Chronic diseases such as cancer, diabetes mellitus, epilepsy, osteoporosis and cardiovascular among others are not well diagnosed, because symptoms of these diseases are often less apparent (progress slowly) than acute and communicable diseases. With the rapid urbanization and the unhealthy lifestyles, the disease profile in India is gradually shifting towards an ample growth in the chronic diseases segment. According to the World Health Organization (WHO), India has the highest number of patients with diabetes and 60 percent of the world’s cardiac patients belong to India It is also estimated that India has the largest number of coronary artery disease related deaths in the world. The bio-pharmaceutical industry expert says that the chronic disease-related therapeutics is the fastest growing segment in the Indian pharmaceutical market.

Nanotechnology-enabled bio-pharmaceuticals are the most innovative and highly specialized alternative medicines for curing chronic diseases. For example, nanomaterials such as quantum dots, metallic nanoparticles, polymeric nanoparticles, nanofibers, carbon nanotubes, dendrimers and liposomes are ideal candidates for developing contrast agents for the cancer imaging, nanomedicines and drug delivery systems. These nanomaterials are suitable for molecular imaging and drug delivery systems because of their unique characteristics such as:

1.available large surface areas; which can be functionalized with one or more targeting molecules at a wide range of densities; 

 2.their plasma circulation time that can be tuned over several orders of magnitude based on their physicochemical properties

 3.their capability to include contrast agents and drugs at predetermined ratio either in the interior or on the surfaces

These functionally modified nanomaterials help in early detection of chronic diseases. In addition to this, they also detect the microorganisms and viruses associated with infections. In this article, we have analysed the immense potential of nanotechnology in India’s pharmaceutical and biotechnology industries.

Nanotechnology-enabled bio-pharmaceutical R&D and products in the Indian industry are still in the early stages of evolution. Only modest amount of investments have been made so far and most of projects are moving through different phases of research/clinical trials (phase I-III), even though a few nano-based drug delivery systems have already reached the market. The Indian bio-pharmaceutical industry is witnessing business opportunity trends such as merger & acquisitions/takeovers/collaborations/in-licensing, increase in R&D investments, innovations in healthcare and drug delivery as well as product penetration into the tier I to tier VI markets to make significant inroads into nanomedicine and nanodiagnostics.

Market Outlook and Products:

The scope of nanotechnology in bio-pharmaceutical industry is very wide and it is finding applications in diverse areas such as tissue engineering, nanomedicines, diagnostic tools, image enhancement devices, nanorobots, implant technology, biosensors, biomarkers, bioactive surfaces and as carriers of diagnostic and therapeutic modalities.

The market size for nanomedicine and nanodevices in India as of today is very small. There is a large number of Indian companies that have developed nanomedicines, which are already in the pipeline stage while some have even reached Phase III clinical trials, and greater focus is on innovative and blockbuster medicines.

Oncology, diabetes mellitus, arthritis, viral infections etc. are the potential areas where nanotechnology can have significant impact for the Indian bio-pharmaceutical industries in the future. With rising incidence of diabetes mellitus and cancer in India and the emergence of new products on the horizon, nanotechnology is bound to make a significant impact on the Indian bio-pharmaceutical industry.

The growing size of the Indian geriatric population, rising prevalence of chronic diseases, adoption of product patents and aggressive market penetration driven by the relatively small and medium-sized companies will be the driving forces influencing the growth of the Indian nanomedicine market. 

The most prolific Indian public companies, which are engaged in the nanomedicine product development.

Fresenius Kabi Oncology Ltd. (erstwhile Dabur Pharmaceuticals Ltd.) made its foray into the field of oncology with the launch of ‘Nanoxel’, which is a novel nanoparticle-enabled formulation of Paclitaxel in 2007. It was India’s first indigenously developed nanotechnology based chemotherapy agent and a revolutionary drug for various types of cancer treatment. The company has been the front-runner in launching many generics in oncology.

Lupin Ltd., one of the world’s largest producers of tuberculosis drugs, with 12 factories and six research centres in India and Japan, has launched ‘Genexol-PM’ (paclitaxel nanoparticle) nanomedicine for cancer treatment by tie-up with the South Korean company Samyang Corporation. Genexol-PM is a PEG-poly (lactic acid) micelle formulation of paclitaxel with particle size in the range 20 to 50 nm. It reduces Cremophor EL-related toxicities and increases therapeutic efficacy.

Cipla Ltd., one of the world’s largest generic pharmaceutical companies with a presence in over 170 countries, has successfully developed and manufactured Paclitax Nab (nanoparticle albumin bound) product for the treatment of metastatic breast cancer.

