Areas of work

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

Innovation

Healthcare systems thrive because of continuous research & innovation in the fields of science and technology that results in finding new treatment outcomes to address unmet medical needs.  In India, there has been a clear shift in the innovation landscape. In recent years, the Central Drugs Standard Control Organization (CDSCO) has approved a wide range of new therapies including biotherapeutics, biosimilars, monoclonal antibody-based drugs, and mRNA vaccines, and 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 strong 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 evolution process, and we are committed to facilitating an environment where innovation thrives—not only through scientific breakthroughs, but through policies and partnerships that support the entire value chain.

Looking ahead, India’s pharmaceutical industry, with a vision to grow to USD 120–130 billion over the next decade, requires a holistic set of policy interventions to shift from volume to value and enable the industry to leapfrog. Balancing innovation with accessibility is key. By building a regulatory environment that ensures access to life-saving medicines in an expeditious manner and also by stoking an ecosystem that rewards innovation, India can achieve sustainable growth. 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 considerable time, effort and investment. Protection of intellectual property and its meaningful enforcement is, therefore, critical for pharmaceutical companies, and pivotal to ensuring continued innovation.

Despite progress, research-based biopharmaceutical companies continue to face barriers that create uncertainty and discourage investment in innovation. A predictable, transparent, and science-based IPR environment will not only foster breakthrough discoveries in India but will also enable the country to sustain its position as a trusted global supplier of high-quality medicines. At, OPPI, we actively engage with the government and regulators to develop a policy framework work that encourages innovation and trade and builds confidence in our members to invest in R&D in India.

OPPI also works shoulder to shoulder with the Government of India for greater incentivization for innovation. This includes policy measures such as tax deductions and other stimuli to the sector, as well as enabling the growth of Global Capability Centres (GCCs) in various cities. These initiatives enhance India’s standing in global markets and contribute to the national economy by creating employment. Today, nearly 90,000 highly trained professionals are employed in GCCs across the country, strengthening India’s talent pool considerably.

Protecting Intellectual Property from infringement is another critical factor in encouraging investment in innovation.

OPPI continues to advocate for policies that provide robust enforcement against infringement and data theft, creating an environment where companies feel confident to invest and bring new therapies to patients.

By strengthening patent protection, incentivizing R&D, and creating an enabling ecosystem, India can.

Fostering innovation, enhancing ease of doing business and establishing a clear, strategic framework for a robust IP regime in India will attract greater global investment, expand its talent base and deliver long-term economic and health benefits and empower India to realize its full potential as a global centre for innovation.

For research based pharmaceutical industry, generation of regulatory data generated in the course of developing a drug product (required for making regulatory submissions) is cost and time intensive and also involves significant risks. As India advances on the path of discovering, developing and delivering new drugs and treatments, the need for a  regime where the regulatory data package so generated and submitted before drug regulatory authorities is protected for a specified period of time from its unfair commercial use by third parties without the innovator’s concurrence.

Effective and enforceable patents together with a robust RDP creates a sustainable ecosystem that fosters innovation. It does not extend the patent term or creates ‘evergreening’. Safeguarding the test data submitted for regulatory approvals not only protects the integrity of research but also gives innovators the confidence to invest the substantial resources required for drug development. While RDP is a global obligation under the WTO TRIPS Agreement, its scope in India remains limited, allowing reliance on innovator data for follow-on approvals.

OPPI continues to champion stronger RDP policies that align with international best practices. Strengthening this framework will help attract global investment, support research, and ensure that patients benefit from both timely access and continued innovation.

In India, the pre-grant opposition system was introduced under the Patents Act, 1970 as a mechanism to ensure that patents are granted only to inventions that meet statutory requirements, thereby fostering transparency and accountability. While PGO provisions exist in the Patents Act, 1970 to prevent grant of frivolous patents, in practice it gets abused resulting in delays and uncertainty for innovators, particularly in the biopharmaceutical sector. Despite recent amendments aimed at improving efficiency, challenges remain in terms of timelines, cyclic filings, and procedural bottlenecks that slow down the grant of legitimate patents and delay patient access to new treatments.

OPPI continues to advocate for a more predictable, transparent, and time-bound opposition process. A balanced framework that preserves checks against weak patents, while also preventing frivolous or cyclical challenges, is essential for creating confidence in India’s patent system and encouraging sustained investment in innovation.

Access

Enhanced healthcare access is central to achieving equitable health outcomes in India. It improves disease prevention, strengthens disease management, and increases life expectancy.

As India marches towards its healthcare vision @2047, expanding access will require strategic collaborations between the public and private sectors, alongside targeted interventions to build an inclusive, resilient, and future-ready healthcare system.

An essential factor will be to expand health insurance coverage—particularly for the “missing middle” that currently falls outside both public insurance schemes and private health coverage. Innovative insurance models and collaborative frameworks are needed to ensure affordable access and financial protection for this segment. At the same time, strengthening healthcare infrastructure remains critical. This includes increasing hospital capacity, upgrading facilities, addressing regional disparities, and ensuring the availability of skilled healthcare professionals across urban and rural areas. A multi-stakeholder approach, bringing together policymakers, industry, academia, and civil society, will be key to unlocking these opportunities and delivering equitable, high-quality healthcare to all Indians.

Government initiatives such as the National Health Mission and Ayushman Bharat under PMJAY have already expanded coverage and improved infrastructure, while other schemes continue to upskill healthcare professionals and promote community engagement.

