Areas of work

At OPPI, we endeavour to play a supportive role in building a resilient pharma industry, in an inclusive, sustainable manner. Our efforts focus on driving progress and change in our three pillars of advocacy – Innovation, Access and Ease of Doing Business.

Innovation

In India, too, there has been a perceptible shift in the innovation landscape. Over the past few years, the Central Drugs Standard Control Organization (CDSCO) has approved 58 biotherapeutics, biosimilars, monoclonal antibody-based drugs, and mRNA vaccines, along with 9 cell and gene therapy products.

These advancements reflect the growing value of innovation in shaping the future of healthcare. At OPPI, we believe that fostering a vibrant research ecosystem, incentivizing R&D investments, and nurturing specialized talent in pharmaceutical sciences are critical to sustaining this momentum. Our member companies are at the forefront of this shift, and we are committed to facilitating an environment where innovation thrives—not just through scientific breakthroughs, but through policies and partnerships that empower the entire value chain. To this end, OPPI actively engages with government bodies and key stakeholders to support the development of enabling frameworks that accelerate innovation, strengthen academia-industry linkages, and deliver meaningful health outcomes, especially for the underserved.

The development of new medicines requires a lot of time, effort and investment. Intellectual Property thus becomes a pharmaceutical company’s most valuable resource, and its protection, through the right policies, pivotal to that company’s future success.

At OPPI, we create the conditions that assure our members this, encouraging them to invest in R&D, while we work with the government to create a pro-innovation regulatory and trade agenda. Given that almost all our members are global innovation-based companies, a strong IPR framework becomes even more essential.

OPPI works shoulder to shoulder with the government and Ministry of Health, pressing for greater incentivization for innovation. This includes tax deductions and other stimuli to the sector, such as the setting up of GCCs in various cities. This enhances their value in global markets as well as contributes to the country’s economy by creating employment. At present, close to 90,000 highly trained people work in GCCs all over the country, strengthening the talent pool of the country considerably.

Protecting Intellectual Property from infringement is another very important factor in encouraging investment in innovation. Thus, working towards creating policies that ensure the most stringent protection against data theft and infringement, is another of OPPI’s goals.

As India sets forth on the path of discovering, developing and delivering new drugs and treatments, an environment where strong Regulatory Data Protection becomes the value addition to propel innovation.

Effective and enforceable patents and robust RDP are two factors that go hand in hand to create a sustainable innovation ecosystem. Thus, it becomes vital that test data shared for gaining regulatory approval is safeguarded. This will give innovators the confidence to invest the huge sums that are needed for drug development.

OPPI, with its innovation-driven members, has been championing the case for strong RDP policies in the country.

Patent infringement can be both very detrimental and demotivating to innovators. In India, the Indian Patents Act, 1970 aims to control this problem, through pre-grant opposition. This is a critical mechanism designed to ensure that patents are granted only to inventions that fulfill statutory requirements. It provides an opportunity for any person, third party or the Government, in writing, to challenge a patent application after its publication but before it is officially granted, fostering transparency and accountability in the patenting process.

The proceedings, raised with the India Patent Office are attended to in a strictly time-bound way, saving time and money. OPPI represents the interests of its member companies when they need to file such applications, protecting their vast investments in innovation.

Access

Enhanced healthcare access significantly improves health outcomes by strengthening disease prevention, optimizing management, and increasing life expectancy. As India charges ahead towards its healthcare vision for 2047, strategic collaborations between the public and private sectors, along with planned interventions, will become vital in bridging gaps and building a more inclusive and resilient healthcare system.

Whether it is harmonizing the Medical Regulatory framework, streamlining pricing and bulk procurement policies, or fostering collaboration in the rare diseases segment to maximise impact, OPPI plays a crucial role in engaging with key stakeholders to ensure that the policy framework is robust. By strengthening regulatory functions, we not only safeguard patients from substandard products, but also advance health equity, ensuring broader and more reliable access to quality healthcare.