Conclusions

In recent years, many Indian companies such as Piramal Enterprises Ltd., Cadila Healthcare Ltd., Dr. Reddy’s Laboratories Ltd., and Ranbaxy Laboratories among others have made new chemical entities research wing, which is an integral part of their growth strategy and have scaled up operations in the nanotechnology segment. Many multinational bio-pharmaceutical companies are planning to launch their nanotechnology-based products or invest in R&D operations in India either by setting up their subsidiaries or through joint research and collaboration and in/out licensing agreements with the Indian companies.

Plasma therapy is an experimental approach to treat COVID positive patients and help them recover faster

Many options are being explored to treat COVID-19. These include new drugs specifically designed to target, as well as “repurposed” drugs – that is existing drugs designed to treat a different disease. By far the oldest treatment being tested though is convalescent plasma. This involves using blood plasma from people who have recovered from COVID-19 and infusing it into patients who currently suffering from this disease .

Plasma is the liquid portion of blood that remains when all red and white blood cells and platelets have been removed.

We now know that the key component of plasma for treating infections is antibodies. Antibodies are Y-shaped proteins that are highly specific for whichever infection a person has previously encountered. They are produced in vast quantities by B cells of our immune system in order to bind to the invading virus and then target it for destruction. The concept of vaccination relies on stimulating antibody production to infections not yet met. In contrast, using convalescent plasma involves the transfer of antibodies from donors who have already mounted an immune response, thus offering immediate (but transient) protection to the recipient.

Convalescent plasma treatment was also tested during the Ebola virus outbreak in 2013-2016. Several case reports showed promising results, but again, large-scale randomised trials were not performed more extensive studies are now in the line to provide vigorous evidence either for or against the use of convalescent plasma. Worldwide there are over 60 clinical trials  are going actively recruiting COVID-19 patients to study the effect of convalescent plasma. Patients are typically given about 500ml plasma intravenously, and their progress is then carefully monitored.

How safe is convalescent plasma?

It’s important to keep  in mind that there are many potential risks with receiving plasma from another person. Mild side effects are  developing a fever or allergic reactions, such as a rash and an itchy sensation. The plasma should  be compatible with the recipient’s blood group to prevent transfusion reactions.

Conclusion:

Fingers crossed for a positive outcome for convalescent plasma use in COVID-19. Hopefully, our improved understanding of therapy will also be valuable for this pandemics  situation in  the future.

Corona Virus (Covid-19) has almost impacted every industry, causing deep loss in global economy. Pharma industry is no exception. In this blog let us understand the impact on the pharmaceutical industries.

1.Cost of Drugs and Raw materials.

The impact Covid-19 has formed in China and the lockdown in India, United States, and other countries, further increases the chances of shoot up in the cost of raw materials and drugs. 13% of the brand and generic manufacturers are based out of China and according to the FDA, as of 2018, 24% of medicines and 31% of medical ingredients were imported from India.

Example

The cost of paracetmols tablets and vitamin tablets have increased nearly 40-50%

2.Reshaping the pharmaceutical supply chain.

Woodcock, director of the US Food and Drug Administration’s Center the EFCG delegates spoke of the need to safeguard the world’s supply of medicines from the liabilities inherent in relying on any one region for a significant proportion of essential raw materials and APIs. The COVID-19 pandemic did not seriously impede the production and shipment of pharmaceuticals in the first quarter of 2020 later on it increased by China dominates the world’s supply of active pharmaceutical ingredients and their chemical raw materials.

3. There are two types of drugs.

1.Brand Name Drugs

These are products protected with a reliable supply chain and profitable to the manufacturers.

2.generic drugs.

    The profit for these types of drugs is very marginal and the supply chain is lean. The API plant for these are often overseas with India and China dominating the API market. According to a recent survey, emergency care, anesthesia care, and pain management drugs are the drugs which mostly get affected due to shortage.

The current situation might cause a shortage and increase in demands of certain medications such as Hydroxychloroquine and Chloroquine, which are most talked about during these pandemic times.

It is believed that the shortage might not occur for now as companies have stocks at least for the next 5 months.

3.FDA Policies:-

The Covid impact, demand for drugs and the lockdown in various countries may force the FDA to allow relaxation in a few areas

The review process of Generic medicine is lengthy, the demand and shortage created may also force minor changes

FDA might also rethink the number of inspections on the overseas manufacturing plants.

4.Digital Health:

Digital health might be the next big thing as telemedicine / video consultations, health-related videos and apps are gaining popularity.

Investment in online portals that help doctor-patient interaction will increase.

Conclusion: To control the drug shortages that occur often companies will reassess their strategies on the primary and secondary market for manufacturing.

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