OPPI is committed to working with the Government stakeholders to improve access to healthcare to wider population. Complementing these efforts, OPPI member companies also support access through Patient Assistance Programmes (PAPs), which subsidize innovative therapies and raise awareness about treatment options. OPPI also works closely with state governments to facilitate the bulk procurement of medicines at preferential pricing, ensuring cost control and consistent quality.

A multi-stakeholder approach—bringing together policymakers, industry, academia, and civil society—will be essential to bridge gaps and deliver equitable, high-quality healthcare to all Indians.

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 improper dosage while safeguarding the benefits of OTC medicines in enhancing healthcare access.

As certain medicines transition into the OTC space through a soon expected amendment to regulatory provisions, the need for a robust OTC policy becomes increasingly critical. Establishing clear safety and efficacy profiles prior to expected amendments 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 Diseases affect a small but significant section of India’s patient population. Limited access to rare diseases medicines and the unavailability of effective treatments continue to pose serious challenges, leaving many patients vulnerable and underscoring the urgent need for greater support in rare disease management.

The National Policy for Rare Diseases 2021 (NPRD) has identified 63 rare diseases and established a framework to improve access and treatment. This includes the creation of 14 Centres of Excellence (CoEs) at leading government tertiary hospitals, equipped to diagnose, prevent, and treat rare conditions. Patients registered at these centres are eligible for financial assistance of up to ₹50 lakhs, providing meaningful support for advanced care.

OPPI continues to closely work with the Government stakeholders to shape up policy framework that enables early access of rare diseases drug products such as waiving of the requirement of local clinical trials for certain drugs, expediting approvals and facilitating imports. OPPI member companies have also established Patient Support Programmes that provide 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

India’s pharmaceutical sector is one of the largest globally, supported by a strong domestic manufacturing base. India ranks third globally in pharmaceutical production by volume and 14th in terms of value of production exporting to over 200 countries The government anticipates the industry to grow to USD 130 billion by 2030 and US$ 450 billion market by 2047. To sustain this growth and attract further investment, continuous efforts are being made to reduce regulatory burdens, streamline processes, and enhance the ease of doing business.

A robust intellectual property (IP) and RDP framework is central to this vision. An effective IP regime builds investor confidence as it reduces litigation risks and provides companies with the assurance to commit to long-term research and development projects.

OPPI is actively engages with its member companies to promote adherence to regulatory requirements and international best practices, while also working closely with government bodies on broader policy frameworks. Collaborative efforts between industry, government, and academia are vital to bridging R&D gaps, addressing infrastructure challenges, and ensuring that India’s potential as a global innovation hub is fully realized—balancing innovation, access, and growth.

The Indian healthcare system is evolving rapidly witnessing significant innovations and breakthroughs in medicine and treatment options. To keep pace with this progress, it is important  that the country’s regulatory framework evolves parallelly,  ensuring patient safety, streamlining production, and optimizing costs in order to enhance accessibility and efficiency in healthcare delivery.

As the Government takes steps to streamline the regulatory framework, OPPI, representing it’s innovation-driven members, works closely with various Government  departments to advocate for policies that promote data harmonization, and establish accelerated regulatory pathways. These efforts are geared towards ensuring faster and more efficient drug approvals and launches – thus saving time and resources; safeguarding investments in innovation, and ultimately providing patients with timely access to advanced medical options.

Indian pharmaceutical industry has the potential to move further up the value chain by prioritizing quality and compliance. A robust quality and compliance framework cultivates an environment that promotes increased research and development, further driving industry advancement.

OPPI and its member companies are committed to ensuring adherence to WHO Good Manufacturing Practices (GMP), WHO Good Distribution Practices (GDP) and also the applicable Indian regulatory requirements. GMP ensures that production and testing processes are clearly defined, validated, and documented, while GDP safeguards the integrity of products throughout the distribution chain.

By advocating for the uniform application of revised GMP guidelines mandatory application of GDP guidelines, OPPI works to enhance technical standards, protect product quality and efficacy, and mitigate risks such as counterfeiting and wastage—ultimately strengthening the reliability and efficiency of India’s pharmaceutical supply chain.

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 price fixation, price monitoring, statutory compliances, 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) notified the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) to establish clear code ensuring transparency, integrity, and accountability in the marketing practices of pharmaceutical companies across India. This marked a significant shift in India’s pharmaceutical marketing practices, with the Code being made mandatory for all pharmaceutical companies. The UCPMP introduces a framework with formal complaint and appeal mechanisms, along with stricter enforcement actions. It requires that all drug-related information provided by companies be accurate, up-to-date, and objective, and prohibits practices that could misleading.  It also sets detailed standards for engagement with healthcare professionals(HCP) and organizations, covering activities such as continuing medical education (CMEs) and research collaborations and requires disclosures to be made by the pharmaceutical companies (in the prescribed format) in respect of the samples handed out to the HCPs and expenditure incurred by pharmaceutical companies in CME programs conducted by them directly or through third parties .

OPPI continues to work with stakeholders to ensure that the implementation of UCPMP is streamlined that business integrity strengthened while supporting an environment of ethical, transparent, and patient-focused practices.

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 Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers on matters related to the National Pharmaceutical Pricing Policy, 2012 and Drugs (Prices Control) Order, 2013 including the pricing of scheduled and non-scheduled medicines, pricing exemptions for innovative medicines, implementation of ceiling pricing and MRP 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 tax/duty exemptions to help build a policy environment that supports sustainable and equitable access to medicines.

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