Access is a crucial factor in achieving healthcare equity, dependent on several factors, such as the rural-urban healthcare divide, insurance coverage, infrastructure availability, and the awareness among patients and stakeholders. Addressing these challenges holistically is essential to ensuring that quality healthcare reaches all segments of the population.

The Indian government has initiated multiple programs to address these challenges and transform the nation’s healthcare system. The National Health Mission improves the availability of medical equipment and supplies and promotes community participation and engagement in healthcare decision-making. The Ayushman Bharat scheme, under the Pradhan Mantri Jan Arogya Yojana (PMJAY), is a health insurance program that provides coverage of up to INR 5 lakhs per family per year for secondary and tertiary care hospitalization. Additionally, various other schemes focus on upskilling healthcare professionals and strengthening medical infrastructure, ensuring broader access to quality healthcare across the country.

OPPI has been actively collaborating with the government to achieve these healthcare objectives. Patient Assistance Programmes (PAPs) by our member companies increase access to innovative therapies in a subsidised manner. It aims to raise awareness about various ailments and the treatment options available. OPPI is also working closely with state governments and agencies to facilitate the bulk procurement of medicines at preferential pricing. This will ensure cost control and quality as well.

Over-the-counter (OTC) medicines enhance access to treatment for minor ailments, enabling individuals to self-medicate without a prescription, potentially reducing healthcare costs and reducing the burden on healthcare professionals. The key factors driving this trend include increasing consumer awareness, broader consumer access to essential medication, and socio-economic benefits to the public health care system.

While self-medication offers convenience and accessibility, ensuring its safe and effective use is essential. A well-defined policy framework can help guide responsible self-care, mitigating risks such as misdiagnosis or improper dosage while safeguarding the benefits of OTC medicines in enhancing healthcare access.

As more medicines transition into the OTC space through deregulation, the need for a robust OTC policy becomes increasingly critical. Establishing clear safety and efficacy profiles prior to deregulation is essential to maintaining consumer trust and healthcare standards. OPPI has been committed to this cause, collaborating with the relevant ministry to establish a stringent yet suitable framework for OTC medicines, while ensuring its members adhere to all the required guidelines.

Rare Disease affects a small yet significant section of India’s patient pool. However, limited access to medicines and the unavailability of effective treatment continue to pose serious challenges. As a result, many patients face significant health risks, highlighting the urgent need for better support and accessibility in rare disease management.

To address this challenge, the National Policy for Rare Diseases (NPRD) has identified 63 rare diseases for which they have laid down guidelines for assistance. This includes establishing 12 Centres of Excellence (CoEs) which are premier Government tertiary hospitals with facilities for diagnosis, prevention and treatment of rare diseases. Patients who register at these centres are eligible for financial assistance of Rs. 50 lakhs towards their treatment, significantly improving access to care.

OPPI has been working with the Ministry of Health & Family Welfare to understand the demand for these medicines, as well as facilitate bulk procurement and preferential pricing for the same. Additionally, the government has taken steps to streamline access by waiving local clinical trials for some medications, expediting approvals and facilitating imports. The member companies have established Patient Support Programmes, providing critical assistance to individuals affected by rare diseases.

Efficient public procurement practices are essential in ensuring enhanced access to medicines and advancing healthcare equity. Combined with resilient supply chains, this also serves to increase availability of these medicines, particularly during times of need.

Improved government procurement practices involve better sourcing, streamlined purchasing and effective management of medicines, ultimately making them more accessible. OPPI works with both the central and state governments to smoothen the operational, logistic and infrastructural challenges and address medicine availability. We encourage state governments to buy in bulk at preferential prices, directly from manufacturers, with supply going directly to government hospitals. This approach ensures reliable availability and strengthens overall access to essential medicines.

Ease of Doing Business

The Indian government anticipates the country’s pharma market to reach Rs 7.5 lakh crore by 2025, growing at 10-12%, supported by a robust domestic manufacturing base and rising exports. India ranks third globally in pharmaceutical production by volume and exports to over 200 countries. To attract greater investment, the government has been continuously working to reduce the regulatory burden on the industry and increase the ease of doing business in the country.

