As globally about $128 billion worth of branded drugs are going off patent in the coming next two years, many bulk drug and generic manufactures in India are gearing up to grab the huge upcoming market opportunities. Many of them are complying with Good Laboratory Practices (GLPs) to attain regulatory approvals for their generic products. Many global as well as Indian companies are also tweaking their business strategies by merging, collaborating and forming partnerships to set up laboratories and research establishments complying with international GLP guidelines.
Knowing the significance of GLP implementation, Indian government has also taken several steps to establish a national authority to monitor GLP. In the year 2002, the Department of Science and Technology has established a National GLP Compliance Monitoring Authority.
According to some reports from our New Delhi Bureau, the Union health ministry, in collaboration with the state drug authorities, will take up an assessment of the state drug testing laboratories, both in the public and private sectors, with respect to GLP compliance.
The massive exercise is planned in view of a proposal for capacity building of the laboratories with huge investments which is under the consideration of the Planning Commission for implementation during the current Five Year Plan period.
The move is initiated following a report of the Parliamentary Standing Committee some time back that found that many of the central and state drug testing laboratories are not equipped well or not compliant with GLP standards.
On March 3, 2011 India accepted the invitation of OECD Council to become a full adherent to OECD Council Act related to Mutual Acceptance of Data (MAD) in assessment of chemicals and to join that part of chemicals programme related to MAD, with all of the rights and obligations of OECD member countries.
With the attainment of OECD membership, India now has the right to take part as a full participant in joint meeting of the countries and Working Party on the Chemicals, Pesticides and biotechnology that concerns MAD, as well as in the Working Groups on Good Laboratory Practice and of National Test Guideline co-ordinators.
The major implication of India's full adherence to the MAD system is that non-clinical health and environment safety data generated in India under the conditions of 1981and 1989 Council Act will be accepted by OECD member countries and other adhering countries for purposes of assessment and other uses related to protection of man and environment.
At present, there are only about 24 test facilities listed certified in the country under the National GLP programme. While giving his views on the growth prospects of GLP complaint companies in India, K.B. Sunil Kumar from Aurigene Discoveries Ltd in Hyderabad said, “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.”
Good Laboratory Practices are essential particularly for the chemical, biotechnology and pharmaceutical manufacturing industries which deals with systematic approach and procedures for recording minute, sophisticated and intricate measurements of research data that are needed for new inventions, discoveries and manufacture of new products being used in development of lifesaving medicinal drugs for human consumption or for other purposes of chemical and biotechnology industries.
Any organization conducting a non-clinical study is required to follow good laboratory practices, which help regulatory authorities assure 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.
“For any new product to be approved by the regulatory authorities, it is important that firms should support their claim with suitable and evident data obtained in the laboratories. Improper documentation of data, not complying with GLP guidelines may lead to erroneous measurements and in turn it may lead to wrong assessments about the intended products,” said Kumar.
In fact, good laboratory practice 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.
While giving insights about GLP and its importance in maintaining the quality and safety of the food and medicinal products, Dr. Surendranath Vice President, USP Hyderabad, said, “Good Laboratory Practices play a significant role in ensuring safety and quality of products of human consumption. USP Hyderabad offers world’s best laboratory environments in India dedicated to ensure quality safety of drugs and food supplements in the country.”
USP (United States Pharmacopoeia) has established one of the finest laboratories in Hyderabad adhering to world class standards of laboratory guidelines and is equipped with state of the art modern laboratory equipment with all standard safety precautions well in place.
In South India, USP is among the very few research laboratories in the country that complies with stringent disciplinary lab procedures. GLPs are essential to analyse 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.
Regulatory authorities in many countries are insisting manufacturers of industrial chemicals, pharmaceuticals, veterinary drugs, pesticides, cosmetic products, food products, feed additives etc to establish through data that use of these products do not pose any hazards to human health and the environment.
Non-hazardous nature needs to be established through studies and data, which will be examined by the regulatory authorities of the concerned countries. GLP is a system, which has been evolved by Organization for Economic Co-operation and Development (OECD).
For marketing any drug or pharmaceutical or chemical product in USA, the regulatory agencies such as Food and Drug Administration (FDA) and the US Environmental Protection Agency (EPA)] and the National Toxicology Program (NTP) require studies to be conducted in accordance with GLP.
For marketing the drug, chemical products in other parts of the world, the manufacturing firms will have to adhere to OECD GLP principles.