As we mark our 71st Independence Day this August 15, how far have we progressed on the medicines security front? The commonly accepted definition of food security is when “when all people, at all times, have physical and economic access to sufficient, safe and nutritious food to meet their dietary needs and food preferences for an active and healthy life.”
Substitute food for medicines and it’s clear that while we have made commendable progress, we are still far from complete independence on the medicines front. Until we can secure physical and economic access to quality medicines for all Indians, India Pharma Inc will have fallen short of expectations.
For instance, we are still dependent on other countries for many of our intermediates and APIs. Any tension at our national borders has us staring in the face of shortages. Of course, today we are much more organised and have back up plans in place. So while it will call for planning and strategising, we will not be in the same dire position as during the Beijing Olympics.
Another instance is the flashpoints on intellectual property rights (IPR), patents and copyright issues. For example, India is a long time member of the USTR priority watch list. The Regional Comprehensive Economic Partnership (RCEP) negotiations in Hyderabad too could force the Indian pharma industry into a corner.
But the journey to become the pharmacy of the world has made pharma companies from India more resilient. Companies are becoming adept at changing strategies. If Prime Minister Modi’s Make In India defines strategy in the domestic market, then President Trump’s Make America Great Again chant has the same pharma companies setting up and acquiring overseas manufacturing units based in the US.
In the first of two Independence Day special issues, the Express Pharma issue dated August 1-15 has articles from industry insiders trace the milestones of India’s pharma industry in the past seven decades. Highlighting the regulatory milestones, Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates ends on a hopeful note, saying that ‘the silver lining among these clouds is that the entrepreneur-driven Indian pharma industry is bound to ride on these challenges and emerge as a global pharma superpower in next 10 years, if not through ‘Make in India’ by ‘Make overseas’ route, since Indian pharma is now mastering the international regulatory compliance standards.’
Giving a regulator’s perspective, Kapil Bhargava, Former Dy Drugs Controller (I) CDSCO comments that from the days when syrups were stirred with wooden paddles and filtered through felt bags, with no thought of contamination, there is a realisation today that making and distributing poor quality medicines leads to loss of credibility for everyone, both public and private healthcare and the manufacturers.
And to round off the perspectives, we have a profile of one of India’s oldest pharma companies, Indoco Remedies, tracing its evolution in tandem with India Pharma Inc.
The country has had help from various global regulatory agencies and organisations. These influences continues to date and rightly so, as rules need to be harmonised with global practices. Thus Jorge A Coarasa, Senior Economist (Health), World Bank spells out how his organisation is partnering with the Biotechnology Industry Research Assistance Council (BIRAC) to make India’s strategy of ‘Decade of Innovation 2010–20’, a reality. World Bank’s ‘Innovate in India for Inclusiveness’ project will provide grant funding to a consortia of private, public, and academic institutions, led by cutting-edge institutions in their respective field, to accelerate the development of low-cost, select vaccines, biopharmaceuticals, diagnostics, and medical devices that address public health priorities in India. It is hoped that this project will be a big step towards achieving self sufficiency in these areas.
These global collaborations serve another need to harmonise our regulations. This could be seen as interference in our policies, to prevent safeguards in line with our public health needs. For instance the backlash to India’s first and so far only compulsory license for sorafenib is still cited as an example of India’s weak laws on IPR.
However, India has no choice but to harmonise its regulations if it wants domestic pharma companies to compete globally. For instance, India’s track and trace requirements set by the Directorate General of Foreign Trade (DGFT) are substantially different from key markets like the US and EU. For example, India has mandated specific numbers that must be used as the initial digit of a Global Trade Item Number (GTIN). Global standards implemented in dozens of countries allow the manufacturer to determine the initial digit. Industry sources have pointed out that this inconsistency creates labelling confusion and causes system errors, resulting in the distribution of Indian products being stopped.
So India’s pharma industry faces it own ‘tryst with destiny’. While regulators will be a crucial link to decide which path they will choose at this juncture, pharma companies from India today have the heft, size and scale to make their own destinies. Watch out for the second part of the Independence Day Special in the August 16-31 issue.