by NK Ganguly
Recently, Union Health Minister, Mansukh Mandaviya highlighted that research and innovation are essential for the continued growth of the pharmaceuticals sector. Speaking at the first Governing Council meeting of the National Institute of Pharmaceutical Education and Research (NIPER), he said the focus should shift from self-sustenance through research focus to profit-based model, building industry linkages and ramping up infrastructure Should be brought
He also underlined that it is important to ensure the functioning of flexible and people-friendly regulatory mechanism with impeccable standards in sync with time and space for the growth of the pharmaceutical industry.
In line with this, the government has taken various steps such as new program for promotion of pharma innovation, research and innovation in pharmaceuticals is being launched through Center of Excellence (CoE).
While India’s pharma industry has progressed by leaps and bounds to transform 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 has driven home the point that we need to drastically reduce our dependence on China for APIs.
The government is also launching schemes to help change the landscape by promoting local production of APIs, and that effort should not be lacking. But APIs are only part of the challenge 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 a hepatitis C drug that changed the entire landscape for the disease in India. Much the same happened with COVID medicines.
Sometimes a competitive bid to manufacture a drug fails due to patent and other issues. Therefore, it opens a new era of making available drugs in India that are novel discoveries and where regulators can help create a fast-track approval system. Currently, the approval system for any new drug entering the market in India is very lengthy.
One of the regulatory aspects that needs attention is regarding drugs that are nearing patent expiry. This opens a new era of making available medicines in India which are new discoveries. In such cases, regulators must give timely permission so that manufacturers can market them. We should have a new category for things like checkpoint inhibitors for cancer treatment to enable local manufacturing.
The checkpoint inhibitor currently costs Rs 78,000 per shot. Two companies in India have started manufacturing it which will give many cancer patients a chance to live longer as the cost will be less. A speedy approval process is important for the production of patented drugs and there is a need to create a special category.
We need to look at our patent laws to facilitate our pharma industry to become a global player. This is even more important now as Indian companies are moving into manufacturing drugs for biologic therapy, some through licensing, some through our own efforts. We need to highlight this revolution as they drastically reduce drug costs due to import substitution.
For example, some Indian companies are trying to develop drugs to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. We should have a special dispensation for such initiatives so that these drug manufacturers get some tax relief as they need to make huge investments.
Thanks to innovation, a handful of Indian drugmakers are also making a mark in cell therapies such as CAR T cell therapy for the treatment of various cancers such as leukemia, lymphoma, myeloma and solid tumors. These developments are promising for a range of cancer patients and need to be promoted on priority by the government. But it is not a one-way street for the pharma industry, and with the presidency of the G20, India’s leadership must 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 become a truly global leader.
Taking advantage of the G20
India with its G20 Presidency has a unique opportunity to remove trade barriers in many countries for our pharma products. We should also create a support system to provide medicines that are patent in India and new drug discoveries or off patent that India is making to neighboring 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 the markets of Japan, Europe, USA and Australia, they will be able to enter developing countries which will bring more profit to Indian Pharma companies.
India should take the lead in creating a G20 pre-qualification system or alternate route system for drugs on the lines of WFP qualification for faster access to the market. The G20 can make agreements among its members to create a freer market for medicines that are manufactured in countries that are struggling or do not have those capabilities.
Now is a good time to take stock and change gears for the pharma sector in India. We should also aim to lead the supply chain, especially for critical products, to reach the status of a leading pharmaceutical manufacturer.
In its quest to touch the $130 billion mark in terms of value by 2030, the pharma industry must keep innovating and upgrading its manufacturing capabilities as well as conforming to regulatory requirements to match global standards.
The author is former DG, Indian Council of Medical Research. The views expressed are personal.
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