Pre-clinical CRO business-post GLP in INDIA By Dr.A.Vijayalakshmi. M.Sc., Ph.D., CGLP, Member, Global G.M.P Professional Association

ABSTRACT :

In India, number of Contract Research Organizations to generate high quality data in support of applications for regulatory approval are more. The increase in competency of CROs in contributing to the growing demand for pre-clinical services is playing a major role in the business of individual CROs. The changes in regulatory approval processes increase the demand for pre-clinical services, thereby contributing to the market growth. In general, all CROs do not comply with International regulatory requirements such as Good Laboratory
Practice (GLP) standards, which may lead to several quality issues. The principles of GLP is to ensure and promote safety, consistency, high quality, and reliability of chemicals in the process of non-clinical and laboratory testing. National GLP Compliance Monitoring Authority (NGCMA), India is playing a key role in certifying GLP Compliance to the CROs. In addition to the above, the availability of scientific expertise in the country will bring business growth in India. The scenario in the pre-clinical CRO space has changed tremendously as India is emerging as a great platform for pre-clinical research especially after MAD (Mutual Acceptance of Data) agreement with OECD (Organization for Economic Co operation and Development). This article gives an overview about the impact of GLP in pre-clinical CRO business.

Keywords: CRO, NGCMA, GLP, MAD, OECD

INTRODUCTION :

Pre-clinical CRO Market appears to be widely expanded and the companies compete against each other based on pricing and an array of services. Ultimately the selected CRO should be the one-stop solution to cater the need of the customers. Presence of established CROs, better quality of work, scientific experience and logistic advantages are a few factors which contribute to the dominance of pre-clinical market. Indian pre-clinical CROs market will grow at considerable rate because India offers pre-clinical services at lower costs than developed nations. The segment of pre-clinical CRO market includes biopharmaceutical companies, pesticide manufacturers/companies, Government and academic institutes, and medical device companies. In addition to the availability of cost-competitive, skilled workforce, knowledge in cutting edge science and technology, regulatory requirements and other factors such as substantial investments are very much necessary for the business. All the regulatory authorities are making it mandatory to conduct pre-clinical toxicity studies under GLP conditions in a GLP certified lab. So GLP certification plays a major role in the growth of the CRO business.

Indian CROs-An Overview

Indian CROs were on par with global CROs because of the Indian GLP certification and stringent rules which was Internationally recognized. At present total 50 organizations are Indian GLP certified which includes CROs, and Research and Development Labs. Indian CROs are now
gearing up for the challenge to establish themselves for providing pre-clinical development services on par with global CROs.

Demand for pre-clinical services

Pre-clinical studies play a major role in chemical development process and mandatory for the further advancement of the potential molecule. Pre-clinical experiments using animal models are now requiring stringent regulations. Pre-clinical services are being considered as the fastest growing outsourced segment in the industry. Indian CROs have a successful history of providing toxicology support by delivering high quality data to its customers.

Benefits of GLP certified labs/organizations

The Principles of Good Laboratory Practice (GLP)have been developed to promote the quality and validity of test data used for determining the safety of chemicals and chemicals products. The main focus of GLP is to ensure that test data is reliable, repeatable and auditable and is
easily recognized by regulatory authorities worldwide. GLP labs/organizations had the advantage of Compliance with GLP regulatory requirements (OECD, EMA, US-FDA, US-EPA), traceability of GLP study data.

Key strengths of Indian CROs

The big advantage for India is the availability of skilled manpower with the required professional qualifications and good communication skills. The presence of state-of-art facilities provide cost-effective operations and high quality outcomes with reliability. India respect 3R’s (Reduce, Replace and Refine) in both planning and execution of animal studies in line with the international norms of Institutional Animal Care and Use Committee (IACUC) and also National guidelines of Committee for the Purpose of Control and Supervision on Experiments on Animals(CPCSEA).

National and International regulations, mandate for pre-clinical data (In-vivo, in-vitro) to seek approval for clinical trial. Hence already the trend has been set for safe animal studies. Though we have many animal facilities to meet the needs of non-regulatory and exploratory animal studies, there are only very few Good Laboratory Practice (GLP) certified laboratories in all relevant areas of expertise to serve all the needs of regulatory requirements. With the upcoming opportunities in pre-clinical research, we need more GLP certified labs in India to meet the increasing demand.

Challenges and Opportunities

Within the next few years, pre-clinical services are likely to become a significant component outsourced to India. One of the key challenges will be to have state-of-the-art well-equipped facilities to develop and provide discovery services. The rise in outsourcing of pre-clinical
studies to CROs and the growing abilities of CROs to offer additional value add services are expected to reach the global marke.

In recent years, leading Indian CROs invested in state-of-art facilities which not only provide toxicological services, but also a range of services required for discovery, early and advanced pre-clinical development required for identification of molecules for clinical development. At present, regulations on importing animals have been streamlined. Because of technology development, logistical issue of reaching out to multinational clients are also made easier.

In order to function as an effective CRO, the following are the prerequisites: GLP Certificate in all relevant areas, Experts in the field of toxicology, pharmacokinetics and pharmacology, Timely delivery reports, Animal facilities that have Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) accreditation.

SWOT Analysis-Evaluation Criteria for CRO selection and competitiveness

In order to evaluate the CROs, an idea about detailed overview of Pre-clinical CRO market is very much necessary. Recent trends and developments and changing marketing strategies of the industry made the necessity of SWOT (Strength, Weakness, Opportunity and Threat) analysis. SWOT analysis will be very much useful to identify significant trends and factors driving or inhibiting the market growth.

Selection of CROs are playing the major role in development of molecules and regulatory submissions. Though many CROs have well established general toxicology services for pre- clinical studies, but very few are specialized in emerging services of regulatory requirements.

DISCUSSIONS

Though improved efficiency and need for reduction in cost further escalates the demand for outsourcing the project to Contract Research Organizations, lack of standardization to regulatory policies can potentially affect CRO market growth in recent years. As we aware that, our National.

GLP Compliance Monitoring Authority (NGCMA) is providing the GLP certificate in different areas of expertise which includes Physical chemical Testing, Toxicity Studies, Mutagenicity Studies, Environmental Toxicity Studies on Aquatic and Terrestrial Organisms, Studies on
Behaviour in Water, Soil and Air; Bioaccumulation, Residue Studies, Studies on Effects on Mesocosms and Natural Ecosystems, Analytical and Clinical Chemistry Testing. Some other areas which did not cover under the above category can be specified under ‘Others ‘so that
according to the relevance, after GLP inspection, the areas of expertise can be considered by NGCMA. In addition to the areas of expertise, the type of Test Item(s) such as Industrial Chemicals, Pharmaceuticals(Human), Pharmaceuticals(Veterinary), Agrochemicals, Cosmetic
Products, Food Additives, Feed Additives, Medical Devices are mentioned in the GLP certificate based on the expertise in carrying out the studies and maintaining the GLP compliance on those type of studies using such chemicals.

Usually the main source of information of CRO was their website and brochures which clearly states about their infrastructure and capabilities in conducting of various types of studies and their GLP certification and other relevant accreditation status which will further help to get more business.

CONCLUSION:

Highly competitive human resources, pricing strategies, quality of service, versatility, customer focus, timely completion of the projects, company accreditations, certifications and reliability of services will attract the CRO business. So we expect more number of GLP certified labs in India in order to bring India to the next level in the global CRO market.

ACKNOWLEDGEMENT:

I wish to thank Institute of Good Manufacturing Practices, India (IGMPI) for giving opportunity to present this article.