. Kuhad. Other members include the vice-chancellors of Banasthali Vidyapith, Panjab University and the Shri Vaishnav Vidyapeeth Vishwavidyalaya, the director of Inter University Accelerator Centre and two joint secretaries of the UGC....

Novalead Pharma recently said it has found that 42 existing drugs can be helpful in treating patients at different stages of coronavirus infection. The conclusions of the startup, which is backed by Tata Capital Healthcare Fund, are based on a study of 2,100 approved drugs and 30 potential viral and human targets. “The major advantage with this approach is that the drugs being approved are already proved to be safe for humans, are being actively manufactured and therefore can be immediately put to use in a very short time,” the company’s chief executive Supreet Deshpande said in a statement. The Pune-based company, which is into the field of drug repurposing, deployed its computational technology for identifying existing drugs which may be potentially effective against the SARS-Cov2 virus (coronavirus) as well as for minimising the impact on the human body, as per the statement. Till now, there is no drug or vaccine that has been developed against the coronavirus infe...

Digital transformation lies at the center of healthcare businesses’ internal conversations, said Saurabh Saxena, Country Director, India, Micro Focus. As every industry is seeing a transformational shift in the use of next-generation technology, healthcare and pharmaceuticals industries face the most stringent levels of regulations and oversight, he added. In highly complex operations, the central risk to patients’ ensues from poor processes which come from regulatory non-compliance. Maintaining regulatory compliance, however, can also lead to increased overheads which can undermine productivity and profitability stacked-up on top of a demanding business environment, Saxena told Pharmabiz.  The factors creating a challenging business environment are demand for personalized medicines and treatments; ageing populations are placing stress on critical services, and patients taking more control over provider choices.  Adopting new age technologies in software deve...

National Pharmaceutical Pricing Authority (NPPA) has issued a letter to all the State and Union Territories’ chief secretaries asking to issue/pass suitable instructions to district administrations/concerned authorities to facilitate the pharmaceutical companies and ensure unobstructed movement of raw materials, packaging materials, and manpower required to accomplish work-related to production, packaging and distribution during the lockdown period. After the lockdown announcement made by PM Modi, to prevent community transmission of coronavirus (COVID-19) in the country, the pharma industry along with retail chemists, wholesalers, pharma C&F agents of drugs and medicines and other members associated with the supply chain started facing a problem in the movement of goods, especially during the initial days of lockdown. S V Veerramani, Chairman and Managing Director, Fourrts Laboratories said, “ The Government doesn’t want a shortage of medicine supply in the country and f...

The global rare disease drug market is expected to touch $242 billion by 2024 with a Compound annual growth rate (CAGR) of 12.3 per cent between 2019-2024. Globally, the definition of rare disease (RD) is at nascent stage although it is evolving constantly. It is assumed that there are approximately 8,000 different types of RDs, with more being discovered each day. Particularly in India, nearly 450 RDs have been enlisted. Due to its poor diagnosis mechanism, low prevalence and limited treatment options, often it is addressed as an ‘orphan’ disease. Rare diseases in India The Ministry of Health and Family Welfare, Government of India announced that so far only about 450 rare diseases have been recorded in India from tertiary care hospitals. The most common rare diseases include haemophilia, thalassemia, sickle-cell anaemia, primary immunodeficiency in children, auto-immune diseases, lysosomal storage disorders such as Pompe disease, Hirschsprung disease, Gaucher’s disease, cy ...

Dr Harshit Jain, Founder & CEO, Doceree writes about the potential of AI implementation in the pharma industry and the role it can play in enhancing operations in various segments In the wake of digitisation, Artificial Intelligence (AI) has taken a leap in the pharmaceutical industry ranging from discovery to go to market. It has a wide-reaching potential in the pharma industry such as research & development, clinical trials, marketing and sales analytics. Using a machine learning programme can reduce the time spent on examining data, saving money and allowing researchers to focus on other issues. Artificial intelligence (AI) is everywhere, from fantasy football to customer service, we will soon be encountering AI programmes in almost every sphere of our lives. But, it is equally important to know what AI technologies are going to be truly transformative. Let’s have a sneak peek that how it runs the gamut of pharma space prolifically. Role of AI in ‘Drug Discov...