India@75: Phenomenal journey of the pharma industry

Published on Nov 11, 2022 04:34 PM IST

The article has been authored by N K Ganguly, former, director-general, Indian Council of Medical Research.

The Indian pharmaceutical industry has come a long way since the country’s independence. India is today a <span class='webrupee'>₹</span>1.67 trillion size domestic market for drugs, and over 90% of this space is captured by locally produced medicines.(HT_PRINT)
The Indian pharmaceutical industry has come a long way since the country’s independence. India is today a 1.67 trillion size domestic market for drugs, and over 90% of this space is captured by locally produced medicines.(HT_PRINT)
ByHindustan Times

The Indian pharmaceutical industry has come a long way since the country’s independence. India is today a 1.67 trillion size domestic market for drugs, and over 90% of this space is captured by locally produced medicines. Over the past few decades, with gradual progress, India has evolved into the third largest drug maker in the world in terms of volume. It now supplies pharma products worth $24.47 billion (FY22), to 200 countries across the world and generates an annual net trade surplus of $17 billion. We are a major exporter of generic medicines and vaccines and have gained recognition as the pharmacy of the world.

This has been a gradual, painstaking and arduous journey as the scenario was a different scene when India became independent. Although in terms of medical structure, we had important, eminent institutions such as the Calcutta Medical College, Madras Medical College, and Lahore Medical College, all medical equipment, drugs, and raw material were imported. After independence, the Government established the Central Drug Research Institute, the Indian Institute of Chemical Technology in Hyderabad and the National Chemical Laboratory in Pune, and a few others. These steps helped to increase capacity and infrastructure for research and development of new drugs.

The government initially established two companies - Indian Drugs and Pharmaceuticals Limited (IDPL) for drugs and Hindustan Antibiotics in Mukteshwar, mainly for penicillin. For vaccines, two companies were set up in Kasauli, Himachal Pradesh and Coonoor, Tamil Nadu, to produce purely generic medicines for which patents had expired. They produced vaccines for DPT, cholera, typhoid, rabies, etc. India could not make polio vaccines till 1970 and imported them from other countries with the oral formulation coming from Russia.

Among private players, Khwaja Abdul Hamied had already set up one of India’s oldest pharma companies, Cipla in 1935; Indravan Modi set up Cadila pharmaceuticals in the early 1950s, Kallam Anji Reddy set up Dr Reddy’s Laboratories in Hyderabad and Bhai Parvinder Singh set up Ranbaxy in 1961. Most of these started as small companies making generic drugs. A few vaccine companies also came up with the Serum Institute in Pune being the major one.

We have many firsts to our credit, some of them, even before independence. The world’s first chemical drug was discovered by Dr U N Brahmachari in 1920. In 1945, Dr Yellapreggada Subba Rao, a biochemist, discovered tetracycline which is an antibiotic that cures a number of bacterial diseases typhoid, plague and TB. Dr Apte discovered the cholera vaccine which was produced in Kasauli; he also discovered the plague vaccine which helped protect large parts of the world from the epidemic.

Our entry into biosimilars is fairly recent –the launch of a biosimilar to bust clots by Gennova Biopharmaceuticals was notable, and it was the second company in the world to launch that drug.

Indian pharma’s strength is that it can make generic versions of most drugs. One example was during the Covid pandemic, when companies made generic versions of any drugs soon after their launch across the world. Global pharma companies then started giving open licences. Two major open licences were given by Gilead – one for Hepatitis C drug and the other for the Covid drug Remdesivir to enable local production. Pfizer also gave open licences to Indian pharma companies for its Covid drug.

India’s venture into new drug spaces created disruption in the global market. One example is the drugs for AIDS which were initially very expensive. So Cipla created an HIV generic drug and we invoked a World Trade Organization (WTO) rule that says if there is a national emergency, one could sell the drug bypassing patents. Cipla’s generic HIV drug saved a lot of lives around the world, enabling needy patients in many low and iddle income countries to access it. In the same way, Lupin went on to become one of the major suppliers of anti-TB generics for the world.

By the time Indian pharma companies started production of vaccines on a commercial scale, China had monopolised the Active Pharmaceutical Ingredient (API) space. This forced many Indian companies to make their own discoveries of APIs in line with the requirements of different regulators. At that time, a drug maker needed clearance from a WHO-certified regulator to sell medicines outside the country. As compared to today, when we have a top-class regulator in line with FDA stipulations.

India’s drug regulatory initiatives started in a small way. While the Drugs and Cosmetics Act paved the way for drug approval, states went on to set up their local regulatory bodies for drugs that were already in the market, that other companies wanted to produce. However, our drug regulatory bill hasn’t been passed in Parliament as yet. A major barrier was that there were several windows for clearances for different drugs which still creates delay. There will be better uniformity if the drug regulatory bill is passed in Parliament.

Although there were huge barriers for Indian companies in the area of biosimilars in markets such as Europe, Japan and the United States (US), we overcame these by cracking down on spurious and contaminated drugs. While we are a member of the WTO, we have to be cautious as many international companies want a slice of the Indian market. During my tenure at Indian Council of Medical Research (ICMR), there were several disputes which came up, but we successfully negotiated these and were able to go beyond the domestic market with our products. We also created some very good formulations and alternative methods of synthesis to compete in international markets because our prices were the lowest.

As the pharma industry grows, we need a better regulatory environment where our system of review becomes as strong as the USFDA review and eliminates multiple windows for clearances. We also need to make sure that our companies make profits in India because if they won’t make profits, they won’t have enough to invest in Research and Development (R&D). There is also a priority need to encourage funding and investments through research-linked incentives, grants, subsidies as well as higher tax provisions and concessions for R&D. An enabling environment is needed for industry-academia collaboration to ensure translatability of research happening in the labs to the market. This will require infrastructure support such as technology transfer offices, industry- supported centres of excellence, incubation centres and more. The Government of India has recognised the vital role of the pharma sector in realising India’s vision of an Atmanirbhar Bharat. We need to take the vital next steps to ensure that the benefits reach our patients and consumers and we are able to realise the vision of Indian pharma @2047.

The article has been authored by N K Ganguly, former, director-general, Indian Council of Medical Research.

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