Recently, Union Health Minister, Mansukh Mandaviya highlighted that research and innovation are necessary for the sustained growth of the pharmaceuticals sector. Speaking at the first governing council meeting of National Institute of Pharmaceutical Education and Research (NIPERs), he said that the focus must shift from self-sustenance to a profit-based model through research focus, creating industry connect and ramping up infrastructure.
He also underlined that ensuring functioning of resilient and people-friendly regulatory mechanisms with impeccable standards sustained over time and space is of critical importance for the growth of pharmaceutical industry.
In line with this, the government has initiated various steps such as pharma innovation, new programme to promote research and innovation in pharmaceuticals is being taken up through Centres of Excellences (CoEs)
While India’s pharma industry has progressed by leaps and bounds to turn the country from an importer of drugs to a major exporter, we are still largely dependent on China for APIs for drug manufacturing. The COVID-19 pandemic drove home the point that we need to drastically reduce the dependence on China for APIs.
The Government is also initiating schemes to help in changing the scenario by fuelling the local production of APIs, and that effort should not be slackened. But API is only part of the challenge that the Indian pharma industry is facing.
Addressing regulatory issues
Indian drug makers also have to deal with global companies licensing drugs in India, which happened for the Hepatitis C drug that changed the complete scenario for the disease in India. Much of the same thing happened with COVID drugs.
Sometimes a competitive bid to manufacture a drug fails because of patent and other issues. So, this opens up a new era of making available drugs in India, which are new discoveries and where regulators can help in creating a fast-track approval system. Currently, it’s a very long approval system in India for any new drug to enter the market.
One of the regulatory aspects that needs attention is about drugs that are nearing patent expiry. This opens up a new era of making available drugs in India, which are new discoveries. In such cases, regulators should give a nod in time so that manufacturers can market them. We should have a new category for things like a checkpoint inhibitor for cancer treatment to enable local manufacturing.
Checkpoint inhibitors currently cost Rs 78,000 a shot. Two companies in India have started manufacturing it which will give many cancer patients a chance to live to live longer because the price will be lesser. A quick approval process is crucial for producing patented drugs and a special category needs to be created.
We need to look at our patent laws to facilitate our pharma industry becoming a global player. This is all the more important now since Indian companies are moving into manufacturing drugs for biological therapies, some through licensing, some through our own effort. We need to highlight this revolution because they reduce the cost of the drug drastically due to import substitution.
For example, some Indian companies are trying to produce a drug for treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, and ulcerative colitis. We should have a special dispensation for this kind of initiative so that these drug makers get some tax relief since they need to make huge investments.
Thanks to innovation, a handful of Indian drug makers are also making their mark in cell therapies like CAR T cell therapy for treating different cancers like leukaemia, lymphoma, myeloma, and also solid tumours. These developments are promising for a range of cancer patients and the Government needs to promote these on priority. But it is not a one-way road for the pharma industry, and with the presidency of the G20, India’s leadership should be attentive to the needs of the industry.
The Government should help with manufacturing facilities, tax relief, incentives, funding and improving the regulatory environment to enable the pharma industry to truly become a global leader.
Leveraging G20
India has a unique opportunity with its G20 presidency to remove trade barriers in many countries for our pharma products. We should also create a support system to provide drugs that are patented and new drug discoveries in India or off patent which India is manufacturing for neighbouring countries like Sri Lanka, Bangladesh, Nepal, and some African and South American countries.
We should negotiate to remove trade barriers so that even if Indian manufacturers cannot access markets in Japan, Europe, the USA, and Australia, they would find entry into developing countries which would benefit Indian pharma companies more.
India should take the lead in creating a G20 pre-qualification system or an alternative pathway system for drugs along the lines of the WFP qualification for quicker access to the market. The G20 could forge agreements among its members to create a seamless marketplace for the drugs which are manufactured in some of those countries for those who are struggling to build those capacities or don’t have those capacities.
Now is a good time to review and shift gears for the pharma sector in India. We also must aim to become a supply chain leader particularly for critical products in order to reach the status of a major drug manufacturer.
The pharma industry must keep innovating and upgrading its manufacturing capabilities while also harmonising regulatory requirements to match global standards in its quest to touch the $130 billion mark in value terms by 2030.
-The author is former DG, Indian Council of Medical Research. Views expressed are personal.
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