India at 75: How the country’s pharmaceutical sector evolved since attaining independence

Over the decades, the country’s pharmaceutical industry has made of capable of producing all types of drugs, including vitamins, antibiotics, semi-synthetic penicillin, steroids, hormones, and synthetic phytochemicals.

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After independence, the concept of Pharma Franchise became prominent and the government started taking steps toward enhancing drug production in the country.

Since India’s independence on 15th August 1947, the country’s pharmaceutical sector has witnessed immense growth over the past few decades and emerged as one of the leading providers of drugs and medicines to countries across the globe. From being non-existent in the 1960s to supplying essential drugs to more than two hundred countries in the fight against the coronavirus pandemic, the industry has inked many milestones. At present, India has earned a worldwide reputation for producing high-quality, low-cost generic drugs.

According to reports, the pharmaceutical industry in India was valued at an estimated US$42 billion in 2021. The industry has built itself in such a way over the years, that today it is world’s largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports and it is also the largest vaccine supplier in the world by volume, accounting for more than 50% of all vaccines manufactured in the world.

According to the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, domestic pharmaceutical market turnover reached Rs 129,015 crore (US$18.12 billion) in 2018, growing 9.4 per cent year-on-year and exports revenue was US$17.28 billion in FY18 and US$19.14 billion in FY19.

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Before independence, the pharma sector was restricted to the import of bulk drugs and there was no major manufacturing in the Country for advanced generics, plus the growth rate was minimal. After the country attained independence in 1947, it witnessed a major drug growth post-independence after various modifications implied to the whole set up.

Over the decades, the country’s pharmaceutical industry has made of capable of producing all types of drugs, including vitamins, antibiotics, semi-synthetic penicillin, steroids, hormones, and synthetic phytochemicals. After independence, the concept of Pharma Franchise became prominent and the government started taking steps toward enhancing drug production in the country. In March 1954, Hindustan Antibiotics Limited (HAL) was launched and it became the country’s first government-owned-drug manufacturer under the ownership of the Ministry of Chemicals and Fertilizers. Moreover, it was the first government corporation in India to launch a recombinant DNA product, rHU-Erythropoietin (Hemax) in 1993. The company was established in cooperation with the WHO and UNICEF with the social objective of providing affordable drugs throughout India.

Now, the company has diversified into the agricultural and veterinary areas too. Meanwhile, the manufacturing plant located in Pimpri has facilities to produce bulk drugs (capacity 60 MMU annually) as well as formulations in various dosage forms – injectables (132 million vials), capsules (250 million), tablets (120 million), large volume parentrals (12 million bottles annually), liquid orals, etc.

ALSO READ | India at 75: Major Healthcare policies and schemes since attaining independence

At present, India also contributes nearly 57% of Active Pharmaceutical Ingredients (APIs) and 69% of Finished Pharma Products (FPP) to the WHO’s Pre-Qualified list. All this has been possible due to various initiatives taken by the government to boost the domestic pharmaceutical industry. In 1970, the Indian Patents Act was passed and it was the first patent act introduced after India became independent. According to industry experts, it made the way for process patents and restricted patenting of end-product which enabled manufacturers to develop alternative processes for proprietary products that were already there in the market and ultimately helped the industry to flourish.

This was followed by the implementation of The Drug Policy in 1978. The introduction of this policy along with the Price Control Order of 1979 turned out to be landmark events for the pharmaceutical industry in India. Interestingly, this provided the foundation of the National Drugs Authority and intended to maximize the production of bulk drugs locally providing leadership to public sector undertaking. Consequently, this step reduced dependence on imports and encouraged the local industry.

Although enacted in the United States, the Hatch-Waxman Act, 1984 helped in the proliferation of generic drugs and assisted a lot in the growth of the Indian generic industry. It is noteworthy that the Act established the economic and legal foundation for the present-day generic pharmaceutical industry. Moreover, the Economic Reforms in 1991 in market liberalisation, linked the Indian pharmaceutical industry with the world economy.

As a result of these crucial reforms, the domestic pharma industry has grown by leaps and bounds and currently exports medicines and drugs worth $19 billion throughout the world. Recently, the Cabinet also approved two schemes, namely the Production Linked Incentive (PLI) Scheme and the scheme on Promotion of Bulk Drug Parks to promote domestic manufacturing of critical Key Starting Materials/Drug Intermediates and APIs (Active Pharmaceutical Ingredients) in India. According to reports, the pharma industry can contribute significantly to the country’s ‘Make and Discover in India’ vision and achieve the USD ~120-130 billion by 2030.

Experts opine that India has a lot of potential of becoming a hub for international clinical trials and play a pivotal role in global pharmaceutical research and development.

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