Good Laboratory Practices are considered as the backbone of the research - driven industries across the world. With ever-evolving pharma and biotechnology industries and changing trends in businesses, manufacturing and research, India is fast streamlining its regulatory mechanisms and systems to strengthen GLP among the industry, hospitals and clinical trial organizations.
As pharma and biotechnology industries involve high level regulated research over a long period of time, it is imperative for them to continuously improve GLPs to achieve better results and meet future challenges.
In fact, GLP is an essential part of good manufacturing practice detailed in schedule M of the Drugs and Cosmetic Rules. It involves a number of good practices in quality control laboratory which are to be undertaken to carry out an analysis with a defined degree of accuracy and precision.
GLP generally refers to a system of management controls for laboratories and research organizations to ensure the consistency and reliability of results as outlined in the OECD Principles of GLP and other national regulations. India became a provisional member of the OECD’s working group on GLP in April 2003.
In February 14-18, 2010, OECD along with NGCMA carried out evaluation of Indian GLP programme and this resulted in approval of Indian GLP programme by OECD leading to mutual acceptance of data in April 2011. With this, India joined the group of 34 nations from developed countries who have a “fully adherent status”. India is the third emerging economy after South Africa and Singapore to join the OCED member countries.
Though the importance of GLP have been recognized a bit late in India, the country is fast catching with the global standards. Since the year 2002, the state and central governments have taken several steps to strengthen the GLP regulations.
Of late, the recent Supreme Court order to ‘halt all the clinical trials’ in India not only gave a shock to the entire pharma and biotechnology industry in country .However it was an eye -opener for the national and multinational companies and clinical trial organizations that Indian law will not tolerate any irregularities regarding the implementation of regulations, norms and GLPs.
As India has emerged as one of the leading high quality low cost generic manufacturer, many countries across the globe are looking towards India for sourcing generic drugs and medicines.
The US, Europe, CIS, Latin America and Africa are some of the major countries that are procuring quality pharmaceutical products from India. It clearly proves that Indian pharma and biotechnology industry upholds international standard quality and abides by stringent regulations, standard procedures and most importantly good laboratory and manufacturing practices.
The fact India today holds the largest number of USFDA approved manufacturing units outside USA proves that Indian laboratory standards are on par with the western GLPs. “All the leading companies in India have adopted international standards and many more are coming forward to comply with USFDA GLP and GMP standards. In fact, India’s credibility as a GLP and GMP abider has lead the country grow as a leading destination for sourcing generics for countries like USA, EU, Africa and other Latin American. These countries are increasingly depending on India for high quality low cost medicines. It proves beyond doubt that we are one of the best in the world. With the support of government of India, Pharmaexcil is exploring to tap newer markets in Japan, China and South East Asian region and pushing forward to achieve the set export target of $25 billion by 2020,” said, Dr. P.V. Appaji, Director General Pharmexcil.
India’s foray into pharmaceutical and biotechnology industry began in late 1980s and early 1990s and it gained momentum with the advent of liberal economic policies and global outlook during 1993. Today the country could gain the global reputation for its high quality standard in a short span time only because it had followed USFDA norms, GLP and GMP regulations.
Importance of GLP
GLP plays a vital role in the pharma and biotechnology sectors as these industries are highly regulated and deal with molecular and cellular level chemical and biological reactions. Standard laboratory practices are essential for the very survival of pharmaceutical and biotechnology industry across the globe. As the world is continuously evolving, so too are the diseases and various ailments are evolving in the world today. To contain the diseases, it is imperative for the pharma and biotechnology industry to continuously work to discover new drugs, vaccines, and manufacturing process and treatment methodologies. To achieve all these, it is not quite easy. The industry should abide by certain set procedures and regulatory norms.
As pharma and biotechnology industries are dealing with microscopic and cellular level organisms and atomic and molecular level chemical constituents that may exhibit rapid changes with the surrounding environment such as light, temperature, humidity, air, water and dust, it is very much important for the manufacturing units and testing laboratories to follow certain standard and good laboratory practices.
Development of sustainable process and GLP further enable scientists to discover or invent newer products that work efficiently and accurately. “Good Laboratory Practices play a significant role in ensuring safety and quality of products of human consumption. We at Tofflon offer one of the world’s best laboratory and manufacturing equipment that are highly compliant with cGMP and GLP regulations, said. Fengmin Wu, assistant of chairman Tofflon.
USP in South India is among the very few research laboratories in the country that complies with stringent disciplinary lab procedures. GLPs are essential to analyze the manner in which non-clinical safety studies are planned, performed, monitored, recorded, reported and archived. For any organization to produce reliable data that complies with regulatory agencies, good laboratory practice guidelines, specifications and regulations, it is important to have advanced equipment and well trained staff.
Need to strengthen GLP
Despite attaining great heights in exports, India still lacks a strong regulatory frame work. Even today GLP certification remains a voluntary process, although most Indian pharma companies dealing with international clients or exporting to foreign regulated markets look to attain such certification.
To strengthen the GLP regulations in India, the central government had established the National Good Laboratory Practice Compliance Monitoring Authority in the year 2002. This authority works under the control of Department of Science and Technology. While this was undoubtedly a step in the right direction, there are still only about 33 GLP inspectors and about 12 GLP certified labs in the country.
The recent Supreme Court observation on clinical trials reflects the lackadaisical attitude of our regulatory authorities. Moreover there are many loopholes that are needed to be plugged in. In addition, the ruling on whether a trial design violates ethical principles is left to individual local ethics committees. There is no central register of Ethical Committee decisions. Better infrastructure for regulation, ethics review and monitoring is required. The Clinical establishments (Registration and Regulation) Bill, 2007, which is yet to be approved, proposes compulsory registration of all clinical trial establishments subject to compliance with prescribed standards.
The bill also calls for setting up a National Council entrusted with forming the standards required. This type of more rigorous regulatory oversight, together with increasing interest from foreign firms, should help boost the Indian clinical trials market.
To further strengthen the clinical trials regulations in India, the central government had appointed Prof. Ranjit Roy Chaudhury committee for recommendations. Recently the committee has submitted its report to the government with 30 important proposals.
The committee’s proposal right from accreditation of centres conducting human studies to compensation, audiovisual recording of the informed consent and joint monitoring by state drugs control departments are seen to ensure that India will become a leading hub for clinical trials in the times to come.
The current GLP scenario
Currently in India there are only around 25 test facilities listed certified under the National GLP programme. “With growing awareness and appetite to comply with global standards, manufacturing companies and research laboratories in India are now gearing up to comply with the GLP guide lines. It is only a beginning. In the next two to three years, many companies will have GLP compliant status which will enable Indian companies to get faster and cost-effective regulatory approvals,” says K.B. Sunil Kumar from Aurigene Discoveries Ltd in Hyderabad.
It is imperative for every organization conducting a non-clinical study to follow GLPs, which assures regulatory authorities that the data submitted is a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments. “Product approvals at the state, central and international level are approved by the regulatory authorities, if and only if proper evidence based data is submitted. Improper documentation of data or not complying with GLP guidelines may lead to erroneous measurements and in turn it may lead to wrong assessments about the intended products and thus may disapprove the permission,” said Kumar while explaining the importance of GLPs of obtaining product approvals.