PHARMA INDUSTRY
Redefine strategies for post-Pandemic era
The pandemic has created enormous challenges to the world. The post-pandemic era could open up new opportunities. India has the potential to take a leadership role in such an endeavour and establish itself as the “Pharmacy capital of the world”.
The Role Of pharmaceuticals in providing universal healthcare as targeted in various national and international policies, such as Health For All By 2000 AD, Millenium Development Goals, Sustained Development Goals… But many acute and chronic malaises are still not curable with drugs discovered, manufactured and marketed by pharmaceutical companies.
Much advances have been made in finding suitable drugs for several diseases. However, most are palliatives treating symptoms rather than the diseases such as cardiac and central nervous system disorders, metabolic diseases such as diabetes, immune compromised conditions, genetic diseases, various forms of cancers. For all of these treatments are lifelong. The only area where curative medicine has succeeded is bacterial infections with the advent of a plethora of antibiotics following the discovery of penicillin in the 1940s.
General improvement in public health due to provision of potable water, control on environmental degradation, immunisation programmes, availability of appropriate drugs… have considerably improved life expectancy. Reduced morbidity due to parasitic infections through use of broad spectrum anthelmintics, control of most bacterial infections through use of broad spectrum antibiotics are examples of the contributions of the healthcare industry.
Indian drugs reach every part of the globe…
Indian pharmaceutical industry has grown since independence from large importers of modern (allopathic) drugs to a prized exporter. Advances in chemical technology needed for the production of bulk drugs and the amended provisions of the Indian Patents Act 1970 which disallowed patent protection for products and limited exclusive rights only to novel and innovative processes, enabled Indian companies to master the production of bulk drugs. Over the last few decades, India established its capability to manufacture and export practically all organic chemical based molecules which form the base of generic drugs and formulations. In value terms, India exports to over 150 countries exceed the value of domestic sales and today, in volume terms, India is the third largest producer of bulk drugs and formulations in the world. India has been rightly called the pharmacy capital of the world implying that drugs made in India reach every part of this globe.
Unmet Medical Needs
Most R&D based Multinational Pharma companies, in the last few decades, concentrated on R&D for the development of chronic ailments based on their market needs rather than medical needs across the globe. Diseases such as cholera, malaria and tuberculosis have re-emerged and there are no drug remedies available in the market or in the pipeline to treat these. In the case of TB and malaria, co-existing morbidities and multi-drug resistance continue to ravage mankind. Thus poor man’s diseases such as filariasis, onchocerciasis, schistosomiasis, leishmaniasis, trachoma, chagas disease and many periodic endemic viral infections cause unacceptable levels of mortality.
Little R&D on drugs for poor countries
Over 20 per cent of the global populations of 7 billion, mostly living in poor countries, are at high risk of being affected by infectious diseases, which kill annually 17 million people. And yet there is very little R&D effort to develop vaccines or drugs for them, primarily since there is no assurance of return on investments since the drugs for these diseases are for the poor who are unable to afford them. In other words, companies whose primary motive is on maximising profits, do not find it attractive to invest in new drug discovery efforts on these. The case of antibiotics is worth looking at. The last new class of antibiotics, the Rifamycin class of drugs for treating tuberculosis, was discovered 50 years back. The number of antibiotics including derivatives and fixed dose combinations under development during 1983-87 was 18 which shrunk to five during, 2003-07 and further to two, during 2005-11.
The number of vaccine producers in the world is only around a dozen, half of them in India. Most of the vaccine work researched in United States and Europe are directed to finding vaccines for seasonal flu. During the last one year the focus is on respiratory viral infections in view of the Covid-19 pandemic.
Strategies for growth of Indian pharmaceutical industry
Since drugs are needed to meet medical needs regardless of economic downturns, pharmaceutical markets are generally insulated from boom and built cycles. However, the disastrous economic downturn of 2020 will affect both brown field and green field investments in this sector as R&D work yields returns only over the long term.
In the area of R&D, India has the advantage of low costs, abundance of skilled manpower and adequate and diverse ethnic population mix needed for validating efficacy of drugs through randomised clinical trials. Vaccines for typhoid, rota virus, Hepatitis B… have been developed by Indian companies in addition to production for the Indian and export markets of vaccines for measles, DPT, Japanese encephalitis, polio, mumps rubella… Efforts to utilise the new platforms successfully used for developing Covid-19 vaccine via mRNA and DNA should be a priority area for Indian companies.
Also important is to include intense studies for discovery of vaccines for several cancers, including therapeutic vaccines. Development of new biologicals, using recombinant DNA and monoclonal, immunotherapy, gene therapy, gene editing (CRISPR technology) are priority areas for investments. If such efforts are successful, India can claim to be the vaccine capital of the world.
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Bharat Biotech and Serum Institute of India  |
| Opportunities and lessons from Covid-19
– Active research for drug discovery for diseases affecting the poor. – Intensity and collaboration among pharmaceutical companies, academic and public sector labs. – Global alliances for tackling major disease could ensure adequate funding for drug discovery and distribution modalities. – India should emerge also as the supplier of vaccines for neglected diseases. – Research platforms newly validated for the Covid vaccine should be tried out for other emerging infections and even for diseases such as cancer. – Create open source drug discovery models and ensure transparency in exchange of information of R&D. – India as an outsourcing destination for research, manufacture, clinical trials and marketing of new drugs. – Drug discovery groups and regulatory agencies should work together to enable fast approvals, especially for emergency use in life threatening cases. Limitations – Today drug discovery and development is almost entirely carried out by R&D based multinational companies who have their own strategies and agenda which are not shared with others including regulatory bodies. – Government funding on healthcare in India is currently 1.5 per cent of GDP which is expected to increase to 2.5 per cent (still far too low). – According to the Indian Constitution, healthcare is in the concurrent list with the states being the agency for implementation of healthcare policies. There is a need for better coordination. – There is no mechanism in place for collaboration between universities and public or private sector companies. – In modern research areas affecting healthcare, like in the case of m RNA platforms, rDNA technology, Gene editing, gene therapy, immunotherapy, stem cell research… enough skilled human resources are not available. The global pandemic of Covid-19 has affected over 200 countries in the world and has so far infected over 100 million people and resulted in over 2.7 million deaths world-wide. There is very little R&D effort to develop vaccines or drugs for diseases widely prevalent in developing countries.
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