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Cancer stands as one of the foremost contributors to global mortality, claiming roughly 10 million lives in the year 2020 alone. In India, over 1 million new cancer cases are diagnosed every year. The most common cancers in India are breast, cervical, oral, and lung cancer. 

To treat cancer, various anticancer medicines are used that can destroy or slow the growth of cancer cells. Chemotherapy is the use of drugs to treat cancer, and several anticancer drugs like platinum compounds, taxanes, vinca alkaloids, and others are widely used. Targeted therapy that blocks the growth of cancer cells by interfering with specific molecules are also prescribed. 

India is home to a thriving pharmaceutical industry that manufactures affordable generic medicines, including anticancer drugs. There are over 250 manufacturers of anticancer medicines in India that provide chemotherapy drugs as well as targeted therapies. The anticancer drugs market in India was valued at $1.2 billion in 2018 and is projected to grow steadily. 

Domestic manufacturers play a key role in improving access to essential anticancer medicines in India through localized production. However, there are still challenges around equitable access, high costs of newer drugs, availability of quality generics, and regulatory policies that need to be addressed. Overall, the availability of anticancer drugs in India has increased significantly, giving hope to millions of cancer patients in the country.

Types of Cancer Prevalent in India

India faces a rising burden of cancer. The most common cancers affecting the Indian population are breast, cervical, head and neck, lung, and colorectal cancers. 

Breast cancer has now become the leading cancer among Indian women, surpassing cervical cancer in prevalence. According to the Indian Council of Medical Research, breast cancer accounts for 14% of cancers in Indian women. It is more common in urban areas compared to rural parts of the country.

It accounts for approximately 12.5% of all cancers in women. The incidence is higher in rural India due to a lack of screening and HPV vaccination. It accounts for approximately 12.5% of all cancers in women. The incidence is higher in rural India due to a lack of screening and HPV vaccination. 

Head and neck cancers, including oral cancers, are the third most common type of cancer in India. They represent 7.5% of cancer cases and are more prevalent among men than women. Tobacco chewing is a major risk factor for these cancers in India.

Lung cancer is the most common cancer among Indian men, accounting for 10.9% of new cancer cases. The main cause is tobacco smoking, although air pollution also contributes to lung cancer risk. The incidence of lung cancer is rising steadily along with increased smoking rates.

Colorectal cancer has shown an upward trend in India and now represents 7.5% of cancers. Diet, obesity and sedentary lifestyles contribute to increased colorectal cancer risk. Higher rates are seen in urban parts of India.

Other common cancers in India include stomach, liver, prostate, oesophagal, bladder and ovarian cancers. The cancer profile of India reflects both lifestyle factors as well as infection-related cancers.

Anticancer Medicines Used in India

India has approved and widely uses all the major categories of anticancer medicines:

Chemotherapy Drugs

• Alkylating agents like cyclophosphamide, ifosfamide, melphalan etc. These work by damaging the DNA of cancer cells, causing them to die.

• Antimetabolites like 5-fluorouracil, gemcitabine, methotrexate etc. These interfere with DNA and RNA growth and replication. 

• Anthracyclines like doxorubicin, epirubicin etc. These intercalate DNA strands and prevent replication.
• Plant alkaloids like etoposide, teniposide etc derived from the Periwinkle plant. These inhibit topoisomerase enzymes needed for DNA unwinding.

• Platinum compounds like cisplatin, carboplatin, oxaliplatin etc. These cross-link DNA strands to prevent replication.

Targeted Therapy Drugs

• Tyrosine kinase inhibitors like imatinib, erlotinib, sorafenib etc. These block tyrosine kinase enzymes needed for cell growth signals.

• Monoclonal antibodies like trastuzumab, rituximab, cetuximab etc. These bind to specific proteins on cancer cells to inhibit growth signals. 

• Proteasome inhibitors like bortezomib, carfilzomib etc. These block the proteasome protein recycling system in cells.

• Immunomodulators like thalidomide, lenalidomide etc. These boost the immune system to attack cancer cells.

Immunotherapy Drugs

– Immune checkpoint inhibitors like nivolumab, pembrolizumab etc. These block proteins that inhibit T-cell immune responses.

