The massive exercise of Union Health Ministry in collaboration with the state drug authorities to assess the state drug testing laboratories with respect to their compliance to Good Laboratory Practices (GLP) will help the ministry to understand the level of preparedness of laboratories and will also help in expediting compliance.
This assessment is planned in view of a proposal for capacity building of the laboratories with a massive investment which is under the consideration of the Planning Commission for implementation during the current Five Year Plan period.
The move is also initiated following a report of the Parliamentary Standing Committee some time back that found that many of the Central and state drug testing laboratories were not equipped well or not compliant to the GLP standards.
Moreover with a view to speeding up procedure to trace spurious drugs and initiate actions against the guilty, the health ministry has initiated a number of steps like fixing the time-limit for testing the drug samples collected by the drug inspectors and asked the states to follow the deadlines to the maximum extent possible.
The ministry also requested the Indian Pharmacopoeia Commission (IPC) to provide reference standards to the government testing labs within the next four-to-six months so that the labs can speed up the testing procedures.
Following the observations that the drug testing laboratories were delaying the process which leads to delay in corrective actions, the ministry has issued general guidelines to be followed by the labs. Pharmaceutical products with high performance liquid chromatography (HPLC ) should be tested within 90 days and products without HPLC should be cleared within 45 days, subject to the availability of method of analysis, the ministry said.
The ministry also asked the state health departments to ensure adequate financial provision for drawing more number of samples by the drug inspectors. As per the present provision, drugs inspector shall draw the samples only after payment of the cost of the drugs. The fund allotted for the purpose, are generally insufficient and thus, the provisions of the Drugs and Cosmetics Rules pose a hindrance in drawing sufficient number of samples for test/analysis.
Though the time-limits were fixed for testing, the ministry however did not put any deadline for launching prosecutions in the court against spurious/sub-standard drug cases, considering the practical difficulties. There was also a growing demand to define time-limit for the same, as there is no such provision in the Drugs and Cosmetics Act.
However, the states have pointed out that the drug inspectors could initiate action only after necessary investigations at the place where the samples are drawn and also where the drug manufactured. This exercise in most of the cases is of inter-state nature and time consuming. As such it may not be feasible to prescribe time limits for launching of prosecutions, it was pointed out.
Commenting on the Health Ministry’s move to carry out an assessment of GLP compliance with regards to state drug testing labs, Dr. BR Jagashetty, Drugs Controller, government of Karnataka said that the move was a positive one and was long pending.
“While we have not yet received any circular to this effect, all that can be stated is that highest quality standards need to be maintained when drug samples were tested. Therefore, labs needed to adhere to good practices to deliver the right reports, he added.
In Karnataka, all the three drug test labs located at Bengaluru, Hubli and Bellary coming under the umbrella of the state drugs control department are already adhering to GLP, he said.
While private labs were already seeking the GLP certification through a formal inspection process, the state labs should also take on a similar exercise, viewed the Karnataka Drugs Controller.
The Health Ministry is pushing for upgradation of the Central Drug Testing Laboratories which would require 442 additional posts and augmentation of their infrastructure on a large scale. The present drug testing capacity of the six laboratories is 8,000 samples per annum, which is targeted to be increased to 24,000 samples per annum.
There are 160 drugs testing laboratories in the approved private and government sectors in various states. The state drugs testing laboratories test statutory samples from the Drugs Inspectors of the respective state drugs control departments. It was also found that state drugs testing laboratories are not fully equipped with adequate manpower and infrastructure.
Though it is not mandatory to get GLP accreditation in India, some manufacturers have already implemented the concept voluntarily. India has about 24 certified GLP laboratories, around 50 per cent of them are privately owned evaluating drugs & pharmaceuticals. Data generated by this GLP certified laboratories are accepted by the OECD countries.
With this GLP regimen in India companies will be able to save the cost of getting their test data generated in GLP-compliant facilities outside the country. Indian test facilities will also save the expense of hosting multiple foreign inspection teams. India, at present, enjoys the status of a Provisional Member of the OECD for the purpose of GLP.
Another intent of GLP is to regulate the practices of scientists working on the safety testing of prospective drugs. With the obvious potential impact on consumers and patients recruited for clinical trials, the safety of drugs became a key issue and GLP was seen as a means of ensuring that scientists did not invent or manipulate safety data and a means of ensuring that GLP compliant studies are properly managed and conducted. Hence GLP became the consumer essential, the regulatory safeguard, the guarantee that the safety data were being honestly reported to the registration or receiving authorities as the basis of a decision whether or not to allow a new drug onto the market in 30 OECD member countries, said Dr. Manu Chaudhary, JMD, Director-Research, Venus Remedies Ltd.
Visible trends in GLP
Now GLP is being imposed on the industry by regulatory authorities, in the same way as Good Manufacturing Practice (GMP) had been before and its becoming difficult for the non-GLP certified companies to register their drug in the developed market.
India is recognized the world over as a country on par with any 34 OECD member countries (including countries like USA, UK, Japan and countries in EU) for scientific conduct and data generated by test facilities. Indian R&D companies developing products (e.g. pharmaceuticals, pesticides or others) would get better acceptability globally after GLP. It would lead to tremendous employment opportunities in the country CRO business. Technical barriers to trade will also be eliminated with this.
Once the GLP inspection is conducted in non-member and found to compliance with the OECD norms, their data will be accepted in other member countries than the one to which they are submitting data and which has sent inspector to verify the accuracy of compliance to OECD, said Dr. Chaudhary.
Challenges to GLP compliance
GLP certification was established by the regulatory bodies to ensure that research submitted to them is not only properly executed, but is also documented thoroughly enough so that any scientist skilled in the art can follow the documentation and replicate the results. The level of detail required to achieve this level of documentation is so much so that the cost of generating the documentation exceeds the cost of the research itself. GLP is a slow systematic way of testing which required specialized skill sets making cost of GLP work done in emerging countries at par with regulated markets.
Except big and medium scale companies it'd be almost impossible for SME to venture into GLP, said the JMD and Director-Research, Venus Remedies.
The GLP system was created for measurable quality controls and has evolved by member countries of the Organization for Economic Cooperation and Development (OECD) out of concern that organizational processes and conditions of non-clinical health and environmental studies
The keys issues cover:
Inflexibility: Under GLP, every step taken must be decided and documented in advance and each study must then be scheduled, but the scope of GLP is very limited.
Pace: Because of the documentation burden, GLP studies take four to five times longer to execute.
Cost: All of that documentation makes the cost of GLP five to 10 times greater, depending on the complexity of the study.
Scientific challenges: Skilled and creative scientists do not work in GLP environments, as the work is not only repetitive, mostly paperwork rather than conduct experiments and discus scientific implications to move the programme forward.
Throughout the world, regulatory systems are becoming more and more stringent and GLP is a quality system adopted for harmonization of quality and regulatory standards which cover holistic approach from experiment planning, performance, monitoring, recording, reporting and archiving. Efforts made by National Good Laboratory Practice Compliance Monitoring Authority (NGCMA) are credible but a lot more can be done to improve GLP awareness, opine experts.