The Union health ministry will soon amend Drugs and Cosmetics Rules, 1945 for fixing 60 days time limit for the government laboratories to furnish test reports on the statutory samples sent for testing, except in the cases where animal testing is required.
According to sources, the Drugs Technical Advisory Board (DTAB) of the ministry has recommended to the government that for prescribing time limits for government laboratories, a directive may be issued by the government to the state governments or Drug Control Authorities to adhere to a time limits of 60 days for furnishing the test reports on statutory samples by the government drug testing laboratories except in the cases of seras and vaccines and other such special products which may require animal testing.
The matter was deliberated in detail by the DTAB in its 70th meeting held on August 18, 2015. In the meeting, the members were of the view that the pharma industry has made tremendous progress in the last three decades by drug testing facilities in the government labs have not been strengthened to match the growth.
There is acute shortage of manpower, equipments and infrastructure in many of the state laboratories. The sample load also has a bearing in delayed testing of the drugs. The state drug control authorities must prioritise and move for the strengthening of the state drug laboratories under the central schemes launched by the central government to strengthen drug regulatory infrastructure.
Earlier, the issue was considered by the Drugs Consultative Committee (DCC) in its 48th meeting held on July 24, 2015 and members were of the view that drugs are required to be tested for all the test prescribed under the Pharmacopoeia to declare them as of standard quality or not. Biological products require certain sophisticated testing for animal testing. For patent proprietary medicines, method of analysis has to be procured from the licensing authority or the manufacturer for testing such products. Testing laboratories have also to obtain the reference standards for comparison during the testing. Apart from this laboratories receive large number of statutory samples for test and the laboratories do not have sufficient manpower, equipment, reagents and other infrastructure for completing the test and analysis in specified time limits.
After deliberations the DCC, however, recommended that an upper limit of 60 days for the government drug testing laboratories for furnishing the test reports on statutory samples of drugs may be prescribed, while simultaneous efforts should be made to strengthen the laboratories in terms of man power, equipments, reagents and other infrastructure to adhere to the said time lines.
To avoid unnecessary delays, the DTAB also recommended that in the case of the patent and proprietary medicines, the drug inspector, sending the sample should simultaneously obtain the method of analysis from the manufacturer or the licensing authority and forward to the Government analysis. The laboratory should arrange for reference standard, if required, in advanced so that the testing is not delayed and in the rare case where the government analyst is of the opinion that he will not be able to adhere the time limit, he may see extension of time limit for completing the test explaining the reasons for the delay.