– Cancer vaccines like sipuleucel-T. These boost the immune system’s ability to recognize and destroy cancer cells.

– Adoptive cell transfer – modifying a patient’s T cells to recognize and kill cancer cells when reinfused.

– Cytokines like interferons and interleukins stimulate immune cells to attack cancer.

This covers the major classes of anticancer medicines being used for the treatment of various cancers in India. The availability and affordability of these global standard therapies have improved significantly in recent years.

Top Anticancer Drug Manufacturers in India

India is home to a thriving pharmaceutical industry that produces a wide range of anticancer medicines for the domestic market as well as export. Some of the top anticancer medicine manufacturers, dealers, suppliers, and exporters in India include:

Ellia Cytocare

Specializes in oncology and generics. 90+ oncology drugs including oral solids, injectables and biologics. Key drugs: Lenalidomide, Thalidomide, Bortezomib, Sorafenib, Tamoxifen. Oncology formulation facility in India with a capacity of 200 million units per year.

Sun Pharma

Headquartered in Mumbai, Sun Pharma is one of the largest pharma companies in India and has a strong oncology portfolio. They manufacture chemotherapy drugs like docetaxel, paclitaxel, gemcitabine, and irinotecan as well as targeted therapies like erlotinib and sorafenib.

Dr Reddy’s Laboratories

Based in Hyderabad, Dr Reddy’s is another leading pharma company in India with a wide range of oncology products. They make both chemotherapy medications and targeted drugs for various types of cancer. 

Cipla

Headquartered in Mumbai, Cipla is a major Indian pharma company that manufactures anticancer medicines including cisplatin, carboplatin, capecitabine, lenalidomide, and more. They export their oncology products to over 150 countries.

Lupin

Pune-based Lupin Limited has a portfolio of cytotoxic injectables, hormonal therapies, and targeted oral therapies for cancer treatment. Their anticancer drug portfolio includes etoposide, doxorubicin, letrozole, erlotinib, and more.

Natco Pharma

Hyderabad-based Natco Pharma is an oncology-focused company that makes affordable generic cancer medicines for the Indian market. Their portfolio includes drugs like imatinib, bortezomib, and lenalidomide.

Cadila Healthcare

Ahmedabad-headquartered Zydus Cadila manufactures a range of oncology medications including tamoxifen, fulvestrant, lenalidomide, azacitidine and more. 

Alembic Pharma

Vadodara-based Alembic Pharma is a major manufacturer of generic oncology drugs including imatinib, oxaliplatin, letrozole, and azacitidine that are exported globally.

Biocon

Bangalore-based Biocon manufactures biosimilar versions of anticancer biologics like trastuzumab (Herceptin), pegfilgrastim (Neulasta), and bevacizumab (Avastin).

The strong manufacturing base for anticancer medicines has made India the pharmacy of the world for affordable generic cancer drugs.

Manufacturing Process of Anticancer Drugs

The manufacturing process of anticancer drugs involves several key steps, including development, testing, approval, and mass production.

Development

The development of a new anticancer drug begins in the laboratory. Scientists identify potential biological targets involved in cancer growth, such as proteins or gene mutations. They then design therapeutic agents that can interact with those targets and disrupt cancer cell proliferation. This early phase involves extensive research to synthesize drug compounds and test their anticancer effects in vitro and in animals.

Testing

Once a promising lead compound is identified, it undergoes rigorous testing to evaluate its safety and efficacy. Preclinical testing continues in animal models to gather more data on dosage, side effects, and treatment potential. If results remain positive, the drug developer submits an Investigational New Drug application to the regulatory body, which allows testing in human clinical trials. 

Clinical testing occurs in three phases, each with more participants. Phase 1 trials assess safety and dosage in a small group of patients. Phase 2 expands the safety profile and also evaluates effectiveness in a larger cohort of patients. Finally, Phase 3 trials confirm the efficacy and monitor adverse reactions through controlled, large-scale studies.

Approval  

After successful clinical testing, the drug developer submits a New Drug Application containing all preclinical and clinical data. Regulatory bodies like the FDA thoroughly review the application and decide whether to approve the drug. The review process aims to ensure the anticancer medicine is safe and effective for its intended use.

