Recently, Union Health Minister Mansukh Mandaviya stressed that research and innovation are necessary for the sustained growth of the pharmaceutical sector. Speaking at the first board meeting of the National Institute for Pharmaceutical Education and Research (NIPER), he said the focus must shift from self-sufficiency to a profit-based model by emphasizing research, creating links with industry and strengthening infrastructure.
He also pointed out that ensuring the functioning of resilient and user-friendly regulatory mechanisms with impeccable standards maintained over time and space is of crucial importance for the growth of the pharmaceutical industry.
With this in mind, the government has launched various measures such as pharmaceutical innovation, a new program to promote research and innovation in pharmaceuticals is supported by Centers of Excellence (CoE)
While India’s pharmaceutical industry has made leaps and bounds to transform the country from a drug importer into a major exporter, we still largely depend on China for APIs for drug manufacturing. The COVID-19 pandemic has made it clear that we need to drastically reduce reliance on China for APIs.
The government is also launching programs to help change the scenario by fueling local production of APIs, and this effort should not be let up. But the API is only part of the challenge facing the Indian pharmaceutical industry.
Resolve regulatory issues
Indian drug makers also have to deal with global corporations licensing drugs in India, which happened for the Hepatitis C drug that changed the entire disease scenario in India. Much of the same has happened with COVID drugs.
Sometimes a competitive bid to manufacture a drug fails due to patents and other issues. So this opens a new era of making drugs available in India which are new discoveries and where regulators can help create a fast track approval system. Currently, it’s a very long approval system in India for any new drug that comes into the market.
One of the regulatory aspects that deserves our attention concerns drugs whose patents are nearing expiry. This ushers in a new era of making medicines available in India which are new discoveries. In such cases, regulators should give a nod in time for manufacturers to bring them to market. We should have a new category for things like checkpoint inhibitor for cancer treatment to allow for local manufacturing.
Checkpoint inhibitors currently cost Rs 78,000 per injection. Two companies in India have started manufacturing it, which will give many cancer patients a chance to live longer as the price will be lower. A fast approval process is crucial for the production of patented medicines and a special category must be created.
We need to review our patent laws to enable our pharmaceutical industry to become a global player. This is all the more important now that Indian companies are moving into the manufacture of drugs for biological therapies, some through licensing, others through our own efforts. We have to highlight this revolution as they significantly reduce the cost of the drug due to import substitution.
For example, some Indian companies are trying to produce a drug for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. We should have a special exemption for this kind of initiative so that these drug companies get a tax break because they have to make huge investments.
Through innovation, a handful of Indian drug makers are also making their mark in cell therapies like CAR T cell therapy to treat different cancers like leukemia, lymphoma, myeloma but also solid tumors. These developments hold promise for a range of cancer patients and the government must promote them as a priority. But it’s not a one-way street for the pharmaceutical industry, and with the G20 presidency, India’s leaders should be mindful of the industry’s needs.
The government should help with manufacturing facilities, tax breaks, incentives, funding and improving the regulatory environment to enable the pharmaceutical industry to truly become a global leader.
Leveraging the G20
India has a unique opportunity with its G20 Presidency to remove trade barriers in many countries for our pharmaceutical products. We should also create a support system to provide patented medicines and new discoveries of medicines in India or off-patent that India manufactures for neighboring countries like Sri Lanka, Bangladesh, Nepal and some countries in Africa and from South America.
We should negotiate to remove trade barriers so that even if Indian manufacturers cannot access the markets of Japan, Europe, the United States and Australia, they would find an entry in developing countries, which which would further benefit Indian pharmaceutical companies.
India should take the lead in creating a G20 pre-qualification system or an alternative pathway system for medicines modeled on the WFP qualification for faster market access. The G20 could strike deals among its members to create a seamless market for drugs that are manufactured in some of these countries for those struggling to build that capacity or who don’t.
Now is the time to review and shift gears for the pharmaceutical sector in India. We must also aim to become a leader in the supply chain, especially for critical products, in order to achieve major drugmaker status.
The pharmaceutical industry must continue to innovate and improve manufacturing capabilities while harmonizing regulatory requirements to match global standards in its quest to reach the $130 billion mark in value by 2030.
-The author is the former CEO of Indian Council of Medical Research. The opinions expressed are personal.
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