27th August

As the industry experiences a resurgence of consumer and manufacturer interest in natural extracts and fine chemicals, India’s pharma sector is in prime position to put the country at the forefront of production in both. The country’s rich biodiversity supports diverse botanical resources, while having a longstanding history of fine chemical manufacturing capabilities, allowing it to competitively determine its pricing for global markets.

International organisations looking to source fine chemicals or natural extracts for pharmaceutical should carefully evaluate suppliers, ensuring that they have implemented robust quality control and compliance measures. This becomes even more important as more complex techniques are used to find more novel bioactive compounds and characterise botanical materials.

The market dynamics driving demand for natural extracts and fine chemicals

Research from the World Health Organization estimates that approximately 80% of populations in developing countries rely primarily on traditional medicine for healthcare, [1] with botanical preparations representing substantial proportions of these traditional medicine systems. This creates a number of large established market for herbal medicine ingredients alongside emerging opportunities for pharmaceutical-grade botanical products.

Demand for fine chemicals and pharmaceutical intermediates market has expanded in a similar capacity, with global market values estimated at USD 80–100 billion and growth driven by increasing industry outsourcing of chemical synthesis. Again, India has long been at the forefront of this work, with a deep understanding of the complexity of modern pharmaceutical synthesis which has led to a concentration of fine chemical manufacturing capabilities in the region.

As the pharmaceutical industry evolves to prioritise more complex molecular entities such as biologics, antibody-drug conjugates and targeted small molecules, there has been corresponding demand for specialised pharmaceutical intermediates. These require advanced technologies to produce and oversee, as well as considerable investment to put into action, hence the increasing popularity in outsourcing these tasks to specialised organisations.

India owes its reputation in the natural extracts market to its botanical diversity, with the subcontinent hosting approximately 15,000 plant species with documented medicinal properties. As the region’s pharma sector became formalised, it developed a series of strict infrastructural and regulatory frameworks to support in these key capabilities, boasting international regulatory and quality certifications including from the United States FDA and ISO 9001 standards.

Quality control challenges in standardisation of natural extracts

Botanical ingredients are variable, thanks to inherent differences in growing, harvesting and extraction conditions for each plant; this creates fundamental challenges in quality control for anyone working in this field. Unlike synthetic active pharmaceutical ingredients with defined chemical structures, botanical extracts [2] can sometimes be made up of hundreds of chemical constituents whose compositions will vary depending on the stage of the supply or manufacturing chain. This compositional complexity requires a multi-faceted approach to quality control, which combines identification of botanical species, quantification of marker compounds or active constituents and assessment of potential contaminants.

Botanical identification simply means ensuring that materials are derived from the correct species and parts of the plant, as specified in formulations or regulatory submissions. This can prevent issues around product efficacy or safety concerns, particularly if any substitute species are used which may contain toxic constituents. Chemical standardisation typically focuses on marker compounds, the characteristic chemical constituents that allow for assessments of batch-to-batch consistency. Selecting the appropriate marker compounds requires consideration of chemical stability, analytical accessibility and relevance to therapeutic activity.

As botanical materials may accumulate heavy metals from soil, retain pesticide residues from agricultural practices or harbour microbial contamination from growing environments or post-harvest handling, a comprehensive contaminant assessment must also be undertaken. Regulatory frameworks including the United States Pharmacopeia and European Pharmacopoeia establish limits for the likes of lead, cadmium, mercury and arsenic, while pesticide residue screens for hundreds of pesticides simultaneously.

Regulatory frameworks governing natural products and fine chemicals

Within pharmaceutical manufacturing regulations, fine chemicals and pharmaceutical intermediates are considered intermediates (or starting materials) rather than finished drug products. This means that all quality requirements are established through drug master files, regulatory submissions for finished products and pharmacopeial standards where applicable, as per ICH Q7 guidance. [3] Regulators put increasing emphasis on transparency and control within the supply chain transparency, requiring pharma manufacturers to assess and qualify their suppliers of starting materials and intermediates, conduct supplier audits and maintain ongoing monitoring to ensure sustained levels of quality and regulatory compliance.

One hurdle for manufacturers looking to bring pharmaceuticals derived from natural products to international markets is the number of differences in regulations across different jurisdictions. Although FDA precedents have been set for botanical drug development, its New Drug Application pathway ensures that consideration is given to controls over botanical raw materials and manufacturing processes, as well as strategies for clinical development. [4]

India’s regulatory framework covers traditional and botanical ingredients, with provisions encompassing Ayurvedic, Siddha, and Unani medicines. This dual approach has allowed the country to establish quality standards for botanical raw materials and synthetic ingredients reflects India's unique position to bridge traditional medicine systems and modern pharmaceutical manufacturing techniques.

Supplier qualification and ongoing performance monitoring

One essential form of risk management for manufacturers sourcing natural extracts or fine chemicals is conducting comprehensive supplier qualification work. This typically encompasses an initial assessment, on-site audits to evaluate facilities and operations, qualification batches demonstrating ability to meet specifications consistently, followed by ongoing performance monitoring ensuring sustained compliance. The ICH recommends risk-based qualification [5] activities, especially for critical materials, complex synthesis or suppliers with limited track records.

The process of supplier qualification is an extensive one, from a desktop evaluation of capabilities, to on-site visits for a detailed exploration of facilities, equipment and operations. This encompasses an assessment of everything from the maintenance of machinery to document storage, in order to determine whether manufacturers are following good practice requirements in regard to the materials they are working with. Qualification batches then let manufacturers evaluate a supplier’s ability to consistently produce materials which are up to spec, analysing multiple batches created during routine manufacturing conditions.

Once these assessments have been made, any subsequent monitoring should be conducted to ensure sustained compliance with quality system requirements; these are generally routine unless any fundamental changes are made to processes, or issues have been identified. Any alteration to manufacturing strategies, facilities or key personnel can have a serious impact on the quality of output, requiring an evaluation of potential impacts and possible re-qualification activities.

Industry platforms to help source natural extracts and fine chemicals

The multi-step process of finding new suppliers of natural extracts and fine chemicals is neither a quick nor efficient one, often requiring visits to multiple sites in order to find the most appropriate partner for a manufacturer’s needs. Taking place from 23 to 26 November 2026, this year’s edition of CPHI & PMEC India [6] will be split across two venues, making the process of establishing new sourcing partnerships easier than ever.

The CPHI portion of the show, hosted at the IICC in Yashobhoomi, will focus on pharma ingredients, including specialised zones dedicated to natural extracts and fine chemicals & intermediates. Meanwhile, across the city at Greater Noida’s IEML, the PMEC event will spotlight international expertise in machinery and equipment, including lab & analytical technologies. These zones on the show floor have been designed to let pharmaceutical professionals conduct comparative evaluations of multiple suppliers within compressed timeframes, with both shows conveniently located for attendees to maximise their time and personnel across the city.

Industry events like this provide concentrated access to supplier ecosystems, giving pharma companies a way to efficiently evaluate the technical capabilities of any prospective partners. These face-to-face interactions also make it easier to discuss quality systems and regulatory compliance, providing insights far beyond what can be gleaned from websites or marketing materials. Complementing the show floor, CPHI & PMEC India will also feature comprehensive conference programming, with tracks addressing regulatory developments, quality control methodologies and sourcing strategies. For pharmaceutical manufacturers developing natural product-based formulations or sourcing pharmaceutical intermediates for complex synthesis, this offers a valuable forum for supplier discovery and technical evaluation, giving them the chance to establish relationships with suppliers who can support quality requirements and objectives around regulatory compliance.