Manufacturing

Once approved, the anticancer drug moves into mass production and distribution. Manufacturing must follow Good Manufacturing Practices to guarantee quality, purity, and consistency between batches. Facilities are carefully controlled and monitored. With cytotoxic anticancer drugs, extra precautions are taken to protect personnel from exposure during the production process. After quality control checks, the drugs are packaged, labelled, and shipped to healthcare providers for patient use.

Challenges in Manufacturing Anticancer Medicines 

Manufacturing anticancer medicines comes with several key challenges that manufacturers in India need to overcome.

High Costs

The costs involved in researching, developing and manufacturing anticancer drugs are extremely high. Bringing a new cancer drug to market can cost over $1 billion in investments. The complex molecular structures of these drugs, stringent regulatory requirements, and small target patient populations all contribute to the high costs. Many Indian manufacturers struggle to marshal the significant financial resources required for anticancer drug development.

Complex Manufacturing Process 

Producing anticancer medicines requires complex manufacturing infrastructure and processes. These medications contain complex active ingredients that necessitate multiple chemical synthesis steps. Maintaining sterile conditions and following Good Manufacturing Practices (GMP) adds to the intricacy. Companies need advanced equipment, cleanrooms, quality control systems and specialized personnel to successfully manufacture these drugs. Lacking the right facilities and expertise poses challenges for Indian companies.

Toxicity Concerns

Anticancer drugs have narrow therapeutic indexes and high toxicity. Preventing contamination and ensuring precise dosages are vital given the risks involved. Indian manufacturers must implement rigorous quality control and toxicity testing to avoid adverse effects. Handling cytotoxic compounds also requires protecting workers and safely disposing of chemical waste. Companies need to invest in protocols and equipment to address the toxicity concerns around anticancer drug production.

Overcoming the hurdles of high costs, complex processes and toxicity concerns remains an ongoing struggle for anticancer drug manufacturers in India. Companies willing to make the necessary investments in infrastructure, workforce and quality can lead the way in domestic production.

Initiatives to Make Anticancer Medicines Accessible

The Indian government and other organizations have taken various initiatives to improve access to anticancer medicines for patients across the country. Here are some notable initiatives in this field:

Government Schemes

– The National Pharmaceutical Pricing Authority (NPPA) has brought several anticancer drugs under price control to make them more affordable. For example, prices of drugs like Imatinib, Lenalidomide, and Bortezomib have been reduced over the years through price regulations.

– The Pradhan Mantri Jan Arogya Yojana provides financial protection for cancer treatment and medicines at empanelled hospitals for poor families. 

– State governments provide free or subsidized anticancer medicines at government hospitals for economically disadvantaged patients.

Partnerships 

• The Government has partnered with domestic and global pharmaceutical companies to locally manufacture international patented drugs at affordable prices. For instance, Natco Pharma has partnered with MSF to produce the generic anticancer drug Sorafenib at a fraction of the original price.

• Non-profits like the Cipla Foundation and the Cancer Patients Aid Association provide free/subsidized anticancer drugs and treatment to underprivileged patients.

• Public-private partnerships to upgrade healthcare infrastructure for better cancer diagnosis and treatment facilities across India.

Awareness and Access Programs

• The National Cancer Control Program aims to promote early detection and prevention of cancer. Free screening camps are set up to improve diagnosis.

• Campaigns like the Pink Ribbon Movement and World Cancer Day educate people about cancer and the importance of screening/early diagnosis.

• Doorstep drug delivery, and mobile dispensaries by pharmaceutical companies and NGOs to provide anticancer medicines in remote areas. 

• Investments in healthcare logistics and cold chain infrastructure to better distribute essential anticancer drugs.

The government and social organizations have made concerted efforts to promote equitable access to anticancer treatment, especially for underprivileged patients. However, more work is needed to strengthen healthcare infrastructure and manufacture drugs at affordable prices for wider reach.

The Future of Anticancer Drug Manufacturing in India

The future of anticancer drug manufacturing in India looks promising, with immense growth potential driven by increasing demand, favourable government policies, and a strong innovation ecosystem.

Growth Potential

• The anticancer drugs market in India is projected to grow at a CAGR of 12% from 2022 to 2027, reaching nearly $3.2 billion. This growth will be fueled by the rising prevalence of cancer, improved access to treatment, and increased healthcare expenditure. 