OPPI is actively engaged with its member companies, promoting adherence to WHO guidelines and to Indian government regulatory requirements as well. Simultaneously, OPPI works closely with government bodies through sustained policy advocacy on issues ranging from pricing to broader policy frameworks—ensuring that industry perspectives are represented in the evolving regulatory and economic landscape.

The Indian healthcare system is evolving at an unprecedented rate, witnessing multiple innovations and breakthroughs in medicine and treatment options. To match this progress, it is imperative that the country’s healthcare regulatory system evolves as well, ensuring patient safety and streamlining production, and optimizing costs to enhance accessibility and efficiency in healthcare delivery costs.

As the government takes steps to streamline the regulatory system, OPPI, representing its vast innovation-based members, works alongside the ministries to advocate for policies that promote harmonising of data, and establish accelerated regulatory pathways. These efforts could lead to faster and more efficient drug approval processes and launches – saving both time and resources; protecting the investments in innovation and ultimately providing patients with superior medical options.

The Indian pharmaceutical industry can move up the value chain by prioritizing quality and compliance, thereby gaining recognition, fostering trust, attracting investment, and enabling the development and export of high-value, innovative products in the global market as well. A robust quality and compliance framework also cultivates an environment that promotes increased research and development, further driving industry advancement.

OPPI and its member companies have been diligently working to ensure adherence to WHO – GMP (Good Manufacturing Practices) and WHO – GDP (Good Distribution Practices) Guidelines and to the Indian government regulatory requirements. GMP ensures that the processes necessary for production and testing are clearly defined, validated, reviewed, and documented, while GDP keeps the integrity of pharmaceutical products throughout the distribution chain, from the manufacturer to the end user. OPPI and its members play a pivotal role in advancing technical standards and enhancing supply chain practices within India’s pharmaceutical sector. OPPI has been advocating for mandatory application of the GMP and GDP guidelines, safeguarding the standards of production. By maintaining compliance throughout the supply chain, the industry can uphold quality and efficacy of products, mitigate counterfeiting, and minimize wastage, ultimately fostering a more reliable and efficient pharmaceutical ecosystem.

OPPI plays an active role as spokesperson for our vast body of members to ensure they are well represented when discussing and putting in place polices concerning pricing, duties and taxation in the pharmaceutical industry. Meeting with all the stakeholders and the relevant state and central government we drive for clarity in issues related to M&As, GST, custom duties, etc, ironing out issues to ultimately optimize benefit for patients.

We prioritize both pricing and policy as required. By addressing key regulatory hurdles and offering solutions we help expedite increased access to innovative therapies for a greater number of patients. OPPI also plays a pivotal role in shaping policy frameworks related to taxation and pricing, acting as a bridge between the government and our members to foster a balanced and progressive regulatory environment.

In 2024, the Department of Pharmaceuticals (DoP) via a notification announced the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024, to establish a clear set of guidelines that ensure transparency, integrity, and accountability in the marketing of pharmaceutical and medical device products across India. It marks a significant shift in India’s pharmaceutical marketing regulations and is mandatory for pharmaceutical and medical device companies.

This quasi-judicial code includes formal complaint and appeal mechanisms, operating under heightened scrutiny and stricter enforcement actions. Under these regulations, companies must ensure that information about drugs is up-to-date, accurate, and objective avoiding misleading the patient either directly or by implication. Similarly, stringent guidelines are laid down about engagement with HCPs and organisations.

For a large section of the Indian population, affordability of medicines determines its accessibility. At OPPI, we engage with the broader policy framework that shapes this landscape. In collaboration  with the financial leaders of our member companies and other stakeholders, we contribute to discussions with the Ministry of Finance on matters related to the National Pricing Policy (NPP), including the pricing of scheduled and non-scheduled medicines, updates to pricing for new batches of medicines, and the recognition of value from incremental innovation.. We also monitor and respond to operational implications of changes in taxation policies such as GST structures, customs duties, and exemptions to help build a policy environment that supports sustainable and equitable access to medicines.

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