India’s largest drugmaker Sun Pharmaceutical Industries Ltd and its peers Cipla Ltd., Glenmark Pharmaceuticals Ltd, Cadila Healthcare Ltd and Biocon Ltd are making cancer drugs under one of the two Production Linked Incentive (PLI) schemes for the sector, according to information shared by the department of pharmaceuticals with Mint. They are among the 55 companies selected for incentives to produce 175 high-value medicines in India.
At present, most cancer drugs are imported, making them prohibitively expensive. That’s when India’s cancer burden is expected to rise from 26.7 million disability-adjusted life years or DALYs—the sum of healthy life lost to a disease—in 2021 to 29.8 million in 2025, according to data from the Indian Council of Medical Research (ICMR).
The PLI scheme is a “great boon” as cancer drugs will not only become cheaper for Indian patients, but South American and southern African nations will also benefit, said Shyam Aggarwal, chairperson, medical oncology department at Sir Ganga Ram Hospital, Delhi.
Dr Aggarwal cited the example of cancer-treatment tablets such as Dasatinib, Lenalidomide, Nintedanib and Sunitinib that now cost around ₹4,000 a month. “However, imported drugs cost around ₹1.5 to 2 lakh per month because they also include the cost of research in their selling price.”
Earlier Trastuzumab, another cancer drug, cost ₹70,000-80,000 per month, but the price dropped to ₹12,000 a month when Indian companies started manufacturing it, he said.
When more Indian drugmakers start manufacturing these medicines, prices are expected to fall even more as they are still unaffordable to a large section of Indians, Dr Aggarwal said.
Sun Pharma is developing Dasatinib and Cadila is manufacturing Lenalidomide for blood cancer. Sun Pharma is also producing Sunitinib for kidney cancer and gastrointestinal stromal tumour and Nintedanib for lung cancer.
“Sun Pharma has applied under the PLI scheme for a range of molecules, and manufacturing has already commenced,” the company spokesperson told Mint. “This initiative by the GOI (Government of India) is a significant step towards boosting domestic production and strengthening the positioning of India as the pharmacy of the world.”
Biocon and Cadila have signed up to produce Trastuzumab, which is used to treat breast and stomach cancer; and Bevacizumab used for cervical, colorectal, lung and brain cancer, and renal cell carcinoma.
Under the second PLI scheme for the pharma sector, a lot of anti-cancer drugs that India never produced will now be manufactured here, said Viranchi Shah, president, Indian Drugs Manufacturers Association (IDMA). “As an outcome of this, India will be able to cater both the domestic and global requirements.”
Boost to high-value pharma
India’s pharma industry is the third largest in the world by volume and worth about $40 billion by value. While the country contributes 3.5% of total drugs and medicines exported globally, these are mostlylow-value generic or copycat versions. Most of the patented drugs are still imported.
To boost local manufacturing of high-value drugs, the central government launched the PLI scheme for pharmaceuticals in 2021 with a financial outlay of ₹15,000 crore. In addition, the bulk drug PLI scheme incentivizes local production of active pharmaceutical ingredients (APIs) or raw materials used to make final formulations.
Expenditure on equipment, plants, R&D, clinical trials, product development and regulatory compliance can be claimed as incentives under the PLI schemes.
“More than 175 high-value medicines, including medicines to treat cancer, rare diseases and auto-immune disorders, as well as vaccines, are being manufactured under the scheme,” said the spokesperson for the department of pharmaceuticals.
The eligible products have been split into three categories.
Category 1: Biopharmaceuticals (includes biologics, biosimilars and vaccines); complex generic drugs; patented drugs or drugs whose patent expires during the scheme tenure; orphan drugs or drugs for rare diseases.
Category 2: Raw materials for medicines.
Category 3: Auto-immune, anti-cancer, anti-diabetic, anti-infective, cardiovascular and psychotropic drugs, as well as anti-retroviral drugs (including HIV-treating medicines).
The government’s objective is to make treatment affordable amidthe rising burden of both communicable and non-communicable diseases such as tuberculosis (TB), heart ailments and diabetes—the biggest cause of morbidity and mortality in the country.
Among the selected drugmakers, Torrent Pharma Ltd, Lupin Ltd., Biologicals E Ltd and Emcure Pharma Ltd manufacture medicines for various communicable and non-communicable diseases.
Companies manufacturing asthma-prevention Albuterol inhalers include Sun Pharma, Cipla and Lupin. Cipla is also manufacturing a combination drug—Fluticasone + Salmeterol—inhaler for treating chronic obstructive pulmonary disease (COPD).
Sun Pharma, Cadila, Torrent Pharma and Lupin manufacture Dapagliflozin for diabetes mellitus.
Emcure Pharmaceuticals produces Tenecteplase, which is used to dissolve blood clots after a heart attack or a brain stroke. Cardiovascular diseases are the leading cause of death in India, accounting for an estimated 27% of all deaths.
The companies mentioned above declined to comment on queries emailed by Mint.
Twice the targeted amount
According to the spokesperson of the department of pharmaceuticals, investments under the sector PLI scheme have already reached ₹34,347 crore, twice the targeted amount even as the scheme period is not yet over.
“As of December 2024, against the sales target of ₹2,94,000 crore for the entire tenure of the scheme, sales worth ₹2,35,384 crore, including exports worth ₹1,51,106 crore, have already been achieved,” the spokesperson said. “The sales target under the scheme is expected to be exceeded by a significant margin.”
According to Sudarshan Jain, secretary general, Indian Pharmaceutical Alliance (IPA), the two PLI schemes are aimed at creating self-reliance in APIs and helping large companies to become globally competent and take India’s pharma agenda to the next level.
“Both the schemes are doing well in terms of self-reliance. We have started producing bulk drugs like Penicillin-G and Clavulanic Acid in India,” Jain said. “As we are moving forward, large companies are upgrading their product range and getting into complex generics. This is strengthening our base for exports.”
Shah of Indian Drugs Manufacturers said PLI 2 is more about developing newer technologies, citing the example of biosimilars where India’s presence is very minimal.
“Once we start manufacturing these products, scale up and start suppling to the global market and automatically ecosystem evolves within the country, we will be able to make novel Biologics-which is an innovative drug,” he said. “Some of these drugs are for rare diseases globally and patients rely on government programes. This medicines under PLI will improve the accessibility of these drugs to the patients.”