• India’s cost competitiveness gives it an advantage in exporting affordable generic anticancer drugs globally. Pharmaceutical exports from India are expected to reach $30 billion by 2030, with anticancer drugs being one of the key growth drivers.

• The National Pharmaceutical Pricing Authority has fixed the prices of 92 anticancer drugs, expanding access for patients. The government aims to further improve the affordability and availability of essential anticancer medicines.

Innovations 

• India is strengthening its capabilities in innovative R&D for novel anticancer drugs, including immunotherapy drugs, targeted therapy, and combination drugs. 

• Biotechnology parks, incubators, and funding initiatives like the Biotechnology Industry Research Assistance Council (BIRAC) are supporting biotech startups focused on cancer research.

• Academic and industry partnerships are leading to breakthrough innovations. For example, the collaboration between Tata Memorial Centre and pharmaceutical company Cipla led to the development of the novel lung cancer drug, TMC278.

Export Opportunities

• India’s low-cost production and large skill pool provide competitive advantages in manufacturing generic anticancer drugs for export. 

• Indian pharma companies like Natco Pharma, Cipla, and Sun Pharma are already key exporters of affordable generics to Africa, South America and Asia.

• Leveraging export opportunities can make Indian manufacturers global leaders in anticancer drugs, boosting both economic growth and India’s strategic interests.

• Government export promotion policies like tax benefits, export credits, and trade agreements will further boost exports of pharma products.

In summary, increasing demand, policy support, cost competitiveness, and a vibrant innovation ecosystem make India well-positioned to become a global manufacturing hub for affordable and innovative anticancer drugs.

Conclusion

In summary, cancer remains one of the leading causes of death in India, with prevalence continuing to rise. The most common cancers in the country include breast, cervical, head and neck, colorectal, and lung cancer. While there are many approved anticancer medicines available, access remains a key challenge for patients due to high costs and limited healthcare infrastructure. 

To improve access, the Indian government has launched schemes to provide affordable or free treatment options. Local pharmaceutical companies play a critical role as the main manufacturers of generic anticancer drugs, helping bring down prices. Top manufacturers like Ellia Cytocare, Sun Pharma, Lupin, Dr Reddy’s, Cipla and Natco supply important cancer drugs like erlotinib, gefitinib, imatinib, and sorafenib.

Manufacturing anticancer medicines involves complex processes to ensure safety, efficacy and quality. Pharma companies continue to invest in advanced technologies and facilities to ramp up production. However, challenges remain around the lack of raw materials, skilled labour and regulatory policies. 

Overall, the market for anticancer drugs in India is projected to grow steadily, aided by rising demand, government initiatives, and growth of the pharmaceutical manufacturing sector. Key priorities going forward will include boosting domestic manufacturing capabilities, enhancing affordability and access for patients, and supporting innovation in developing novel anticancer drugs.

FAQs

Q: What are the most common cancers in India?

The most common cancers in India are breast, cervical, head and neck, colorectal, lung, stomach, and prostate cancer. This is based on the cancer burden data from the National Centre for Disease Informatics and Research.

Q: Which anticancer drugs are manufactured in India?

Some of the major anticancer drugs manufactured in India include trastuzumab, rituximab, bevacizumab, cetuximab, sorafenib, imatinib, erlotinib, and temozolomide. Both small-molecule drugs and monoclonal antibodies are produced by Indian pharma companies.

Q: What are the challenges in manufacturing anticancer drugs in India?

Challenges include lack of access to the latest technologies, high capital investment requirements, complex and expensive manufacturing processes, maintaining high-quality standards, shortage of skilled workforce, and competition from MNCs.

Q: How can the accessibility of anticancer medicines be improved in India?

Improving accessibility requires boosting local manufacturing capabilities, reducing prices through generics, improving healthcare infrastructure, increasing health insurance coverage, and collaborations between government, industry and academia.

Q: What is the future outlook for anticancer drug manufacturing in India?

The anticancer drug market in India is expected to grow significantly in the coming years driven by rising cancer prevalence, increasing healthcare spending, policy support, and growth of biosimilars. India has the potential to become a major global hub for high-quality and affordable anticancer medicines.